2. Content of Presentation…
Introduction
Criteria and formula for determining the quantum of
compensation in case of clinical trial related deaths
Risk factor
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
3. 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.
4. Cont………
The Drugs and Cosmetics Rules have been amended
vide GSR 53(E) dated 30-01- 2013 inserting a Rule
122DAB in Schedule „Y‟. The amendment specifies the
procedure for processing of reports of Serious Adverse
Events (SAEs) including deaths occurring during
clinical trial to arrive at the cause of death/injury to
the subject, and to determine the quantum of
compensation, if any, to be paid by the Sponsor or his
representative, whosoever have obtained permission
from the Drugs Controller General(India) {DCG(I)} in
a time bound manner.
5. Criteria and formula for determining the quantum of
compensation in case of clinical trial related deaths
The members of Independent Expert Committee discussed the various possible
factors that could be considered while deciding the quantum of compensation.
The following factors emerged. (Listed below are not on the basis of priority)
F1: Age of the Subject
F2: Risk of death
F3: Income of the Subject
F4: Co- morbidity of the subject at the time of SAE (Death)
F5: Expected Survival,
F6: Dependency on the deceased
F7: Concomitant medication
F8: Gender of the subject
F9: Negligence during the conduct of Clinical Trial
F10: Duration of the disease
F11: Industry V/s Academia V/s Institute v/s Sponsor,
F12: Expectedness of drug to cause death.
6. Risk factor
The risk factor shall be divided in a scale of 0.50, 1.0, 2.0,
3.0 and 4.0. However in case of patients whose expected
mortality is 90 % or more within 30 days, a fixed amount of
Rs. 2 lac may be given. The five grade of the scale is divided
as follows:-
0.50 -terminally ill patient (expected survival not more
than (NMT) 6 months)
1.0 -Patient with high risk (expected survival between 6 to
24 months)
2.0 -Patient with moderate risk
3.0 -Patient with mild risk
4.0 -Healthy Volunteers or subject of no risk
7. 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)
8. 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
9. 5. Adverse effect due to concomitant medication, excluding
standard care, 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
10. 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.
11. 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
12. 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.
13. 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.
14. 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
15. 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
16. 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)
17. 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
18. 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
19. 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).
20. 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.
21. 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
22. 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.
23. 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.
24. 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
25. 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.
26. 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
27. 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
28. 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.
29. 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%2
0SOP%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
