Leading Clinical Operations in a Post-pandemic World

As evidenced by the results of our first global clinical site survey, COVID-19 has impacted most non-coronavirus clinical trials. Fewer new patients are being recruited and enrolled into clinical trials, including oncology trials. Study sites are competing for supplies and struggling in the rigidity of trial protocols. Site staff are fatigued but whole-heartedly committed to furthering research. Program and study leaders are aware of these and other challenges but are likely not be sure what to do; none of us has experienced anything like this.

While we try to figure out the “now,” we are also looking ahead to the “later.” Governmental and societal experts are making numerous recommendations to prepare for a post-pandemic world. Many are focused on providing consistent leadership, communicating well, and remaining optimistic without being Pollyanna. Those are good and helpful approaches, however, alone they are insufficient.

A recent article suggests that the first step to preparing for the post-pandemic time is to “reintroduce yourself and your people to your customers.” After all, this pandemic has changed us and so, too, has it changed customers. Research will need to be done to gain a new understanding of targets by geography, market, and demographic.

A similar approach applies to the healthcare industry, specifically in clinical development. Leading biopharmaceutical companies will need to conduct insightful market research with clinical trial sites and vendors. Additionally, proactive pharma leaders should have direct discussions with either a large sample of, or at least with their most valuable, investigator sites and staff. Assumptions and observations need to be confirmed and gaps and needs must be identified. From these insights, plans can be built that help trial sites, study participants, and vendors succeed in whatever the future looks like.

Now is the time to gather the insights that can improve your studies, programs, and organizational practices. The “COVOD-19 slow down” is the time to regroup, take inventory, be honest, and plan. Clinical SCORE has taken a head start by surveying more than 350 investigators and site staff from 42 countries to learn about the effect of COVID-19 and start to gather specific recommendations on how CROs and sponsors can help. The situation is changing rapidly and we are resurveying these sites, with an updated report expected mid-May.

With insights and a collective effort, we can help you shape the post-pandemic world of your trial sites, investigative staff, vendors, and most importantly, patients.