Clinical trials: Pharma companies do not follow post-trial obligations; assent of children not taken

By Syed Akbar
Hyderabad:  A majority of pharma companies and hospitals
conducting clinical trials in the country fail to observe ethical
aspects like assent from minors and post-trial obligations towards the
volunteer.

Many of them resort to what is called "selective reporting" wherein
only good results are reported to the Clinical Trials Registry-India
(CRTI), while adverse results are kept under the wraps.

A group of pharmacologists, which dug into the records of the CRTI,
found that the quality of reporting of clinical trials "is less than
satisfactory". A little over 500 clinical trials were studied by the
team comprising Preeti Yadav, Jaykaran, Mayur Chaudhari and Deepak
Saxena. They noticed that there was no system of post-trial
obligations in most of the cases. Post-trial obligations describe a
duty by research sponsors to provide a successfully tested drug to
research participants, who took part in the relevant clinical trials
after the trial has been conducted.

"There is a discrepancy in disease burden of India and areas of
clinical trials registered in clinical trial registry, particularly in
case of infectious diseases that are very common in the country, but
clinical trials addressing this issue are very less. Informed consent
was mentioned in 67.5 per cent clinical trials. Assent taken from
children was not mentioned in any clinical trial although 8.6 per cent
clinical trials studied related to childhood diseases," the
researchers noted. They suggested that assent should be taken from
children if they are above seven years of age.

In many cases there was no information to patients regarding
availability of drugs to them after completion of clinical trial. The
study revealed that a majority of clinical trials in the country are
sponsored by multinational pharmaceutical companies. This is one of
the reasons for neglect of clinical trials in the case of infectious
diseases and neglected tropical diseases.  They also observed that
disease to be explored in clinical trials by pharmaceutical companies
was not based on healthcare need of that region but based on expected
commercial gain.