Expert Insights

Expert Insights

Why You Need a COVID-19 Risk Assessment Plan

Why You Need a COVID-19 Risk Assessment Plan
01 May 2020

Historically, the clinical research industry has not been the most nimble or quick to evolve. Change comes slowly. But COVID-19 has certainly changed everything — and fast.

When the very real threat of this coronavirus became apparent, regulatory bodies issued emergency guidance and advice for clinical trials, enabling researchers to adapt existing trials to continue as best as they could. As trials resume or continue — and even as researchers begin tentatively looking forward to launching new trials, post-COVID — a critical element not to be overlooked is a COVID-specific lens. This includes a thorough, risk-based plan to ensure patient safety, compliance, conduct of trials, and data integrity.

Here at Synteract, once the emergency guidance was issued, we translated that advice into practical action. We repurposed some of our tools and processes that we already had in place for risk-based monitoring, adapting them into a COVID-19-specific risk assessment tool to help guide project teams.

Naturally, risk assessment is not unique to the present crisis; risk management in clinical research is critical to identifying, analyzing, and responding to any project risk to proactively alleviate any flaws. A risk management plan should already be in place for all studies.

But COVID-19 has introduced new risks that must addressed and mitigated. Our team assembled an assessment specific to these risks. Working with facilitators, we identified risk factors for each study, adapting and changing management and operational plans where appropriate. We also reached out to sponsors to ask what risk assessments they had completed incorporating their requirements into an overall COVID-19 response strategy. And we worked with our biometrics team to ensure that we capture any additional information about COVID-19 to determine what its impact would have on the safety and efficacy of the study.

Getting a Plan in Action

Here’s how we’re tackling risk assessment in the time of COVID-19:

  • First, we reach out to sponsors to get informed on steps they’ve completed. Have they done a revised risk assessment? Have they made any study conduct decisions?
  • Next, we hold an internal risk assessment meeting with stakeholders – such as the project manager and leads – to first identify risks, then agree upon mitigation plans. Risks are identified by asking core project questions, such as evaluating what the overall objectives are for the trial and what the critical data and endpoints are, reviewing every possible risk and opportunity conceivable, including probability and detectability. We also assess any ongoing or emerging risks because of COVID-19.
  • We bring our results to a meeting with the sponsor, focusing on high-impact, high-probability risks that can be detected centrally or onsite, and present our mitigation plans.
  • Finally, we monitor the plans for any ongoing risk assessment.

Having a risk assessment plan is not about checking boxes and filling out a spreadsheet. It’s about taking the time to consider every factor that could possibly be a threat in this new environment.

Is all this effort really necessary? Of course, the answer is a resounding yes. As this situation rapidly evolves and more information comes to light about the virus itself, the safety of the patient and the trial integrity could change. Tackling risk assessment and taking the steps now ensures all regulation requirements are met, all parties are safe, and your trial and data remain compliant and effective as we navigate into our new future.

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