The major goal of the Clinical Research Resource and Facilities Core is to increase the amount of clinical studies that meet the Good Clinical Practice (GCP) guidelines that are carried out at Charles R. Drew University (CDU): This core will facilitate opportunities for faculty to perform clinical studies on the Clinical Studies Center by: a) Providing a Quality Assurance Manager whose responsibilities will include; (1) assisting investigators to prepare IRB, IND and FDA applications, (2) educating research coordinators/PIs at the onset of their studies to ensure that GCP guidelines are met at the outset, (3) evaluating ongoing clinical studies to ensure that GCP guidelines are met as the study is carried out, (4) providing logistical support for the Data Safety Monitoring Board (DSMB), (5) educating the Community Faculty in regards to GCP guidelines, b) Providing research coordinators to enable studies whose funding does not support a dedicated research coordinator to be carried out; c) Providing Research Subject Advocates (RSA); (1) to ensure that participants are treated fairly and safely; (2) to evaluate their experience as research subjects, (3) to educate community members (not faculty) regarding research and their potential role as participants.

Public Health Relevance

There are many fewer clinical studies in minority populations compared to the Caucasian population. Pathophysiolgy and clinical responses to treatment often differ in these two populations. Less information in minority populations has been shown to have a deleterious effect on health outcomes. A robust Clinical Studies Center at CDU will help repair this discrepancy and contribute to less health dsparities in minorities.

Agency
National Institute of Health (NIH)
Institute
National Institute on Minority Health and Health Disparities (NIMHD)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
5U54MD007598-10
Application #
9471238
Study Section
Special Emphasis Panel (ZMD1)
Project Start
Project End
Budget Start
2018-05-01
Budget End
2019-04-30
Support Year
10
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Charles R. Drew University of Medicine & Science
Department
Type
DUNS #
785877408
City
Los Angeles
State
CA
Country
United States
Zip Code
90059
Elsaid, Ahmed F; Shaheen, Magda; Ghoneum, Mamdooh (2018) Biobran/MGN-3, an arabinoxylan rice bran, enhances NK cell activity in geriatric subjects: A randomized, double-blind, placebo-controlled clinical trial. Exp Ther Med 15:2313-2320
Sinha-Hikim, Amiya P; Mahata, Sushil K (2018) Editorial: Obesity, Smoking, and Fatty Liver Disease. Front Endocrinol (Lausanne) 9:1
Chung, Seyung S; Dutta, Pranabananda; Austin, David et al. (2018) Combination of resveratrol and 5-flurouracil enhanced anti-telomerase activity and apoptosis by inhibiting STAT3 and Akt signaling pathways in human colorectal cancer cells. Oncotarget 9:32943-32957
Schwartz, Steven; Bazargan-Hejazi, Shahrzad; Pan, Deyu et al. (2018) Association of Psychiatric Diagnostic Conditions with Hospital Care Outcomes of Patients with Orthopedic Injuries. Perm J 22:
Jenders, Robert A; Adlassnig, Klaus-Peter; Fehre, Karsten et al. (2018) Evolution of the Arden Syntax: Key Technical Issues from the Standards Development Organization Perspective. Artif Intell Med 92:10-14
Maxwell, Annette E; Castillo, Laura; Arce, Anthony A et al. (2018) Eating Veggies Is Fun! An Implementation Pilot Study in Partnership With a YMCA in South Los Angeles. Prev Chronic Dis 15:E132
Elshimali, Yahya I; Wu, Yong; Khaddour, Hussein et al. (2018) Optimization Of Cancer Treatment Through Overcoming Drug Resistance. J Cancer Res Oncobiol 1:
Hanuscin, Chris; Zahmatkesh, Golara; Shirazi, Anaheed et al. (2018) Socio-Demographic and Mental Health Profile of Admitted Cases of Self-Inflicted Harm in the US Population. Int J Environ Res Public Health 15:
Hasan, Mohammad Kamrul; Friedman, Theodore C; Sims, Carl et al. (2018) ?7-Nicotinic Acetylcholine Receptor Agonist Ameliorates Nicotine Plus High-Fat Diet-Induced Hepatic Steatosis in Male Mice by Inhibiting Oxidative Stress and Stimulating AMPK Signaling. Endocrinology 159:931-944
Ferrini, Monica G; Gonzalez-Cadavid, Nestor F; Rajfer, Jacob (2017) Aging related erectile dysfunction-potential mechanism to halt or delay its onset. Transl Androl Urol 6:20-27

Showing the most recent 10 out of 190 publications