COVID-19: Factors Affecting Conduct of Clinical Trials

As clinical programs face challenges following the pandemic, companies have continued to adapt to the impact. Hurdles have included paused trials, use of virtual visits, reevaluation of timelines, documentation changes, and delayed product releases. The shift in resources of the healthcare system, travel availabilities, and patient inclination all play a role in trials when obtaining follow-up information and enrolling new subjects. However, the FDA has looked for opportunities to support and advance COVID-19 related products, which has also created opportunities for companies to get to the market sooner. The list below shows some of the major impacts of the pandemic, as well as possible learning opportunities for medical device, pharmaceutical, and biotech companies.

| Stat OneImpacts of COVID-19 on Industry:

  • Difficulty in recruiting patients, especially ones who are at greater risk to poor outcomes with the virus
  • Analysis implications from additional missing data in primary or secondary endpoints that required in-person assessment
  • Challenges to monitoring and collecting study data based on access to medical center procedure changes restricting who can enter facilities
  • Potential delays in the ability to conduct studies at trial sites where available staff is reduced
  • Additional consideration needed with respect to study safety endpoints in patient populations at risk for poor outcomes from COVID-19

Learning Opportunities:

  • Identify and assess policies while strategizing product development programs
  • Adaptions in protocol design, endpoints or study data collection methods might lead to improvements for future studies after the virus is diminished
  • Strategies for managing sites, subject recruitment, and monitoring may also provide future efficiencies

While the industry continues to face these unavoidable factors, it will remain important for companies to reevaluate clinical programs, protocols, and policies for the future of their pipeline and in-line products. Stat One understands the impact that COVID-19 is having on product development and clinical programs. With adaption proving to be evident, our team can assist in balancing patient safety and respecting trial changes with product development efficacy and statistical power.