Clinical trials

Competency Group: Business

Type: Process

Description: A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (vaccines, drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether these interventions are safe, efficacious, and effective. Clinical trials include behavioral human subjects research involving an intervention to modify behavior (increasing the use of an intervention, willingness to pay for an intervention, etc.) Human subjects research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision-making for the subject or the test itself imposes more than minimal risk for subjects.

Citation for Description: Definition of Clinical Trials. (2011). Retrieved from The Gates Foundation, http://www.gatesfoundation.org/grantseeker/Documents/Clinical_Trials.pdf

Advantages: Clinical Trials are necessary for any product that has direct influence on the human system. Clinical trials are overseen by both local and international regulations - therefore they are a necessity for any product development.

Limitations: Can be very expensive in terms of both time and money. Because of the issues involved - some products may never make it to market at great expense to the company.

Target Audience: R&D

Relevant to Universal Design: Yes

Stages and Steps: 6.3

Free Resource: National Institute of Child Health and Human Development. (n.d.). Clinical research & clinical trials. Retrieved from http://www.nichd.nih.gov/health/clinicalresearch/.

Free Resource: Bioinformatics Core Facility. (2009). Clinical trials worldwide. Retrieved from http://wiki.isb-sib.ch/bcf/Clinical_Trials_Worldwide.