Hyderabad: The number of patients who have enrolled in clinical trials in the country has increased steadily over the last four years, from 859 in 2015, to 3,869 in 2018 (till November). This has been attributed to better regulation such as the formation of ethics committees in hospitals and the accreditation process that has been made mandatory.
In Telangana state, 432 patients have enrolled in clinical trials in various institutions this year. There are 10 accredited centres and five of them have to yet complete their process.
Accreditation from NABH (National Accreditation Board for Hospitals & Healthcare Providers) has been made mandatory for clinical trials from 2018. This has been the turnaround for clinical trials as an ethics committee is now mandatory in hospitals carrying out the trials and the cases are evaluated from time to time.
Dr Sumeet Roy, senior scientist with a life science company explained, “The accreditation process has made it very stringent as there is now documentation and also evaluation. This has helped to bring in the confidence which was the major lacunae noted earlier.”
Most of the clinical trials are being carried out to test new molecules for the treatment of cancer, particularly breast and lung cancer. New drugs for treatment of hypertension and diabetes are also on trial along with a five to 10 year assessment study carried out for old drugs that have been in the market for some time.
Dr N. Jayalatha, director of MNJ Cancer Hospital, says that new molecules in the treatment of breast and lung cancer are showing encouraging results. “There are quite a few of them which are now at the stage of human trials and we are working on them. The trials for the new molecules are mostly on end-stage patients. In some cases we see encouraging results and in some we have not found the results satisfactory.”
Consent had been a major issue with clinical trials and patients have complained that they were not aware of what drug was being administered or what trials carried out.
Dr Syed Imamuddin, senior professor and cardiologist at Osmania Medical College, says, “The issue of consent has made us now take it in four languages. We take the consent in English, Telugu, Urdu and Hindi. In some cases, if the mother tongue is any other Indian language the consent is taken in that. The forms are submitted to them to read and understand, evaluate, and then opt for agreement. These safeguards are a must for clinical trials now.”
Clinical trials of diabetes and hypertension drugs are carried out on those patients who were not responding to medicines they were being given.
Dr R.B. Raju, senior cardiologist, explained, “We have to try all the existing medicines and then only opt for a trial. In the case of hypertension and diabetes we cannot take those patients who have complications of the organs. This is because they are already using an extra drug for the complication which cannot be discontinued. Hence, the selection of patients is based on a lot of parameters and guidelines.”
In the case of cancer patients, it is mostly stage 4 patients who are taken into the trials. Dr Vijay Anand Reddy, senior oncologist, says, “The medicines that work for stage 4 patients give us accurate data of how the drugs will work in the body. The effective drugs for stage 4 are then scaled up to stage 1 and stage 2 cancer patients. The norms are very clear and patients who know that they have no other option are often found to be more than willing (to participate in the trial). The experience with each patient has been different and it is not possible to generalise the profile. But one thing noted is that there is willingness to try new drugs and see if it works, mostly in end stage patients.”