By Dr. Caleb Harris & Dr. Fine One Laloo
May 20 is observed as International Clinical Trials Day. The year was 1714, Dr. James Lind, a naval surgeon and physician onboard the British Navy ship, HMS Salisbury carried out the first controlled clinical trial ever recorded in medical science by taking 12 sailors suffering from bleeding gums and skin ulcers, divided them into six pairs and treated them with six different remedies. Among the six remedies, the duo treated with a quart of cider a day was well enough to nurse the others after a week. His paper ‘Treatise of the Scurvy’ was published in 1753. To commemorate the day that this clinical trial was started, the European Clinical Research Infrastructure Network (ECRIN) launched International Clinical Trials Day in 2005.
Clinical trials fall under the broad umbrella of Clinical research. All clinical trials are clinical research whereas all clinical researches are not clinical trials. Clinical research ranges from a simple collection of personal information related to a disease, to using a new drug or treatment technique. Participating in clinical research is an altruistic and noble gesture because sometimes the trials that they are involved in may or may not be beneficial to the participants; however it helps researchers and doctors to subsequently treat the disease better, based on the data collected from the trial.
The public perception regarding Clinical Trials is at times negative, probably because some have not been done ethically. The Nazi Human Experiments, during World War II, has had a long and lasting negative impact for generations. German doctors subjected prisoners in the concentration camps to several harmful and painful experiments in the effort to discover effective remedies for diseases. Post World War-II, the Nuremberg code was put into force which at its very core stresses on the voluntary consent of participants in the trial. Subsequently, the World Medical Association, in 1964, developed the Declaration of Helsinki wherein the basic principles include respect for individuals, the right to make informed decisions, recognition of vulnerable groups and more.
The 21st century saw the unprecedented growth of clinical trials regulations, monitoring and participation. With the advent of many chronic and deadly diseases, clinical trials have become mandatory for introducing new drugs. On this note, there have been wide misconceptions among the masses regarding how clinical trials are conducted.
Once a drug has been tested in laboratory animals and has been proven to be safe and effective, a clinical trial is usually initiated in a small group of human volunteers. If found to be safe, it is then tried out in a larger number of patients to see if it is effective. There are several stringent rules and regulations put up by Indian Council of Medical Research (ICMR) and other regulatory bodies to safeguard the participants and their rights. One of the main protective mechanisms is the Informed Consent Document (ICD). This contains all the details pertaining to the clinical research in an easily understandable language, including the benefits and risks of participation. A participant who consents to participate in a clinical trial can withdraw at any particular time without citing any reasons whatsoever and there will not be any indifference directed towards them for withdrawing. The second is the Institutional Ethics Committee (IEC) which has to be mandatorily set up at all institutions involved in clinical research. The IEC is an independent entity chaired by someone from outside the research institute and decides on all matters relating to the conduct of trials or any research. IEC members comprise laypersons, social scientists, patient representatives and religious leaders, among others.
NEIGRIHMS is part of an Oncology Clinical Trial Network (CTN) which is a group of 11 centers across India. CTN is a project of Biotechnology Industry Research Assistance Council (BIRAC) which falls under the Department of Biotechnology, Ministry of Health and Family Welfare, Government of India. CTN aims at making the collaborating centres ready for Clinical Trials of major diseases which plaque the state and the nation as a whole. Clinical trials for cancer have been carried out for some years now. NEIGRIHMS is looking forward to conducting clinical trials of new drugs in the future through this CTN. It is important for such clinical trials to be conducted in our state (and region) as relying on research done on other patients (from different ethnicities) to treat our patients may not be in the best interests of our patients.
Many patients and caregivers construe clinical trials as something which is of no direct benefit to them and fraught with risks, but this is far from the truth. A clinical trial is performed under a controlled environment and hence the safety of the participant is given a lot of importance. All the necessary interventions are performed (extra) carefully, thereby minimizing the errors. Besides, several new drugs (which have been proven in other trials) may be made available to patients who may otherwise not have access to such treatment, usually free of cost.
Clinical Trials have transformed the way we treat patients and unless the participants are aware of the processes involved, it would be difficult to perform future trials. Misconceptions need to be cleared in order to enable us to move forward, with the single goal being to provide the best possible care for the sick.
(Dr Fine One Laloo. Pharm.D. is Clinical Trial Coordinator, Department of Surgical Oncology, NEIGRIHMS, Shillong).
(Dr Caleb Harris is Associate Professor and Head, Department of Surgical Oncology, NEIGRIHMS, Shillong)