Office of Clinical Research Annual Report 2017 July 1, June 30, 2017

Transcription

1 Office of Clinical Research Annual Report 2017 July 1, June 30, 2017 Table of Contents Title Page Number Mission Statement 1 Objective 1 Research Services 1 Research Highlights 2 Figure 1 Number of Clinical Trials 2 Figure 2 Active Clinical Trial Locations 3 Figure 3 Pending Clinical Trial Locations 3 Figure 4 Completed Clinical Trial Locations 4 Figure 5 Active Clinical Trial Therapeutic Areas 4 Figure 6 Pending Clinical Trial Therapeutic Areas 5 Figure 7 Completed Clinical Trial Therapeutic Areas 5 Figure 8 Investigative Phases of Active Clinical Trials 6 Figure 9 Investigative Phases of Completed Clinical Trials 6 Figure 10 Subjects Screened/Pre-screened 7 Figure 11 Subjects Enrolled 7 Figure 12 Subjects Visits 8 Figure 13 Sponsor Site Visits to the OCR 8

2 Mission Statement: Advancing Health through Best Practices in Clinical Research The mission of the Office of Clinical Research (OCR) is to maximize expertise in the field of clinical research by providing research support to University of Tennessee Health Science Center (UTHSC)- affiliated investigators to improve the quality, efficiency and regulatory compliance for the conduct of clinical research. The UTHSC OCR is a premier research support center for clinical translational research within the Mid- South area conveniently located within the UTHSC Memphis campus. The UTHSC OCR offers individualized fee-based research services for the development, set-up, initiation, quality control, financial management, and closeout of clinical research trials for investigators. Objective: The OCR will provide research services to UTHSC affiliated investigators to improve the quality, efficiency, and regulatory compliance of the conduct of industry-sponsored clinical research trials and enhance the institution s ability to fulfill its research mission. Research Services: Services provided at the UTHSC campus, OCR Pauline Clinical Research, Methodist University Hospital, Methodist Germantown Hospital, Methodist South Hospital, Methodist North Hospital, Methodist Healthcare-Sutherland Cardiology Clinic (1211 Union Avenue and Methodist Germantown and Methodist North), Regional One Health, and Hamilton Eye Institute. OCR services have been contracted with investigators at Campbell Clinic, and St. Jude Children s Research Hospital. Services available to UTHSC affiliated investigators include: Education and training of new or inexperienced investigators in the conduct of clinical research Institutional Review Board submissions Guidance in regulatory compliance issues and adherence to federal regulations, assistance with completion and management of regulatory documents Budget preparation and negotiations Prospective reimbursement analysis Invoicing and tracking payments Liaison services as needed to sponsors and off-site clinical locations Coordinators available to attend investigator meetings with principle investigators Research nurse coordinator and non-nurse coordinator support to facilitate site management of day to day implementation of clinical trials Assist with development, training, and monitoring of existing department or new research personnel Coordination of pre-study setup visits and site initiation visit meetings for all new clinical trials Contract negotiation for each clinical trial (CDA, CDT, and amendment processing) Assist sponsors to locate investigators for new clinical trials and support facilitation of interaction with sponsors and contract research organizations Assess trial feasibility for interested investigators Coordination of site initiation and monitoring visits Access to appropriate clinical space, laboratory facilities, and equipment Use of clinical trial management system to facilitate clinical financial reporting Last updated 1/14/2019 Page 1 of 8

3 Research Highlights: MERGE software system for clinical trials management OCR research personnel increased to meet investigator demands Standard Operating Procedures available to investigators Further development of Manual of Operating Procedures Standardized personnel training documentation Monthly education and training for OCR personnel on relevant research topics Updated OCR work policies for multiple locations Assisted with the implementation of two new investigator initiated trials, including IRB, budget, personnel, and regulation. Offering Liaison services to assist sponsors location of qualified UTHSC investigators Assist investigators to identify opportunities to participate in new clinical trials Development and creation of new study related documents for investigator use (Site source documents, logs, etc.) The following figures illustrate OCR activity from 2012 to the present: Number of Active Clinical Trials Number of Clinical Trials Fiscal Year Figure 1: The number of OCR supported active clinical trials has grown from two trials in 2013 to 43 trials in 2017, demonstrating an increase of activity every year since initiation Last updated 1/14/2019 Page 2 of 8

4 Active Clinical Trial Locations 7% 1% Pauline Clinic 13% 4 Methodist University Hospital Methodist LeBonheur Methodist South Methodist North Methodist Germantown 14% 4% 1% Regional One Health Sutherland Cardiology Clinic Hamilton Eye institute Figure 2: OCR supported active clinical trials were implemented primarily at Methodist Hospitals through the fiscal year Pending Clinical Trial Locations 6% 3% Pauline Clinic 4% 8% 50% Methodist University Hospital Methodist South Methodist North Methodist Germantown Sutherland Cardiology Clinic Hamilton Eye Institute West Clinic 11% Figure 3: OCR supported pending clinical trials will also be primarily implemented at Methodist Hospitals Last updated 1/14/2019 Page 3 of 8

5 18% Completed Clinical Trial Locations Methodist University Hospital 28% Methodist LeBonheur Methodist South Methodist Germantown 18% Methodist North Regional One Health Hamilton Eye Institute Figure 4: There were eleven OCR supported clinical trials completed Active Clinical Trial Therapeutic Areas Cardiology Clinical Pharmacy 1 3% 5% 37% Hematology Hepatology Infectious Disease Neurology Ophthalmology Pediatric Pulmonology 16% 5% Rheumatology Figure 5: Most OCR supported active clinical trial were in cardiology (37%) during the fiscal year, with other fields minimally represented Last updated 1/14/2019 Page 4 of 8

6 Pending Clinical Trial Therapeutic Areas 7% Cardiology Neurology 11% 3% 18% 10% 30% Ophthalmology Rheumatology Hepatology Endocrinology General Medicine Preventive Medicine Hematology Otorhinolaryngology Obstetrics and Gynecology 11% Pulmonology Figure 6: Upcoming OCR supported clinical trials are anticipated to be based in Cardiology and Hepatology. Completed Clinical Trial Therapeutic 13% Areas Cardiology 37% Clinical Pharmacy 25% Infectious Disease Ophtalmology Pediatric 13% 1 Figure 7: OCR supported completed clinical trials through the fiscal year were from diverse therapeutic areas, ie primarily Cardiology Last updated 1/14/2019 Page 5 of 8

7 Investigative Phases of Active Clinical Trials Phase 1 2 Phase 2 7 Phase 3 11 Phase 4 12 Other Number of Clinical Trials Figure 8: OCR supports all Phases of clinical investigation including Interventional, Observational, Registry, PI initiated, and NIH studies Investigative Phases of Completed Clinical Trials Phase 1 1 Phase 2 0 Phase 3 3 Phase 4 2 Other Number of Clinical Trials Figure 9: The majority of the OCR supported completed clinical trials were Phase 3 Last updated 1/14/2019 Page 6 of 8

8 Subjects Screened/Pre-screened Number of subjects Fiscal Year Figure 10: The number of subjects screened/pre-screened in OCR supported clinical trials have increased significantly Subjects Enrolled Number of subjects Fiscl Year Figure 11: The number of subjects enrolled into OCR supported clinical trials have grown each year Last updated 1/14/2019 Page 7 of 8

9 Subject Visits Number of subject visits Fiscal Year Figure 12: The number of subjects visits into OCR supported clinical trials have substantially increased year over year Sponsor Site Visit to the OCR 53 Number of Visits Fiscal Year Monitor Visits Site Initiation Visits Figure 13: The number of sponsor monitor visits had continued to increase. Fourteen new OCR supported clinical trials were initiated. Last updated 1/14/2019 Page 8 of 8