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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

The protection of patients is being undermined by the European Medicines Agency’s (EMA) renewed reticence about releasing clinical data for independent review, according to an influential non-profit drug monitoring organization, which sees recent shifts to a more liberal approach falling victim to drug industry pressure.

Since it was set up in 1995, the EMA had come under attack from health campaigners, academics, and some prominent politicians over what they described as its excessive secrecy with the clinical trial data underlying the decisions the agency takes on drug approvals. A decade ago, when Guido Rasi took over as EMA director, significant relaxations and wider access were hailed as real progress, even by the—highly critical—EU Ombudsman. But the improvements are now being rowed back, says 

, the Paris-based publisher of independent drug reviews.

EMA’s transparency policy is “marred by too many failings,” it says in a lengthy analysis it published in May.

 It says secrecy has persisted and even become more pronounced in some areas, with new processes increasing response times with a queuing system, provision of documents staggered over months, and a delay to allow drug companies to institute legal proceedings when they disagree with the disclosure of their documents. Under the new processes, the identity of applicants for release of data can also now be disclosed to the pharmaceutical company that produced the document requested, 

 adds, suggesting that this risks undue pressure on its operations.

, when pharmaceutical companies have brought cases before the European courts to prevent EMA from releasing documents relating to marketing authorizations, EMA has refused to provide documents requested by 

, citing the existence of these legal proceedings as grounds for its refusal, “even when our requests were unrelated to the case.” The EMA’s intention in refusing to disclose these reports was to protect the commercial interests of the pharmaceutical companies that produced them, and to prevent the theoretical risk that a competitor could use the data as a basis for developing a similar drug. But the EU Ombudsman found the argument that disclosure of these clinical study reports could undermine the companies’ commercial interests to be unfounded, argues 

. The Ombudsman’s opinion led EMA to reform its transparency policy from 2011.

But EMA “struggled to meet its obligations on transparency,” and now the implementation of its policy of proactive disclosure appears to have stalled, too. The “major advance” achieved when EMA began spontaneously publishing large quantities of clinical data from marketing authorization applications in 2016 has been blunted by the opportunity given to companies to black out portions of these documents before their publication, including data from clinical study reports. On occasions, as much as 90% of the document has been so redacted. EMA has been particularly secretive toward 

, it alleges, systematically refusing to disclose major documents containing clinical data produced by pharma companies, as well major documents on adverse effects such as vital data in periodic safety update reports.

Hopes that EMA’s new transparency policy would provide wide access to clinical data from marketing authorizations proved over-optimistic, as disagreements between the agency and pharma companies over some or all of the reports disclosed have ended up before the European courts, and the disputes “have made EMA less transparent, at least in its dealings with 

’s case is built upon what it calls the right of European citizens to access clinical data related to marketing authorization applications. “This is a right that helps better protect patients,” it argues. The right of access to documents held by European institutions is a general principle in European Union law, it says. “Transparency is supposed to be the default position for European institutions, and non-disclosure of data the exception.” EMA is required to apply these principles, it insists.

The failings are of a scale that should justify an official inquiry to analyze the causes, according to 

, which expresses the hope that an inquiry would trigger renewed attention from the European Parliament and lead to appropriate remedies. What Prescrire wants to see is additional resources for EMA so it has no excuse for delays in meeting its transparency obligations. It also wants “strict oversight and close monitoring” of any redactions made to released documents. And it wants “fair consideration of applicants with no ties to industry, such as 

It blames the pervasive trend among drug regulatory agencies to withhold information on “a weak culture of transparency” and “fear of legal challenges by pharmaceutical companies.” The 2014 Clinical Trials Regulation, in force since the beginning of this year, included a number of advances in transparency, requiring EMA to publish clinical study reports once marketing authorization has been granted, via a publicly accessible database maintained and controlled by the agency. This went live in late January, “but we fear that the transparency requirements set out in this regulation will be undermined,” admits 

. The rules still allow pharma organizations to redact any data they consider commercially sensitive. “EMA must show that its policy is in line with the need to keep patients safe, rather than pretending to be transparent while allowing pharmaceutical companies to hide clinical data,” concludes 

https://english.prescrire.org/en/26A06BA9AEE5C0FDC137141EB68F92D2/Download.aspx

Articles

Just-released analysis by Prescrire contends that the agency “is backtracking on commitments to clinical data transparency.”

Report Admonishes EMA Efforts to Reform Trial Transparency 

AmerisourceBergen has launched Clinical Trial Navigator, a solution suite that assists with biopharmaceutical clinical trial recruitment specifically within community-based specialty practices. Leveraging AB’s research community AdvanceIQ Network, Clinical Trial Navigator unites oncology practices and their patients with trials through digital site selection, patient identification, and enrollment tools.

Read more about Clinical Trial Naivgator 

Clinical Trial Navigator matches biopharma companies with independently-owned specialty physician practices to increase recruitment.

AmerisourceBergen Launches Clinical Trial Navigator

Solutions Services Director, Remarque Systems

One of the widespread notions about decentralized clinical trials (DCTs) is that Big Pharma has an advantage because DCTs require more bandwidth and greater financial resources than “traditional” trials. That may discourage small-to-midsize biopharmaceutical and biotechnology innovators, but it's not true.

While small-to-midsize pharmaceutical and biotech companies may feel they lack the expertise to conduct DCTs, and that these trials are too expensive, DCTs can be easier to recruit for. DCTs can also deliver long-term cost savings that may offset any additional up-front investment.

DCT savings result from efficiencies realized through telemedicine's time-saving and burden-reducing conveniences, electronic consent (eConsent), electronic patient-reported outcomes (ePRO), electronic clinical outcome assessments, and use of wearable/sensor technologies. DCTs can also enable the recruitment of a broader base of patients, thereby shortening enrollment timelines. Such advantages can reduce trial durations by one to three months, yielding further savings.

DCTs have become a vital component of the current research landscape more than a whim. Although now fixed in the future of clinical development, DCTs are still referred to variously as “remote,” “virtual,” “site-less,” “direct-to-patient,” or “hub-and-spoke” trials. DCTs have become increasingly common in the wake of the COVID-19 pandemic and are expected to gain market share in the post-COVID era.

DCTs have achieved buzzword status in the industry, generating confusion over what they are. The Association of Clinical Research Organizations (ARCO) defines a DCT as a trial that "brings the trial to the patient by utilizing local healthcare providers, optimizing digital health technologies. Enabling the patient's voice to accelerate medical product development, speed delivery of therapies to patients, and create efficiencies across clinical research processes."

The focus on patient-centricity, with its advantages of convenience and flexibility, makes DCTs especially appealing to patients, contributing to high rates of participant satisfaction. DCTs are also increasingly attractive to small-to-mid-size biopharma and biotech companies, though the perceived challenges of conducting these trials may make some sponsors apprehensive. However, in our experience, those perceptions are often driven by common misconceptions about the DCT model.

One misperception is that DCTs are 100 percent remote. In actuality, DCTs more typically adopt a hybrid model representing varying degrees of decentralization, with some activities conducted on-site and others happening remotely. For example, after the initial visit to the principal investigator's site, the remaining visits may be conducted via telehealth. That can be a compelling inducement for patients to participate, particularly those living with rare diseases and who live hundreds of miles from a trial site.

DCTs also offer geographic and population flexibility, enabling recruitment across regions, ethnicities, and socio-economic groups, often leading to faster enrollment, fewer screening failures, and greater retention. Moreover, with fewer sites, DCTs come with fewer review boards, potentially lower regulatory costs, and potentially less-complicated protocol amendments.

Nevertheless, DCTs require extensive planning and steps to ensure patient safety, regulatory adherence, and clean, robust data production. Therefore, small-to-midsize companies entering the DCT space need to consider the factors cited in the following sections.

Trial design, budget, and vendor management

Regardless of company size, mastering trial design, budget, and vendor selection for DCTs is critical. To a great extent, these three factors are inter-related in that the first factor can influence the other two. Unlike in a traditional trial, in which investigators enter data from patients who visit the site, participants in a DCT may enter data themselves or use remote data-gathering devices. The DCT sponsor must therefore use trial design to determine how to integrate, manage, and analyze the data and which technologies and personnel to deploy for these tasks.

Managing vendors can be a considerable hurdle for small and midsize sponsors, particularly when integrating discrete data collection, analysis, and reporting methods. That's because collecting data across multiple third-party systems can make the process exceedingly complicated—

 expensive. Yet even as costs pile up for staffing, partnerships, shipping, call centers, and visiting nurses, small-to-midsize sponsors need to remember that DCTs can deliver cost savings and should account for those savings in their budget calculations.

Remote data collection in a DCT raises a number of questions regarding the format in which the data are collected and delivered and how to secure the data from the vendor. Partnering with a technology vendor that employs a "source-agnostic" data management system can answer those questions, making a DCT more cost-effective. Such a system can readily aggregate data from multiple data feeds, including the remote, wearable, and leave-behind technologies that can facilitate provision of eConsent, direct-to-patient supply of investigational product (IP), investigator-participant interactions, home health visits, collection of ePRO, and connectivity in general.

 Used with permission, ACRO DCT Data Flow Map

Working within a single operating system across many platforms can still seem challenging to small-to-mid-size innovators who lack the large staffing resources of Big Pharma. However, the solution isn't necessarily to hire a big CRO with a large staff and related bureaucracies. Instead, sponsors should identify a technology partner with a centralized operating platform that aggregates all the data and facilitates risk management, incorporating the kind of automation on which DCTs thrive.

Incomplete or less-than-robust data can doom even the best-designed trial. The risks of suboptimal data may feel heightened in a DCT, in which data are largely patient-reported or uploaded from a wearable or other remote device, raising concerns that patients may overlook their reporting requirements or that a technology glitch may create a device malfunction.

Anticipating and minimizing such risks is especially important for small-to-midsize sponsors. Unlike their large pharma competitors, they often rely on reaching key milestones to satisfy investors and maintain adequate funding for continued operations. A key risk-mitigation strategy is to use a platform with dashboards that can instantly identify patterns of missing or anomalous data. The ability to view reports and status on dashes that continually centralize, analyze, and track data and risks in real time can level the playing field. The sponsor's size and resources become far less of a factor in a DCT’s success. Therefore, small-to-midsize sponsors should perform due diligence to find a tech provider that can deliver a comprehensive data view in a consistent format regardless of source and across multiple platforms.

For sponsors, one of the most appealing features of DCTs is their use of high-touch technology to automate data collection, interpretation, and reporting processes. That is especially important for maintaining centralized safety and efficacy databases, which are essential for monitoring and assessing the status of a DCT. Bringing all the data into one central location helps the sponsor see the complete picture of a trial cost-effectively. Centralization also places the data within easy reach of investigators and other DCT stakeholders, particularly patients; accessibility is at the heart of DCTs' patient-centric promise and appeal.

One of the drawbacks of traditional clinical trials is that they employ time- and labor-intensive analytical processes to detect data inconsistencies or worrisome patterns. In a DCT, an integrated data management system alleviates that drawback by providing workflow oversight and insights. Today, machine-learning algorithms perform those processes in real time—with greater speed, accuracy, and consistency. Moreover, DCT sponsors can establish pre-determined alerts that signal data anomalies requiring a closer look. An integrated, algorithm-driven system can thus address potential risk factors by significantly strengthening data certainty.

For some sponsors and trial personnel, DCTs call for new and different skill sets than those required for traditional clinical trials; they also require the deployment and management of new technologies. Large pharma companies would seem to have the edge here in that they were already heavily investing in data management processes and systems well before the advent of DCTs.

In reality, small and midsize sponsors can seize a significant logistical advantage. Unburdened by established (and potentially outdated) data management processes and systems, these companies can adopt new source-agnostic systems, amalgamate best practices, and coordinate a roster of best-in-class vendors to optimize DCT results.

Moreover, the freedom to select and customize various technologies according to their individual needs allows small-to-midsize companies to minimize staffing requirements and streamline workflows while tracking safety, clinical, and operational risks in real time. Such benefits can also facilitate the protection of patient safety, regulatory compliance, and delivery of clean, conclusive data—thus assuaging any concerns about navigating the evolving DCT landscape.

, Solutions Services Director, Remarque Systems

QbD Manual for Decentralized Clinical Trials: The Quick Reference Guide. Association of Clinical Research Organizations (ARCO). 2021. Available at: 

ACRO Decentralized Clinical Trials Complete Map. ACRO Decentralized Clinical Trials Working Party, Association of Clinical Research Organizations (ACRO). 2021. Available at: 

DCTs can be a great tool for small-to-midsize pharma and biotech companies despite misconceptions of them being advantageous for only Big Pharma.

Unraveling DCT Misconceptions

Protocols are becoming more stringent and tougher to enroll, and the biopharmaceutical industry faces the need to expand its patient access and diversity globally. Additionally, with the backdrop of global instability, the industry is also shifting its global strategies to mitigate risks should instability continue to increase. In this interview, Melika Davis, SVP of Global Clinical Operations at BeiGene, will discuss her perspectives.

BeiGene has spoken about the need to expand the clinical trial ecosystem and bring more patients into that system. Can you explain what you and BeiGene are doing to add more trial sites to that ecosystem and why this is so important?

: Expanding the clinical trial ecosystem means more options for underserved patients. The major clinical trials have historically been run in the G7 countries—and ours have as well—but we also realized that we needed to expand our trials beyond our start. We recognized the opportunity at BeiGene to place clinical trials in China because a significant, underserved population was there. About a quarter of the world’s cancer cases are in China, but over the years, and specifically in the last four to five years, we have grown tremendously beyond China to serve additional populations—which is critically important for patients. We are now running multi-regional clinical trials around the world. Now we're looking at South Korea, Latin America, and beyond the main G7 countries in Europe. But we have to be careful—we're a small biotech. We're not a big pharma company. We're trying to be as strategic as possible in where we need to go. Our expansion plan is in its infancy, but we've made tremendous progress.

What are you doing to plan for global instability risks and wars?

: We quickly put a business continuity plan together because of COVID. When COVID first started occurring, we didn't know what to expect. I think we are well prepared to handle global instability—but wars are complicated. First and foremost, we are humanitarian. The first thing that I always think about is the patients. No matter who they are, they are global citizens. How do we make sure that they get their study drug? That is of the most importance. It's challenging to do this in a time of war, but we're working with and hearing what the regulators are saying and looking at NGOs and other organizations to assess their plans. We're also trying to build bonds with them to ensure that we don't disrupt the supply chain.

It isn't easy to do. We're open to different solutions and trying to be as creative as possible without violating any regulations or any sanctions that may be happening. We have to be mindful of that, too.

You've talked about expanding your study system geographically, and you've looked to expand your trials outside of the largest cancer sites. What are you and your team doing to bring the physician and patient communities together into your building ecosystem?

: We're approaching this on two fronts. One front is the data. We strongly believe that the data needs to be globally available. That is important because as we generate our data, we should share that data regularly and as soon as possible. We are following, of course, all of the practices and the ethics and compliance regulations, the data transparency and disclosure guidelines. But it's also essential to get this information out to the scientific community as quickly as possible. The sooner we share this information, the sooner the community can develop an evidence-based understanding of our treatments.

The other front is operations. From an operational perspective, we always look at how we can make sure that patients know that clinical trials are available to them. It's the same thing for the community physicians. Are they interested in participating in a clinical trial? If so, we would work with them and look to make this participation a lot less burdensome. We recently talked about potentially creating a forum of community physicians, nurses, those taking care of patients, patients themselves, and patient advocacy to speak to us about our clinical trials. How can we improve them? What are their thoughts? Really considering that in the future.

We're also looking at the technologies we can use to make patient participation easier, for example, electronic informed consent and wearables. Also, how can we ensure that patients can go to sites close to their community and do lab tests, for example? I think COVID has taught us that it can be done.

Decentralization is a topic on everyone's minds now, and everyone's talking about it at medical meetings. Do you think that decentralized clinical trial approaches are here to stay? Or do you think it's a fad?

: I think they are here to stay. It's been, what now? More than ten years that we've been talking about decentralized trials? I hope that they will continue because the future is utilizing technology as much as we can and being as transparent and collaborative as we can. I'm talking about biotech companies, pharma companies, research institutions, and regulators. If we want to beat cancer, that's what we should be doing.

What are your thoughts on the patient diversity movement?

: As part of our mission, patient diversity, equity and inclusion is key. We want to make sure that we have diverse patients with diverse backgrounds. The FDA's recent 2020 guidance was beneficial. We set up a task force and created a cross-functional BeiGene clinical trial diversity initiative. We set our objectives to build on the existing efforts that we had done. We've also established a BeiGene Clinical Trial Diversity Institute, which is geared towards training clinicians and making sure that we understand where underserved patients are and which support staff are helping these patients. We need to understand the landscape. We also have patient education and advocacy efforts.

I think it does not just work that we as an industry have to do, but also the research centers. We're looking at a lot of ideas. First, going into community centers will help. We can do some good work there to ensure a diverse population of patients and facilitate community-engaged clinical development. We are starting to implement these initiatives. I'll add that we are very particular when we do our study feasibility to understand where diverse patients are, and then make sure we include community centers into our line of sight.

Hopefully, all of that and the other actions we are taking should help us have a more representative patient population in clinical trials.

Excellent. Why is BeiGene predominately CRO-free? Since you're expanding into different regions of the world and need to build clinical trial infrastructures, how is BeiGene establishing these infrastructures in other countries, and why not use CROs? Why have you vertically integrated all your operations internally?

: I like how you say it. It is vertically integrated. Although it's vertical, it's also horizontal...we built an internal capability in our clinical development team, specifically in clinical operations. We believe that by having an internal team, we will allow for more flexibility, which will allow for faster decision making and better clinical site relationships, which I think is important. In addition, by doing all of this, we will be more cost-efficient. Before 2018, 100% of our trials were handled through CROs. Looking at our portfolio today, more than 90% of our trials are handled internally.

In four years, we are seeing that we're able to start our clinical trials a lot faster. We joke with our team that the speed at which we go is fast, and what takes weeks or takes months for a CRO to do with starting trials, it takes us days or weeks to get it done. That disrupts the standards by creating new ones, which we're very proud of. It speaks towards the relationship that we have with our clinical sites. I think that's incredibly important. You cannot do that through third parties. You have to do it in-house.

Melika Davis, SVP of Global Clinical Operations at BeiGene, discusses her perspectives on patient access, diversity, and risk mitigation.

A Changing World Demands Changing Biopharmaceutical Strategies

Clario announced an expansion of its partnership with cognitive science company, Cogstate, to jointly provide data quality solutions to support the unique requirements of neuroscience assessments for therapeutic development.

Collaboration combines Clario's eCOA innovations with Cogstate's experience in neuroscience research to yield high quality endpoints.

Clario and Cogstate Expand Partnership

Headlands Research announced a partnership with Pfizer Inc. to launch new research sites in areas with highly diverse populations. The partnership’s first site will be located at a new Headlands facility in Brownsville, Texas.

Partnership will launch new research sites in areas with highly diverse populations.

Headlands Research and Pfizer Announce Partnership

SCRS Global Oncology Site Solutions Summit — 1/28-1/29

The SCRS Global Oncology Site Solutions Summit is the place for research sites, sponsors, CROs, and solution providers to come together to learn, communicate and collaborate in ways that will propel cancer research to new levels. Attendees can expect insightful and data-driven content, thought-provoking breakout sessions, and engaging networking opportunities that proactively address increasingly complex challenges within oncology clinical research. Be a part of the collaborative forum for oncology research stakeholders to discuss site sustainability and improve patient access to trials.

Events

SCRS Global Oncology Site Solutions Summit — 5/21-5/22

The war in Ukraine continues to threaten the safety of clinical trial patients and healthcare providers, with serious consequences on the health and wellbeing of people and families. On International Clinical Trials Day, we talk about the impact on both people and scientific progress with Lionel Bascles, Global Head of Clinical Sciences and Operations, and Megan Heath, CSU Region Head and global clinical task force lead at Sanofi.

How does the war in Ukraine affect research into new medicines?

: War affects every aspect of a person’s life. That includes healthcare. Can you imagine what it’s like to need care, to depend on continued treatment during an armed conflict? It also includes things like participating in a clinical trial. And it adds up: every person who participates in a clinical trial contributes to scientific progress, whether they’re a patient or healthcare provider, someone who provides support in the clinic, or one of the many, many people who keep the supply of medicines moving. If you lose any one of them, the effects can be far-reaching, maybe more than you realize. It can’t be said enough: without the people who participate in clinical trials, without volunteers and clinicians, there simply would be no new medicines. No new vaccines.

This crisis has made us redouble our efforts: it’s our duty to be there for those working at our clinical sites and the patients they care for. We must do whatever it takes to mitigate the effects of disruption, because it is unacceptable for our patients, and for science, to become just so much collateral damage.

Moving hospital equipment and furniture underground in Ukraine, March 2022. Photo courtesy of Roman Fishchuk.

 How have your teams been adapting to keep clinical trials going?

: So, I am part of a task force that works closely with the local Ukraine team, who have been incredibly resourceful and adaptive. From the start of the conflict, our teams have been working closely with people who have a vast store of on-the-ground knowledge. As you might imagine, each of them is adapting continually to a changing situation. Quite often, they’re going to extraordinary lengths to help patients and investigators. They’ve been coming together to solve problems like getting medicines across borders and through cities, or getting supplies to study sites, or helping migrating patients stay on their protocols, and keeping investigators connected to their patients.

: Megan’s task force has been working night and day to coordinate and provide support, because if any one of those steps fails, the patient’s own health may be impacted. I am convinced that all our efforts are a source of hope. Personally, I would never want to lose the trust of anyone involved in our trials.

 What makes it so challenging? Can’t a lot of clinical trials happen remotely, with telemedicine?

: We learned some valuable lessons in the early days of the pandemic about being flexible and pivoting quickly. We’re laser focused on keeping all our patients in their studies and to give them some continuity, and we know that demands a lot of flexibility, ingenuity, and patience.

The Ukrainian authorities also built on lessons learned in 2020: very soon after war broke out on February 24th, they issued guidance to help maintain clinical trials. But the disruption is unpredictable. We need to constantly secure new routes, new carriers, new approaches to supply sites, new ways to ensure patients can access their treatments. Our studies rely on consistent, periodic assessments that need to be performed in hospitals – but those hospitals are in cities that have become fully militarized, where doing things like running a routine MRI are out of the question.

 How have you been able to mobilize to keep up with things like displacement, patients migrating, supplies not being available?

: When the situation started to escalate, our Global Security team worked with us locally to prepare for military impacts, including migration. Millions of people in Ukraine have been displaced, including our patients—people who have volunteered to participate in a clinical trial at one of over 100 sites.

Since then, we’ve been working with people who bring a lot of different specialties to the table, all trying to figure out what our patients and investigators need from one day to the next, and how we can support them.

 Can you give me an example of how you have helped a patient?

: One thing that stands out to me is the first of our patients who migrated out of Ukraine to an EU country. As a sponsor, we never know who exactly the patients are, but we need to make things happen for them. With migration, there are so many questions to sort out. The study was not running in the sanctuary country and hadn’t been approved by the health authorities there—could we talk with them? There was no supervising doctor to administer treatment and do assessments—could we find someone qualified? The assessment required special equipment—could we find it? The patient had built a strong relationship with their investigator in Ukraine—could we help the two doctors communicate?

: As Lionel said, we’d been tested by the pandemic, so we knew we could do it. Our mindset is to focus completely on the task at hand—just fix the problem in front of us, right now–and adapt to change as the constant. Importantly, our legal, medical, insurance, supplies and clinical teams were prepared to swing into action to make the right connections.

And the solidarity around Ukraine helped. The health authorities understood they needed to act quickly and worked closely with our regulatory team to find solutions. It’s thanks to their guidance and approval that the patient is still on their trial. Other countries have followed suit, keeping patients treated, protocols observed, and science moving forward whenever possible.

 Are things working out like this for other patients who have been displaced?

: It’s not always possible to keep patients on their trial, to keep doctors connected. But we’re doing everything we can to facilitate that. In Ukraine, where many patients have migrated within the country, the partnership of local teams has been humbling.

Roman Fishchuk, Olesya Gerych, and Kuziuk Mykhailo, colleagues working on clinical trials in Ukraine. Photo taken at the Central Municipal Hospital #1 in Ivano-Frankivsk, March 2022. Photo courtesy ofIvanna Kirieieva.

: Well, for example, our warehouse staff worked night and day to move medicines from a high-risk warehouse into a safer place while still maintaining the cold chain. Our distributors have been working closely with us so we can get drugs from Montpellier, France to Ukraine when air transport isn’t possible and roads and couriers are blocked. And when it became too dangerous or impossible to supply study drug kits to some locations, we successfully explored how to extend their shelf-life.

Behind the scenes, at all hours of the day, a lot of people have been working together to make things happen. That’s supply chain innovation.

Communication is a big challenge—what kind of support are you providing?

: We are there for patients, to treat them wherever they are, wherever they’re from, however we can. I’m proud of how quickly our medical information teams set up a global hotline run by a Ukrainian-speaking team. They learned how to manage calls from Ukraine study participants and investigators as they move, and how to coordinate activities with service providers in many different countries. Patients anywhere in the world can reach out and get a response from medical professionals—and it makes a difference.

 What are you taking away from this experience?

: Every day, we strive to bring science to the patient—and I think that has happened. For these patients, clinical research was part of their healthcare journey. It wasn’t something extra—they saw this as their miracle. That has made a deep impression on everyone, I think, and really solidified our commitment.

: We are not the only company whose development of new medicines and vaccines will be impacted by this conflict. Like many others, we will see delays in scientific advancement that reverberate throughout society. On International Clinical Trials Day, I’d like to recognize the dedication and resilience of those who contribute to science in the face of adversity and, on behalf of everyone in our team, express our deepest hope for a return to peace.

Lionel Bascles, Global Head of Clinical Sciences and Operations, and Megan Heath, CSU Region Head and global clinical task force lead at Sanofi discuss, the impact of the war on patients and scientific progress.

A Hidden Cost of War in Ukraine: Clinical Trials and New Medicines

Vice President, Vault CDMS, Veeva Systems

Each year, the global health community celebrates International Clinical Trials Day on May 20, the anniversary of James Lind’s famous scurvy experiment in 1747 on H.M.S.

. Lind’s discovery—that sufferers of the disease recovered faster if they included citrus fruits in their diet–is considered one of the earliest examples of a successful controlled clinical trial.

Today’s clinical studies benefit from access to advanced technology, vast volumes of data, and expertise that spans therapy areas and regions. Yet, the overall objective is consistent with Lind’s study 275 years ago: getting innovative, tested, and safe treatments to those who need them most.

Given the scale of the ambition, it’s easy to overlook just how quickly change is happening in the clinical research sector. The advent of paperless trials is a good example. The first study to be conducted using electronic data capture (EDC) took place in the 1970s; by 2012, clinical trials had come to rely on EDC, and paper-based trials had gone from default to exception. Moving to EDC has significantly improved the oversight and accuracy of clinical data management. Here are a few other areas where advancements are simplifying studies and shaping the future of clinical trials.

An industry united to accelerate innovation

The unprecedented speed of the COVID-19 vaccine trials has also reset expectations of study lifecycles. It took just 11 months for the first vaccines to be granted emergency authorization, beating the previous record from 1967, when the mumps vaccine was developed within four years.

Outside of COVID research, other concepts such as platform, bucket, and umbrella studies continue to drive new collaborations across our industry, including with regulators. The shared goal is to reduce the time and cost of providing life-saving treatments to patients. One great example is the 

 attempting to re-engineer Phase II breast cancer trials by aligning personalized medicine with adaptive trials.

Another area of significant progress is in executing digital trials where in just ten years, technology has made studies more patient-centric. 

The first, widely discussed virtual trial took place in 2011

, allowing volunteers to participate regardless of their proximity to sites. This has evolved to enable decentralized trials, helping patients gain access to treatments and making it easier to participate in a study while allowing study teams to capture data remotely.

Looking ahead, we hope to see an ambitious standard adopted industry-wide for decentralized trials in the coming years. Our aspiration is to execute trials according to the patient’s wishes, from one day to the next. Data collection will become distributed, but trial data will continue to be aggregated and harmonized on a central platform for effective oversight and management.

For patients, studies should start to feel like part of everyday life so that data is collected and shared seamlessly from wearables or patient-facing applications. To make this a reality, the seamless integration of technology is becoming a priority across the industry. The FDA made progress in this area in 2018 when it 

, allowing patient data to be linked to traditional clinical trials, real-world studies, observation studies, and registries.

The COVID-era further underscored that patients need ways to contribute clinical trial data quickly, and the industry needs to streamline processes for accelerated drug development. We will soon see the focus for sponsors and CROs shift from integrating technology to empowering patients to easily share outcomes during a study without navigating through a myriad of applications and site portals.

Laying the foundation for the future of connected digital trials

There are many reasons to be optimistic about the next era of clinical trials and the milestones we will achieve in the years ahead. Now is the time to lay the 

 for complete and concurrent trial data to speed innovations. As clinical trials evolve and become more complex and dynamic, they will require flexible protocol design, modern data management, and patient-centric technologies that can support decisions in close to real-time.

Despite Lind’s discovery, it took 42 years for the Admiralty to make lemon juice compulsory on ships. The industry is now making progress much faster, supported by technology. Companies are committing to a digital trials future for seamless information sharing across sponsors, CROs, research sites, and patients. This accelerates trial execution, improves information sharing, and speeds the delivery of innovative medicines and treatments to patients in need.

We’ve seen what a united industry can do to accelerate new treatments in the face of great obstacles. With digital solutions, patients can be assured of trials that deliver safe medicines to improve health outcomes at a pace we could not have imagined in past decades.

, vice president, Vault CDMS, Veeva Systems

From the first trial on H.M.S. Salisbury to advancing towards a digital trials future.

Clinical Trials Day: Celebrating 275 Years Since the First Controlled Trial

Senior Vice President and General Manager, CVS Clinical Trial Services™

May 20 is celebrated internationally as Clinical Trials Day, an effort led by the Association of Clinical Research Professionals (“ACRP”) to recognize and honor the dedication of clinical research professionals and the important role they play in conducting clinical research to help improve public health.

 This is something near and dear to the hearts of everyone working at CVS Health’s Clinical Trial Services, which officially launched on this day one year ago.

While clinical research has always been critical to the development and acceptance of innovative medicines, devices and techniques, the national spotlight has never been as focused on clinical trials as it was during the COVID-19 pandemic. Life-saving trials for the now-approved vaccines played out before a national audience, and CVS Health was instrumental in this effort, as more than 300,000 volunteers opted to hear more about these trials from us. The company formally launched Clinical Trial Services (CTS) on this day in 2021 to advance a human-centric, community-based model for clinical trials.

One year later, CTS hopes to become the industry’s largest, fully integrated, community-based clinical research solution. While CVS Health has long recognized that clinical trials are paramount to public health, we are steadfast in our commitment to addressing longstanding issues with recruitment, diversity, and access to clinical trials.

CVS Health’s community-based model for clinical research

Research has shown that inconvenient trial sites and complex recruitment and enrollment requirements can drive low engagement. For patients, our community-based model seeks to break down these barriers by allowing many to participate in their homes, virtually, or at our expanding network of community sites. It allows research to be integrated into their daily lives and as an extension of their healthcare journey.

As 85% of the US population lives within a 10-mile radius of a CVS Pharmacy location, we are enthusiastic about the ability to deliver this value proposition for patients and sponsors across the United States, and across therapeutic areas that include vaccines, cardiovascular studies, immunology, dermatology, and oncology.

The model is powered by our clinical staff of affiliated principal investigators, health care providers, and clinical research coordinators. Their passion for delivering human-centric clinical research fuels our work and culture. For example, Nurse Practitioner Nicole Pickett in Newnan, Georgia, recently shared that she joined the CVS Health Clinical Trial Services team to help lay the foundations of this new endeavor and is excited about contributing to the future of medicine itself. CVS Health is proud to employ a diverse workforce, aiming to build trust in local communities by ensuring that team member demographics are representative of that communities in which we operate.

Since its inception, CVS Clinical Trial Services has engaged more than 18 million eligible trial participants and enrolled thousands into 33 trials across vaccines, respiratory, cardiovascular, and neurology, working collaboratively with many of the top 20 biopharma sponsors and the National Institutes of Health (NIH). We use predictive algorithms to identify ideal candidates for clinical trials, building upon our trusted relationship with over 100 million members, patients, and consumers. For example, drawing on these patient relationships, we successfully enrolled over 1,000 patients nationally into respiratory syncytial virus vaccine studies. We are also using this technology to ensure the inclusion of traditionally underrepresented groups in our trials.

Clinical trials are a vital tool to advance novel therapeutic options, but only if they are conducted effectively. CTS can deliver on the promise of clinical research by advancing a human-centric, community-oriented model that can overcome longstanding issues in clinical trial recruitment and diversity. One year into this journey, we have made great progress in developing the structure needed to support this model. We are more excited about the future of CTS and clinical trials than ever before. Today, on Clinical Trials Day, we give thanks to everyone who has worked hard to make this possible, and especially our clinical trials professionals.

, Senior Vice President and General Manager, CVS Clinical Trial Services

Tony Clapsis, SVP and General Manager, CVS Clinical Trial Services, reflects on industry’s progress.

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