A broad look at clinical research regulations

[Adam Fleming]

Clinical research regulations are directives that are aimed at making clinical research more effective and ethically justifiable. The tool or mechanism by which regulators ensure that clinical research regulations serve their purpose is what is called Good Clinical Practice (GCP).

Regulatory bodies around the world, irrespective of whether they function at national or global levels, formulate respective clinical research regulations that are aimed at ensuring that organizations involved in clinical research follow GCP guidelines. The idea is to bring about standardization and harmonization in the guidelines.

The broad aim of clinical research regulations, which has to ensure adherence to GCP guidelines, is to bring about quality and ethics into clinical research. Clinical research regulations consider any clinical research as being sufficient or effective only if it is conducted according to the principles of GCP and meets the criteria set out in GCP guidelines.

 

What are Good Clinical Practices?

Good Clinical Practices are a set of international quality standards formulated by the International Conference on Harmonization (ICH). The ICH is a global body that defines and sets forth guidelines for the clinical profession, which those in the industry and governments all around the world have to comply with. Many national clinical research regulations work alongside the guidelines issued by the ICH. Also, clinical research regulations usually work in tandem with similar guidelines for pharmaceuticals and medical devices.

ICH guidelines on clinical research regulations have regulations on all the major aspects of clinical research, such as:

Drawbacks of the clinical research regulations:

Some critics of the clinical research regulations have assailed it for its lack of punch in regulating a few areas of critical importance. Some of the criticisms levelled against clinical research regulations relate to the following:

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