Answered by Dr Arun Bhatt in Pharmabiz.com
Q. What is the definition of a legally acceptable representative (LAR)?
As per Schedule Y, an LAR is a person who is able to give consent for or authorize an intervention in the patient as provided by the law(s) of India). This would usually include parents, adult children, adult siblings, and spouse.
Q. Can a daughter-in-law sign as LAR for her mother-in-law in informed consent process?
If mother-in-law is literate, you do not need an LAR. If mother-in-law illiterate, she can put her left hand thumb impression on the consent form. In this situation, you do not need an LAR but an impartial witness. In such a situation, the daughter-in-law will sign as an impartial witness.
Q. Do we need to take DCGI approval for conducting comparative efficacy trials on already marketed drugs in India? Which one will be the comparator product in such cases among different old drug brands?
You need to consider whether this study falls into one of the new drug categories as per Drugs & Cosmetics Rules and whether it is truly a Phase IV post-marketing trial. The relevant definitions are:
● Indian GCP definition
● Phase IV
Studies performed after marketing of the pharmaceutical product. Trials in phase IV are carried out on the basis of the product characteristics on which the marketing authorization 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-marketing studies.
After a product has been placed on the market, clinical trials designed to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical products.
You do not need DCGI approval if the product is not a new drug as per the definition in Drugs & Cosmetic Act. However, you will need ethics committee approval.
The choice of comparator depends on the objectives of the study.
Q.What is Named Patient Programme in clinical trials? Do we require an additional approval from DCGI for conducting such studies in India?
Named patient programme or expanded access programme covers use of an unapproved drug outside clinical trial setting.
A patient with:
● advanced disease
● no approved treatment options
● no appropriate clinical trial options
May consider trying to get a new, unapproved drug outside of the clinical trial.
Access to a scientifically-tested drug outside of a clinical trial and prior to regulatory approval is usually referred to as compassionate use.
Expanded Access Programme (EAP)
A pharma company in the late stages of drug development including the Phase III clinical trial stage can offer EAP for patients who are unable to enroll in a clinical trial. The regulatory authority generally approves these programmes if the drug has demonstrated some effectiveness in the on-going clinical trials.
Q.What are Phase 0 studies?
FDA guidance document, Exploratory IND Studies, offers recommendations about safety testing, manufacturing, and clinical approaches that can be used in very early studies, sometimes called exploratory, or phase 0 trials.
Q. What is the definition of a legally acceptable representative (LAR)?
As per Schedule Y, an LAR is a person who is able to give consent for or authorize an intervention in the patient as provided by the law(s) of India). This would usually include parents, adult children, adult siblings, and spouse.
Q. Can a daughter-in-law sign as LAR for her mother-in-law in informed consent process?
If mother-in-law is literate, you do not need an LAR. If mother-in-law illiterate, she can put her left hand thumb impression on the consent form. In this situation, you do not need an LAR but an impartial witness. In such a situation, the daughter-in-law will sign as an impartial witness.
Q. Do we need to take DCGI approval for conducting comparative efficacy trials on already marketed drugs in India? Which one will be the comparator product in such cases among different old drug brands?
You need to consider whether this study falls into one of the new drug categories as per Drugs & Cosmetics Rules and whether it is truly a Phase IV post-marketing trial. The relevant definitions are:
● Indian GCP definition
● Phase IV
Studies performed after marketing of the pharmaceutical product. Trials in phase IV are carried out on the basis of the product characteristics on which the marketing authorization 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-marketing studies.
After a product has been placed on the market, clinical trials designed to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical products.
You do not need DCGI approval if the product is not a new drug as per the definition in Drugs & Cosmetic Act. However, you will need ethics committee approval.
The choice of comparator depends on the objectives of the study.
Q.What is Named Patient Programme in clinical trials? Do we require an additional approval from DCGI for conducting such studies in India?
Named patient programme or expanded access programme covers use of an unapproved drug outside clinical trial setting.
A patient with:
● advanced disease
● no approved treatment options
● no appropriate clinical trial options
May consider trying to get a new, unapproved drug outside of the clinical trial.
Access to a scientifically-tested drug outside of a clinical trial and prior to regulatory approval is usually referred to as compassionate use.
Expanded Access Programme (EAP)
A pharma company in the late stages of drug development including the Phase III clinical trial stage can offer EAP for patients who are unable to enroll in a clinical trial. The regulatory authority generally approves these programmes if the drug has demonstrated some effectiveness in the on-going clinical trials.
Q.What are Phase 0 studies?
FDA guidance document, Exploratory IND Studies, offers recommendations about safety testing, manufacturing, and clinical approaches that can be used in very early studies, sometimes called exploratory, or phase 0 trials.
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