PREPARED BY:

BHAUMIK R BAVISHI (15MPH301)DEPT: PHARMACEUTICAL ANALYSIS

NIRMA UNIVERSITY

Compensation in Clinical Trial

Content of Presentation…

IntroductionGuideline by drug controller general of India 1) Compensation Clinical Trial Related Injury 2) Compensation Clinical Trial Related Death 3) Compensation Clinical Trial Related SAE Procedure for Compensation Compensation FormulaLimitation

Introduction

Something, typically money, awarded to someone in recognition of loss, suffering, or injury or death.

One of the major issues which has emerged is of compensation to research participants for clinical trial-related injury or death.

The Government of India has come up with regulations regarding compensation for research participants.

GUIDELINES BY DCG(I) DRUG CONTROLLER GENERAL OF INDIA

1) Compensation Clinical Trial Related Injury 2) Compensation Clinical Trial Related Death 3) Compensation Clinical Trial Related SAE (other than death)

1) Compensation Clinical Trial Related Injury

Injury occurring due to any of the following reasons is considered as a clinical trial‐ related injury or death and the nominees of the subject are entitled to financial compensation.

1. Adverse effect of investigational product

2. Violation of approved protocol, scientific misconduct or negligee by the sponsor or investigator

3. Failure of investigational product to provide therapeutic effect 4. Use of placebo in placebo‐controlled trial

5. Adverse effect due to concomitant medication, excluding standard care, necessitated as a part of approved protocol

6. Injury to child in utero because of participation of parent in clinical trial

7. Clinical trial procedure involved in study

2) Compensation Clinical Trial Related Death

In case of death occurring in the trial subjects, their nominees would be entitled to financial compensation, which will be over and above any expenses incurred due to medical management of the subject.

Expenses of medical management and financial compensation, in case of trial‐ related injury or death, shall be borne by the sponsor of the clinical trial.

The sponsor shall give an undertaking to the licensing authority, along with the application for clinical trial permission, to provide compensation in case of clinical trial‐related injury or death.

In case the sponsor fails to provide free medical management for injury to the subject or financial compensation to the nominee of a subject who has died in a clinical trial, the licensing authority, after giving an opportunity to show cause will suspend or cancel the clinical trial and/or restrict the sponsor (including his representative) to conduct any further clinical trial in the country

3) Compensation Clinical Trial Related SAE(other than death)

Considering the definition of SAE, the following four sequelae other than death are possible in a clinical trial subject, in which the subject shall be entitled for compensation in case the SAE is related to clinical trial.

1) A Permanent Disability 2) Congenital Anomaly or Birth Defect 3) SAE causing life-threatening Disease or 4) Reversible SAE in case it is resolved.

Conti...

1) A Permanent Disability 100% permanent disability to a subject may not be considered

equivalent to the death of the subject Quantum of compensation in case of 100% disability should be

80% of the compensation of death of the subject Quantum of compensation for less than 100% disability

C= (Dx80xC)/100X100D= Percentage disability the subject has suffered. C= Quantum of Compensation which would have been due for

payment to the subject’s nominee(s) in case of death of the subject.

Conti...

2) Congenital Anomaly or Birth Defect Following situations may arise due to congenital anomaly or

birth defect.a) Still birth b) Early death due to anomaly For a & b the quantum of compensation such SAE should be

half of the base amount for SAE resulting into death = INR 400,000 (Rupees Four Lakhs)

c) No death but deformity which can be fully corrected through appropriate intervention

d) Permanent Disability (mental or physical) For c & d: INR 400,000 ((Rupees Four Lakhs)) + Medical

Management as long as required

Conti...

3) SAE causing life-threatening Disease

Compensation = N x W

N= Number of days for which the trial subject remained under life-threatening situation requiring medical care, irrespective of number of days of hospitalization

Conti...

4) Reversible SAE in case it is resolved

Compensation per day of hospitalization in such case should be double the minimum wage

Compensation = 2 x W x N

W=Minimum wage per day of the unskilled worker (in Delhi)

Compensation has been paid by Government of India (ministry of health & family welfare) since 2005 are as follows:

Year Total SAEs of Death

Death related to Clinical

Trials

Compensation paid

2005 128 5 52006 137 2 02007 136 4 42008 288 8 72009 637 16 132010 668 22 212011 438 16 162012 436 16 16

Procedure for Compensation

  The Investigator shall report all serious and unexpected adverse events to the licensing authority, the sponsor and the ethics committee, within 24 hours of the occurrence of the events.

I. In Case of Trial Related DeathII. In Case of Trial Related Injury and SAE

In Case of Trial Related Death

• In case of occurrence of the serious adverse event of death, an independent expert committee constituted by the licensing authority will examine the cases and establish the cause of death and recommend to the licensing authority the quantum of compensation.

• The ethics committee shall, after analysis, forward its report on the serious adverse event of death along with its opinion on financial compensation to the expert committee, with a copy of the report to the licensing authority, within 21 calendar days of occurrence of the serious adverse event(s).

Conti...

The sponsor and the investigator shall forward the reports on the serious adverse Event of death, after analysis to the ethics committee, expert committee and the head of the institution where the trial has been conducted, along with a copy of the report to the licensing authority (DCGI) and repetitive head of institution) within 10 calendar days after occurrence of the adverse event of death.

The expert committee shall examine the report of serious adverse event of death and give its recommendations to the licensing authority within 30 days of receiving the report from the ethics committee. While examining the event, the expert committee may take into consideration the reports of the investigator and sponsor.

Conti...

The licensing authority shall decide the quantum of compensation for clinical trial‐related injury and shall pass orders within 3 months of receiving the report of serious adverse events.

The sponsor shall pay the compensation for clinical trial‐related death as per the order of the licensing authority, within 30 days of the receipt of the order of the licensing authority.

o The sponsor shall submit to the licensing authority details of compensation provided or paid for clinical trial‐related death, within 30 days of the receipt of the order of the licensing authority

ll. In case of Trial Related Injury and SAE

The sponsor and the investigator shall, after analysis, forward the reports on serious adverse events to the ethics committee, licensing authority (DCGI) and the head of the institution u where the trial has been conducted, within 10 calendar days after occurrence of the adverse event of death, this is the section on injury, not death.

The licensing authority shall decide the quantum of compensation for clinical trial‐related injury and shall pass orders within 3 months of receiving the report of serious adverse events

The sponsor shall pay the compensation clinical trial‐related injury as per the order of the licensing authority within 30 days of the receipt of the order of the licensing authority.

The Ethics committee (IRB and Compensation Committee) shall, after analysis, forward its report on Serious Adverse Events to the licensing authority(DCGI), along with an opinion on financial compensation within 21 calendar days of occurrence of the serious adverse events

The licensing authority (DCGI) shall determine the cause of injury and pass orders as deemed necessary. The licensing authority shall have the option to constitute an independent expert committee, wherever necessary, to arrive at the cause of the serious adverse events and quantum of compensation to be provided. 

Compensation Formula

Compensation Formula For SAE or Death

Compensation Formula = B x F x R 99.37

Computing the 3 factors viz. a) Age b) Risk and c) base amount

B = Base amount (i.e. 8 lakhs)F = Factor depending on the age of the subject (based on

Workmen Compensation Act)R = Risk Factor depending on the seriousness and severity of the

disease -scale of 0.5 to 4

Compensation amount will vary from a minimum of Rs.8 lakhs to a maximum of Rs.73.60 lakhs depending on the age of the deceased and the risk factor.

The formula for calculating the quantum form clinical trial related injury:

C2 = A x B (1 – F/100) x D/100Where,C2 is the loss of dependency to the family of the injured research

subject.D - Percentage disability caused to the research subject due to the

clinical trial.A - It denotes the contribution from research subject’s salary to

his/her family. B - It is a multiplier connected to the age of the research subject

Limitation

No compensation should be paid for the failure of a medicinal product to have its intended effect or to provide any other benefit to the patient.

No compensation should be paid for injury caused by other licensed medicinal products administered to the patient for the purpose of comparison with the product under trial.

No compensation should be paid to patients receiving placebo in consideration of its failure to provide a therapeutic benefit

o No compensation should be paid (or it should be abated as the

case may be) to the extent that the injury has arisen:

through a significant departure from the agreed protocol; through the wrongful act or default of a third party, including a

doctor’s failure todeal adequately with an adverse reactionthrough contributory negligence by the patient.

Reference

• http://www.cdsco.nic.in• Revised Compensation SOP 23.09.2013.pdf. (n.d.).

Retrieved March 31, 2016, from http://www.cmch-vellore.edu/static/research/Files/Revised%20Compensation%20SOP%2023.09.2013.pdf

• Clinical Trials In India Ministry Of Health And Family Welfare Government Of India. 30 Aug 2013

http://mhfw.nic.in/index1.php?lang=1&level=4&sublinkid=3719&lid=2641• http://www.abpi.org.uk/our.../guideline.../compensation

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