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Is it necessary for sponsor/investigator to get ethical clearance for the clinical trial on medical device before submitting to SEC through CDSCO? Will the SEC scrutinize the documents related/reviewed by EC. Who submit the proposal sponsor or investigator?
Dr Sreevatsa
As per CDSCO FAQs on NDCTR 19
• Submission and approval of clinical trial by Ethics Committee (EC) and CDSCO may go in parallel. However, if EC approval is available, the same should be submitted along with the application to CDSCO.
• The approval granted by the EC of each site shall be intimated along with copy of such approval to the CLA within a period of 15 working days of such approval.
SEC reviews regulatory documents submitted for clinical trial approval (CTA). This could include EC approval letter, if submitted as part of clinical trial approval.
CDSCO usually gives conditional approval asking the sponsor/investigator to get the EC clearance before initiation of the trial. The approval letter mentions that clinical trial at each site shall be initiated after approval of the clinical trial protocol and other related documents by the EC of that site, registered with the Central Licencing Authority under Rule 8.
The sponsor or CRO would submit the clinical trial approval application to CDSCO. The investigator should submit the application for EC approval.
Is it necessary for a sponsor to obtain ethics committee approval for real-world studies?
Dr Alan Dsouza
Data for real-world studies comes from a variety of sources – Electronic Health Records (EHRs), registry data, claims data, patient-reported outcome data, and data collected from wearables. This data is usually collected for documentation and monitoring of the health status of patients. However, when such real-world data are used to generate evidence in academic research or for regulatory submission, following ethical issues should be considered:
Privacy: the right of an individual to control or influence the information that can be collected and stored by whom, and to whom that information may be disclosed or shared.
Confidentiality: the obligation of the academic researchers, and medical institutions, to the participant to safeguard the entrusted information.
Data sharing: The clinician/medical institution should ensure the protection of patient’s privacy when they share patient’s data with the industry, other institutions, and other researchers.
• Data De-Identification - The medical institution which has a repository for patient data should have a standard operating process for storing such data in de-identified - anonymized format.
• Informed Consent - The patients are not aware that their medical data collected routinely would be used for real-world research studies and would be shared with other institutions or pharma industry. Hence, informed consent would be a crsitical consideration for real-world studies.
• For real-world studies with prospective design – survey, registry, pragmatic trial, informed consent is essential
• For real-world studies with retrospective design-case–control, cross-sectional study, cohort study – the academic researcher or the investigator should provide justification for rationale for waiver of informed
The Ethics Committee should consider all ethical issues with a specific focus on:
• Purpose of the study – academic, commercial.
• Risk–benefit assessment.
• Scientific design.
• Protection of privacy and confidentiality.
• Informed consent process – waiver.
• Applicable international rules for global registry, e.g., GDPR, Health Insurance Portability and
Accountability Act.
• Data de-identification-anonymization.
• Collaboration with other local or international institutes - data sharing.
• Registration of study in Clinical Trials Registry - India.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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