Clinical trials are highly regulated research studies using human volunteers to answer specific health questions.
Carefully conducted clinical trials are the fastest and safest avenue to find better ways to prevent, diagnose, and treat diseases. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
For information about currently running research and clinical trials or information for participants visit:https://www.uclahealth.org/clinical-trials
For financial disclosure forms, submission guidelines, standard terms, and additional information visit: http://clinicaltrials.ucla.edu
The university classifies sponsored projects by the type of research, as well as by funding source. Classification of a project will determine which office on campus has the authority to negotiate and execute the sponsored project agreement.
Here are some examples:
A Clinical Trial as defined by UCLA is "The controlled, clinical testing in human subjects of investigational new drugs, devices, treatments, or diagnostics, or comparisons of approved drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes." Such studies may be conducted under an industry-developed protocol or an investigator-developed protocol. These studies are most often conducted in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration, under Phase I, II, III, or IV, although they can be designed with the sole purpose of collecting and analyzing data about approved drugs or devices in order to contribute to medical knowledge about the treatment of a disease or medical condition. Financial support for a clinical trial must be provided by a private entity, including pharmaceutical companies, interest groups, or charities. In all cases, the study must include the prospective enrollment of human subjects and the controlled testing of a drug, device, or diagnostic under an approved protocol. Studies like retrospective chart reviews and analysis of existing medical data are not clinical trials. This definition applies to both Sponsor Initiated Trials and Investigator Initiated Trials.
The Clinical Trials Administration Office ("CTAO") only has the authority to negotiate and execute agreements that meet the UCLA definition of a clinical trial and when it is funded by a pharmaceutical, device, biotech company, or for-profit Clinical Research Organization (CRO) whether directly of through another academic medical center or non-profit organization (i.e. Pfizer to Yale to UCLA).
A Clinical Research Study at UCLA is more broadly defined to include research such as fretrospective chart reviews and analysis of existing medical data. The Office of Intellectual Property Administration has the authority to negotiate and execute agreements for clinical research studies, other than clinical trials, as defined above, funded by industry.
The Office of Contract and Grant Administration has the authority to negotiate and execute agreements for clinical research studies and clinical trials funded by the government or a non-profit entity.
A Material Transfer Agreement is characterized by UCLA as a transfer of experimental materials either to or from UCLA for the purpose of conducting research. Usually no funding to cover the cost of the research transfers hands and the materials are prohibited from being used in humans. Contact the Office for Intellectual Property Administration for assistance.