4 Is of Clinical Trials

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By Sharath Chandra Rao Silvery (PGP12094) Revathi konkimalla (PGP12089) Vivek Gite (PGP12107) Indian Institute of Management Anupriya Gupta (PGP12063) 1/16/13

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Raipur

Issues
In some clinical trials, subjects are enrolled

without their consent.

Subjects are not informed about all

potential side effects and Risks involved in the conduct of clinical trials.
Ample compensations for accidental injury

like Insurance, Rehabilitations, Life long support is not ensured to the subjects.
disclosed.

Personal information of the subjects are Staff conducting the clinical trials are not
Indian Institute of Management trained and qualified. Raipur 1/16/13

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Children may be less capable of

understanding risks and the consequences of their actions, given their educational experience, emotional maturity, and limited life experiences, than many adults. dependent relationship with their adult caretakers, they are more susceptible to coercion.

As Children are minors and are in a

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Indian Institute of Management Raipur

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Interest Groups: Organized

Pharmaceutical Companies:
Pfizer GlaxoSmithKline Sanofi Aventis Merck Johnson and Johnson Amgen Novartis Roche
4 4 Indian Institute of Management Ranbaxy Raipur 1/16/13

 Sponsors
Project Manager CRA/Monitor CRO (Contract Research Organization) Data Manager Bio statistician Medical Writer

Investigators Medical and Health Insurance industry: ICICIHealth Insurance

5 5 1/16/13 Royal SundaramHealth-Insurance Raipur Indian Institute of Management

Interest Groups: Unorganized

Patients Doctors

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Institutions
WHO Drugs Controller General of India (DCGI) Indian Council of Regulations Medical

Research (ICMR)

Clinical Trials Registry-India (CTRI) Institutional Review Board (IRB) Independent Ethics Committees (IEC) Food and Drug Administration(FDA) Office for Human Research
7 7 Indian Institute of Management Protections(OHRP) Raipur 1/16/13

Information
India hasa large heterogeneous population

pool and has World Class Facilities with low cost of medications, investigations and hospitalization. manufacturing facilities.

India possesseslarge generic drug India possesses aworld class printing, data-

processing and translation infrastructurefor biostatistics and bioinformatics at low cost.

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Number of Clinical Trial Certificates Issued:

Phas 200 e 5 I 44 II 50 III 90 IV 200 6 48 35 116 200 7 47 45 135 200 200 201 201 8 9 0 1 54 54 55 67 61 61 46 64 140 108 95 92

17 18 26 31 39 38 42 201 217 253 286 262 234 265

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Steps to prevent unethical practices

Informed Consent:
Subjects should be fully informed about the

objectives of the study. the study.

Subjects should consent to participate in Subjects have the right to withdrawal at

any point during study.

Non-exploitation:
Provide remuneration to test subjects. Inform subjects about all potential side
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Ensure ample compensations for accidental

Indian Institute of Management Raipur

effects and Risks.

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Precautions/Risk minimization:
Design the study such that risks to

subjects is minimized.

Ensure there are no adverse side effects.

Professional competence:
All personal involved in trials should be

trained and qualified. personnel.

A strong sense of ethics essential for

Transparency and Accountability:

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No aspects of the study should be hidden.

Indian Institute of Management (except for privacy reasons) Raipur 1/16/13

Thank You

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Indian Institute of Management Raipur

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