International Clinical Trials Day 2015

This day commemorates the day Dr.James Lind began his clinical trials into the cases of scurvy. Lind was the first physician to conduct a controlled clinical trial. While working as a surgeon on the ship HMS Salisbury, Dr.Lind conducted a comparative trial for sailors affected with scurvy. There were 12 sailors grouped into pairs and provided dietary supplements from cider to oranges and lemon. The idea was to find the most promising cure for this disease. The trial lasted six days and the group that was given fruit showed noticeable improvement thus providing evidence of the link between scurvy and citrus fruits. This day is a salute to his efforts on the first clinical trial in modern history.

Clinical Trials Day is a day to raise awareness on the importance of research to healthcare and the significance of relevant partnerships between clinical researchers, healthcare practitioners and patients. Clinical trials are a global challenge as countries partner with each other in conducting them. There is a need for transparent, ethical communication and coordination to work in the best interests of patients.

This day salutes the efforts of clinical researchers, clinicians, patients and the public who make clinical trials possible and improve the lives of those afflicted with challenging diseases/disorders. Clinical trials bring hopes of a cure to a number of people living with chronic/genetic/rare disorders. This is a day to recognize and empathize with patients across the world who live in the hope of curatives.

Clinical Trials Day is celebrated across the globe in research institutes, hospitals, labs, pharma and biotech companies and clinical research organizations (CROs). It is a day for clinical researchers and clinicians to meet clinical trial patients, patients-in-waiting, and patients with chronic/genetic/rare disorders to hear and understand their side of the story. Patient perspectives are significant reminders that clinical trials have a deep human component with the ability to impact people’s lives in an important way.

What are Clinical Trials?

Clinical trials are research studies to find safe and effective drugs, therapies, devices and medical strategies for human diseases and disorders.

Clinical research studies are of two types:

• Interventional studies (clinical trials)– Patients receive medical interventions such as drugs, therapies, procedures or devices, according to strategies planned by the investigation team. Interventional studies may be comparative testing which is better than many past methods. For example, in testing a new blood pressure drug, investigators may compare its efficacy in relation to existing blood pressure drugs.
• Observational studies – Here, patients receive no interventions apart from their usual routine medications or therapies. Investigators simple observe and assess their health outcomes as per the designed protocol. For example, investigators may observe a group of elderly patients with Alzheimer’s disease to understand how their lifestyle impacts deteriorating memory.

Clinical trials involve human volunteers or participants in the research study. Clinical trials are very important in advancing medical therapies, protocols and improved healthcare. They’re led by principal investigators, usually a medical doctor supported by a team of other professionals like researchers, nurses, social workers and health care people. They can take place in hospitals, labs and research institutes. The length of clinical trials varies from a few weeks to years. Participants are usually briefed on all details of the trial.

Clinical trials have standard guidelines on who can participate. This is called eligibility criteria. Some trials may be looking for people with the target disease while others may look for healthy volunteers. The factors that make someone eligible for a clinical trial is known as inclusion criteria and the factors that disqualify a person from participation is known as exclusion criteria. These factors could include age, gender, type of disease, stage of the disease, past medical history and complications, current drugs etc.

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Participants are usually given full details of the trials in order to enable them to make an informed decision. Informed consent is essential from all participants to take any trial forward.

The backbone of all clinical trials is the patients involved who volunteer as part of the study. Many patients have benefitted greatly from ongoing clinical trials which often give them a new lease of life in the form of a new drug/therapy.

Clinical Trials in India

The Indian Council for Medical Research (ICMR) sets the guidelines for conducting clinical trials in India.

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ICMR formally came into being in 1949 after the Indian Research Fund Association (IRFA) was reconceptualised. From then on, ICMR has established several research institutes to study nutrition, immunology, viruses, tuberculosis, leprosy, toxicology, cancer, human genetics etc. ICMR has a Central Ethical Committee and several subcommittees to take decisions on ethical issues related to human research and participation.

The National Institute of Medical Statistics (NIMS) is an institute affiliated to the ICMR and established India’s first Clinical Trials Registry (http://ctri.nic.in/Clinicaltrials/login.php) in collaboration with the World Health Organization (WHO) and Department of Science and Technology (DST). The idea of the Clinical Trials Registry is to encourage all clinical trials being conducted in India to be registered before enrolling participants. The Clinical Trials Registry-India (CTRI) aims at ensuring transparency, accountability and ethical standards for trials in India.

At present, the clinical trials climate in India has cooled due to new restrictions and regulations. In 2013, a US-based NGO called PATH (Programme for Appropriate Technology) illegally tested the cervical cancer vaccine on nearly 24,000 tribal girls in Andhra Pradesh and Gujarat. This led to a total of 7 deaths following which the Drugs and Cosmetics (Amendment) Bill 2013 was introduced in Rajya Sabha to strengthen the drug regulatory system through the setting up of a Central Drugs Authority.

However, in February 2014, the then Health Minister, Ghulam Nabi Azad announced that the government may consider relaxing norms for clinical trials after more than 50% drop in the number of clinical trials in India after the new pharmacovigilance rules.

Clinical Trials Day 2015 Theme

This year, the Indian Society for Clinical Research (ISCR) has rightly chosen the theme, “Patients First”.

According to the ISCR president, Suneela Thatte, the theme has been chosen to recognize the role of clinical trial patients in inventing new drugs and therapies. A number of workshops are being planned to highlight the importance of the role of patients in clinical trials and the need to adhere to safety rules and patient welfare.

Thatte stated that India’s share in the global clinical trials is very low at less than 1.5% of the total share. ICSR has launched a nationwide advocacy programme called NavChetana to create an enabling environment for clinical research by highlighting its significance and necessity.

Significantly, ISCR will be relaunching its publication, “Clinical Trials – A Guide for Participants” under the NavChetana banner. The concept behind this publication is to empower patients into understanding clinical trials better to take an informed decision.