Clinical Trials

There are several definitions for a clinical trial. The University of South Alabama follows the definition provided by the National Institute of Health (NIH). Per the NIH, a clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. It is important to note that not all human subject research is considered a clinical trial.

If you are approached by a pharmaceutical company to conduct a clinical trial or if you want to develop an Investigator-Initiated clinical trials please contact the Director of Clinical Trials.

Wendy Blount, RN, MSN
Director, USA Health Clinical Trials
(251) 445-9834
wlblount@health.southalabama.edu

▼   Regulations

Clinical trials that use a product that is regulated by the Food and Drug Administration (FDA) must follow FDA regulations. Additionally, clinical trials must adhere to the principles of Good Clinical Practice, most important of which is ICH E6: Good Clinical Practice- Consolidated Guidance. Below are important links to review prior to starting any clinical trials.

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

ICH Guidance Documents

ICH E6: Good Clinical Practice- Consolidated Guidance

The below information is vital information to conducting clinical trials at the University of South Alabama. 

▼   Training

Personnel conducting clinical trials require additional training. Training requirements can be found on the Training webpage. All key personnel and investigators should take the required training. Key personnel are any research personnel that significantly contribute to the integrity of the research date. Examples of key personnel include coordinators and Investigators. Pharmacist should be considered key personnel when an investigational product is involved.

▼   Investigational New Drug (IND)

Numerous clinical trials that use a drug governed by the Food and Drug Administration (FDA) require an Investigational New Drug (IND) application to be filed with the FDA. The person or entity that files the IND is considered the Sponsor.

The Sponsor is ultimately responsible for all aspects of the study. Such responsibilities are clearly defined in the federal regulations.

University of South Alabama’s Investigators should be sure to consider all the required Sponsor responsibilities before submitting an IND. Investigators should refer to the IND Guidance for comprehensive information about INDs.  

▼   ClinicalTrials.gov

If you have filed an IND with the FDA then you are response for reporting your clinical trial on clinicaltrial.gov. Please refer to the clinicaltrials.gov webpage for additional information.

▼   Policies and Procedures

University of South Alabama Investigators and research personnel must follow University policies. Clinical Trial Policies and Procedures are in the process of being created. You can contact the Director of Clinical Trials for any questions related to policies.

Wendy Blount, RN, MSN
Director, USA Health Clinical Trials
(251) 445-9834
wlblount@health.southalabama.edu

▼   Investigator-Initiated Clinical Trials

Investigator-Initiated clinical trials are studies in which the Investigator has developed the study design and has written the protocol. Investigators who want to develop their own clinical trials should review the information on the Investigator-Initiated webpage.

Investigators should contact the Director of Clinical Trials for assistance with study development.

Wendy Blount, RN, MSN
Director, USA Health Clinical Trials
(251) 445-9834
wlblount@health.southalabama.edu