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BE guidelines regarding investigator

BE guidelines recommend investigator should possess appropriate medical qualification, experience for conducting pharmacokinetic studies

Can chairperson of EC directly write to sponsor to clarify some of the queries of clinical trial raised in EC meeting?
Dr. Sreevatsa

Please see an extract from FDA's comment on IRB-sponsor relationship.

The interrelationship and interaction between the research sponsor (e.g., drug, biologic and device manufacturers), the clinical investigator and the Institutional Review Board (IRB) may be very complex. The regulations do not prohibit direct sponsor-IRB contacts, although, the sponsor-IRB interaction customarily occurs through the investigator who conducts the clinical study.

The clinical investigator generally provides the communication link between the IRB and the sponsor. Such linkage is agreed to by the sponsors and investigators when they sign forms FDA-1571 and FDA-1572, respectively, for drug and biologic studies or an investigator agreement for device studies. There are occasions when direct communication between the IRB and the sponsor may facilitate resolution of concerns about study procedures or specific wording in an informed consent document. The clinical investigator should be kept apprised of the discussion.

In the scenario you have described, it is the investigator who is asking EC to approach sponsor. This is not acceptable. The EC has to put questions to investigator and he has to get responses from sponsor.

Is it mandatory to be a principal investigator (PI), one needs to be a clinical pharmacologist, or qualified (medical graduate without specialization) with enough experience can perform the duties of PI for BA/BE studies in particular and clinical trials in general?
Dr. K. Sudhakar Reddy
None of the guidelines prescribe a degree for the PI. The guidelines stress on training and experience for carrying out all responsibilities of PI as required by the protocol, GCP, and regulations.

Indian BE guidelines recommend:
The investigator should possess appropriate medical qualification and relevant experience for conducting pharmacokinetic studies.

Indian GCP recommends:The investigator should be qualified by education, training and experience to assume responsibility for the proper conduct of the study and should have qualifications prescribed by the Medical Council of India (MCI).

Schedule Y and Indian GCP recommend the need for a clinical pharmacologist for phase I, see the definition:
Human/Clinical pharmacology trials (phase I).
Phase I trials are usually carried out by investigators trained in clinical pharmacology and having the necessary facilities to closely observe and monitor the subjects.
However, for phase II-III trials, the PI has to be qualified in the discipline and experienced. E.g. for a study in stable angina, the PI has to be an MD who is licensed to practice as a physician and who is treating/managing such patients. However, if the trial includes angioplasty, she/he has to be a cardiologist who is experienced in the procedure.

What is the current situation of regulations for medical devices? Rajesh Krishnan
The regulatory approach to devices is under development. In general DCGI office treats device along the drug lines. In August 2010, CDSCO has released to draft guidance for common submission format for registration of medical devices in India requirements for conducting clinical trial(s) of medical devices in India.

Is there any guideline in ICMR, DCGI regarding herbal related trial?
Ayush has recently released guidelines on GCP for clinical research on Ayurveda, Siddha and Unani medicines and other traditional medicine.

Indian GCP covers a section on Herbal. The approach to regulatory depends on the category of product described in the guidelines.(see below).

7.5.1. Categories of Herbal Products
The herbal products can belong to any of the three categories given below:

a) A lot is known about the use of a plant or its extract in the ancient Ayurveda, Siddha or Unani literature or the plant may actually be regularly used by physicians of the traditional systems of medicine for a number of years. The substance is being clinically evaluated for same indication for which it is being used or as has been described in the texts.

b) When an extract of a plant or a compound isolated from the plant has to be clinically evaluated for a therapeutic effect not originally described in the texts of traditional systems or, the method of preparation is different, it has to be treated as a new substance or new chemical entity (NCE) and the same type of acute, sub acute and chronic toxicity data will have to be generated as required by the regulatory authority before it is cleared for clinical evaluation.

c) An extract or a compound isolated from a plant which has never been in use before and has not ever been mentioned in ancient literature, should be treated as a new drug, and therefore, should undergo all regulatory requirements before being evaluated clinically.



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