BY YAJIE LI, FRANK GAO, & YUEXIA LI - REGULATORY & ACCESS Consulting, PAREXEL INTERNATIONAL
Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special considerations. In China, in order to establish clear guidelines to optimize clinical trials during COVID-19, the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of the P.R.C (People’s Republic of China) summarized NMPA’s management experience and solicited the external opinion from the industry, including investigator and sites. This resulted in the introduction of Guidance for the Management of Clinical Trials during the COVID-19 pandemic, which was implemented in July 2020. The objective, scope and key points for the guidance are summarized as below.
The objective: To protect subjects’ safety and encourage responsibility by the sponsor to ensure the quality of clinical trials and data authenticity, accuracy, integrity and traceability.
Scope: The guidance applies to all drugs being developed during the COVID-19 pandemic, including COVID-19 drugs seeking emergency approval.
- Basic principles:
- Subject protection principle: Clinical trials should be conducted to protect the rights and interests of the participants even during the extreme circumstances of a pandemic. Specifically, during the pandemic, all clinical trial participants should take personal protective measures in accordance with the national COVID-19 pandemic prevention and control requirements. In particular, personal protective management should be strengthened to effectively protect subjects.
- Pharmacovigilance and risk management: The sponsor should reinforce the establishment of a pharmacovigilance system during clinical trials and frequently update and improve the risk management plan, protocol and informed consent form (ICF) according to the pandemic situation
- Follow good clinical practice (GCP): Sponsors and investigators shall evaluate in a timely manner the risk of protocol deviations caused by the pandemic, truthfully record the deviation according to relevant requirements, and report to the Ethics Committee (EC) in timely manner if the safety of subjects is impacted. During the pandemic, there will be changes in clinical trial protocols, changes in trial sites, the addition of new investigators and communications among all parties, which should be accurately recorded and archived for future reference.
- Management of clinical trials of COVID-19 drugs:
- Strengthen timely reporting and risk assessment of drug clinical trial information: The sponsor shall report the progress and safety summary information of clinical trials for COVID-19 drugs to CDE on a daily basis. Prior to the initiation of clinical trials, sponsors shall complete and submit protocols, IB, ICF and EC approval letters to CDE. If relevant documents are updated during the clinical trial, they should be reported in a timely manner to the EC and CDE.
- The impact of COVID-19 pandemic should be considered in the design and implementation of a clinical trial.
- Site selection: Designated hospitals for the treatment of COVID-19 that have not been filed as drug clinical trial institutions shall complete the filing in accordance with relevant regulations. For special cases such as makeshift hospitals and medical treatment teams, it is necessary to communicate and confirm with regulatory authority in advance.
- On-site monitor and audit: the on-site monitoring for clinical trials shall be carried out with the consent of the clinical trial site. All audit activities should be postponed or cancelled during COVID-19 pandemic. For critical trials where an audit is considered essential, an on-site or remote audit may be carried out when an agreement is reached with the investigator and clinical trial site.
- Management of clinical trials for all other drugs during the COVID-19 pandemic: During the COVID-19 pandemic, all aspects of clinical trial management are still in effect and all relevant rules and regulations need to be followed. All measures taken in response to the pandemic should be aimed at maximizing the safety of subjects, ensuring the quality of trial data to the extent possible, and minimizing the impact of the pandemic on the integrity of the clinical trial.
- Application of digital technology in clinical trials during the COVID-19 pandemic: During the COVID-19 pandemic, sponsors may choose to utilize digital technology to remotely manage the clinical trial. All aspects of such clinical trial management must be well planned and GCP compliant. Additionally, communications with regulatory authorities on the use of technology is highly recommended.
How Parexel can help:
Our 1,000+ consultants worldwide, including 80+ former regulators / inspectors / assessors, are optimally positioned to understand just what type of information biopharmaceutical companies need to share with the NMPA for their products and how to effectively collaborate to develop the most effective regulatory and product development strategies for new potential treatments in the combat against COVID-19 and other critical diseases.
Information cited in this article is from: