• Clinical trials are experiments or observations done in clinical research.
• Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices).
• Clinical trials generate data on safety and efficacy.
• They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial.
• Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers.
• Clinical study design aims to ensure the scientific validity and reproducibility of the results.
• The current trend is to take clearances from respective ethics committee and start trials without registering with CTRI. The registry was launched in 2007, and trial registration was made mandatory by the Drugs Controller General of India (DCGI) in 2009.
• Trial registration involves public declaration and identification of investigators, sponsors, interventions, patient population etc. before recruitment.
• The data and reports of various trials are often difficult to find and in some cases do not even exist as many trials are abandoned or not published due to negative or equivocal results.
• Currently, all trials in India are registered on the Clinical Trials Registry India (CTRI).
• Of the trials registered with the CTRI (as on June 30, 2017), 3,318 are prospective and 5,604 are retrospective registrations which means details of these trials were uploaded after the companies conducting them had begun recruiting patients.
• To ensure transparency, safety and quality standards across human trials, India’s apex research body has made it mandatory for all researchers to register trials before they begin.
• Beginning April 1, the Clinical Trials Registry India (CTRI) will register clinical trials/studies prospectively before the first participant is enrolled.
• Under the new rule, any researcher conducting a trial for drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioural treatment, rehabilitation strategies, including in the AYUSH system, must register before enrolling the first participant.
• The trials that have already begun will not be registered after April 1, 2018.
• Clinical Trials are of two types:
a. Investigator-origin trials: It is led by an institution/clinician and could be funded by the institution itself or by a government agency.
b. Pharma- or medical-device-driven trials: In this, research is designed by the company, the clinicians are chosen by them and the team of researchers are given a fee by them.
• Bilateral agencies may also fund certain trials, and these may be done through the government or certain NGOs.
• Informed consent is at the heart of enrolment, so it is the participant’s right to know of every aspect of the trial. There is a 16-point check-list for this, including letting the patient know of the nature of the research, what the study is about, what it hopes to prove, what previous studies say on the subject, risks, possible benefits, compensation (life and disability insurance, travel allowance, compensation for loss of wages).
• There is a confidentiality clause that does not allow the person’s name to be disclosed.
• A person can opt out of any study at any point in the process without being penalised and can continue to have the standard of care treatment provided.
• All expenses of the medical treatment are borne by the funding agency, including toxicity management (either due to the new drug or the standard of care, like chemo).
• Every trial will have to be approved by a government-recognised ethics committee, consisting of an amalgam of people, ranging from clinicians, priests, lawyers, sociologists and social workers.
• This body of people is available for the person enrolled in the study. They also monitor the trial and will take a call on compensation in case of any adverse event.
Which of the following statements are true regarding Clinical Trials in India?
1. They are conducted only after they have received approval from ethics committee in the country.
2. Except government organisations, no other pharmaceutical company can sponsor clinical trial.
3. Currently all trials in India are registered on the Clinical Trial Registry India.
4. A person can opt out of any Clinical Trial at any point in the process without being penalised.
A. 1, 2 and 3
B. 2, 3 and 4
C. 1, 3 and 4