Clinical Trials Overview

What are Clinical Trials?

Any 'approved and regulated' research that studies a treatment to be used in the future (post Regulatory Approvals) for the treatment of patients suffering from a particular disease condition can be termed as a Clinical Trial. The outcomes of Clinical Trials can help us know more about the safety and efficacy of these treatments.

In what scenarios would we need to conduct a Clinical Trial?

Following are some scenarios where a Clinical Trial would be mandatory:

• For any new drugs which have not yet been approved by the regulatory authorities.

• For exploring new routes / methods for drug administration, for example, an approved drug given in a tablet formulation which could futher benefit the patients if administered as an injectable.

• For exploring if a drug already approved, could be used to relieve symptoms or treat another disease condition.

Clinical trials need to be planned, conducted and reviewed at every step of the process, to ensure participant safety and clear 'non-biased' outcomes. Clinical trials need approvals even before they begin. The document which contains all the relevant details on how the trial should be conducted, what is the aim of the trial etc is called the 'Protocol'. The Protocol itself needs reviews and regulatory approvals before any participant is allowed to be enrolled or even screened for a trial.

Apart from the Regulatory Agencies like the FDA and PMDA who are reviewers of the Clinical Trial process, there are other committee's who need to review and approve the progress of the trial periodically. For example, the IRB (Institutional Review Board) is one such committee, it should include atleast 5 members with varying backgrounds, to periodically review the all aspects of a clinical trial to keep a check on the institutional, social, scientific and legal implications. The IRB reviews the Protocol, with the aim to protect the welfare, rights, and privacy of human subjects participating in the clinical trial. After the trial actually starts, the IRB is required to review the progress at least once a year.

DSMBs (Data and Safety Monitoring Boards) is committee of clinical research experts, such as physicians and statisticians, and patient advocates who monitor the progress of a clinical trial and review safety and efficacy data while the trial is ongoing. It is their primary responsibility and concern to know if patients are safe, the data is complete, and if the test or treatment is working. Not all clinical trials are reviewed by DSMBs, the IRB determines if a Clinical Trial needs a DSMB review.

Benefits of a Clinical Trial

• Newer and better treatments could be discovered.

• It is a regulated and strictly controlled experiment where experts are involved and are responsible and accountable for participant safety.

• Results, both, good and bad, are documented, reviewed.

Risks of a Clinical Trial

Clinical trials carry risks too, there may be side effects or the treatments may not be 'as good as' or 'better than' the currently available therapy.