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Applied Clinical Trials December 2021

Proactive, pervasive, and strategic planning lead industry into future.

Biopharma-Academic Collaborations in 2021

At the onset of the pandemic, the industry had to adapt quickly to keep trials afloat. This forced change helped researchers understand when and how to implement alternative approaches to improve clinical research. Methods and technology that were being explored pre-pandemic–from remote monitoring to video visits to phone visits, eConsent and EHR–have come front and center during the past 18 months and will remain for the foreseeable future.

Now, as we head into 2022 the big question remains: Is our industry ready to sustain this pace of change?

According to recent research from Oracle and Informa

, the answer is yes. Our study found that 97% of organizations who implemented changes to their clinical trials approach during the pandemic indicated their organization would continue using at least one of these new methods. Remote monitoring, video visits, EHR, and phone visits were the approaches most likely to continue.

Here are three more predictions for the life sciences industry as we enter 2022.

Confidence in the data generated from newly adopted clinical trial approaches will continue to grow

With the introduction of new approaches and technology in clinical trials–especially those related to remote data collection from patients–comes an increase in data volume and variety. More importantly, the data is only as a good as the confidence that people have in it.

Oracle and Informa’s recent study found that 92% of respondents who implemented new clinical trial methods during the pandemic are equally or more confident in the data collected from these methods, compared to data collected via pre-pandemic methods. This confidence will continue to build as comfort with, and expansion of, newly adopted technologies and approaches expand.

 on decentralized trials, nearly half of respondents said that data reliability and quality (50%) and data collection (45%) were key concerns in adopting decentralized clinical trials. This significant increase in confidence in the past year supports the industry’s continued progress towards more decentralized models.

Community sites will provide opportunities for expanded patient recruitment

In order to attract new trial participants, it is critical for pharmaceutical companies to make it easier for patients to access trial locations that are convenient for them. Our study found 61% of respondents believe allowing patients’ choices will have a positive impact on clinical research and well over half (58%) said that their organizations plan to give patients the option to choose how they participate in clinical trials moving forward.

To this end, retailers like CVS and Walgreens for example, could become more popular as trial locations. By collaborating with these locations, sponsors will have expanded opportunities for patient recruitment because they will be offering patients the convenience and comfort of visiting community sites in which they are familiar.

With the industry still adjusting to new approaches in aspects of study start-up, recruitment, and data collection, regulators will respond by allowing a wide berth to help accommodate the adoption of these methods. This regulator flexibility will be key, but further implementation of decentralized methods will be driven by the industry at large.

The pandemic has and continues to put enormous pressure on the entire life sciences industry and those organizations running clinical trials. At the same time, it has provided the impetus for moving at least some aspects of clinical trials out of pilot mode and into action. In 2022 we will continue to move into the new era of clinical trials supported by technological innovation.

Articles

Data, patient recruitment, and regulators all highlighted in these three predictions for the new year.

Life Sciences in 2022: A Transformation Continues

Publicis Health announced the acquisition of BBK Worldwide. BBK enables biotech and pharmaceutical customers to accelerate R&D programs, driving research forward through the integration of patient-centric services and proprietary technology, complementing Publicis Health's existing CTE capabilities.

As part of the acquisition, Publicis Health will acquire BBK Holdings, which in addition to BBK Worldwide, is the parent company of creative advertising agency 320Agency, technology company TCN® Technologies, and solution center RSG Engagement Solution Center. BBK's leadership team and organizational structure will remain in place.

Acquisition to expand clinical trial expertise through technology and patient centricity.

Publicis Health Acquires BBK Worldwide

Vibrent Health announced the integration of electronic health record (EHR) data into its Digital Health Solutions Platform, a platform that enables collection of health data from broad sources including biospecimens, genomics, environment, lifestyle and behavior, and wearable device data for clinical research and trials. 

Vibrent Health developed its EHR integration tools to support the National Institutes of Health’s 10- year, million-person 

Read more about Vibrent's EHR integration 

New HL7 standards enable access to EHR data to accelerate clinical research and digital trials.

Vibrent Health Integrates EHRs

Worldwide Clinical Trials, Inc. (Worldwide) and Science 37 Holdings, Inc. today announced a collaboration to enable decentralized clinical trial delivery in which patient visits for the provision of healthcare or trial assessments and laboratory tests are localized in the patient’s community. With this new partnership, Worldwide will leverage Science 37’s Operating System.

Through this partnership, Worldwide Clinical Trials becomes part of the Science 37 CRO Certified network.

New partnership to bring increased efficiency and patient centricity in trial execution. 

Worldwide Clinical Trials and Science 37 Announce Collaboration

Decentralized clinical trials (DCTs) could bring cutting-edge medical treatments to more patients than ever before. Patients who 

can’t travel to academic medical centers

 can now join many trials from their homes or from local clinics and pharmacies.

Overall, the clinical research industry has embraced DCTs. As of 2021, 

 use at least one form of decentralized technology. DCTs also allowed Pfizer, Janssen, Moderna, and Astra-Zeneca to test their COVID-19 vaccines.

COVID-19 accelerated technology adoption and challenged the status quo in clinical trials. The adoption and support of DCTs is part of that paradigm shift.

. Research sites and sponsors also worry about whether DCT technology will be affordable, secure, and able to integrate with their existing systems.

For decentralized clinical trials to achieve their full potential, research sites and sponsors need technology that can get up and running quickly and that works for physicians, clinical researchers, and participants.

Here are a few challenges that come with decentralized trial technology and tips for how your research team can overcome them.

1. Ensuring technology is available and affordable

To make decentralized clinical trials fast and effective, research sites need to have technology in place before each trial begins. If sites have to learn new software for every trial, the 

 cost sponsors thousands of dollars, cause sites to miss their study deadlines, and slow down the process of getting drugs to patients. This is just one example of the ripple effect that inefficiency can create.

 worry about the cost of new technology. 

 from the Tufts Center for the Study of Drug Development showed that unclear ROI was most organizations’ number one concern about technology.

Ideally, sites would choose and set up their own clinical trial software that they use for all (or almost all) of their studies. The site staff could then win studies by showing sponsors that they already have the technology to run decentralized trials.

This technology adoption is what a sponsor wants to see, because it shows that the site can handle remote monitoring and run an efficient, innovative trial. However, adopting technology is only one piece of the puzzle. In order to maximize their return on investment (ROI), an organization should compliment technology adoption with process improvement.

Your software vendor should help you with this process by providing case studies or testimonials about the ROI their other customers have seen. With 97% of sponsors now using some form of 

, having an effective technology infrastructure will help your site remain competitive and win studies, leading to a high ROI.

2. Helping clinical research staff understand new technology

In addition to worrying about how much decentralized trial technology will cost, clinical research teams often worry about 

how long it will take to implement new tech

One-third of Clinical Research Associates said that the 

, and two-thirds said they didn’t receive enough technology training to efficiently do their jobs.

To make decentralized trials successful, research sites and sponsors need to 

. But they also need to choose software vendors who offer a thorough 

Decentralized clinical trials also don’t work well if physicians at academic medical centers and local clinics aren’t willing to use the technology. Many doctors already find clinical trials stressful—

 said they wouldn’t run a second trial.

Therefore, it’s important that decentralized clinical trial software has physician-friendly features. Investigators need to log onto a software program or app and instantly see which tasks they need to complete and which forms they need to sign.

If you’re choosing DCT software for your site team, make sure you search for intuitive, physician- and staff-oriented software.

3. Including diverse participants in decentralized clinical trials

Because traditional clinical trials often take place at academic medical centers (AMCs) in major cities, they frequently suffer from 

Decentralized clinical trials can bring cutting-edge treatments to patients in rural or impoverished areas and 

to patients who can’t afford to take time off

However, sites and sponsors attempting decentralized clinical trials need to acknowledge that some patients 

don’t have access to smartphones or computers

. Even if research sites supply patients with phones, tablets, or wearable devices, the patient may not have reliable Internet access.

This is why decentralized clinical trials can’t rely solely on technology. Some patients may do all of their check-ins via phone or computer, but others may need to visit neighborhood clinics or pharmacies to have their data collected.

Even participants who have access to technology may not feel comfortable using electronic patient diaries or ePRO software. With hybrid trials, participants can sometimes check in from work or home using technology. But at other times, they can visit the research site or a local doctor’s office to learn how to use DCT apps correctly, ask questions, and undergo testing.

4. Keeping participant data secure and private

With the rise of regulations like GDPR and CCPA, research sites need to think carefully about how to protect patient data during decentralized trials.

Although it’s easy to share patient documents through online drives or email, these methods aren’t always secure or compliant with GDPR, HIPAA, and regulations from national bodies like the FDA or EMA.

Many decentralized trials also rely on investigators and participants signing forms online. If you’d like to take advantage of those capabilities, it’s especially important to look for software that complies with your country’s regulations around eSignatures.

In the US, that means finding software that complies with 

If you’re looking for new clinical trial technology, ask potential vendors whether their software complies with all national and international clinical trial standards. You should also ask which cybersecurity policies they have in place to protect patient data.

Decentralized clinical trials often rely on patients recording their own data at work or at home, which can increase the risk of protocol deviations. A participant might wear a device wrong or record their data incorrectly in their electronic patient diary.

Research sites can use a few methods to keep data accurate during decentralized trials. First, research site staff can give patients thorough training on 

how to use all apps, software programs, and wearables

Clinical research organizations can also rely on devices that automatically record data where possible. Although participants will still need to know how to wear the sensor or device, research professionals won’t have to worry about participants recording their data incorrectly.

 where participants check in at local pharmacies, labs, and clinics. The local facility can then record the patient’s data according to the study protocol and use software to send it to the research site.

Decentralized clinical trials can produce far more data than traditional, site-based trials. In a traditional trial, clinical research teams can only collect data from patients when they visit the site in person every few weeks or months.

With decentralized clinical trials, sites can receive data from patients electronically on a daily basis. Decentralized trials also help investigators see how a drug works in a participant’s everyday environment. The technology 

, and that produces insights that can’t be gained in a traditional setting.

But this flexibility also means that a patient’s health data might vary depending on the environment they’re in. Investigators could see differences in blood pressure because of work stress or temperature fluctuations because of external weather.

Your study protocols will need to account for how different environments may impact your data and the conclusions you draw. Your protocols will also need to account for the tremendous amounts of data flowing in from different software programs during a decentralized trial.

two-thirds of clinical research professionals

 say they already have to perform duplicate data entry because their software programs don’t speak to one another.

With more data coming in because of decentralized trials, duplicate data entry becomes even more time-consuming and unsustainable. This is where technology integrations can help.

Clinical research professionals need integrated software programs that can automatically share data with one another. For example, some electronic data capture (EDC) programs can integrate with electronic Investigator Site Files (eISFs) so the clinical research team doesn’t need to manually transfer data from one to the other.

Some software vendors will build manual integrations between CTMS systems, eISFs, and data capture programs like EDCs, ePRO, or eCOA. But to make technology integrations possible, you need clinical trial software with an open API.

 from other vendors. By contrast, software platforms with a closed API can only integrate with programs from the same manufacturer.

Closed APIs force research sites and sponsors to either give up on integrations or buy eISF, EDC, eTMF, or CTMS platforms all from a single provider, even if that provider’s software isn’t best-in-class for every category.

A lack of integrations leads to repetitive, time-consuming work, while being forced to use software from a single provider leads to inefficient, difficult-to-use technology.

In the words of former FDA Commissioner Scott Gottlieb, MD, the industry needs to "

 that reward collaboration and data sharing across the clinical research enterprise.” Open APIs and well-integrated software play a critical role in making data-sharing across platforms possible.

Decentralized clinical trials won’t run nearly as efficiently without the benefits of well-integrated technology.

Making decentralized clinical trials a reality

Decentralized clinical trials can provide promising medical treatments for underrepresented patients across the world. But this vision won’t become reality until clinical trial professionals have access to secure, well-integrated software that’s easy to use for both staff and participants.

Research sites, CROs and sponsors need to look for this technology now to make decentralized trials safe, fast, and efficient in the future.

 is Florence Healthcare’s VP of Product

New era of technology brings unique obstacles.

Overcoming the 7 Biggest Challenges in Launching Decentralized Trials

Phesi Inc. today released the results of its global analysis of all clinical trials conducted in 2021. The data show that breast cancer was the most studied disease area, followed by COVID-19. Overall, oncology dominated the top five, which also included non-small cell lung cancer, solid tumors and multiple myeloma.

Within breast cancer clinical development 25,000 investigator sites have been solely dedicated to recruiting patients since 2017; this trend was not impacted by COVID-19; this includes pharma and academic studies and the same investigator sites involved in multiple trials. This means an average of 5,000-7,000 people are continually working on breast cancer clinical trials, with Phesi’s model showing this is likely to continue.

Data also show COVID-19 to be second most studied disease area, and further highlight patient enrollment challenges.

Phesi Analysis Shows Breast Cancer Was the Most Extensively Studied Disease Area in 2021

Lovers of European Union minutiae of clinical trials regulation have a feast to digest before the end of January. That is when a new rule comes into effect with the snappy title of "Commission Implementing Regulation (EU) 2022/20 of Jan 7, 2020 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials.

Those who like to work only from primary source can check out verbatim the just-published–and rebarbatively-phrased–

. Those who would prefer a quick overview, this is the place for you, because your columnist has benefited from a comment by Silvia Garcia, who is senior manager for science policy, regulatory and drug development at the European drug industry federation, EFPIA, and who is particularly involved in clinical trials and pharmacovigilance.

According to Garcia, the main thrust of the new rule is to establish how the EU's member states are to work together and organize themselves in order to avoid duplication of work in these safety assessments. Some double-handling has been happening until now, since the national competent authority or ethics committee in each country has assessed safety reports on its own.

Under the new dispensation, there will be a lead member state in each case, and the safety assessment will be handled in a more coordinated way. With the EU's new clinical trial information system also coming into operation at the end of January, there will be one central submission for all studies concerned with the same investigational medicinal product–which will replace the current frequent practice of a dozen or more assessments in parallel by different countries where studies with the same IMP are running

Garcia and her staff have added a little more guidance on the technical changes, including the novelty of "saMS" that the new rules create–which denotes a "safety assessing member state," a formal concept that did not exist in EU rules until now. What this means in effect is that the saMS will handle the assessment of a suspected unexpected serious adverse reaction report in a more coordinated fashion, with one central submission of a development safety update report per IMP via CTIS for all studies concerned, and one centralized assessment of that DSUR instead of a dozen parallel assessments in different countries where studies with that IMP are running.

The work-sharing concept of the new rule has been compared to procedures for periodic safety update report single assessment (or PSUSA for the cognoscenti) in the post-marketing setting. In addition, the rule defines the process and timelines for a regular assessment of submitted SUSARs, which could bring some advantages, say those who are close to these processes.

The EU itself says in its new rule that it "should strengthen participants’ safety in clinical trials and contribute to improved data robustness regarding the safety profile of investigational medicinal products and their corresponding active substances."

Against the background of the implementation of CTIS later this month, with all the changes implied for the entire clinical trials community in Europe and beyond, the introduction of saMS is of course a drop in the ocean. But then, everyone is already totally prepared for CTIS–aren't they?

New guidance looks to streamline safety assessment process.

Cutting to the Chase on European "Safety Assessing Member States" in Clinical Trials

The report shows a rise in peak sales, reduced cost of development, and reduced length of cycle times, which collectively, indicate that pharma companies are starting to see the benefits of optimized processes from previous years and innovative changes to the R&D process. The COVID-19 vaccine development process may serve as a blueprint for the industry to plan, design and execute studies more efficiently across R&D portfolios.

Deloitte's analysis also found that the combined cohort of pharmaceutical companies continue to rely on external sources to fuel innovation for more than half of their late-stage R&D pipeline, increasing to 71% in 2021 from 51% in 2018. The cohort also revealed a significant increase in the number of co-developed assets, rising from 32% in 2020 to 46% in 2021. This suggests that almost half of forecast revenues from the late-stage pipeline are being generated through collaborations and scientific partnerships.

Deloitte Releases 12th Annual Pharmaceutical Innovation Report

The Patient-Centered Outcomes Research Institute (PCORI) has opened the application periods for 

 that offer up to $297.5 million in total funding. The latest PCORI Funding Announcements (PFAs) include up to $262 million for comparative clinical effectiveness research (CER) studies that help determine which health care options or approaches work best for patients and their caregivers given their particular circumstances.

These first funding opportunities of 2022 advance PCORI’s ambitious three-year funding commitment plan totaling $1.8 billion, which the PCORI Board of Governors approved last year.

PCORI Offers Up to $297.5 Million Through New Funding Opportunities

 today announced results from a Tufts CSDD analysis which shows that, on average, decentralized clinical trials (DCTs) are associated with reduced clinical trial timelines and can achieve net financial benefits ranging from five to 14 times for Phase II and Phase III trials, respectively. The findings are based on financial modeling and analysis of trial data from the 

Tufts Center for the Study of Drug Development

 (CSDD), Tufts University School of Medicine, and more than 150 clinical trials enabled by Medable software.

Featured Content

Applied Clinical Trials December 2021

Biopharma-Academic Collaborations in 2021