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Applied Clinical Trials May 2022

ACT's biennial Salary Survey takes a look at the future of industry following increased adaptation of decentralized technology 

Salary Survey: The Age of COVID

Emerging tools in data analytics, automation, EMR aggregation, and even social media are enabling faster and easier patient recruitment

Patient Recruitment Goes High-Tech

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.

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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.

Articles

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.

Connection to Communities is Key to Boosting Clinical Trial Engagement

Women in drug development continue to be underrepresented in leadership roles. Although various reasons have been given for this disparity, one possible explanation concerns gender-based microaggressions experienced by women in the workplace. To investigate this proposed cause of gender disparities in the drug development workforce, Tufts Center for the Study of Drug Development conducted 26 interviews among a diverse group of women professionals in drug development. These interviews focused on participants’ experience with microaggressions in the workplace and the effect of these microaggressions on teamwork and communication. The research team found that gender-based microaggressions in the drug development workplace can negatively impact collaboration among teams and can affect retention of women employees.

Drug development is among the many areas within Science, Technology, Engineering, and Math (STEM) where women professionals continue to be underrepresented. Although the gender diversity in the drug development industry has improved over the years, women, and particularly women of color, are still noticeably underrepresented in leadership roles. Only 30% of all C-suite positions are filled by women, with a mere 4% of this group representing women of color (Berlin et al., 2019; Sandle, 2021). There have been many reasons put forth to explain this gap, including perceived role incongruity between women and male-typed jobs (Eagly & Karau, 2002), overt discrimination (McCord et al., 2017), and deeply entrenched systemic barriers (Hall et al., 2018). Another contributing factor to this gap are gender microaggressions, defined as subtle behaviors and comments that most often unintentionally demean or denigrate individuals based on their gender (Capodilupo et al., 2010). Though subtle, microaggressions are ubiquitous, occurring daily in the lives of women in the workplace. Though some argue that microaggressions are harmless, amounting to nothing more than minor insults (Lilienfeld, 2017), the emerging research on workplace gender microaggressions has demonstrated their deleterious effects on both cognitive and affective outcomes on women professionals (Kim & Meister, 2021; Meister et al., 2017).

Naturally, we wondered how gender microaggressions might manifest in drug development and what impact they might have on women professionals navigating this industry. To shed light on this topic, Tufts Center for the Study of Drug Development recently conducted a qualitative study to examine how gender microaggressions manifest among different work teams in drug development. We interviewed a total of 26 women across different areas, including sponsor organizations, contract research organizations (CROs), vendors, and academic research centers, representing a variety of different functions, levels, and work experience. Importantly, our sample was also racially diverse: 50% were women of color representing Asian, Black, Latina and multi-racial women, allowing us to capture nuanced ways gender microaggressions manifest for women of color.

Of the different types of microaggressions that we uncovered, devaluation emerged as a common form of slight that women encountered on a regular basis. Devaluation describes behaviors or comments that put down or diminish a woman’s input or contribution, the most common example being interrupting women while they speak or misattributing their work to a male colleague. These experiences were shared unanimously across the diverse sample of women we interviewed.

Our study’s racially diverse sample provided important nuance to how gender microaggressions manifest for women of color. Women of color not only had to contend with the usual forms of gender microaggressions, such as devaluation and misattribution of work, but also had to navigate an added layer of microaggressions that intersected their gender and racial identities. These included unsolicited comments that otherized different aspects of their racial and ethnic identity (i.e., colleagues repeatedly mispronouncing their names; being mistaken for another woman of color). Important distinctions also emerged within our racially diverse sample. Black women, in particular, shared how they felt otherized by belabored comments from colleagues about their hair that made them feel uncomfortably spotlighted. Assumptions of incompetence and lack of intelligence for Black and Latina women also emerged. Conversely, Asian women were assumed to be overly competent, which was often accompanied by the assumption that they do not need resources or help or that they are naturally experts in data analysis even if they were not.

The potential impact of gender microaggressions on team productivity

Regularly experiencing these types of slights were linked with cognitive depletion, emotional exhaustion, and behavioral changes, including overcompensation as well as withdrawal. Importantly, constantly navigating these dynamics was also associated with lowered productivity and team performance, stemming largely from lowered trust towards and a tendency to limit one’s interactions with the aggressor. Naturally, this can pose a challenge to team productivity and effectiveness, which we detail below.

Lowered trust towards one’s colleague can lead to decreased information sharing and communication, which are hallmarks of effective teams (De Jong et al., 2016). This is particularly worrisome within the context of drug development given the collaborative nature of many cross-functional teams whose success depends on effective communication and idea sharing.

Moreover, several of the behaviors that women encountered, such as interruptions or misattribution of their work were directly linked to lowered productivity. In one example, a project manager (PM) described a situation in which the Principal Investigator (PI) would constantly email her male colleague about her project. Repeated incidents such as this created redundancy and delays in the project, all of which could have been avoided had the PI reached out to the correct PM, in this case, the woman.

Such interactions that we have described so far may seem minor at first blush. However, when experienced on a regular basis at work among one’s colleagues, the psychological and emotional toll can be taxing. In fact, the growing research on workplace microaggressions has linked these interactions to emotional and cognitive exhaustion as women manage their emotions while they decipher the meaning and intent behind many of these often-unintentional slights that are committed unbeknownst by the aggressor (Holder et al., 2015; Kim & Meister, 2021). Though unintentional, these micro interactions have the potential to have macro effects if left unchecked. In fact, many of the women in our sample talked about their intent to leave the organization, and many of them had, at the time of the interview, recently left what they viewed as toxic and exclusionary teams and organizations. Losing talent is the ultimate cost to teams and organizations as it can result in a “brain drain” of diverse, high potential talent (Wernick et al., 2016).

What then can organizations do to address these all-too-common forms of team dynamics? The solution is creating an inclusive organizational culture where individuals, regardless of their background, feel welcomed and have the potential to develop and grow. However, creating such an environment is easier said than done. While many organizations have heeded the calls for more inclusive workplaces by organizing Diversity, Equity, and Inclusion (DEI) panels, talks, and workshops, etc. such efforts will fall short if they are not accompanied by an intentional and systematic way of benchmarking progress. After all, how does one know there is a problem when one does not measure it? How does one know there is improvement if there are no metrics to track over time? While tracking personnel data, such as turnover statistics, is vital, such statistics would be well paired with antecedent indicators that can help predict and prevent the loss of diverse talent.

We propose measuring the occurrence of these dynamics within organizations and teams to identify areas that need resources related to training and dialoguing. We believe that microaggressions are best addressed through conversation and perspective-taking. The ability to measure and track these dynamics can serve organizations well as they can “get ahead of the problem.”

Cross collaboration is increasingly necessary for producing high quality science (Reardon, 2022). Microaggressions, however, can hinder team effectiveness by stifling communication, trust, and cohesion among teams. Further, these dynamics can signal exclusion, ultimately contributing qualified women to leave such organizations or quit the industry altogether in search of more inclusive environments. Thus, the ability to identify, measure, and benchmark these dynamics can help organizations take a more proactive approach to ensure that they are creating an inclusive environment where all individuals, regardless of their social identity, can thrive.

Corresponding Author, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 145 Harrison Avenue, Boston, MA 02111. 

Berlin, G., Darino, L., Greenfield, M., & Starikova, I. (2019). 

Capodilupo, C. M., Nadal, K. L., Corman, L., Hamit, S., Lyons, O. B., & Weinberg, A. (2010). The manifestation of gender microaggression. In D. W. Sue (Ed.), 

Microaggressions and Marginality: Manifestation, Dynamics, and Impact

De Jong, B. A., Dirks, K. T., & Gillespie, N. (2016). Trust and team performance: A meta-analysis of main effects, moderators, and covariates. 

Eagly, A. H., & Karau, S. J. (2002). Role congruity theory of prejudice toward female leaders. 

Hall, W. M., Schmader, T., Aday, A., Inness, M., & Croft, E. (2018). Climate control: The relationship between social identity threat and cues to an identity-safe culture. 

Journal of Personality and Social Psychology

Holder, A. M. B., Jackson, M. A., & Ponterotto, J. G. (2015). Racial microaggression experiences and coping strategies of black women in corporate leadership. 

Kim, J. Y., & Meister, A. L. (2021). Disrupting the effects of gender microaggressions for women leaders: Allies as triggers of redemptive sense-making. 

Lilienfeld, S. O. (2017). Microaggressions: Strong Claims, Inadequate Evidence. 

McCord, M. A., Joseph, D. L., Dhanani, L. Y., & Beus, J. M. (2017). A meta-analysis of sex and race differences in perceived workplace mistreatment. 

Meister, A., Sinclair, A., & Jehn, K. A. (2017). Identities under scrutiny: How women leaders navigate feeling misidentified at work. 

Reardon, S. (2022). Scientific collaborations are precarious territory for women. 

Sandle, T. (2021). Getting there: Strategies to improve gender equality in pharmaceuticals and healthcare. 

Wernick, B., Wojda, T., Wallner, A., Yanagawa, F., Firstenberg, M., Papadimos, T., & Stawicki, S. (2016). Brain drain in academic medicine: Dealing with personnel departures and loss of talent. 

International Journal of Academic Medicine

26 interviews conducted by Tufts CSDD found that gender-based microaggressions can negatively impact collaboration and affect retention of women employees.

The Impact of Gender Microaggressions on Team Performance in Drug Development

The HIV Vaccine Trials Network, funded by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH, today launched a new HIV awareness campaign and the Red Ribbon Registry with the goal of helping end HIV. Built by Oracle, the cloud-based registry makes it easy for anyone to volunteer to be considered for an HIV clinical study—getting us one step closer to a cure. 

To learn more or volunteer for an HIV clinical study visit 

Oracle extends technology first built to fight COVID-19 to accelerate efforts to get a safe and effective HIV vaccine to market.

Oracle and NIH Networks Collaborate to Help End HIV

Suvoda LLC announced the broad availability of eConsent as part of its unified platform, providing a solution that gives clinical trial teams more electronic control over the consent process. This offering will enable remote monitoring and the ability to track consents, screening, and randomization data in one place.

New eConsent moves from early adopter to general availability, unifying with IRT technology.

Suvoda Launches eConsent

With the ever-growing trend in pharma to outsource clinical research to CROs, optimizing this partnership becomes essential for maximizing its benefits. Successful interaction among all the members of such a collaboration is key to accomplishing mutual goals. But every interaction requires skills in communication and relationship management to create a shared vision of strategic partnering and trust. Each stage of the process has its own benefits and risks, and each pain point while collaborating refers to a specific problem that relevant parties are facing.

Inefficient interaction between sponsors and CROs can hold back the quality of clinical trial data and compromise research outcome. To further analyze the specifics of the CRO-Sponsor communication, OCT Clinical, a European CRO, launched a survey among industry professionals involved in clinical trials across the US and Europe to get first-hand data from the immediate participants of such partnerships.

The survey was fielded among OCT Clinical’s customer and partner databases of over 8,000 contacts. Email invitations were sent out to fill out the survey in Microsoft Forms. As a note of appreciation, the respondents were offered Starbucks gift vouchers. The survey was split into two main categories according to the types of respondents. CROs and pharmaceutical/biotech companies. Overall, 320 respondents across both areas provided thorough replies which were further analyzed to get presented in this article. The aim of the research was to explore the CRO-Sponsor collaboration scenarios and to identify key challenges, weak points, and best practices for each group.

Such surveys are aimed at creating a “win-win” approach for both parties. Sponsors would benefit from more robust and feasible plans, procedural efficiency, and decreased costs, while CROs would get an increasingly reliable and longer-term revenue stream by providing additional value and expanding its service offerings.

The role of CROs is becoming increasingly significant in treatment development as they become more involved in clinical research and are seen more as strategic partners, providing access not only to specialized expertise, but also to patients around the world. According to the aforementioned survey, 81% of respondents indicated CRO-sponsor relationships as 'Very Important' or 'Important' in pharmaceutical research. From the table below we can see that almost 87 % of respondents among Sponsors believe that “meeting project timelines on time” is the number one criteria for evaluating CRO performance.

In addition, “Recruitment fails”, “not delivering according to plan” and “inefficient communication” were mentioned as the most common barriers to successful collaboration between CROs and pharma companies.

Almost 45% of the respondents graded their experience with their current CRO as moderately or completely unsatisfactory. It is worth mentioning however that, there is no apparent difference between working with a global or local CRO, since 60% of those not completely satisfied with their current partnerships work with global CROs.

Hence, one of the most critical insights is that collaboration with global industry players is not a panacea.

In response to the question: “What are the most frustrating/challenging issues when working with a clinical CRO?”, which had the option of an expanded answer, the following statement/points headed the list: quality issues (lack of understanding of therapeutic areas), recruitment issues (finding qualified sites, poor site selection) and communication issues. Illustrative examples are outlined below by expanded answers from Sponsors:

“Staff retention, particularly key employee turnover. Lack of relevant manpower in the company. They don't give their staff time to properly read and truly understand the trials.”

“Non-transparent budget. Unclear overshoot.”

“CROs don’t like to problem-solve and offer suggestions. They’d rather just do as they are told.”

“Lack of attention and lack of proactive thinking. Resulting in unfulfilled promises."

“Holding them accountable for the feasibility is an issue. Feeling disconnected from the sites.”

“Staff turnover, incomplete information.”

This points to the fact that better engagement and strong relationships come from transparency and trust. Once a vision with values and objectives has been established, additional aspects of the partnership and operating strategy can be defined so that both parties build trust through a combination of integrated goals, structure, resources, processes, technology, and metrics.

A separate section of the survey was devoted to the study startup challenges from the perspective of Sponsors. The most common issues here were the following:

The inaccuracies which can occur in CRO-pharma communication can go both ways. While each clinical research project is unique, CRO representatives who have also been surveyed for this article mentioned certain common challenges which originate at the Sponsors’ end. Among the top frequent concerns that the CRO representatives mentioned were: quality issues such as lack of accuracy in study designs and protocols (57% of respondents), lack of understanding of the specifics within certain therapeutic areas and indications (34%) and communication issues such as insufficient or untimely responses (23%).

Incomplete information provided by sponsors is a big barrier to successful collaboration between CROs and pharma.The challenge increases significantly when a sponsor contracts several CROs for a single project.

“A lack of adequate time for the RFP process.”

“Not enough planning, risk management, informative reporting, effective communication and governance structure.”

“One sponsor that I work with is new to fully outsourced trials, so at the beginning of our working relationship they micromanaged us.”

“Insufficient planning and risk management, inefficient communication and management structure.”

“Different understanding of process management, different expectations for interaction processes.”

“Sponsors do not give us responsibility for the decisions we should take. This delays our results, which sponsors will hold us accountable for in the end.”

Uncertainty about responsibilities and decision authority causes major barriers to maximizing potential benefits. The following conclusions can be drawn from the analysis of this survey:

Make sure your team can effectively handle situations like differences in expectations, and understanding of responsibilities. Start with the simplest: calendar meetings—will they be weekly or monthly? Decide and plan your roadmap and get all activities on everyone's calendar. Being proactive in communication can not only improve partnerships and your client commitment but also avoid delays in responses, which can result in delays in the whole clinical research process. Today it is more important than ever to maintain lines of communication, and occasional videoconferencing is a great facilitator in times of limited travel. According to the survey, 58% respondents use applications such as Zoom, Skype, or Teams on a regular basis.

Make a point of “whose SOPs to follow” clear from the start. If a sponsor fully outsources a set of activities to a CRO, CRO’s SOPs could be used as primary ones. In this case, there will be no need to organize additional training for CRO’s team.

Prioritizing opportunities and creating a common vision and goals for the partnership form part of the next important stage in negotiations. Sponsors and their CRO partners can determine the type of relationship they want to establish for both near-term and longer-term objectives. CROs, for their part, require skills in communication and relationship management to create a shared vision of partnering and trust.

Remember to be a partner, not just a vendor, as a clinical trial process is a mutual well-defined commitment to a collaboration. From the very beginning, this is your chance to contribute to a mutually beneficial long-term relationship. Understanding the points discussed above can help prevent barriers from happening.

Considering the above-mentioned points will help create a “win-win” situation for both parties, with a mix of both tactical and strategic elements. The sponsor would benefit from more robust and feasible plans, process efficiencies and decreased costs, and the CRO partner would get to work on new exciting projects and secure great partnerships, by providing additional value and expanding its service offerings.

Survey taken by CROs and pharma/biotech companies seeks answers in maximizing partnership.

What Stands in the Way of an Efficient CRO-Pharma Collaboration?

The HIV Vaccine Trials Network (HVTN) is launching a new HIV awareness campaign and unveiling a national registry that will provide updated HIV information and make it easier to learn about and participate in HIV clinical trials.

Campaign to include creation of registry with updated HIV information.

 HIV Vaccine Trials Network Launches New Awareness Campaign

M3 Wake Research announces the acquisition of Multi-specialty Research Associates (MSRA) in Lake City, Florida. This acquisition expands Wake Research's coverage of clinical research populations in the United States and encompasses communities at 23 locations across eight states.

Addition of clinical research site expands operations into Florida.

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