Rationale for Clinical Trial Regulations

Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials.

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The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation.

These regulations cover the administrative, procedural and ethical aspects of clinical trials.

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Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials:

Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified.

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Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related classifications. Clinical trial regulations concerning the procedural aspects of a clinical trial also relate to ways by which to legally obtain consent from research subjects and ensuring the privacy and confidentiality, something that is of critical importance to the clinical trial.

Ethical: A very grey area of clinical trial regulations; ethics constitute the heart of a clinical trial regulation. Clinical trial regulations concerning the ethical aspects of a clinical trial are basically to ensure the neutrality and objectivity of the trial. These clinical trial regulations have to be complied with to ensure that there is no clash of business interest from the sponsor. A sponsor developing a certain drug or medical device should, going by the rationale of clinical trial regulations, be detached from a group or organization that is in the field of producing these drugs. If there is this kind of interest, there is bound to be a bias in the research, leading to fudged and manipulated results showing undue favor to the product being manufactured in the organization in which the sponsor has an interest.