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Clinical trials for medical devices are different from clinical trials of drugs

Dr Arun Bhatt
Wednesday, November 1, 2023, 08:00 Hrs  [IST]

How clinical trials for medical devices differ from clinical trials of drugs?
Shyamal Talgaonkar

For clinical trials for medical devices, phase wise approach of clinical trials of new drugs is not relaxant.
The clinical trials for medical devices are:
    • Pilot studies in small numbers - 10-30 patients - to assess preliminary safety and performance
    • Pivotal studies in 150-300 patients to assess efficacy and safety
    • Post approval long term follow-up for monitoring safety and effectiveness
For in-vitro medical diagnostic device, the clinical trial conduct/protocol is based on developing a highly sensitive and valid laboratory test.

Should academic clinical trials be conducted as pilot study?  
Dr Harish Kumar Sagar
Academic clinical trials should follow the accepted scientific principles for study design and statistical considerations. Only difference between academic and industry clinical trials is the purpose of clinical trial.
As per NDCTR 2019, academic clinical trial means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used only for academic or research purposes and not for seeking approval of the Central Licencing Authority (CLA) or regulatory authority of any country for marketing or commercial purpose.
(1) No permission for conducting an academic clinical trial shall be required for any drug from the Central Licencing Authority where,
(i) the clinical trial in respect of the permitted drug formulation is intended solely for academic research purposes for a new indication or new route of administration or new dose or new dosage form; and
(ii) the clinical trial referred to in clause (i) has been initiated after prior approval by the Ethics Committee for clinical trial; and
(iii) the observations generated from such clinical trial are not required to be submitted to the Central Licencing Authority; and
(iv) the observations of such clinical trial are not used for promotional purposes.

Can a foreigner participate in a clinical trial in India?
Thrisha Naik
Participation of a foreign national in a clinical trial in another country requires consideration of legal, regulatory, and ethical issues. As per ICMR Ethical Guidance for bio-medical research, immigrants are considered vulnerable population. On occasion, National Institutes of Health USA accepts international patients as clinical research participants. However, those patients arriving from abroad will need to obtain a B-2 temporary visitor’s visa for medical treatment prior to entering the United States for medical treatment. There could also be logistical issues e.g., costs of the baseline therapy in cases where the experimental treatment was an add-on, medical insurance, compensation, language. Inclusion of a foreigner in clinical trial in India would require approval of ethics committee and regulatory authorities.

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

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