Though there is some of awareness about clinical trials in India, a lot of ambiguity and fear are still attached to it. People need to understand that new, effective and fast-acting drugs to treat critical diseases can be produced only after elaborate clinical trials are conducted on humans.
CROs (clinical research organisations) provide publicity through the media by way of advertisements highlighting their activities and calling for volunteers for trials. Once the volunteers contact the CRO, they are counselled. Lotus Labs plans to conduct a one-day national seminar on 'Awareness of Clinical Trials' in Bangalore during end of 2003 where eminent speakers will address issues on the need for conducting trials.
It is mandatory for drug companies to test on humans even after having validated animal trial reports before the drug is introduced into the market. The need to test on humans or healthy volunteers is vital to get more drugs into the market and could be region specific for a particular class of drug. For instance, in the case of drugs for tropical diseases, it may not be adequate to test drugs on volunteers in the US or UK, as India is the region for such diseases and also reports the high number of infection-related (bacterial and viral) deaths.
New molecules have to be tested in India to see that the disease is cured with the new drug.
NO RECRUITING AGENCIES FOR VOLUNTEERS
Volunteers are not engaged through recruiting agencies. The CROs get their volunteers by word-of-mouth and advertisements. Volunteers are never forced to register for a trial but through an informed consent process. Instructions on the quantity of food and water that can be consumed during the trial, apart from possible side-effects of the drug being administered to them, amount of blood to be drawn would be explained in detail.
Volunteers are engaged only after they fully agree to participate in the trials and sign the informed consent form. They will undergo a thorough medical check up and will be inducted for the trial only if found healthy. They are protected by the Institutional Review Board (IRB), which is an independent ethics committee (IEC) that permits the conduct of every trial in the country.
The IRB consists of a chairman who is a medical professional, a high court lawyer, a housewife, social worker, pharmaceutical scientist. Each professional looks at it from his respective angle and the housewife is selected to give a layman's opinion of the trial. Records of each approval granted by the IRB are maintained. The trial will be conducted only if the protocol is approved by IRB who ensure that the volunteer interests are protected. Any amendment to the protocol should be brought to the attention of IRB and approval sought before proceeding with the trial.
HOSPITAL TRIALS
In hospitals, trials are conducted with the consent of the doctors who are apprised on the treatment prescribed. Details are provided on the successful completion of the in Phase I (trial on healthy volunteers) and that it has entered Phase II / III (trials on patients). The Patient is also informed that there has been success in Phase I of the trials and his treatment is likely to be benefit him and it would be monitored by the doctor who will be the Clinical investigator. Even here, patient's consent is needed before commencement of the study.
VOLUNTEERS WITHDRAWING FROM TRIALS
The common reasons are an incidence of personal nature during the course of the study or fear about adverse drug reactions. Minor adverse reactions during the study are adequately addressed since every study is monitored by a trained Medical Professional. If the volunteer has apprehensions during the course of the Study he can withdraw any time after informing the study Director.
At Lotus Labs, where there are about 2,000 volunteers, there has been never such an instance. There have been cases where four to five volunteers have withdrawn during trials and they have not been stopped from walking out of the trials. A consent form is taken from them.
ISSUES ADDRESSED IN AN AWARENESS CAMPAIGN
The primary issue addressed is safety. We highlight the importance of participating in the trial, why it being done and the necessity for the trial. For the trials, a master health check up costing around Rs. 3000 is conducted free of cost. Volunteers get a certificate of health every quarter at no cost.
Volunteers are paid anywhere between Rs. 3,500 and 8,000 per trial. The rate depends on the duration of the trial, which includes the washout period.
GLOBAL SCENE
In the US, the awareness about clinical trials is high. People understand the fact that new drugs are required for humanity. The procedures of approval and selection of volunteers are same all over the world. The remuneration for volunteers in the US is higher than in India.
ADVERSE PUBLICITY FOR CLINICAL TRIALS IN INDIA
There is a lot of adverse publicity given to clinical trials in India. Three things are vital to create awareness in India. Firstly, media must ascertain the role of a CRO in the country. Secondly, the regulatory authorities like the Drugs Controller General of India (DCGI) should not only have clear-cut guidelines based on international requirements on clinical trials but provide clear information about the necessity of clinical trials through websites etc. Thirdly, the entire procedure of clinical trials should be made transparent as is being done by regulatory authorities in the US and UK & Europe.
When the regulatory authorities highlight the importance of a clinical trial, it would carry more weightage than a CRO advocating the need for it. The DCGI, by teaming up with Indian Council of Medical Research (ICMR) or the CROs can play a big role in spreading awareness about trials.
- The authors: V V Raghavan is managing director and Dr. Gopal Muralidharan is chief scientific officer, Lotus Labs Pvt. Ltd.