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Clinical Trials Scientific Aspects AND Legal & Procedural Aspects . M K Unnikrishnan [Aug 2006]. Scientific Aspects of Clinical Trial. Phases of Clinical Trial Phase I : First in man  safety Phase II : First in patient d ose, dosage form Phase III : Efficacy, ADRs

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clinical trials scientific aspects and legal procedural aspects

Clinical TrialsScientific AspectsANDLegal & Procedural Aspects

M K Unnikrishnan [Aug 2006]

scientific aspects of clinical trial
Scientific Aspects of Clinical Trial

Phases of Clinical Trial

  • Phase I : First in man  safety
  • Phase II : First in patient dose, dosage form
  • Phase III : Efficacy, ADRs
  • Post marketing surveillance or Phase IV : Evaluation in the real clinical setting
phase i
Phase I
  • Objectives
    • To assess a safe & tolerated dose
    • To see if pharmacokinetics differ much from animal to man
    • To see if kinetics show proper absorption, bioavailability
    • To detect effects unrelated to the expected action
    • To detect any predictable toxicity
  • Inclusion criteria
    • Healthy volunteers : Uniformity of subjects: age, sex, nutritional status [Informed consent a must]
    • Exception: Patients only for toxic drugs Eg AntiHIV, Anticancer
  • Exclusion criteria
    • Women of child bearing age, children,
phase i contd
Phase I contd
  • Methods:
    • First in Man : Small number of healthy volunteers
    • First in a small group of 20 to 25
    • Start with a dose of about 1/10 to 1/5 tolerated animal dose
    • Slowly increase the dose to find a safe tolerated dose
    • If safe  in a larger group of up to about 50 –75
    • No blinding
    • Performed by clinical pharmacologists
    • Centre has emergency care & facility for kinetics study
    • Performed in a single centre
    • Takes 3 – 6 months [ 70% success rate]
phase ii
Phase II
  • First in patient [ different from healthy volunteer]
  • Early phase [20 – 200 patients with relevant disease]
    • Therapeutic benefits & ADRs evaluated
    • Establish a dose range to be used in late phase
    • Single blind [Only patient knows] comparison with standard drug
  • Late phase [ 50 – 500]
    • Double blind
    • Compared with a placebo or standard drug
  • Outcomes
    • Assesses efficacy against a defined therapeutic endpoint
    • Detailed P.kinetic & P.dynamic data
    • Establishes a dose & a dosage form for future trials
  • Takes 6 months to 2 years [ 35% success rate]
phase iii
Phase III
  • Large scale, Randomised, Controlled trials
  • Target population: 250 – 1000 patients
  • Performed by Clinicians in the hospital
  • Minimises errors of phases I and II
  • Methods
    • Multicentric  Ensures geographic & ethnic variations
    • Diff patient subgroups Eg pediatric, geriatric, renal impaired
    • Randomised allocation of test drug /placebo / standard drug
    • Double blinded:
    • Cross over design
    • Vigilant recording of all adverse drug reactions
    • Rigorous statistical evaluation of all clinical data
  • Takes a long time: up to 5 years [25% success]
cross over design
Cross over design

Group Week 1 Week2 Week3

I Standard Placebo Test

II Placebo Test Standard

III Test Standard Placebo

* A wash out period of a week between two weeks of therapy

phase iv or post marketing surveillance
Phase IV or Post marketing Surveillance
  • No fixed duration / patient population
  • Starts immediately after marketing
  • Report all ADRs
  • Helps to detect
    • rare ADRs
    • Drug interactions
    • Also new uses for drugs [Sometimes called Phase V]
clinical trial legal procedural aspects
Clinical Trial: Legal & Procedural aspects

Elements of a Clinical Trial

  • Aim or objective
  • Protocol : study design
  • Ethics committee clearance
  • Regulatory approval whenever required
  • Informed consent
  • Implementation of protocol
  • Collection of data
  • Compilation of data, analysis and interpretation
  • Report writing
participating parties in clinical trial
Participating Parties in Clinical Trial
  • Patient / Healthy volunteer
  • Clinical Pharmacologist, Clinical Investigator & team: [Qualified and competent]
  • Institution where trials are held : [Approval required]
  • Ethical Review Board or Institutional Ethical Committee:
  • Sponsor
  • Regulatory Authorities:
functions of participating parties
Functions of participating parties
  • [1] Patient / Healthy volunteer : Subject of the trial
  • [2] Clinical Pharmacologist, Clinical Investigator & team:
    • Conducts the clinical trial; reports all adverse events
  • [3] Institution where trials are held :
    • Provides all facilities [Approval required]
functions of parties contd
Functions of parties contd.
  • [4] Ethical Review Board or Institutional Ethical Committee:
    • Supervises and monitors every step;
    • Safeguard the welfare and the rights of the participants
  • [5] Sponsor :
    • Pays for all expenses;
    • Appoints competent investigators,
    • Ships all drugs for the trial,
    • Files all papers to legal / regulatory authorities,
  • [6] Regulatory Authorities:
    • Legal authority on the outcomes of the trial
clinical trial protocol
Clinical Trial Protocol
  • Title & Abstract
  • Introduction
    • General statement of purpose
    • Complete Preclinical results on animal study
    • Clinical data if available
    • Time frame
  • Goals: Primary & secondary objectives
  • Study Design:
    • Type of study
    • Recruitment criteria : Exclusion & Inclusion criteria
    • Randomisation criteria and Sample size
    • Duration of study
  • Data Analysis:
    • Case report forms, Statistical Analysis, Bibliography
informed consent
Informed Consent
  • Informed consent form:
    • Voluntary
    • Explained in simple nontechnical language
    • Translated in the native language of the subject
    • Comprehensive information regarding the trials
      • Benefit of new therapy over existing ones
      • Alternative treatments available
    • All possible adverse reactions
    • Freedom to withdraw from the trial
      • at any time,
      • without giving any reason
institutional ethical committee
Institutional Ethical Committee
  • Independent
  • Competent
  • 5 – 7 members; 5 required for quorum.
  • Member Sec from same Institution
  • Others: A mix of medical non-medical, scientific & non-scientific including lay public
  • Multidisciplinary & Multisectorial
responsibilities of iec
Responsibilities of IEC
  • To protect the dignity, rights & well being of patients / volunteers
  • Ensure a competent review of the protocol
  • Advise on all aspects of welfare & safety
  • Ensure scientific soundness of the proposal
the composition of iec
The composition of IEC

1. Chairperson

2. 1-2 basic medical scientists.

3. 1-2 clinicians from various Institutes

4. One legal expert or retired judge

5. One social scientist / representative of NGO

6. One philosopher / ethicist / theologian

7. One lay person from the community

8. Member Secretary

  • Individuals from other institutions if required
  • Adequate representation of age, gender, community,
problem areas
Problem areas
  • Compensation in drug related injuries
    • Mild and Severe
  • Patient Rights
    • Confidentiality of data
    • Right to withdraw
  • Collection procedures & amount of biological material taken
  • Compensation & Insurance claims
  • Sending bio-material abroad
  • Selection of Patients
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