Compensation in clinical trial

PREPARED BY:
BHAUMIK R BAVISHI (15MPH301)
DEPT: PHARMACEUTICAL ANALYSIS
NIRMA UNIVERSITY
Compensation in Clinical Trial

Content of Presentation…
 Introduction
 Guideline 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 Formula
 Limitation

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

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

 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)/100X100
D= 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 5
2006 137 2 0
2007 136 4 4
2008 288 8 7
2009 637 16 13
2010 668 22 21
2011 438 16 16
2012 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 Death
II. 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/100
 Where,
 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 to
 deal adequately with an adverse reaction
 through 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%20S
OP%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&li
d=2641
• http://www.abpi.org.uk/our.../guideline.../compensation

Compensation in clinical trial

Compensation in clinical trial

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