We are doing one clinical trial in that serious adverse event occurred after completion of study period. What we should do?
Raghu
It would be desirable to report this event to the sponsor. It also should be reported to ethics committee, and regulatory agency after causality and expectedness are assessed. See ICH guidance below.

ICH E2A 3. Post-study events
Although such information is not routinely sought or collected by the sponsor, serious adverse events that occurred after the patient had completed a clinical study (including any protocol-required post-treatment follow-up) will possibly be reported by an investigator to the sponsor.  Such cases should be regarded for expedited reporting purposes as though they were study reports.  Therefore, a causality assessment and determination of expectedness are needed for a decision on whether or not expedited reporting is required

For bioequivalence study of an anticancer agent, is it necessary to dose all the subjects in one single day?
Rendeep Rajendran
There is no regulatory requirement to dose all the subjects in one single. As anticancer drugs usually cause adverse events, it would be desirable to take small cohorts of patients.

Many of the Institutional Ethics Committee do not clearly mention reporting annual status/progress report during the course of study. What are the steps to be taken for this situation especially when you are looking forward to select this site because PI is good/experienced investigator and site infrastructure complies with the current study requirement?
Deepu
ICH GCP mandates that IEC should review the project at least once a year. Indian GCP recommends that IEC has the responsibility of continuing review. Schedule Y EC approval recommends that EC letter mention that EC expects to be informed of the progress.

ICH GCP 3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year.
3.3.3 Conducting initial and continuing review of trials.

Schedule Y
The Institutional Ethics Committee / Independent Ethics Committee expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information / informed consent and asks to be provided a copy of the final report.

Indian GCP
The Ethics Committees are entrusted not only with the initial view of the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring for the compliance of the Ethics of the approved programmes till the same are completed.

It is necessary to bring to the notice of investigator / EC about this requirement and to request that their SOP cover this requirement for annual review.

Kindly let me know whether can we use comparator in Post Marketing Surveillance study. What is the necessity to use comparator after regulatory approval to market the product?
Raghu
The PMS design depends on the objective. If the objective is to assess post-marketing safety of a new drug, comparator is not required. However, if the objective to assess efficacy vis-a-vis other therapy/new therapy on the market and to support marketing claims, a comparator is usually required

Are any foreign reports for the same product (marketed in India) required by DGCI?
Niharika Mathur
Please check the DCGI approval letter. It does not clearly state - local or foreign reports. As a practice, most foreign companies in India send local reports only.

Are local expected events reportable?
Niharika Mathur
As a convention all post-marketing events are considered drug related and are reported to DCGI

Which cases should be included in the PSUR?
Niharika Mathur
All cases - local / foreign - will be in PSUR.

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