What are investigator-initiated clinical trials?

Introduction

You have probably experienced using medicines to relieve symptoms or cure illnesses which you or your family have suffered from when unwell. Do you know what happens along the research and development journey each medicine has to travel before it reaches you?

What are clinical trials?

Before medicinal drugs can be used by they go through a number of clinical trial processes to ensure they are safe to use in people, and effective as treatments.

Potential drug candidates are selected from substances that already exist in nature, such as from plants, animals, bacteria, or fungi. Sometimes they are derived from existing chemically synthesized compounds. Laboratory and animal experiments may be used to predict their effectiveness against diseases and their safety for human use. In the final stages of the development of a drug, its effectiveness and safety also has to be tested in humans, in a research stage called clinical trials. Healthy volunteers or actual patients may be involved this stage. After the government regulatory bodies review the results of these clinical trials, the drugs that are approved as effective and safe use in the treatment of diseases can be called “medicines”.

There are two main ways clinical trials are organized: “industry-sponsored trial” conducted by pharmaceutical companies and “investigator-initiated trials” conducted by researchers themselves. Each of these two types of trials have different roles and contribute to advancements in treatment.

Why Clinical Trials are needed?

Large-scale clinical trials, which are often costly to run, are often conducted by pharmaceutical companies. However, pharmaceutical companies are unable to conduct clinical trials to meet every need. Rare cancers are an example of a group which are of neglected by commercially-driven research. In such cases, drugs may be developed through an investigator-initiated trials in which the researchers initiate the trial themselves. The purpose of such clinical trials is to lead to better medical treatment for patients for whom existing treatments are inadequate, so-called ‘unmet medical needs’.

What problems can be solved by an investigator initiated trial?

Clinical trials are gifts for the future. Because of the cooperation of many people, we can provide new treatments for more patients with a wider range of diseases.