The Technical Note 22/2020 gathers a series of guidelines aimed to sponsors, research centers and researchers involved in the conduct of clinical trials authorized by Anvisa and bioequivalence studies.
Clinical trials authorized by Anvisa may be affected as a result of the pandemic, in various ways, such as isolation or quarantine of clinical trial participants; participants and/or personnel involved in conducting clinical trials being infected by the new coronavirus; closures of clinical research centers; restricted movement of participants; restriction in the availability of health professionals to perform clinical trials. In this context, modifications to the clinical protocol may be necessary in order to adapt it to the new reality.
Clinical trials on drugs for COVID-19:
Anvisa along with the General Management of Medicines and Biological Products (GGMED), which analyzes, the priority requests for consent of clinical studies with drugs for prevention and treatment of COVID-19, within an average of 72 hours after the formal submission of the protocol.
Due to the circumstances of the pandemic, the sponsors monitoring these studies should use alternative criteria and approaches to ensure participant safety and the integrity of trial data, such as:
- A selection of centers with experience in clinical research in order to guarantee adequate compliance with GCP.
- Risk-based monitoring, with detailed definition of the criteria to be used to verify study data.
- Preference to use electronic Case Report Form (CRF) to record all required information by protocol.
- Definition of procedures for how remote monitoring will be performed.
- The type of monitoring approach (face-to-face, remote, centralized) should be described in the protocol and consent term (TCLE).
- In case the Sponsor chooses to conduct centralized monitoring, there should be training and meetings with investigators, and extensive written guidance to ensure the proper conduct of the study in accordance with GCP and the protocol.
- Monitoring reports should be provided in a timely manner to the sponsor for review and follow-up.
Clinical trials with medical devices for COVID-19:
Clinical trials involving medical devices should when applicable refer to Resolutions RDC 375/2020 and 10/2015.
At the time of submission of the clinical trial, the technical information related to the requirements for the performance of the device should be added, considering the medical needs related to the combat of COVID-19.
For bioequivalence studies not yet started, it is suggested to postponement the first and the other periods of hospitalization of the research subjects, in accordance with the local contingency measures established by the health authorities.
For bioequivalence studies already started in which one or more periods of hospitalization have not yet been performed, it is suggested the postponement of these periods. In this case, the potential impacts of this postponement should be described in the final reports of the study.
About Global Regulatory Partners
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