Its Time To Restart Clinical Trials in the US 
(Thursday, April 15, 2021)
With wider vaccination and easing of mobility restrictions in the US, this is the time to restart clinical trials suspended or postponed last year due to the pandemic. But it may not be as simple; there are five areas of consideration for clinical trial restart. First, availability of human resources is still not at the pre-pandemic levels at most clinical trial sites. Last year, March-June saw a big drop in ongoing clinical trials as the pandemic raged on. Many institutions had to lay off or furlough their clinical research staff for lack of work and unpredictability of the duration of the stoppage. The ability of a site to restart clinical trials depends on their ability to bring back those professionals. So, check with your sites if they have adequate staff to conduct your study. Second, clinical research supplies that were procured a year ago may have expired or have other defects. The investigational product, supporting material such as concomitant drugs, equipment such as syringes and tubing, and PPE may not have survived the storage. Many supplies are still in shortage. So, make sure that you have the supplies to conduct your study. Third, the access to patients and recruitment tools have changed in the last year. Advertisement material displayed in waiting rooms is no longer an option as patients are still hesitant to visit clinics. Social media advertisement may work but there is so much Covid related noise that the clinical trial recruitment related information is easy to drown in that noise. The cost of digital marketing has also increased due to demand. So, make sure you have pools of potential participants for your trial. Fourth, many Covid related policies such as requirements of masks and social distance protocols are still in place. So, in person visits to the clinics and group activities are still not feasible. Protocols and procedure manuals need to be updated to address these changes. Fifth, most institutions are requiring re-approval of the trials suspended last year with detailed plans addressing the above considerations. Almost everyone would need a current IRB approval as well. These could add to the time to re-start. Plan for it. The pandemic forced shutdown of almost all clinical trial activities for 14 months. Now, as things get back to the new normal, clinical trials will need to change somewhat before they can be restarted.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: [email protected]
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