April 2020: Preserving Clinical Research Sites During the Coronavirus Pandemic – A PhRMA Blog Post

Jim Kremidas, Executive Director of the Association of Clinical Research Professional (ACRP) posted a PhRMA blog post on April 29, 2020, titled “Preserving Clinical Research Sites During the Coronavirus Pandemic”. The blog post cites the April 8th press release of a study conducted by Continuum Clinical in partnership with ACRP which found 31% of clinical research study sites fear total closure, as COVID-19-related stay-at-home orders and patient concerns over interacting with health care professionals continue to increase. Nearly 80% of sites indicated at least one of their current clinical trials had been put on hold or cancelled in recent weeks.

Of the sites who reported patient dropouts:

  • 80% said patients are unwilling to visit the site for study appointments
  • 52% indicated they believe patients fear interacting with any medical professionals who may be in contact with COVID-19 patients
  • Only 19% of sites said they thought patients would permit home nursing visits by clinical trial staff, a method recently offered by the FDA as an acceptable substitute for scheduled drug administration study visits

The survey also shows investigator sites are facing serious staffing issues, with 38% reporting employees experiencing difficulties working from home and 33% reporting employees are not fully engaged due to coronavirus-related disruptions.

Kremidas states: “Sponsors need to understand how this pandemic is curtailing clinical trial activity and putting many sites on the very edge of financial existence…Sponsors and others have leveraged some of the best aspects of decentralized clinical trials, remote based monitoring, and real-world evidence. In the future this period may be referred to as the “Covid-Catalyst” due to the impact it’s having on advancing clinical operations. As an industry, we are rising to meet a huge challenge with nimble thinking and powerful resolve”.

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