Clinical trials: Just how safe are they?” published on July 18.JULY 24 — We refer to the article “
As the nodal professional association for clinical research in India, Indian Society for Clinical Research, we would like to correct highly inaccurate comments made about clinical trials in India in your article where you have said that CROs are less forthcoming about information to (trial) participants and that participants are mostly poor who risk safety to get paid or for free treatment.
We would like to point out that:
The CRO does not have, nor is permitted to have, any direct contact with a trial participant as patient confidentiality and privacy is an important underlying tenet of any clinical trial. It is the responsibility of the site and investigator to help clinical trial participants understand all they need to know about a trial.
Very strict guidelines are in place in India for the informed consent process. This includes not just a discussion between the investigator and the patient in a language that the patient is most comfortable with, but over the last few years it is also required in India for the Informed Consent process to be audio and/or video recorded. The Informed Consent Form, which is very detailed and informative, has to be signed by the patient and the investigator and a copy of the signed form is handed over to the patient to keep. Guidelines are also in place for the Informed Consent process in cases where a patient is unable to read/write or not in a condition to give consent.
An analysis of clinical trial participants in India will show that clinical trial patients cut across all socio-economic backgrounds so it is erroneous to conclude that clinical trial patients in India are mostly poor.
A participant in a clinical trial cannot make money from a trial. Patients in a clinical trial in India may only be reimbursed for expenses incurred like travel and, in some cases where patients come from other towns/cities, for travel and stay. India regulations governing clinical trials clearly state that the payment towards these reimbursements cannot be so high so as to act as inducement.
Finally your statement about risking safety is also misleading. Regulations governing clinical trials in India are one of the most stringent and comprehensive in the world and the focus of these regulations is patient safety and protection.
* Dr Chirag Trivedi is the president of ISCR.
** This is the personal opinion of the writer or publication and does not necessarily represent the views of Malay Mail Online.