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A medical device manufacturer of cameras for health research entered into an MoU with a non-profit research institute. The investigator is a collaborator in the research institute, which will provide data to the company? Can EC registered with Department of Health Research (DHR) give approval for this academic study?
Dr Sreevatsa
The EC should review - Who is the sponsor of clinical trial? Who is the investigator? What does CT agreement describe about finance/sponsor responsibility?
The sponsor is a company manufacturing a device – camera for health research. So the purpose of study is likely to be commercial. The EC should also check whether the investigator has any commercial interest in the study and whether the sponsor team are part of investigator team. Although the device appears non-invasive, EC has to assess risk of the results of the study. For example, if the camera is used for diagnostic purpose, EC should understand the risk of giving wrong diagnosis to the patients. Considering these issues, it appears that this not an academic trial. So there is no role EC for DHR. The sponsor should get approval of this trial from the CDSCO.
What are serious breaches in clinical trial? When should a sponsor notify regulatory authorities?
Durgesh Mehta
European Medicines Agency on June 30, 2023 notification on serious breaches of the regulation or clinical trial protocol defines serious breaches and mandates following:
Suspected serious breach means an incident which at the time of communication from investigators or from service providers to the sponsor has not yet been assessed by the sponsor to be a serious breach.
Serious breach: Any deviation of the approved protocol version or the clinical trial regulation that is likely to affect the safety, rights of trial participants and/or data reliability and robustness to a significant degree in a clinical trial.
The judgement on whether a breach is likely to affect the reliability and robustness of the trial data depends on a variety of factors, for example: the design of the trial, the type and extent of the data affected by the breach, the overall contribution of the affected data to key analysis parameters, the impact of excluding the data from the analysis etc.
If persistent or systematic non-compliance with the Regulation including deviation from the principles of the GCP or the protocol, is likely to significantly affect the safety and rights of a trial participant in the EU/EEA or on the reliability and robustness of the data of the trial, this will constitute a serious breach. If a systematic and/or significant miss dosing occurred, this would still meet the criteria for a serious breach regardless of whether or not the trial participant(s) suffered adverse reactions as a result of that miss dosing.
Due to the special nature of fraud it is expected that all concerns about potential cases of fraud in clinical trials which the sponsor becomes aware of are reported as serious breaches.
If the sponsor has reasonable grounds based on evidence to believe that a serious breach has occurred, it is expected to report the serious breach first, within 7 days, and investigate and act simultaneously or after the notification. The sponsor should ensure, by means of a written contract that all parties involved in the conduct of the clinical trial, according to their area of responsibility, immediately report any events that might meet the definition of a serious breach to the contact point designated by the sponsor.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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