COVID-19 has altered the drug development landscape

By Abby Mynahan 

In an effort to develop treatments for COVID-19 faster, drug developers have turned to repurposing existing drugs. Innovative approaches are being utilized to test these widely available drugs and other COVID-19 treatments in clinical trials more quickly and propel drug development forward at an unprecedented rate.

Funding and Collaborations for Clinical Trials

Repurposing of generic drugs is often stalled by a lack of funding for the clinical trials needed to evaluate the safety and efficacy of the drugs for their new indications. Pharmaceutical companies typically fund trials, but due to a perceived lack of profitability, they usually are not interested in finding new uses for inexpensive off-patent drugs. Yet a large amount of funding from nonprofits and governments has now been directed to clinical trials testing repurposed drugs for COVID-19.

Several COVID-19 trials leverage international collaboration, which increases the diversity of the sample population and allows studies to recruit patients faster. The Solidarity trial, organized by the WHO to test repurposed drugs for COVID-19, has raised $108 million from 203,000 individual donations, charitable organizations, and governments. Forty five countries are involved in financing or trial management.

However, better coordination between researchers is needed. More than 200 clinical trials are independently testing hydroxychloroquine for COVID-19, which is clearly not the best use of resources.

Adaptive Trial Designs and Real-World Evidence

To speed up the process of determining the safety and efficacy of potential COVID-19 treatments, researchers are using adaptive clinical trial designs and real-world evidence. 

In adaptive trials, results are gathered throughout the trial and used to make modifications. This makes them much more efficient, and can decrease the number of patients needed and save time and money. Multi-arm platform trials are an especially efficient way to evaluate many investigational drugs. For example, the Randomized Evaluation of COVID-19 Therapy (RECOVERY) Trial has only one control arm and multiple investigational arms (testing different treatments) as opposed to one control arm for each investigational arm, which is the typical trial design.

COVID-19 researchers are finding new ways to capture and utilize real-world data, which is observational data collected during clinical practice outside of randomized controlled trials from sources such as electronic health records and patient registries. The conclusions from analyzing real-world data are known as real-world evidence. The FDA has committed to using real-world evidence to inform decision-making around the safety and efficacy of treatments, and they are actively participating in studies of real-world data to answer COVID-19 research questions.

The FDA and Institutional Review Boards are also working to accelerate the application and review process for new clinical trials, which can typically slow down drug development. The FDA created the Coronavirus Treatment Acceleration Program, a special emergency program for possible coronavirus therapies, to move new treatments to patients as quickly as possible. Furthermore, the FDA has been publishing guidances and other information for industry on developing COVID-19-related treatments.

Continuing the Momentum Beyond COVID-19

COVID-19 has impacted drug development for other diseases. The NCI is adapting their processes for cancer clinical trials to minimize the number of hospital visits needed and enable faster enrollment of patients in trials. For example, they are allowing for remote informed consent and gathering research blood specimens and imaging scans during regular clinical care. These shortcuts could also be beneficial for cancer drug development after the COVID-19 pandemic ends.

While some of the approaches described here had been used for drug development prior to COVID-19, they largely represent a significant shift in the drug development process to bring treatments to patients faster and at a lower cost. We hope these changes will help accelerate the repurposing of generic drugs for cancer as well.