Skip to main content

ICH GCP requires EC members to be independent of investigator and sponsor to avoid conflicts of interest

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.



Source: Pharmabiz

Comments

Popular posts from this blog

''Dynamic Indian of the millenium"

As Member Secretary of CLINICOM, I am so thrilled to post this information here:
''Dynamic Indian of the millenium" award conferred

Coimbatore, Jul 4 (PTI) City-based K G Foundation today conferred the 'Dynamic Indian of the Millennium' award on Arun Madhavan, a former member of Prime Minister's special committee for model village development programme under the 20-point programme.


The award, carrying a citation, was given for his 'distinguished achievements and contribution to society over the years', the foundation chairman G Bhakthavatsalam, said at a function got up as part of the celebrations of World Doctors' Day, here.

Besides being conferred a global recognition for his 'project gateway' for promoting India as an investment destination, Arun had delivered a speech at the United Nationas, Geneva, on 'A New dimension to healthcare,' in 1996, he said. The first recipient of this award was the former president, A P J Abdul K…

Isotretinoin in India: A tragedy in the offing

Isotretinoin in India: A tragedy in the offing
Wednesday, March 28, 2007 08:00 IST 
Seema Thakral

Isotretinoin is the drug of choice for severe calcitrant cystic acne vulgaris, which often causes scarring and depression from disfigurement. Isotretinoin has been called "the greatest medical advance of the 1980's." A majority of patients with acne are permanently cleared after a four to five months course of treatment. It has also been used off-label for a variety of oncology uses including: cervical cancer, head and neck cancer, squamous cell cancer of the skin, juvenile chronic myelogenous leukemia (CML), and neuroblastoma. However, the drug is a proved teratogen and carries a significant risk of birth defects, if it taken during pregnancy. Birth defects, which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. There is an increased risk …

An important discovery

"Gene therapy strategies will come in with a major cost advantage since DNA interference technology will act at the DNA level at lower doses, reduce toxicity and only one or two copies of the DNA"- Dr Ramanand Nadig
President Operations and  
Deputy Dean 
Clinical Research Education and Management Academy (CREMA)
Genes are segments of DNA present in the chromosomes in the nucleus of every cell. Genes carry instructions for making proteins, which are then copied by special enzymes into many copies of messenger RNA (mRNA). The mRNA then comes out of the nucleus, into the body of the cell; where it goes on to create the proteins needed for everyday life. Faulty or mutated genes lead to malfunctioning proteins that cause disease. Gene expression can be blocked by restricting the ability of chromosomal DNA to be copied into RNA and made into proteins. This research has given the lead wherein the ways to correct genetic disease by changing mutant gene sequences to its normal has been …