COVID-19 propels clinical trial innovations from prolonged conjecture to a paradigm shift.

Between March and November of 2020, COVID-19 negatively affected more than 1,200 clinical trials worldwide. Some were shut down completely while others were affected by lockdowns, patients becoming reluctant to continue with a trial or a host of other pandemic-related interruptions. As in every other aspect of life, COVID-19 has demanded flexibility, innovation and creative solutions in order to keep things moving forward. Thus, a concept of innovation for clinical trials that has long been discussed but only minimally implemented was widely adapted as a matter of survival.

Decentralized trials (DCT) have been a topic of conversation for at least a decade, but there has been a general reluctance to adopt them as a general practice before COVID hit. Consider that in a 2019 survey by Industry Standards Reports of pharmas and CROs, only 38% stated that virtual trials would be a major component of their portfolios, and only 48% stated that most participants’ activities would be conducted from their homes.

When McKinsey and Company posed the same question in 2020, virtual trials were expected to be in 100% of responders’ portfolios and nearly 90% of those surveyed said that trials would be conducted with activities conducted from participants’ homes. It’s not unusual that when push comes to shove, people are more willing to make innovative changes, and a majority of investigators now expect aggressive adoption of DCT.

An Informa Pharma Intelligence and Oracle survey of the life sciences industry found that 84% of respondents innovated around certain approaches during the pandemic including the most often used methods of remote monitoring, video and phone visits, eConsent and electronic health records (EHR). Upon reflection, 82% said the new methods had a positive impact on their trials and 97% said that at least one of these new methods was here to stay and added online patient recruitment to the list of most likely new DCT adoptions.

When you consider that, even in the best of times, it is widely estimated that 80% of trials are delayed due to enrollment, 48% of sites fail to meet enrollment goals and 70% of patients live more than two hours from clinical sites, these types of changes are long overdue in helping make clinical trials more efficient and cost-effective.

The many benefits of DCT can now be more fully realized.

It took the pandemic to get these innovations into widespread use even though the potential benefits have long been discussed. With DCT trial innovations investigators may now begin to see:

• Increased access to a more diverse patient population and more patient options. (58% of Oracle survey respondents say they plan to give patients the option to choose how they will participate in trials and believe that patient choice will have a positive impact on clinical trials). Reaching out beyond the common travel distance of clinics can give many more patients the opportunity to participate and will broaden the power of clinical research to be beneficial for greater demographic populations.
• Increased retention and timely, enhanced real-world data. Patients communicating from home will stay in trials longer and provide more accurate and personalized information including quality of life data. Caregivers are also more likely to encourage compliance when they are relieved of the burden of having to arrange travel to clinics. (92% of respondents in the Oracle survey reported that they were confident in the quality of data collected under the new methods as compared with data collected pre-pandemic).
• Streamlined operations. Investigators may be able to reduce workloads with a better cost model since Telehealth visits cost up to 50% less than in-person visits. With sites already suffering staff shortages and others reporting that those now accustomed to working remotely wish to continue doing so, DCT innovations can relieve burdens on sites and even reduce the number of sites necessary.
• Increased opportunities for patient engagement. Digital communications will allow potential and current participants to have more frequent communications with more stakeholders, either while deciding to participate or during its execution. Technology used efficiently can actually increase the “human touch” experience.
• Resilience in emergency situations. DCT elements can build adaptability and agility into clinical trial design. COVID-19 was a global wake-up call for how emergencies can disrupt and even derail clinical trial operations. When the standard for trials becomes more decentralized and digitally driven, there will be less disruption during future emergencies.
• Promotion of clinical research as a treatment option. The DCT model can help to move clinical research closer to where patients live and towards a viable healthcare option where clinical trials serve qualified patients as a part of their treatment regimen. This will have great benefits not only for the patients and their physicians, but also for the clinical research community as a whole.

DCT requires upfront planning and investment to overcome obstacles.

Although the DCT model was quickly adopted as a pandemic response, there are obstacles to adopting it as a standard. Digital transformations can be complex and require upfront planning, investment, training and clearly defined metrics for measuring success as new methods are implemented. Virtual elements should be planned carefully from the outset of trial design to ensure that they are strategically integrated and will truly add value to both the trial and the patient.

Barriers to adoption can include ensuring a secure and robust digital infrastructure, quality control of data, privacy concerns, compliance with existing regulatory requirements, cultural issues, proper training for investigators and patient digital literacy. In addition, the organization must be ready for change management across all sectors of their business.

Of course, not all clinical trial operations can transition to virtual. Complex procedures and many assessments and screenings will still require traditional operations. However, even Phase III trials are reporting the adoption of some form of decentralization in a hybrid format.

Industry progress — quick response comes from regulators and governments to big tech.

Necessitated by the pandemic, regulators and governments met the challenge by updating requirements to meet the clinical research need. The US FDA as well as European and Japanese regulators published formal guidelines supporting novel tech approaches. Apple and Google are investing heavily in tools to support DCT, and Stanford and Google have already partnered in a program that sets up clinical trial participation based on a patient’s individual schedule.

New players and collaborative partnerships are emerging in the clinical trial market. Companies with robust online assets, such as CVS and Amazon, are rolling out programs that can quickly adapt to large-scale patient engagement for certain aspects of trial operations. These types of cross-industry partnerships will continue to develop and become a part of the future clinical research model.

The landscape of healthcare continues to evolve and the future of clinical trials and their management will depend on the ability to be flexible and adaptive in a new world being driven by both worldwide medical emergencies and rapidly changing technology.

At George Clinical, we have always advocated both innovation and patient consideration in our overall model and within any given trial. Our scientific leadership model lends itself well to these new paradigms. Our global thought leaders, who are not only influential researchers but clinicians as well, will continue to work as a team to innovate and advance clinical research to ensure the best treatments are implemented into clinical practice in a timely manner for patients the world over.