How will clinical trials change in light of COVID-19?

COVID-19 has impacted almost every aspect of society and the scientific R&D industry is no exception. With clinical trial disruptions, cancellations and delays, many studies have not gone to their original plan. However, now that restrictions are being eased globally, some clinical studies can resume, albeit with a few differences.

Barbara Lopez Kunz, President and Global Chief Executive of the Drug Information Association (DIA) spoke with European Pharmaceutical Review to discuss how COVID-19 has impacted clinical trials and how they will change in the future.

Now the disruptions to clinical trials due to COVID-19 are easing, do you think they will fully regain the pace they did before?

Yes, but most likely in a different form. Several changes that were implemented as a response to the COVID-19 pandemic may be here to stay. These include the use of telemedicine, delivering study drugs directly to patients, remote monitoring and other innovations and changes put in place to decentralise trials.

Do you think that clinical trials for indications other than COVID-19 are being given the appropriate amount of attention and precedence?

This has been a great concern from the start of the current pandemic. We have seen clinical trials for other indications slow down for a variety of reasons, including potential risks to the study’s subjects. Several trials were postponed due to restrictions within different countries, while others were put on hold to convert trial sites into COVID-19 treatment facilities. Although these disruptions have been unavoidable due to the pandemic, we believe they will return to pre-pandemic levels especially given the innovations that have been put in place.

How will clinical trials be changed or adapted as a result of COVID-19?

Beyond the focus on virtual/remote trials, an increase in the use of telemedicine and the use of digital technology to define study endpoints and collect data, sponsors are now looking at study protocols through a more practical lens. They are stimulated by this period of regulatory innovation in which streamlining change – without jeopardising safety – are accepted by agencies in order to maintain trials. For example, how many visits/check-ins/blood samples are necessary to create a usable dataset? The move to develop and validate study endpoints that are clinically meaningful and reflective of true improvements in patient outcomes has long been underway. The requirement during the pandemic to identify clinically meaningful endpoints that can be reported by the patient in place of clinician-reported outcomes has accelerated that process; this impact on trial endpoints will be lasting.

The design of studies will also be changed due to the success of master protocol trials in streamlining the evaluation of multiple treatment and vaccine candidates for COVID-19. The adaptiveness and agility of master protocol infrastructures enabling rapid, efficient and cost-effective response to a study’s needs has demonstrated that the current system of stand-alone trials cannot persist as our sole approach to medicines development. As the utility of master protocol designs for indications beyond oncology is being highlighted, regulatory agencies will be encouraging research sponsors to consider this collaborative approach to drug development.

The focus on speeding up and streamlining the development of medicines places increasing importance on the use of real-world data to produce real-world evidence for development and regulatory decision-making. This encourages our progress towards a learning health system, where clinical research can be part of the continuum of care and real-world data sources, such as electronic health record (EHR) and claims data, can be leveraged as research data.

How will the regulations regarding clinical trials be altered?

It is too early to say how regulations may be altered, but in Europe and the US, regulatory agencies are urging the pharmaceutical community to make these changes voluntarily. New or updated regulations will likely focus on how to maintain and support COVID-19-induced regulatory innovations that have shown to be successful.

What are the challenges for researchers and pharmaceutical companies when adapting clinical trials in a post-COVID-19 world? 

One of the most important challenges will be implementing changes without widening and exacerbating the healthcare and access disparities that currently exist. For example, while remote trials and the use of digital technology to capture data will provide better experiences for some patients, these approaches, by themselves, will do nothing to improve inclusion and access to healthcare services, including clinical trials, for those without digital access, which tend to be the groups that are currently underserved. Pharmaceutical companies must develop and implement hybrid strategies, providing multiple routes of access to clinical trials; socioeconomic and other health disparities should continue to be addressed in the broader healthcare and population services ecosystems.

How would you summarise the current COVID-19 situation?

The coronavirus pandemic continues to cause an incredible amount of pain, suffering and disruption to societies, individuals and families across the world as well as the global economy. However, it has also brought into sharp focus the need for systemwide and in some cases radical changes in the way stakeholders across the healthcare continuum approach drug development and patient care. At DIA, our obligation is to patients worldwide and we will continue to serve as a catalyst, advancing on-going system-level improvements and innovations to accelerate the delivery of therapies.