Clinical trials involve testing new drugs and treatments on humans to evaluate safety and efficacy. They are conducted in phases, starting with small groups and progressing to larger groups. Prior to conducting clinical trials, approval must be obtained from regulatory authorities like the FDA or DCGI. Trials must abide by ethical guidelines like the Declaration of Helsinki, which require minimizing risks and obtaining informed consent. The document outlines the various phases of clinical trials and legal requirements for conducting trials in India, including obtaining necessary permissions and following guidelines on ethics committee approval and compensation.

1. CLINICAL TRIALS
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

2. A clinical trial is an organized research investigate a new methods in
human intended to discover or verify the effect of a drug and/or to
identify any adverse reactions with the object of ascertaining its safety
and/or efficacy
NEED OF STUDIES
These are the integral part of new drug discovery .their relevance in
this respect has developed considerably during the last century. today
before a new drug can be made available evidence of its safety and
effectiveness has to be provided by well-designed well-controlled and
carefully monitored clinical studies in volunteer patients
Types of clinical trials:-5 types
Treatment trials
Prevention trials
Diagnostic trials
Screening trials
Quality of life trials

3. PHASES OF CLINICAL TRIALS
Prior to conduct the trial a approval must be obtain from
IND(INVESTIGATIONAL NEW DRUG )When all preclinical
studies have been completed and an approval has been received
from drug regulatory authorities(FDA,DRUG CONTROLLER
GENERAL OF INDIA DCGI CDSCO) for conducting of clinical
trials.
PAHSE-I
PAHSE-II
PAHSE-III
PAHSE-IV
PAHSE-I
A new drug or treatment is tested in a small group of people(20-80)
In this determines safety, safe dosage range& identify side effects
Health volunteers required
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

4. PAHSE-II
The study of drug in large group of people to find out the broad
range of toxocities.generally conducting in universital hospitals(100-
300)
PAHSE-III
Drug treatment is given to large group of people(1000-3000)to
conform its effeectivenes,moniter sideeffect,compare it to commonly
used treatment. After that should submit the NDA –it contains
pre&clinical studies (post marketing approvals)
PAHSE-IV
Also called post marketing surveillance phase. very important phase
because it often grants additional data about the safety and efficacy
of a product when it has been marketed for patient use.(in patients)n
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

5. Preclinical
studies
IND
application PHASE-I
PHASE-IIPHASE-IIINDA
application
PHASE-IV POST
MARKETING
surveillance
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

6. DECLARATION OF HELSINKI
 The current revision of the declaration of Helsinki is accepted
basis for clinical trials ethics and must be fully followed and
respected by all parties involved in conduct of such trials
 Recommendations guiding physicians in biomedical research
involving human subjects:-
 It is the mission of physician a to safeguard the health of the
people
 The purpose of biomedical research involving human subjects
must be improve diagnostic therapeutic and prophylactic
procedures and understanding of the etiology and
pathogenesis of diseases
 Basic principals:-
 Generally accepted scientific principals through knowledge of
the scientific literature
 The designed experiment should be clearly formulated in an
experiment al protocol should be conform with the laws and
regulations
 Should be conducted by scientifically qualified person
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

7.  Cannot be carried out unless the impotence of
investigations
 Assessment of predictable risks in competition with
foreseeable benefits to the subjects
 Every precautions should be taken to respect the of the
subject privacy to minimizes the impact of the study.
 Physician should outweigh the potential benefits
 Physician should preserve the accuracy of the results
 Physician should not have any relationship with
subjects.Shouls be independent of this official
relationship
 The research protocol should always contain a statement
of ethical considerations.
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

8. Requirements for Conducting Clinical Trials of Medical
Devices in
India
 Covering Letter:-Indicating the precise intent of the application
(e.g. whether the application is for Feasibility study or Safety and
Efficacy study/Post Market study and purpose for conducting the
study), name and address of the manufacturer as well as applicant,
name of the device ich clinical trial is to be carried out along with a
list of documents attached (Index) along with any other relevant
information regarding the subject application. It should be signed
by Authorized Signatory, clearly reflecting the name and
designation of the Authorized Signatory.
 Duly filled Application Form 44:-as prescribed in Drugs &
Cosmetics Act and Rules there under, signed and stamped by the
authorized signatory, clearly indicating the name and designation
of the Authorized Signatory.
 Requisite Fee:-as per the provisions of Drugs &
Cosmetics Act
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

9. 9
DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR
The Global Harmonization Task Force (GHTF)

10. Regulatory status of device in other countries (if applicable)
1. Approved
2. Marketed (if marketed a copy of package insert)
3. Withdrawn, if any, with reasons
4. Free sale certificate or certificate of analysis, as Appropriate
5. ISO Certificates and/or CE certificate (if available)
 Investigator’s Undertakings
 Ethics committee approval letters:-information for constitution
of Ethics
 Committee and Format for approval of Ethics Committee
 Informed consent form:-Checklist for study Subject’s informed
consent
 documents and Format of informed consent form for Subjects
participating in a clinical trial
 Case Record Form: Format for Case Record Form should be
submitted. 10
DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

11.  Patient Record Form: Format for Patient Record
Form should be submitted.
 Case Record Form: Format for Case Record Form
should be submitted.
 Patient Record Form: Format for Patient Record
Form should be submitted.
 Relevant published literature:-for the subject
device/predicate device (s) should be submitted
 Investigator’s Brochure: Investigators brochure
should be submitted.
 Suspected Unexpected Serious Adverse Reaction
(SUSAR) from other participating countries if any
reported and summary of any reported problems should
be submitted.
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

12.  Affidavit:-from the sponsor that the study has not been
discontinued in any country and in case of discontinuation the
reasons for such a discontinuation and that the applicant would
further communicate to DCG (I) about the future discontinuation
and Investigator’s Brochure containing the summarized
information is based on the facts.
 Any other specific relevant information :- Subject device.
 Clinical Study Report: Structure, contents and format for
Clinical Study Report is enclosed
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

13. THE INDIAN COUNCIL OF MEDICAL RESEARCH’S ETHICAL
GUIDELINES ON BIOMEDICAL RESEARCH ON HUMANS(ICMR)
 As of January 2005, it is mandatory for clinical trials in India to conform to the
ICMR’s guidelines and to the guidelines in the Declaration of Helsinki. The Indian
Council of Medical Research’s guidelines were first published in 200026 and this
version of the guidelines would have been applicable for the trials described in this
report. The revised guidelines were published in 200627 and are the relevant
guidelines for ongoing and future research .The guidelines state that: “persons who are
economically or socially disadvantaged should not be used to benefit those who are
better off than them.” (Section III iii b in ICMR, 2000; Section IV iii b in ICMR,
2006)
 The 2000 guidelines state that trial subjects should be fully informed of the research
before they consent: Any research using the [sic] human beings should be selected so
that burdens and benefits of the research are distributed without arbitrariness,
discrimination or caprice.” Research should abide by the principles of “maximization
of the public interest and of distributive justice whereby, the research or experiment
and its subsequent applicative use are conducted and used to benefit all humankind
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

14. THE BASIC ETHICAL PRINCIPAL
1.Should be respect
2.Respect for person
3.Beneficence(maximises the benefits,minimises the harms)
4.Non malfeasance(doing no harm)
ETHICS COMMITTEE(EC)
1.EC approval of protocol / informed consent form (ICF) and notification to
DCGI prior to initiation
2. EC approval for sites without EC
3. EC approval of protocol amendments and notification to DCGI
4. Composition of EC
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

15.  There should be a good research design. a good
research design includes randamisation,placebo
control, and monitoring of the clinical trial.
 Component investigators should conduct the clinical
trial.
 There should be favorable balance of harm and benefit
which includes welfare of the subject/physician's
obligations to his patient and social good
 Compensation should be provided for research injury
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR

16. CLINICAL TRAILS- LEGAL ISSUES IN INDIA
Today, clinical trials are conducted through a regulated approach
following certain guidelines laid down by the International Conference
on Harmonization (ICH), which is spearheaded by U.S.A., Europe and
Japan
To conduct clinical trials in it should approved by the CDSCO. According
to Schedule Y, the requirements and guidelines should be followed are
1.Rule 122A-Permission to import new drugs.
2.Rule 122B- Permission to manufacture new drug.
3.Rule 122DA-Definition of clinical trails.
4.Rule 122E–definition of new drugs.
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DEPARTMNET OF PHARMACEUTICS
K.KRANTHI KUMAR