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