The normal conduct of clinical trials has been significantly impacted across the globe by COVID-19, and every healthcare institution and pharmaceutical company has had to rapidly adapt. The global economy is struggling and industries in every sector have responded with amazing courage and tenacity in the face of an unparalleled threat. Our regulatory experts are closely following the evolution of regulatory guidance on COVID-19 and the approach taken by global regulatory agencies.
When the pandemic was first declared, a task force was assembled within IQVIA to develop COVID-19 mitigation measures which would safeguard patients and clinical research staff in every setting. The use of COVID-19 mitigation measures was encouraged by global regulators and the message came through strongly that pragmatism and patient safety were the priority for the conduct of clinical research. We have supported our customers to navigate the changing COVID-19 landscape and to ensure that vital treatments for patients continue as much as possible.
We are now living a new normal with a global pandemic. And in the pharmaceutical industry, where mitigation measures were first thought to be temporary, all sponsor companies conducting clinical research should now consider permanently building COVID-19 protection measures into study protocols for the long term. At IQVIA Biotech we are working closely with our customers to help them permanently amend protocols to face new realities. Planning for the unexpected and preparing staff is imperative to meet the new risk we see emerging worldwide.
The most important theme that has emerged from global regulators has been the real-time and continuing risk-benefit assessment for all clinical trials. Assessing the risk of starting a new study during a global pandemic is critical; as is the ongoing and real-time risk assessment of clinical research occurring now. Never has risk assessment been so important to support decisions made in a study and to ensure patient safety. We recommend performing risk assessments at the study level, site level, and patient level that are recorded and evaluated on an ongoing basis.
We are now moving into a period where audits are expected from regulators and it is important that all organizations prepare for heightened scrutiny of the COVID-19 period in the TMF and the ISF over the next few months. Documentation should be in place for every clinical trial and a “COVID-19 story” describing actions taken globally and the risk benefit assessment for studies at the country, site and patient level. IQVIA Biotech is working with our customers to ensure patient safety, data integrity and audit readiness across the globe.
Click to review FDA and EMA guidance on clinical trial management during the COVID-19 pandemic: