Can an Ethics Committee member e.g. layman/chairman or anyone in the committee participate in the trial as a subject?
Vidya
If an Ethics Committee member becomes a trial subject on a trial that he/she was involved in approving then there has been a major conflict of interest. The following situations need to be considered:
● IEC member reviews study without any prior knowledge of the study, votes, and then afterwards is approached by clinical research team to participate. Possibly this is OK but the member should no longer be part of the IEC that reviews that study. This will be difficult in practice, so therefore it is not advisable.
● IEC member already knows about the study and is voting in order to be able to participate. This is clearly not acceptable and made worse if there is additional financial incentive for the study (e.g. volunteer study).
ICH GCP requires Ethics Committee members to be independent of the investigator and the sponsor to avoid conflicts of interest.
Is it mandatory to have a qualified pharmacist for pharmacy activities like for dispensing?
Chetan Shingala
I assume your question pertains to site. As per ICH-GCP, the site can have a pharmacist or another individual for IP related responsibilities. See below.
4.6 Investigational product(s)
4.6.2Where allowed/ required, the investigator/ institution may/should assign some or all of the investigator's/institution’s duties for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution.
4.6.3
4.6.3The investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the investigator/institution, should maintain records of the product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and trial subjects. Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.
In an investigator initiated trial the interventions are: one group assigned an approved drug (for same indication) in India and the control group with life style modification. The question is a) Is this a randomized controlled trial or an observational study or other designs? b) What phase of trial is this? c) Do we need DCGI approval?
J. Vijayakumar
● This is clinical trial as you are comparing two interventions. As the comparison is between a drug and a non-drug measure, it is difficult to randomize and blind the study. It will be desirable to have blinded observers and objective endpoints, if the trial results are to be considered valid.
● It’s a Phase IV as the drug is being used for approved indication.
● DCGI approval is not needed.
See ICMR 2006 guidelines excerpt below:There are Phase IV studies that are designed to evaluate the marketed drug in specifically designed studies, which have inclusion/exclusion criteria, objectives and end points. The drug is used for the labeled indication in these studies. Therefore Licensing Authority permission is not needed. However, EC permission is needed.
If one patient has reported the same adverse event throughout the study, are we supposed to count it as one adverse event or are we supposed to count it visit wise? For e.g. if the patient has reported nausea continuously from day 0 to day 14 and if there are 4 visits during day 0 to day 14, then are we supposed to count nausea as one single adverse event or it will be counted as different adverse events?
Shruti Kulkarni
It depends on whether the first event subsided or is continuing. If the first event has subsided, and if the subject complaints of the same event again, it will be considered a new event. If the event has not subsided, only one event will be reported as continuing.
Ethics Committee has their own SOP and their own format for approval. Is it necessary to have approval in Schedule Y format?
Dr. Hemant Zaveri
The EC can have its own format. But the approval format should cover all requirements of Schedule Y.
Dr Arun Bhatt is currently, president, ClinInvent,
Research Pvt Ltd, Mumbai. Readers can send their queries
at: arunbhatt@clininvent.com