- an overview of useful guidelines issued by regulatory agencies in Europe and the U.S.
- some practical considerations related to risk assessments that sponsors must conduct to determine next steps for their trials and patients
- guidance on how a sponsor may tackle changes to its clinical trials due to COVID-19
1. COVID-19: Related Regulatory Guidelines on Clinical Trials
European Union (EU). The European Commission, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) recently jointly published recommendations for sponsors on how to manage the conduct of clinical trials in the context of COVID-19. Their guidance covers, inter alia:
- potential changes that sponsors might need to make in the distribution of a trial drug
- changes that sponsors might want to consider in the monitoring of the trial
- how sponsors may deal with potential protocol deviations
The EMA also issued draft guidance regarding implications of COVID-19 on methodological aspects of ongoing clinical trials. This draft guidance, open for a special short public consultation until April 25, 2020, sets out important points that sponsors of ongoing clinical trials should consider, including:
- planning of how systematic deviations resulting from the measures and individual decisions related to the COVID-19 pandemic are captured
- diligent collection of pandemic-related measures and potentially affected patients, including subpopulations to study the impact on the treatment effect in exposed/nonexposed and affected/nonaffected patients
- conducting risk-assessment of COVID-19 potentially affecting patients and COVID-19 related measures affecting clinical trial conduct
While this guidance is useful, in the EU clinical trials are subject to authorization by the member states’ national competent authorities (NCAs). Any changes to the trial’s benefit-risk ratio or deviations from the protocol need thus to be reported to the relevant NCA(s) and/or Ethics Committee (EC) of the members in which the clinical trial is taking place. This would also include the reporting of potential risks of shortages or availability of investigational and other drugs dispensed as part of the trial.
- Belgian Federal Agency for Medicines and Health Products
- Danish Medicines Agency
- Dutch Health and Youth Care Inspectorate
- French National Agency for the Safety of Medicines and Health Products
- German Federal Institute for Drugs and Medical Devices
- Italian Medicines Agency (available in Italian only)
- Spanish Agency for Medicines and Medical Devices (available in Spanish only)
- Swiss Agency for Therapeutic Products and Swiss Ethics Committees
- UK Medicines and Healthcare products Regulatory Agency
United States (U.S.). The Food and Drug Administration (FDA) issued a Final Guidance on the Conduct of Clinical Trials of Medical Products during the COVID-19 pandemic. The Guidance, which applies to trials of human drugs, biological products and medical devices, addresses potential changes to clinical trials resulting from, among other things, quarantines, site closures, travel limitations, interruptions to supply chain for the investigational product, and infection of patients and/or investigators.
FDA’s key directive is that the safety of trial participants is paramount. FDA advises that any changes made should be consistent with the protocol to the extent possible and should be fully documented with specific information about the relationship to COVID-19 in the clinical study report.
- a discussion of contingency measures to manage trial conduct during disruption
- a listing of all participants affected by a COVID-19-related disruption
- analyses and corresponding discussions that assess the effect of implemented contingency methods on safety and efficacy results of the trial
FDA also advises sponsors, clinical investigators and institutional review boards (IRBs) to ensure that they develop policies and procedures for protecting trial patients and managing trial conduct during disruptions due to COVID-19. These policies and procedures should address, among other things, impact on the informed consent process, study visits and procedures, data collection, study monitoring, adverse event reporting and quarantine measures or COVID-19 itself.
China. During the COVID-19 pandemic, China has been encouraging investigator-initiated studies to explore effective therapies. The Ministry of Sciences and Technology (MOST) is taking the lead to oversee such studies. MOST requires that (i) the studies should be conducted on drugs that are already approved for market in China, (ii) the study drugs should have certain efficacious effects proven through in vitro or animal studies before being administered on humans and (iii) the studies should follow the approved label of the study drugs in terms of administration route and dosage. Notably, the National Medical Product Administration, the drug regulatory agency of China, has issued clinical trial approval for such studies, which it has never done in the past.
2. Evolving Environment, Evolving Risk Assessment
The first step a sponsor should take in light of potential COVID-19 disruptions to its trials is a risk assessment. This is because the risks and disruptions caused by the pandemic may affect the benefit-risk ratio of a clinical trial.
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