What is the accepted age limit for volunteer studies?

	Queries on GCP
	A Monthly Column by Dr Arun D Bhatt

Does a phase IV post-marketing surveillance study require ethics committee (EC) review and approval?

Dr Amar Joshi, Nagpur

According to FDA, approval of Investigational Review Board is required if the investigation is governed by FDA regulations. The clinical investigation of a lawfully marketed drug is exempted in the following conditions:

1) The investigation is not intended to be a well-controlled study in support of new indication for use or to support a change in labelling.

2) The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks associated with the use of the product.

According to ‘‘Ethical Guidelines for Biomedical Research on Human Subjects’’ phase IV study is outside the purview of the ethical committee. However, the guideline insists that adverse reactions induced by the drug should be brought to the notice of the ethics committee.

We plan to develop a diagnostic test for sexually transmitted disease (STD) and wish to use urine samples available with a local laboratory. Does this study require EC approval and consent from the subjects?

Dr Jitendra Goyal, Indore

FDA definition of a ‘‘device’’ includes in vitro diagnostic products - devices that aid in the diagnosis of disease or medical/ physiological conditions. Compliance with IRB and informed consent regulations depends upon the purpose and nature of the study and should be evaluated accordingly. Research involving human biological materials has the potential to uncover detailed medical and genetic information about a specific person. The use of linked or coded biological materials can be traced to a specific person by name or patient number and, therefore, is considered human subject research.

The above research is likely to detect sensitive information (STD) about the patients. According to “Ethical Guidelines for Biomedical Research on Human Subjects”, all general principles of clinical trials for drug trials should be considered for the trials of medical devices. This means that EC approval and Informed Consent procedure should be followed as in drug trials.

What is the accepted age limit for volunteer studies?

Dr Anand Subrahmanyam, Chennai

US FDA suggests that the studies should be performed in adults who are hospitalised or are in other setting permitting observation. The Canadian guidelines on bio-equivalence prescribe the following:

The subjects should be between the age of legal majority and the age on onset of age associated changes in organ function. This description typically coincides with an age range of 18 to 55 years.

How long do the serum samples of a bio-equivalence study need to be stored before they can be disposed of?

Dr Manish Garg, Mumbai

I am not aware of any guidelines for preserving serum samples. Practically, one cannot store samples beyond the period of stability of the drug in the serum sample to be estimated.

In a bio-equivalence study, the subject reported an adverse drug reaction (ADR) after administration of the study medication, but not at the time of Cmax, Can it be termed as unlikely to study medication?

Dharmishtha Prajapati, Ahmedabad

The causality assessment of an ADR is based on the profile of drug. All ADRs may not occur around Cmax. If the ADR is a type B reaction, it may not have any relation to Cmax. It would not be proper to call any ADR unlikely, just because it does not occur around Cmax.

Dr Arun D Bhatt, well-known clinical pharmacologist from Mumbai, and currently president, ClinInvent Research India Pvt Ltd, answers your questions on Good Clinical Practices.

Please send in your questions at: arunbhatt@clininvent.com
All queries should ideally reach him by the 15th of each month