How has COVID changed clinical trials?

COVID has been one of the largest learning opportunities in generations. Every aspect of life, be it social, work, family, health or finances has been affected and caused us all to rethink previous assumptions.

Clinical trials i.e. testing new drugs, devices, vaccines and diagnostics in people has been particularly impacted and created a sense of urgency. Clinical trials have evolved from face to face to hybrid to totally decentralized and virtual.

Projected benefits include:

1. Information and education about participating in clinical trials
2. Increasing recruitment and retention goals
3. Transparency, reproducibility and the open, secure sharing of deidentified patient data 
4. Enabling physician office based virtual clinical trial participation as an element of medical practice entrepreneurship
5. Advancing the development and deployment of data interoperability platforms
6. The expanding role of artificial intelligence in clinical trials
7. Potential implications of virtual trials for cost, speed, regulation, and knowledge generation and dissemination of clinical trials
8. Elements of an IT infrastructure, including integrating data from electronic health records, mobile health applications, remote monitoring, virtual visits, and other relevant technologies with the capability to enhance the interface between clinicians and clinical trial participants
9. Collaborative approaches and incentives involving sponsors, researchers, patient advocacy groups, patients living with the particular condition being studied, and health systems—including regulations, quality measures and outcomes, or reimbursement strategies-- to support the implementation of virtual clinical trials

10. Opportunities and challenges to enhancing equity in access and participation through virtual clinical trials.

Here are some best practices for implementing decentralized clinical trials (DCTs).

Here is a company that creates digital twins for clinical trials.

Here are the issues with using software as a medical device in trials

When medical researchers want insights on prescription-drug side effects or how to support people undergoing cancer treatments, they don’t always turn to patients and doctors. Instead, a growing number of researchers are using algorithms to mine public social media posts for information, The Wall Street Journal reports. Unlike clinical studies that can take years to carry out, social data is cost-effective to collect, available in real-time and potentially more representative of the overall population. The goal is to supplement, not replace, traditional research, and detect issues that patients don’t share or physicians dismiss.

Clinical trials have changed and will continue to evolve. Whether the changes result in value and better outcomes remains to be seen. Hopefully, we won't have to wait too much longer to see whether the changes are innovation theater or not.

Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs

Updated 4/15/2022