Know Why and How Clinical Trials are Conducted

Clinical trials, which play a great role in providing new medications, often are believed unethical and illegal today. But, it’s the lack of awareness on them that make us misunderstand their significance. So, let’s recognize their importance and know what clinical trials are, and why and how they are conducted.

Clinical Trials – Clinical trials are research studies which test the safety and effectiveness of new treatments. It’s always essential to regularly develop new medications and treatments (for various diseases) with fewer side-effects and easy processes. However, a lot of research on them is required before they reach public. The safety and efficacy of these new approaches are checked on animals (pre-clinical studies) and then on individuals (clinical trials). So, the reasons for conducting clinical trials are:

– To know how well the new treatment works
– To know how safe it is
– To compare the existing treatments and determine which is better

The process may, however, take a long time – as long as 10 years or more. Depending on the variety of drug, clinical trials are conducted on healthy individuals or diseased patients. For instance, anti-cancerous drugs have to be tested on cancer patients. The selection of participants, however, is done based on certain factors such as age, gender, the type and stage of a disease, previous treatment history and other medical conditions. The experimental new treatment may, therefore, be beneficial and effective for the participants. It provides a chance to improve their quality of life.

But, are they safe?

Clinical trials ensure safety as specific authorities regulating the studies protect the participants. But, uncertain risks and concerns, which are always associated with medical research, may be unavoidable. However, it is the responsibility of the clinical trial organizer to inform the risks and benefits of the experimental drug to the participant upfront, and start the trial only after his approval.

Possible outcomes of Clinical Trials

Drugs which are successful in these clinical studies will be approved by a national regulatory authority (Food and Drug Administration (FDA) – United States, Central Drugs Standard Control Organization – India) before introducing into the market. However, drugs with negative outcomes showing adverse side-effects will be rejected – Diabetes drug Dapagliflozin and the drug Avastin for metastatic Breast Cancer are rejected by the FDA.

This is how clinical trials conducted today are helpful to supply new treatments. But, the present process is a result of several modifications of the earlier studies.

Trends in Clinical Trials

Several trends in clinical trials were seen from the past till today. Experimentation on new treatments were evident from 1700s, however, modern clinical trials were developed from mid-20th century. A gradual progress and standardization of clinical trial processes was seen at that time. However, the importance of ethical concerns with respect to regulation of clinical trials rose from 1945 and improved the significance of the studies.

In 1964, the World Medical Association designed specific guidelines on use of human subjects in medical research – they are mentioned as the Helsinki Declaration. Regular changes will be made in this for every few years. In 1996, the International Conference on Harmonization published the Good Clinical Practice, a universal standard for ethical conduct of clinical trials.

Though clinical trials are conducted on people of one’s own country, a globalized trend of clinical trials emerged gradually. Strict regulations, elaborate safety requirements, and small populations of the Western countries are some of the reasons which initiated this trend. In order to avoid these problems and to recruit patients quickly, several research-based companies started outsourcing clinical trials to other countries including China, Indonesia, India, Thailand and some other nations of Africa. India has become one of the favorable global destinations for clinical research because of high patient availability, low costs, and a friendly drug system.

Clinical trials, whether national or global, conducted with standard procedures and strict regulation give a chance to provide novel therapies and medication.