Section 7: Clinical trials and drug discovery in COVID-19
What are the main
recommendations for organizing clinical trials during the COVID-19
pandemic?
Adaptations for clinical trials during the pandemic must include all
concerned parties such as patients, clinical research organizations,
clinical trial units, ethical committees, regulatory authorities and
sponsors. Major changes must be approved by the responsible ethical
committee and covered by the Informed Consent Form. Additional risks to
participants should be addressed in the benefit-risk assessment section
of the protocol, together with risk reduction
measures.108 Patients who continue study participation
should postpone site visits or, whenever possible, be replaced by remote
data assessment via telemedicine under strict observation of data
protection regulations. If needed, the duration of stay in the clinic
should be limited and travel arranged to include alternatives to local
public transport. The initiation of new clinical trials should be
critically evaluated. The International Committee of Medical Journal
Editors has clarified that in the event of public health emergencies
such as COVID-19, information relevant for the public health should be
disseminated because this would not preclude subsequent publication in a
scientific journal.118