Alpha Clinic Clinical Trials Investigator Training Program
Alpha Clinic Clinical Trials Investigator Training Program
Applications for the next cohort of ACCTITP Trainees will open Spring 2024!
Who is CIRM?
California Institute of Regenerative Medicine (CIRM) Stem Cell Agency’s mission is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world. CIRM is committed to tackling these challenges by creating a diverse and dedicated workforce that can meet the technical demands of translating novel treatment paradigms to reality, while engendering the necessary appreciation for and sensitivity to the perspectives and participation of communities that have been historically under-represented in the biomedical sciences.
About the Alpha Clinic
The UCI Alpha Clinic (AC) was founded in 2014 and has recently received CIRM support for the next 5 years. The UCI AC REAL incorporates our established partners (Children’s Hospital of Orange County, Long Beach Veterans Administration Health Care, and University of California, Riverside), spans four California Counties (Orange, Riverside, San Bernardino, and Los Angeles), and serves all age groups - from children to our nation’s veterans. The UCI AC REAL expands our leadership role within the CIRM AC network, enabling access to CIRM-funded and FDA-authorized Clinical Trials to an increasing number of patients with unmet medical needs by building strong partners in the neighboring communities (from hospitals to CIRM Community Care Centers of Excellence, CCCEs).
UCI AC educational programs focus on easily accessible training programs for two distinctive categories of trainees by working medical professionals (ACCTITP) eager to embark on a career in regenerative medicine. We will use our internal UCI AC REAL expertise and very qualified industry clinical researchers who have agreed to volunteer their time. An Education Program Manager oversees the administrative and course management of the training program.
About the ACCTITP
The ACCTITP aims to promote equitable delivery of advanced therapeutics through educating community physicians, advanced practice providers (APPs), and pharmacists on scientific progress in regenerative medicine and training them in cell and gene therapy clinical methodology.
- The ACCTITP will be offered as a certificate through UCI SOM Office of Medical Education (certificate approval in process).
- The lectures will be offered as weekly two-hour lecture sessions for 20 weeks (Thursdays from 6:00-8:00 pm over Zoom) with ten half-day clinical research observational sessions in the UCI AC clinics and inpatient units.
Target Audience
Priority will be given to physicians interested in clinical research careers with an emphasis on the delivery of clinical trials in community settings, including our AC REAL sites. We plan to enroll between 4 and 6 candidates every year.
The tuition for this program will be $7,500 USD and will be funded for our UCI AC REAL members.
Program Objectives
1) Develop scientific knowledge regarding stem cell and gene therapy advancements.
2) Teach regenerative medicine clinic trials methodology.
3) Provide practical training in the delivery of regenerative medicine clinical trials.
4) Educate practitioners about the informed consent process and clinical trial participant rights.
5) Expand awareness of ethical issues of regenerative medicine.
6) Train clinical researchers who practice culturally sensitive approaches to clinical trial delivery in diverse, underserved communities and populations.
At the completion of the ACCTITP, successful graduates will possess the knowledge and skills to participate in delivering regenerative medicine clinical trials to diverse populations in community settings.
Curriculum
During the program, trainees will learn a wide breadth of topics related to clinical trials and will make them competitive to become principal investigators (PIs) on clinical trials as their career in clinical research progresses.
Many of these topics include:
1) Biology of Regenerative Medicine
2) Advances in Regenerative Medicine
3) Best Practices in Regenerative Medicine
4) General Considerations for Clinical Trials
5) Guidelines for Good Clinical Practice
6) Ethical issues in conducting research among vulnerable, underserved, and minority population groups
7) Financial considerations in clinical research
8) In-person clinical observership working with experienced clinical trial PIs and staff
Assessment Plan
There will be four categories of assessments throughout the program:
- Weekly quizzes following each session that trainees are expected to achieve a minimally acceptable multiple-choice test score of 100%.
- A midterm following general lecture sections of the curriculum on clinical trials and regenerative medicine, and trainees are required to obtain a minimum score of 80% to pass.
- A cumulative final at the end of the specialized topics of the curriculum following the last lecture of the program and trainees are required to obtain a minimum score of 80% to pass.
- Each trainee must demonstrate acquired practical skills at the end of the in-person observational period, as determined by an oral examination.
Upon completion of all assessments with passing scores, each trainee will earn a certificate from the UCI School of Medicine Division of Medical Education.
Required Application Documents
- Completed application form – Click the “Apply Now” icon below to access the online application.
- Curriculum Vitae (CV), Biosketch, and/or Resume
- Letter of Intent
- Letter of Support from the Department Chair
- Must have completed a terminal degree of PhD, MD, PharmD, or equivalent
We will confirm our cohort of ACCTITP Trainees early Spring for the program start in January 2025.
If you have any questions about the program, please contact Dr. Monique Williams (monique.williams@uci.edu)