Clinical Studies Continuity in Jordan during COVID-19

  Clinical trials in Jordan & all over the world are disrupted amid corona virus outbreak; the pandemic is affecting clinical trials continuity in all the regions.

   Since the Corona virus outbreak is dynamic, the situation is forcing governments all over the world to take strict measures to contain & control the pandemic. In Jordan the government announced total lock-down measures starting from 20th of March in an attempt to control the spread of the novel Coronavirus disease.

    At Jordan Food & Drug Administration (JFDA) we were prompt & proactive to take decisions regarding Clinical Trials & Bioequivalence studies conducted/to be conducted in Jordan.

   A decision to stop all studies (Bioavailability/Bioequivalence) on healthy volunteers was taken on 15th of March by JFDA & the clinical studies committee within JFDA, this decision was effective on all Bioavailability/Bioequivalence studies whether approved but not conducted or even studies that commenced with one period or more. This decision was aiming mainly to preserving the health & welfare of both study volunteers and study staff; & it was in-line with the then recommendations by the government to restrict crowdedness & close encounters between people. 

   And as the infected cases with Corona Virus in Jordan increased, a decision was taken by JFDA regarding the clinical trials conducted on patients on 19th of March; these studies are critical since they have many different conditions to treat & involve different types of treatments & the enrolled patients may sometimes have vulnerable immunity.

   The decision was halting enrollment in ongoing studies, and delaying the launch of new trials. Putting the brakes on clinical trials in Jordan.

   Regarding ongoing clinical trials for patients who are already enrolled, we are committed to keep the supply chain of investigational drugs open & ongoing for these studies, but regarding the continuity of these studies; the decision was left in the hands of the study (CRO, IRB/IEC, PI & The Sponsor) to decide; without compromising both the health status & wellness of enrolled patients as well as the safety of healthcare providers & study staff.

   Amid this pandemic that continues to disrupt the daily lives of millions around the world, all parties involved in clinical trials are re-evaluating their work putting safety of study staff, patients, & healthcare professionals first. They are aiming to minimize disruption of clinical trials by deploying remote-based activities such as virtual doctor assessments, virtual patient visits, remote auditing of clinical-trial procedures; and so on.

Finally, always keep in mind that life will go on & this crises will end , we have to be optimistic and believe that there is light at the end of the tunnel.