DSMB Clinical Trials

COVID-19 and Existing Clinical Trials: More Questions Than Answers?

As we all get inundated with news about COVID-19, containment activity at country level and ways to guard against infection, I am thinking about a subset of the population who may be disproportionally affected: clinical trial subjects and investigator site staff.

As the virus spreads and people are isolated either because they are positive or because they don’t want to be around members of the public who might be, the implication for ongoing clinical trials can be significant in a number of dimensions:

-Are large hospitals and healthcare facilities in affected areas “open for business” as usual with regard to clinical trials?

-Are subjects showing up for their periodic visits to receive medication?

-Are investigator site staff available to see subjects who may show up?

-How will subjects who are infected with the virus be treated and will that treatment potentially disqualify them from continuing in the trial?

-Will any of the above lead to certain trials losing enough subjects to cause the trial to fail?

-Will existing subjects need to go through a process of reevaluation?

-Will new subjects need to be recruited?

How can sponsors and CROs respond as these unknowns begin to gain clarity? Two areas of concern – and where technology solutions can help – are in patient eligibility and endpoint adjudication.

In cases where patient recruitment must accelerate, and the right patients must be identified for a trial, determining patient eligibility accurately and rapidly may be key to whether or not a trial continues, especially if it has lost patients due to the coronavirus. Working in tandem with our partners, AG Mednet is creating workflows in our platform that can be launched in hours to enable eligibility evaluations to begin at once.

For adjudicators, the coronavirus may add a new element to consider when evaluating adverse events. We expect this factor to emerge as a determinant in evaluations of trial participant events. Investigator teams and adjudicators must be ready to factor in the impact of the virus on a trial subject, and need a fluid workflow to create, modify or augment adjudication flows to account for new endpoint or adverse event evaluation criteria.

With tens of thousands of users around the globe and across thousands of investigator sites in more than 80 countries, we are following closely the measures taken by nations to stop the spread of COVID-19. We are also paying close attention to those countries where we know we have a lot of subjects (e.g., China, Japan) and where the transmission rates seem to be moving rapidly. Sponsors, investigators, adjudicators and others working on trials must be ready to respond and try to stem the impact that this epidemic will have on clinical trials worldwide.

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