ETHICAL STANDARDS IN CLINICAL TRIALS

04: COMPENSATION
NORMS
Injury or death induced
financial compensation

01: VULNERABILITY 05: ACCESS TO

TREATMENT

Agree to gain access to Treatment stopped at

treatment the end of the trial

06: DATA INTEGRITY

02: FREE & INFORMED CONSENT
Clinical Data manipulation
Information about trials &
risks

03: USE OF PLACEBOS

Easier to obtain clear

results
CASE STUDY

Clinical
Trial
 STORY

01

02
STORY UNFOLDS…..
 ETHICAL CONCERNS

No consent Help in digestion Not informed

about Side
effects

Under conditions Benefit from the results

medically suited for of the research
experimentation
 STATEMENTS

By CDSCO
By Glenmark

“Claimed
Allegations to be
false”

“Way to extract
money “

“Suspended clinical
trial” “Patient data
falsified”
“38 Kits supplied &
“Departure from GCP
only 3 were issued”
guidelines”
“Received approval
“Questions raised on
to conduct a Phase Ethics Committee.”
IIb study”
By Malpani Hospital
 Demands of Civil Society Organization

● Conduct of detailed investigations and initiate action

against them.

● Investigate all other sites

● Cancellation of the clinical trial registration

● Initiate enquiry against Glenmark

● Medical examination of victims & access to free

medicines

● Compensation

● Amendment in Regulation
SUNPHARMA CASE STUDY

• Letrozole - Breast cancer treatment for post-

menopausal women

• Use in women of child bearing age is strictly

prohibited - estrogen deprivation, ovarian
atrophy, uterine atrophy, foetal death

• Sun pharmaceuticals tested it for inducing

ovulation

• Clinical trials - >400 women

• Unethically tested in Phase III studies

 Case (Cont….)

• In 2008, Brinda Karat raised a query in the

Parliament.

• Research on 150 pregnancies

• Investigation revealed the entire exercise is meant

to push the sales of the drug.

• Drugs continued to be in use under various brand

names
 ETHICAL CONCERNS

• Subjects were not informed they were participating in a trial (DoH §20).

• Informed consent was not obtained (DoH §22).

• Regulatory authority failed to take action.

• Trial was conducted by private practitioners