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For clinical studies in children investigator must be paediatrician


Wednesday, February 03, 2016, 08:00 Hrs  [IST]

What are the options if chairperson resigns from his post on the day of clinical trial approval meeting?
Tushar Mhetre

The EC should handle the situation as per the SOP of resignation/replacement procedure.

The chairperson could chair the meeting if the resignation to become effective requires a notice period.

Some ECs have a chairperson and co-chairperson not – affiliated to the institute. The procedure followed is as follows:

In absence of the chairperson, co-chairperson will chair the meeting. In absence of both, member who is independent of the institution will chair the meeting as acting chairperson.

Can a judge be the chairperson of EC?
Tushar Mhetre

A judge can serve as the chairperson if he/she can fulfill the roles/responsibilities of chairperson.
 
Do regulations allowed conduct of BA/BE/PK study in healthy pediatric volunteers in India? Who can conduct BA/BE/PK study in healthy pediatric volunteers?
Dr Muneesh Garg

See the relevant information from regulations/guidelines.
 Schedule Y recommends:
(v) The pediatric studies should include -
(a) clinical trials,
(b) relative bioequivalence comparisons of the pediatric formulation with the adult formulation performed in adults, and
(c) definitive pharmacokinetic studies for dose selection across the age ranges of pediatric patients in whom the drug is likely to be used. These studies should be conducted in the pediatric patient population with the disease under study.

 ICMR 2006 recommends:
Before undertaking trial in children the investigator must ensure
that -
a. children will not be involved in research that could be carried out equally well with adults;
b. the purpose of the research is to obtain knowledge relevant to health needs of children. For clinical evaluation of a new drug the study in children should always be carried out after the phase III clinical trials in adults.

It appears that BE/PK studies are also to be conducted in adults.

In case any clinical studies are planned in children, the investigator has to be a paediatrician.

When can a site destroy the trial records?
Nirmita Parmar

As per EMA June 2015 draft guidance on GCP compliance in relation to trial master files, the sponsor should notify investigators in writing when their trial records can be destroyed.

What are the timelines for submission of SAE/AE not occurring in a clinical trial? If the product is marketed for more than 5 years, then how do we report this (timelines)?
Ashish Chavda

Schedule Y recommends submission of PSUR till 4 years. See excerpt

  • Subsequent to approval of the product, new drugs should be closely monitored for their clinical safety once they are marketed.
  • The PSURs shall be submitted every six months for the first two years after approval of the drug is granted to the applicant. For subsequent two years - the PSURs need to be submitted annually

However, there is no guidance about timelines of AE/SAE submission beyond 5 years of marketing.

After the product is 5 years old on the market, it would be better to follow 1) safety reporting requirements in CDSCO marketing approval letter, and 2) international practices.

Dr Arun Bhatt is currently, president, ClinInvent, Research Pvt Ltd,
Mumbai. Readers can send their queries at: arun_dbhatt@hotmail.com

 

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