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THE PHARMA REVIEW (SEPTEMBER OCTOBER 2020)

Conducting Clinical Trials and Safety Reporting in COVID-19 Situation

Dr. Neha S. Arora, Dr. Manoj Karwa & Dr. Saurabh Arora

Introduction: The COVID-19 public health emergency has largely impacted the conduct of clinical trials of medical products. The conduct of clinical trials has been impacted due to quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, and sometimes the site personnel or trial participants become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. The different regulatory agencies has come up with specific guidelines on management of ongoing or new clinical trials and safety reporting during this COVID-19 situation. These guidelines discuss about various alternative approach to traditional process while assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The first guidance documents from US FDA on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency was published on March 2020 and recently a update was published on September 21, 2020.

 

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