What are clinical trials?

Clinical trials are scientific studies conducted to find better ways to prevent, screen for, diagnose, or treat disease. These clinical trials may also show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce high-quality data for healthcare decision making.

The purpose of clinical trials is to answer scientific questions. Therefore, these studies follow strict, scientific standards which protect patients and help produce reliable clinical trial results. Clinical trials are one of the final stages of a long and careful research and development process. The process often begins in a laboratory, where scientists first develop and test new ideas.

Source: Novartis

Recent Relevance:

Recently, a case has surfaced where J&J globally recalled its faulty hip implants in 2010, including from India. It was found that the design of the implants led to high wear and tear and, in several cases, increase in the body’s chromium and cobalt levels making the patients vulnerable to damage. It was alleged that the implants had been used without proper clinical trials.

Sources: Economic Times and Financial Express

Importance of clinical trials:

Globally, clinical trials are a critical and indispensable component of the drug development process. No drug we consume today would be available without patients who participated in clinical trials. India, which has about 17% of the world’s population and about 20% of the global disease burden we need indigenous clinical research to develop new and effective medicines and vaccines. Incidentally, a mere 1.4% of new drug trials take place in India.

Source: Financial Express

Current framework of clinical trials in India:

Under the current regulatory framework, clinical trials for a new or existing drug or medical device can only be carried out at centres that have the appropriate facilities and are staffed with competent and experienced investigators to carry out the trials.

These institutes must also have institutional ethics committees (IECs) that are registered with the Central Drugs Standards and Control Organization (CDSCO). Without the registration of IECs, the clinical trial is considered illegal and not recognised by the Drugs Controller General of India (DCGI). Furthermore, the National Accreditation Board for Hospitals & Healthcare Providers (NABH), an arm of the Quality Council of India (QCI), has set up standards that the IECs need to maintain, in order to get the accreditation to carry out trials in India.

Source: Financial Express

Issues relating to clinical trials in India:

• Exploitation of vulnerable groups – The big problem plaguing clinical research is an over-representation of low-income groups among trial subjects. Sometimes clinical research organisations (CROs) recruit them selectively, exploiting financial need and medical ignorance.
• Over-volunteering – At times people over-volunteer for the money. As the only reward from the trial is financial, this results in an incentive to lie about one’s medical history or enrol in multiple trials to maximise one’s income. Such deception is a risk not only to volunteer’s health but also to society, because it can lead to mistakes in trial’s results. Based on faulty trials, unsafe drugs can make their way into the market as a result, or safe drugs can get rejected.

Way ahead

• National registry of trial volunteers – National registry of trial volunteers which will maintain a ready and connected database of trial volunteers and which will alert a CRO when someone signs up for trials in violation of the regulations.
• Encouraging the civil society to participate in trials – There is a need to encourage a wider cross-section of society to participate in research on human subjects. Society at large must realise the valuable service that clinical research subjects perform by making drugs safe for the rest of us. It is imperative that this burden not fall completely on the vulnerable groups.
• Compensation for the volunteers – The Company conducting the trials must pay adequate compensation to the volunteer/volunteer’s family in case of death or permanent disability of the patient.

 Source: The Hindu