What is a Clinical Trial ?
A clinical trial is one of the final stages of a long and careful research process.
Clinical trials are only a small part of the research that goes into developing a new treatment. For example, potential drugs, first have to be discovered, purified, characterized, and tested in labs (in cell and animal studies) long before reaching clinical trials.
About 1,000 potential drugs are tested before just one become eligible for testing in a clinical trial. On average, a new cancer drug has at least 6 years of research behind it before it even makes it to clinical trials.
If this stage of testing is successful, we begin testing the drug in humans. Such studies are vital to the development of new treatments for diseases such as cancer. But the major delay in making new cancer drugs available is the time it takes to complete these clinical trials. On average, about 8 years pass from the time a cancer drug enters clinical trials until it is approved.
A clinical trial, often referred to as a clinical study or research study, is designed to determine whether a new drug or treatment will alleviate a disease or be of potential benefit to patients. Clinical trials allow physicians and researchers to gather information on the benefits, side-effects, and possible applications of new drugs, as well as different drug combinations, doses, and new indications for existing drugs. As a result, the medical community may be able to devise new ways to detect, diagnose, avoid, and control clinical factors responsible for diseases.
Without these studies there would be little hope for new and more effective medicines to combat cancer and other harmful or life-threatening diseases. In order to ensure a maximum protection of the patients participating in a clinical study, the clinical development process is carefully and strictly regulated by a comprehensive set of laws, and monitored by the regulatory authorities of the respective countries and the ethics committees.
There are different types of clinical trials:
- Interventional trials (also called treatment trials) which determine whether new treatments, a new combination of drugs, new ways of using known therapies or new approaches to surgery or radiation therapy are safe and effective.
- Prevention trials look for better ways to prevent cancer in people who have never had cancer or to prevent cancer from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
- Observational trials address health issues in large groups of people. Trial participants may be asked to answer questions about their family histories or give blood samples, but they do not receive treatment for their diseases.
- Screening trials test the best way to detect cancers at an early stage.
- Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for cancer patients.
Once the drug, device or procedure enters the clinical trials process, it must go through several phases ; each trial phase has a different purpose and aims to answer different questions:
