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Real World Evidence studies need review by Ethics Committee


Wednesday, November 4, 2020, 08:00 Hrs  [IST]

Can a site obtain approval of independent ethics committee for a clinical trial project?
Deepti Goel


New Drugs and Clinical Rules 2019 permit approval of a clinical trial independent Ethics Committee under certain conditions in  
Rule 25. Conditions of permission for conduct of clinical trial
(ii) where a clinical trial site does not have its own Ethics Committee, clinical trial at that site may be initiated after obtaining approval of the protocol from the Ethics Committee of another trial site; or an independent Ethics Committee for clinical trial constituted in accordance with the provisions of Rule 7:
•    Provided that the approving Ethics Committee for clinical trial shall in such case be responsible for the study at the trial site or the centre, as the case may be

•    Provided further that the approving Ethics Committee and the clinical trial site or the bioavailability and bioequivalence centre, as the case may be, shall be located within the same city or within a radius of 50 kms of the clinical trial site

Can a sponsor supply investigational product to a clinical trial participant at home?
Rupa Deshpande

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency July 2020 recommends:
If scheduled visits at clinical sites will be significantly impacted, certain investigational products, such as those that are typically distributed for self-administration, may be amenable to alternative secure delivery methods. For other investigational products that are normally administered in a health care setting, consulting FDA review divisions on plans for alternative administration (e.g., home nursing or alternative sites by trained but non-study personnel) is recommended. In all cases, existing regulatory requirements for maintaining investigational product accountability remain and should be addressed and documented.

If there is concern about risk of exposure to COVID-19, home delivery of investigational product that would not raise any new safety risks may be implemented to protect patients from coming to clinical trial sites. In all cases, requirements under FDA regulations for maintaining required investigational product storage conditions and investigational product accountability remain; these requirements must be addressed and documented. If the protocol indicates pharmacy dispensing for self-administration at home, and this is changed to direct-to-patient shipments, then a protocol amendment would be required to permit home delivery of investigational product. If the extent of home delivery is limited to certain participants and not the entire population described in the protocol, documenting the change in the mechanisms of distribution of investigational product administration through protocol deviations may also be acceptable.

If a sponsor is considering providing alternative arrangements for administration of the investigational product infusion  (e.g., home nursing or alternative sites by trained but non-study personnel), the sponsor is expected to perform a risk assessment that considers the nature of the investigational product and the potential risks to both the trial participants and the health care providers responsible for administering the product at the alternative site. This risk assessment should include assessment of risk mitigation strategies. Based on this risk assessment, sponsors should consider whether consulting the appropriate FDA review divisions regarding plans for alternative arrangements for administration of investigational products that are usually administered in a health care setting is warranted.

In all cases, applicable requirements for maintaining required investigational product storage conditions (prior and after reconstitution), investigational product reconstitution specifications per the Investigator’s Brochure, and investigational product accountability remain and must be addressed and documented. Storage conditions and investigational product accountability should be considered if the protocol is amended to permit alternative site infusions.

We plan to conduct Real World Evidence study. Is EC approval necessary for such studies?
Nitin Sawant

Real World Evidence studies include observational studies e.g. retrospective cohort, case-control study, cross-sectional study, community survey, longitudinal study, registry etc. As per ICMR 2017 National Ethical Guidelines, proposals with less than minimal risk where there are no linked identifiers, can be exempted from review by EC. However, Real World Evidence studies are conducted on identifiable patient records. Such studies require review by EC.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com

 

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