Clinical Researcher—October 2022 (Volume 36, Issue 5)

TRIALS & TECHNOLOGY

Krystyna Kowalczyk; Jane Myles

 

The pandemic accelerated the adoption of decentralized clinical trials (DCTs) for medical and pharmaceutical research. DCTs allowed trials to be conducted virtually after early COVID-19 travel restrictions and physical distancing caused site-based trial starts to plunge 50% from January to April 2020. As a result, we learned that patients prefer to visit convenient locations for their care, and our industry can leverage existing services and resources to make clinical research possible at these sites.

Fully remote or hybrid trials conducted from a patient’s home or local trial site (such as the office of a patient’s provider) offer several benefits to clinical research organizations (CROs), pharmaceutical companies, and medical device makers. The benefits of DCTs include greater convenience for participants, faster recruitment, the ability to attract a more diverse cohort, and lower dropout rates because travel-related burdens are eliminated.

DCTs also can help long-term clinical trials gather follow-up data from patients well after the active phases of the trial have concluded. This is particularly important in the field of oncology, where trials typically track patient survival long after study treatment has stopped, often over many years. While oncology has been slower to adopt DCTs than other medical specialties, many oncologists realize this type of service could be a game-changer for cancer research and treatments.

The clinical research field is more crowded than ever, even the largest sites have limited capacity and struggle with maintaining an adequate level of staffing. Compounding this shortage of resources and staffing at large medical research centers is the increasing number of innovative studies around long-term immunotherapies; as part of regulatory requirements, these studies require extended follow-up with participants.

Another challenge oncology researchers face under the traditional site-based clinical trial model is the ongoing struggle to attain patient diversity in trials. The U.S. Food and Drug Administration emphasizes the importance of patient diversity and the democratization of research, but when trials are repeatedly conducted at a small number of sites, they draw from the same geographic and demographic pools. Ultimately, lack of patient diversity has a negative impact on drug development because the products aren’t being tested on all types of patients who might need them.

How DCTs Can Help Oncology Trials

Each one of these challenges can be overcome through the decentralization of clinical trials. Using DCTs for oncology clinical studies provides many clinical and operational benefits to CROs, pharmaceutical companies, and device makers. DCT providers and platforms can help trials cope with site-based resource and staffing limitations by enabling activities to be conducted away from a single trial location via the use of remote software and staff to collect data outside the research center.

DCT platforms and providers are ideal for conducting follow-up procedures required under the trial protocol, such as filling out quality-of-life questionnaires and collecting biometric data. These types of activities don’t have to be performed at a major research center by clinicians with advanced skill sets to meet compliance requirements. By using a DCT model to gather follow-up data, the leaders of academic research centers can focus their scarce resources and expertise on a wider number of clinical trials driving new opportunities for the most cutting-edge oncology treatments. This opens additional modalities for clinical trials beyond the traditional site-based model and allows academic centers to expand their capacity to do innovative research while using clinical resources most efficiently.

Further, DCTs can help ensure a seamless transition from one trial modality to another. For example, a study involving advanced cancer cell therapy may start at a hospital or major research center and initially require careful oversight by a physician. Patients in the study may be tracked closely for a short time after the clinical phase of the trial and then less intensely over a longer period. This may also allow patients seeking the most advanced therapies to travel to academic centers for the induction of that therapy, but then to be followed for safety and efficacy with their own personal oncologist within their community.

As an extension of that thinking, it is possible to leverage DCT technology to bring trials to the patient’s personal physician using means of telemedicine, home health nursing, remote devices, and other DCT technologies that support local physicians who may be new to research. This can be done under the supervisory watch of an academic lead principal investigator (PI), with a central lead PI for remote physicians, or even with the local physician acting as the PI for their own institution. In any case, the ability to bring the best clinical trial to each oncology patient is ultimately where DCTs in the oncology space will evolve.

Bringing Research to the People

Most patients want to go where they are comfortable and where it is convenient. DCTs leverage this patient need by supporting participation in clinical trials and follow-up in community locations (such as their primary care provider’s office) or even at home. Bringing the research to people in their communities and homes is the definition of patient centricity.

Consider the example of a cell therapy program. The opportunity to receive these cutting-edge therapies is limited to a subset of large research institutions. Patients looking for these kinds of innovations will often have to travel to the cities where therapy is available. The therapy itself tends to be relatively quick. Patients will come in for induction and treatment and perhaps have a period of follow- up. However, the intent of these programs is to provide a long- term immunological effect. That means these patients are followed for years rather than months. The ability to transition these programs from institution-based follow-up to regional review of safety profiles can clearly expand access and thereby accelerate enrollment.

Applying the same concept to programs looking at long-term progression or survival can often provide a similar type of benefit. Innovative programs can be closely monitored for initial treatments and responses including adverse reactions, and patients can then continue to get a high level of care within their community.

By no means is this model applicable to every clinical program, but as an industry, we would be well served to challenge ourselves regarding the implementation of clinical programs. We have already entered an era where the concept of decentralized care is becoming normalized. It’s now necessary for our community to expand our thinking, embrace concepts of true patient centricity, and build an infrastructure that will allow us to accelerate the evaluation of innovative compounds changing the lives of patients while supporting their ability to remain engaged in their established social circles.

Conclusion

Enabling long-term clinical trials through multiple modalities such as DCTs would benefit oncology patients, pharmaceutical companies, academic institutions, and clinical researchers. DCTs offer a digital platform that enhances clinical resource and skills allocation, improves participant recruitment and retention, increases compliance, and reduces clinical trial costs.

In addition, DCTs can be a catalyst for oncology research breakthroughs that otherwise wouldn’t be possible through traditional site-based trials. Such clinical and pharmaceutical innovations can save and improve lives.

Krystyna Kowalczyk serves as the President and CEO of Oncobay Clinical, a CRO specializing in immuno-oncology and cellular therapies.

Jane Myles is the Vice President of Clinical Trial Innovation with Curebase, a decentralized clinical trial (DCT) company committed to democratizing access to clinical research.