Member Perspective: Liz Croft Richards, M.D.

Guest Commentator: Member Perspective: Liz Croft Richards, M.D.,  Incyte @Incyte

What pivots have biopharmaceutical companies had to make to their clinical trials during the pandemic and has there been a change in research results due to those shifts?

Among the many challenges the pandemic has created over the last 18 months, the threat to clinical advances in medicine ranks amongst the highest; with the global biopharmaceutical industry seeing specific impact on clinical trial operations and patient access to care.

Global COVID-19 restrictions, study holds, limited patient mobility, and slowing of the supply chain are all areas that biopharmaceutical companies have had to assess and match with innovative solutions.

At Incyte, and across the industry, we have quickly flexed to decentralize our clinical studies and by adapting protocols and study starts, we have allowed qualifying patients to participate remotely and physicians to maximize tele-medicine and virtual data reporting.

In some instances, health authorities and institutional review boards (IRBs) have allowed monitoring and outcome timelines to shift, trial designs to be adapted, and the performance of diagnostic and radiology requirements at non-study sites.

Use of local vendors alongside global providers, sending study medications directly to patients, and even the implementation of artificial intelligence have also provided some relief to the drug resourcing and logistical limits of the supply chain.

Simply, the operational effort to maintain access to clinical trials, ensure patient safety, and maintain data integrity on behalf of the biopharmaceutical industry has been herculean. With the overall impact on research programs being significant, but still yielding reliable results.

Historically, the allowance of amendments, deviations, and adaptations have played an important role in completing clinical trials and maintaining the best interests of patients. The pandemic is no different. Data management committees, IRBs, health authorities, and our monitoring teams all remain active in the oversight of clinical studies and outcomes. The FDA, European Medicines Agency, and other regulatory authorities have provided significant and necessary regulatory guidance for clinical trial performance during the COVID-19 public health emergency.

And while the pandemic continues to impact and change the way we do our work, upholding the integrity of biopharmaceutical research, our results, and most importantly, our ongoing commitment to all patients worldwide remain the most stable and important things we do.

The Chamber recognizes health care innovation as a catalyst for economic growth. Our Health and Life Sciences Action Team is a unique, cross-functional group of 120+ leaders working to leverage the region’s health care, life sciences, and technology assets to transform our 11-county community into the global leader in health care innovation.