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Investigational product should be suitable for delivery to participant


Wednesday, December 1, 2021, 08:00 Hrs  [IST]

We have received clinical research proposals funded by govt agencies. Which Ethics Committee is supposed to approve such projects?
Dr Sreevatsa

New Drugs & Clinical Trials Rules 2019 lists twoEthics Committees:
•    Chapter III Ethics Committeefor ClinicalTrial, Bioavailabilityand Bioequivalence Study.
•    Chapter IV Ethics Committeefor Biomedical and Health Research.
Choice of approving Ethics Committee depends on the type/objective of study - Clinical trial or Biomedical and Health Research as defined below:

“Clinical trial” in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its - (i) Clinical or; (ii) Pharmacological including pharmacodynamics, pharmacokinetics or; (iii) Adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug.

“Biomedical and Health Research” means research including studies on basic, applied, and operational research or clinical research, designed primarily to increase scientific knowledge about diseases and conditions (physical or socio-behavioural); their detection and cause; and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation but does not include clinical trial as defined in clause  
If the objective of the project is clinical trial of a new drug, the approval should be from Ethics Committeefor Clinical Trial, Bioavailabilityand Bioequivalence Study.

If the objective of the project is Biomedical and Health Research, the approval should be from Chapter IV Ethics Committeefor Biomedicaland Health Research.

Same Ethics Committee can approve both these types of projects if it has two registrations - 1) CDSCO and 2) Dept of Health Research – ICMR.

What are the important considerations in supplying investigational product to digital trial participants?
Dr Surendra Joshi

The investigational product should be suitable for delivery to the participants and for being ingested/administered at and returned from their homes. Investigational product whose stability and safety profile is not adequately characterized e.g., early stage of development is unsuitable for dispensing and administration to the trial participants at home. Investigational products requiring preparation, e.g., in a sterile environment, before administration or those that are associated with a high risk of possible adverse reactions e.g., anaphylactic shock are not suitable as well. Precautions must be taken to ensure the medical care of trial subjects who suffer from adverse events/reactions during or after the administration/ingestion of the investigational product.

If trial participants are supplied investigational product directly, they should be given appropriate information about correct storage and use of the investigational product. Steps must be taken to ensure that personal data of the participant are protected from unauthorised or accidental disclosure.

When the investigational product is dispensed outside the trial site, the requirements of Good Manufacturing Practice should be fulfilled.

What are the challenges for data capture outside the clinical trial site using mobile technologies?
Vaishali Thakkar

In such trials, there is a risk that only individuals experienced in using technically would take part in the trials. Hence, a representative sample of trial participants must be ensured to avoid a selection bias. The data-recording tools e.g., wearables should generate correct and valid data. The mobile technologies used should be validated and comply with the relevant standards of accuracy, precision, reproducibility, and reliability.
The trial participants should have given their prior consent to data being recorded by the mobile/wearable device and should be trained in the correct use of the mobile technologies.

The sponsor should have defined process to ensure that the recorded data originate from the trial participants or were generated by the trial participants. The sponsor should not have any access to personal or identifiable information relating to the trial participants.

 

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