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Clinical trial on herbal extract could be conducted using classical preparations

Dr Arun Bhatt
Wednesday, December 4, 2019, 08:00 Hrs  [IST]

Is it necessary for EC to review content of MoU for collaborative research?

Dr Sreevatsa

EC should review MoU as the research proposal could have several ethical considerations. ICMR guidance 2017 recommends EC review of MoU for several issues (see below):

3.3.2 Data acquisition, management, sharing and ownership.

Ownership issues and responsibilities need to be carefully worked out well before data are collected and researchers should ensure clarity about data ownership, publication rights and obligations following data collection. MoUs vetted by the institution and/or EC should be in place.

3.8.1 Ethical considerations in collaborative research.

If there is exchange of biological material involved between collaborating sites, the EC may require appropriate MoU and/or MTA to safeguard the interests of participants and ensure compliance while addressing issues related to confidentiality, sharing of data, joint publications and benefit sharing, etc.

Can allopathy doctor/MD pharmacology resident conduct clinical trial on herbal extract?
Dr Swapnil Agarwal

Clinical trial on herbal extract could be conducted using classical preparations or patent or proprietary products.

ICMR Box 7.7 Classification of drugs/formulation under Ayush.

1. Classical preparations/formulations are those that are to be clinically evaluated for the same indication for which it is being used or as has been described in classical authoritative texts. These classical drugs are manufactured and named in accordance with the formulations described in the authoritative texts.

2. Patent or proprietary products are formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda (or Yoga, Naturopathy, Unani, Siddha, Homoeopathy, SOWA–RIGPA systems, as the case may be), medicine specified in the first schedule, but differ to create a new combination, or use innovation or invention to manufacture products different from the classical medicine. However, this group does not include a medicine which is administered by parenteral route.

If an allopathy physician wants to conduct clinical trial on herbal extract, ICMR guidelines 2017 should be followed:

7.13.2 If IPs/comparators of more than one traditional system of medicine are to be investigated, then investigator(s) from the respective systems should be included in the study as co-investigator(s).

7.13.3 The EC must co-opt a person with relevant expertise (an expert of that traditional system of medicine) to review the proposal, especially the benefits and risks of the intervention, eligibility criteria, doses of interventions, outcomes planned and traditional method of evaluation, if necessary.

7.13.5 While conducting trials using intervention(s) of traditional medicine, the investigator must ensure the quality of the interventional product.

Is there any upper limit of blood collection during BA/BE study?
Dr Samir Advani

ICMR guideline 2017 recommends: The amount of blood drawn for a BA/BE study should be within physiological limits irrespective of study design.

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

 

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