(1) Approval for Clinical Trial

 

1. Clinical trials for any drug shall be initiated only after the permission granted by the Regulatory Authority, and the approval obtained from the respective ethics committee(s). The Regulatory Authority shall be informed of the approval of the respective institutional ethics comittee(s), and the trial initiated at each respective site only after obtaining such an approval for that site.
2. All clinical trial Investigator(s) should possess appropriate qualifications, training and experience and should have access to such investigational and treatment facilities as are relevant to the proposed trial protocol. 

(2) Responsibilities of Sponsor

1. The clinical trial sponsor is responsible for implementing and maintaining quality assurance systems to ensure that the clinical trial is conducted and data generated, documented and reported in compliance with the protocol and Good Clinical Practices (GCP)
2. Sponsors are required to submit a status report on the clinical trial to the Regulatory Authority at regular intervals.
3. In case of studies discontinued prematurely for any reason including lack of commercial interest in pursuing the new drug application, a summary report should be submitted within 3 months. 
4. In case of a serious adverse event (SAE) during a clinical trial, same should be reported promptly (within 14 calendar days) to the Regulatory Authority and to other investigators participating in the study.

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(3) Responsibilities of the Investigator(s)

 

The Investigator(s) is responsible for conducting the trial in accordance with the protocol and the GCP Guidelines and also for compliance. During a subject’s participation in the clinical trial, the investigator should ensure the adequate medical care. Investigator(s) shall report all serious and unexpected adverse events to the Sponsor within 24 hours and to the Ethics Committee that accorded approval to the study protocol within 7 working days of their occurance.

 

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(4) Informed Consent

1. In all clinical trials, a freely given, informed, written consent is required to be obtained from each study subject.   The Investigator must provide information about the study verbally as well as using a patient information sheet, in a language that is non-technical and understandable by the study subject.  The Subject’s consent must be obtained in writing using an ‘Informed Consent Form’. 
2. Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering from severe mental illness or disability), the same may be obtained from a legally acceptable representative (a legally acceptable representative 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). 
3. A checklist of essential elements to be included in the study subject’s informed consent document as well as a format for the Informed Consent Form for study Subjects is given in Appendix V.

 

 

(5) Responsibilities of Ethics Committee

1. Ethics Committee reviews and accords its approval to a trial protocol to safeguard the rights, safety and well being of all trial subjects.
2. Ethics Committee should make, at appropriate intervals, an ongoing review of the clinical trials for which they review the protocol(s). 
3. In case an ethics committee revokes its approval accorded to a trial protocol, it must record the reasons for doing so and at once communicate such a decision to the Investigator as well as to the Regulatory Authority.

 

(6) Human Pharmacology (Phase I)

1. The objective of studies in first phase of the trial is to estimate safety and tolerability with the initial administration of an investigational new drug into human(s). Phase I clinical trials should preferably be carried out by Investigators trained in clinical pharmacology with access to the necessary facilities to closely observe and monitor the subjects.
2. Studies conducted during phase I clinical trials, usually intend to involve one or a combination of the following objectives:-

    

   (a) Maximum tolerated dose:  To determine the tolerability of the dose range expected to be needed for later clinical studies and to determine the nature of adverse reactions that can be expected.

    

   (b) Pharmacokinetics, i.e., characterization of a drug's absorption, distribution, metabolism and excretion.

    

   (c) Pharmacodynamics: Depending on the drug and the endpoints studied, pharmacodynamic studies and studies relating to drug blood levels (pharmacokinetic/ pharmacodynamic studies) may be conducted in healthy volunteer Subjects or in patients with the target disease.

    

   (d) Early Measurement of Drug Activity: Preliminary studies of activity or potential therapeutic benefit may be conducted in Phase I as a secondary objective.

 

(7) Therapeutic Exploratory Trials (Phase II)

1. The primary objective of Phase II trials is to evaluate the effectiveness of a drug for a particular indication or indications in patients with the condition under study and to determine the common short-term side-effects and risks associated with the drug.

2. Additional objectives of Phase II studies can include evaluation of potential study endpoints, therapeutic regimens (including concomitant medications) and target populations (e.g. mild versus severe disease) for further studies in Phase II or III.
3. If the application for conducting clinical trials as a part of multi-national clinical development of the drug, the number of sites and the patients as well as the justification for undertaking such trials in India shall  be provided to the Regulatory Authority.

 

(8) Therapeutic Confirmatory Trials (Phase III)

1. Phase III studies have primary objective of demonstration or confirmation of therapeutic benefit(s). 
2. For drugs intended to be administered for long periods, trials involving extended exposure to the drug are ordinarily conducted in Phase III, although they may be initiated in Phase II.
3. For new drugs approved outside India, Phase III studies need to be carried out primarily to generate evidence of efficacy and safety of the drug in Indian patients.
4. The number of sites and patients as well as the justification for undertaking such a clinical trial in India should be provided to the Regulatory Authority along with the application.

 

(9)  Post Marketing Trials  (Phase IV)

 

Post Marketing trials are studies (other than routine surveillance) performed after drug approval and related to the approved indication(s).  These trials go beyond the prior demonstration of the drug’s safety, efficacy and dose definition.  These trials may not be considered necessary at the time of new drug approval but may be required by the Regulatory Authority for optimizing the drug's use. They may be of any type but should have valid scientific objectives. Phase IV trials include additional drug-drug interaction(s), dose-response or safety studies and trials designed to support use under the approved indication(s), e.g. mortality/morbidity studies, epidemiological studies etc. 

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