Outsourcing-Pharma takes a look at how clinical research organisations (CROs) operating in India can do their best to ensure that clinical trials in the region are carried out ethically.
Recent media reports have alleged that poor and illiterate patients in India are being used, often unknowingly, by some CROs in India as human guinea pigs to test new drugs for the pharma giants of the West, who are increasingly outsourcing trials to this region for fast subject recruitment and major cost savings.
Outsourcing-Pharma.com spoke to two representatives of Chiltern International, the largest independent employee owned CRO in the world, to find out how CROs operating in India can be more responsible for ensuring these trials are carried out according to international standards.
First of all it is important that a CRO does not work with an investigator site in India until they have carried out an appropriate "site selection" process, said Dr Faiz Kermani of Chiltern UK.
The key is then to be extremely careful in the selection of clinical trial investigators: "ultimately the control of the trial is in the hands of the investigator so you need to be absolutely confident you can rely on them to do the job properly," said Kermani.
It is essential to be sure that chosen investigators completely understand and respect good clinical practice (GCP), the consent process and the need for documentation of the consent process, as well as the ethics involved in clinical trials, said Kermani.
"Besides the obvious moral issues, if patients aren't completely aware of the clinical trial process they may not be taking their medication correctly and this could render any data useless."
"Many of the investigators we choose have an already established internationally respected reputation and in addition to this we give them extra training to make sure they are operating properly," Kermani said.
In fact, Chiltern have recently set up a dedicated network of investigators in India (CINISTA), to serve as the preferred primary contact for Chiltern India and function as Principal Investigators or Coordinating Investigators and provide trial sponsors with their views and advice for areas such as trial design, study conduct and interim analysis.
The CINISTA network is spread over 15 cities and is made up of 30 medical and clinical research experts who are key opinion leaders in India for a range of 11 therapeutic areas.
All of them have a rich experience of undertaking global multi-centric trials and are well trained in GCP and a number are ACRP-certified investigators, said the company.
"No other CROs in India are running a similar program," said Dr Umakanta Sahoo, General Manager of Chiltern International, India.
Chiltern also have a network of clinical research associates (CRAs) in place to keep a close eye on the way its trials are run.
"CRAs are the most personal way of checking how a clinical trial is being run," said Kermani.
"As the monitors of clinical trials, a CRA's first priority is to check with the investigator about the consent process, who administered the process and verify the consent form for completion and accuracy," said Sahoo.
Monitors also verify with the investigators whether the patient was given adequate time to understand the informed consent form and the patient information sheet and whether all of the consent process was documented in the hospital records.
"CRAs insist that the patients should sign the consent form in the presence of the principal investigator and also verify with the person who had taken the consent whether a copy of the signed consent form was handed over to the patient," said Sahoo.
"Furthermore, if a CRO is serious about obtaining informed consent, they should make sure the consent form is translated into at least ten regional languages so that the patient can read and understand comfortably the complexities of a trial."
If the patient is illiterate, all the details of the trial must be explained to the patient in a way they can understand and the thumb impression of the subject should be taken in the presence of his/her legally acceptable representative (LAR) with his/her signature to complete the consent process.
If both the subject and LAR are illiterate, then the consent process demands the presence and signature of a witness who is impartial and not associated with the study, said Sahoo.
Considering that consent is an ongoing process, CROs should ensure that any new information /amendments in the protocol which may affect study participation, are briefed to the patients by the investigator appropriately.
"This should be verified by the site monitor during their routine visits," said Sahoo.
"As a practice, the consent forms should also mention the name of the Ethics Committee member for the trial, who can be contacted by the subjects if there are any concerns or questions related to their rights."