U S And Worldwide Clinical Trials

In recent years, much effort has been put into creating international standards for clinical trials and the process by which new medical treatments are approved. Different countries still have their own agencies that ultimately decide on a product’s approval. However, agreement on clinical trial guidelines makes it easier for medical companies to have a new product approved in multiple countries.

International Guidelines on Clinical Trials

Although no single set of guidelines is accepted worldwide, clinical trials in many countries are required to adhere to guidelines known as Good Clinical Practice (GCP).

A group called the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is responsible for establishing GCP guidelines. The European Union, United States and Japan set up the ICH to set international requirements for the approval of new medical products.

GCP guidelines promote quality and ethical conduct in a clinical trial. They spell out specific recommendations on clinical trial design and execution. Regulatory agencies in many countries (including the United States, European nations, Japan, Canada, India, South Africa and Australia) all require that clinical trials follow GCP standards.

Worldwide Clinical Trials and Approval Agencies

The U.S. Food and Drug Administration reviews clinical trials of new drugs and medical devices and decides if the product will be approved for sale and use in the United States.

In the European Union, the European Medicines Agency performs a similar function. In India, the Drugs Controller General of India approves new drugs. In South Africa, the equivalent agency is called the Medicines Control Council.

Although these agencies function independently of one another, they all adhere to GCP guidelines. Consequently, products approved in one of these countries can often be approved in another without having to repeat the clinical trial. As a result, new drugs are made available to patients worldwide more quickly.

Resources

CenterWatch. (2010). Overview of clinical trials. Retrieved December 9, 2010, from http://www.centerwatch.com/clinical-trials/overview.aspx

ClinicalTrials. (2007). Understanding clinical trials. Retrieved December 9, 2010, from http://clinicaltrials.gov/ct2/info/understand

Indipharm. (n.d.). India: The opportunity. Retrieved December 9, 2010, from http://www.indipharm.com/indiatheopportunity.cfm

International Conference of Harmonisation. (n.d.). History and future of ICH. Retrieved December 9, 2010, from http://www.ich.org/cache/compo/276-254-1.html

National Cancer Institute. (2010). Cancer clinical trials. Retrieved December 9, 2010, from http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials

National Marrow Donor Program. (2010). What is a clinical trial? Retrieved December 9, 2010, from http://www.marrow.org/PATIENT/Undrstnd_Disease_Treat/

Undrstnd_Treat_Opt/Lrn_Clinical_Trials/What_is_a_Clinical_Trial/index.html

South Africa Department of Health. (2000). Guidelines for good practice in the conduct of clinical trials in human participants in south Africa. Retrieved December 9, 2010, from http://www.doh.gov.za/docs/policy/trials/trials-full.html

U.S. Food and Drug Administration. (2009). Development and approval process (drugs). Retrieved December 9, 2010, from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm