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FAQs In Clinical researchQ. We have a protocol for a global trial, which is approved by DCGI and EC. Itdoes not mention the total patients number and sites to be included in India. Weplan to increase the number of sites and patients. Do we need to go to EC and DCGIoffice for approval or will the old approval what we received will suffice? Could youplease clarify?
The current CDSCO checklist requires data on number of sites and patients in India. Theapproval is based on this data. Hence, even if the global protocol does not mention thenumber of Indian sites/patients, it is essential to obtain the amendment approved by ECand DCGI. The DCGI office recommends that such amendments should be approved byIEC and notified or submitted for approval from DCGI office. See the relevant extract.Those amendments which require notification to the Licensing Authority but need notwait for permission1. Additional investigator sites2. Change in investigator with the consent to withdraw from the earlier investigator 3. Amended investigators brochure, amended informed consentThose amendments which require prior permission of the Licensing Authority1. Additional patients to be recruited2. Major changes in protocol with respect to study design, dose and treatment options3. Any change in inclusion or exclusion criteria
Q. Is it possible to conduct phase 4 study as a comparative study? Is it possible toconduct phase 4 study in such small patient e.g. 400?
ICH E 8 guidelines on general considerations for clinical trials defines phase IV asfollows:3.1.3.4 Phase IV (variety of studies: - therapeutic use)Phase IV begins after drug approval. Therapeutic use studies go beyond the prior demonstration of the drug's safety, efficacy and dose definition. Studies in phase IV areall studies (other than routine surveillance) performed after drug approval and related tothe approved indication. They are studies that were not considered necessary for approval but are often important for optimising the drug's use. They may be of any type but shouldhave valid scientific objectives.Indian GCP defines phase IV as:Studies performed after marketing of the pharmaceutical product. Trials in phase IV arecarried out on the basis of the product characteristics on which the marketingauthorization was granted and are normally in the form of post-marketing surveillance,assessment of therapeutic value, treatment strategies used and safety profile. Phase IV
 
studies should use the same scientific and ethical standards as applied in pre-marketingstudiesYou can conduct phase IV as a comparative study if the objectives are scientifically justified. The sample size depends on the objectives and endpoints and has to bestatistically valid.
Q. We are conducting a multicentre, multinational BE trial on patients with areference drug marketed in US. Can a sponsor conduct such studies i.e. directlyphase III study in India without conducting phase I or II or without any previouspre-clinical data?
The sponsor will have to provide the data required as per Schedule Y for permission toconduct clinical trials.This includes● Drug and the therapeutic class● Chemical and pharmaceutical information● Animal pharmacology● Animal toxicology● Phase I, II, III as applicable● Regulatory status in other countriesIf the sponsor wants to conduct phase III in India, he will have to provide above pre-clinical information and data of phase I and II to DCGI office.
Q. Can the chairperson or the designated member of an IEC review & approveminor (patient / safety related) amendments to the protocol & ICF without thepresence of other members?
Yes if the EC has an SOP for such proceduresIndian GCP covers this under interim review.2.4.2.7. Interim ReviewThe IEC should decide and record the special circumstances and the mechanism when aninterim review can be resorted to instead of waiting for the scheduled time of themeeting. However, decisions taken should be brought to the notice of the maincommittee. This can be done for the following reasons:i ) Re-examination of a proposal already examined by the IEC;ii) Research study of a minor nature such as examination of case records etc;iii) An urgent proposal of national interest.ICMR guidelines 2006 recommend as follows:
 
2. Expedited ReviewThe proposals presenting no more than minimal risk to research participants may besubjected to expedited review. The Member- Secretary and the Chairperson of the IEC or designated member of the Committee or Subcommittee of the IEC may do expeditedreview only if the protocols involve -1. Minor deviations from originally approved research during the period of approval(usually of one year duration).2. Revised proposal previously approved through full review by the IEC or continuingreview of approved proposals where there is no additional risk or activity is limited todata analysis.3. Research activities that involve only procedures listed in one or more of the followingcategories:a) Clinical studies of drugs and medical devices only when -i) Research is on already approved drugs except when studying drug interaction or conducting trial on vulnerable population or ii) Adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor nature isreported.4. Research involving clinical materials (data, documents, records, or specimens) thathave been collected for non-research (clinical) purposes.ICMR guidelines also permit such review in research on interventions in emergencysituation and on disaster management.
Q. What is a different between protocol deviation and violation?
Protocol Deviation: Any alteration/modification to the IRB-approved protocol. The protocol includes the detailed protocol, protocol summary, consent form, recruitmentmaterials, questionnaires, and any other information relating to the research study.Protocol Violation: Any protocol deviation that is not approved by the IRB prior to itsinitiation or implementation.● Major Violation: a violation that may impact subject safety, affect the integrity of studydata and/or affect subject's willingness to participate in the study.● Minor Violation: a violation that does not impact subject safety, compromise theintegrity of study data and/or affect subject's willingness to participate in the study.
Q. If we want to do 4-week single dose dosing in phase I then how many weeks'animal toxicity data is required?
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vanivenkat

with out DCGI Approval can we Do the Site Inititation? if Site and Sponsor have understanding and DCGI intimates that approval will come the next weak in that case can we go for site intitiation

reply02 / 03 / 2010
nicky02

Yes...........Before screening we need Permission from EC(After submission of DCGI Approval letter to EC) that we can go head for screening.

02 / 22 / 2010
Ranjeet Prasad

can you mail me this document on my email id rajdoct80@gmail.com. Hope you will consider my request and you will do same.

reply10 / 29 / 2009
prakashmathewbio

i want an soft copy please do help me .. please send me to prakashmathewbio@gmail.com

reply06 / 30 / 2009
julsel0075564

Hi Nicky, I wanat the Q & A soft copy Pls mail me @ vinay _tiwari6@yahoo.com

reply06 / 20 / 2009
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