Clinical Research Training
UCLA ISAP Program of Clinical Research Education and Training
for Drug Abuse Professionals
Introduction
To increase the clinical research expertise among health care
professionals addressing drug abuse and addiction, ISAP is providing
a NIDA-funded program of clinical research training combining
formal coursework and practical experience. The program is designed
for M.D.s and Ph.D.s who are intensely interested in focused training
in clinical research involving drug abuse and addiction. Given
the stature and history of the UCLA faculty and facilities dedicated
to drug abuse research and treatment, the program expects to draw
well-qualified trainees who will ultimately become proficient
in clinical drug abuse research. To further the breadth of the
training experience and the relevance of the education, recruitment
efforts seek to attract qualified candidates of ethnic/cultural
minority groups and women.
By immersion in the uniquely integrated environment of research
and practice offered by ISAP, post-residency psychiatrists and
other physicians receive comprehensive training in the clinical
research methods pertinent to the study of drug abuse and its
treatment. The two-year training initially includes two postdoctoral
fellows (M.D.s or M.D.-psychiatrists), expanding in the second
year of the project to include an additional M.D. and one non-M.D.
clinical professional from a community-based treatment setting.
The program educates the trainees in clinical research methods
and in the means of incorporating research findings into clinical
practice. The clinical experiences offered in the training program
emphasizes clinical trials of new pharmacotherapies and innovative
behavioral treatments for drug abuse.
Goals
The overarching goal of the UCLA ISAP Program of Clinical Research
Education and Training for Drug Abuse Professionals (CRETDAP)
is to develop a coordinated, sustainable infrastructure of dedicated
education and training that will produce independent health care
professionals capable of conducting and disseminating clinical
research pertaining to drug abuse and its treatment. The specific
aims of the program are:
- To provide trainees with a comprehensive understanding of drug abuse research and clinical practice, entailing interdisciplinary clinical research training lasting two years at postdoctoral level under the guidance of preceptors.
- To educate trainees to have full competence in using experimental techniques appropriate for the investigation of drug abuse, emphasizing advanced technologies, procedural reliability, validity, and limitations of research.
- To encourage trainees to investigate a defined clinical research issue in drug abuse, with a focus on clinical trials research, starting them on a course of clinical research that will continue beyond the two-year training period.
- To prepare trainees to become independent clinical researchers by teaching them to write publication-quality manuscripts reporting scientific results, to draft grant applications, and to become part of national research communities by attending meetings, seminars, and symposia where they may present research as well as gain knowledge.
- To increase diversity in the training program through identification of promising candidates from underrepresented ethnic minority groups and through soliciting applications from these potential candidates.
Training
Program Overview
The CRETDAP comprehensive education program consists of a two-year
period of coordinated clinical research training combining coursework,
seminars, and practical experience. Trainees acquire (1) a comprehensive
education in a variety of disciplines, ranging from epidemiology
of drug abuse to neurobiology of addiction and consequent effects
on the brain; and (2) in-depth clinical research experience, with
a focus on conduct of clinical trials research in both institutional
and community-based settings. After the first three-quarters of
the first year of the program, in which trainees gain knowledge
in a core curriculum consisting of seminars and selected classes,
trainees spend the remainder of their time in hands-on clinical
research at several inpatient and outpatient sites. The curriculum
is be distinct from other ISAP NIDA-supported training (i.e.,
the T32 program) in that it departs from the strong emphasis on
psychosocial/sociological/preclinical aspects of drug abuse, instead
emphasizing the realms related to clinical issues.
Trainees are required to complete a grant application by the middle of the second year of the program and at least one publication-quality manuscript, submitted for publication during the second year. Each trainee’s curriculum will be tailored to address a chosen emphasis, and the program's extensive hands-on research opportunities are designed to provide the experience needed by trainees to become proficient in conducting independent clinical research and in applying research findings in clinical practice.
Clinical Training Experience--The Practicum Approach
The program makes use of the "practicum" approach. Briefly, the practical experiences—practica—provide supervised opportunities for trainees to apply the knowledge and specific skills gained in courses and seminars as well as gain "hands-on" experience in drug abuse research and clinical processes. Thus, specific practica are associated with stages of clinical research as conducted in the "real world" (i.e., in outpatient clinical trials in community-based treatment programs as well as both inpatient and outpatient trials in various institutional settings). The practica commence in the fourth quarter of Year 1 of the program following didactic education and formal training in clinical research procedures and good clinical practices occurring over the first three quarters of Year 1. During the first three quarters of Year 1 the trainees also “audit” clinical research studies underway and assist the study physician or study director.Focused Clinical Training in a Comprehensive Context
In addition to the breadth and strength of ISAP research activities in which the training program operates, trainees will be further exposed to other populations and research topics due to the inclusion of remote locations in the training realm, to occur after Year 1. Future “distance training” via webcast and tele/video conferencing will enable the interaction among trainees, preceptors, and drug abuse professionals in remote regions with those at UCLA. Likely future collaborative elements are an addiction psychiatry training program in Hawaii and a treatment clinic in a county adjacent to Los Angeles but sufficiently distant from UCLA to make regular commuting for training infeasible. The innovative distance training is one aspect of the program intended to attract younger candidates who might otherwise be unable or reluctant to embark on a clinical research education program because of difficulty in accessing a comprehensive, dedicated program with highly regarded interdisciplinary faculty and a range of research opportunities.
Training Program Management
Program Direction The training program is directed by Thomas Newton,
M.D., Richard Rawson, Ph.D. (who is Associate Director of ISAP,
co-Director of DARC), and Walter Ling, M.D. (Director of ISAP).
Dr. Newton will be assisted by Training Director Tom Freese and
an Administrative Supervisor as liaison between CRETDAP and ISAP
administrative functions.
Program Faculty
Descriptions of the primary faculty as educators and as preceptors
are presented in brief below. All primary CRETDAP faculty members
(who comprise the membership of CAREC) have had experience in
supervising graduate students in drug abuse research training.
Thomas Newton, M.D., CRETDAP PI, is a board-certified psychiatrist. Dr. Newton graduated from Yale University, School of Medicine in 1985 where he did his thesis on Magnetic Resonance Imaging in Psychiatry. He did his psychiatry residency at UCLA’s Department of Psychiatry and Biobehavioral Sciences and is medical director of UCLA’s inpatient substance abuse services. Dr. Newton is currently an Associate Clinical Professor at UCLA’s Department of Psychiatry and is also a member of the Brain Research Institute at the UCLA School of Medicine. Dr. Newton and his research projects and staff constitute a major component of ISAP’s UCLA-based Addiction Studies Neurobiology Unit. He is also DARTC Co-Investigator.
Richard Rawson, Ph.D., CRETDAP Co-Investigator, Associate Director of ISAP, ITG Co-Investigator, and an Associate Researcher in the Department of Psychiatry and Biobehavioral Sciences at UCLA. Rawson is the founder of the Matrix Institute on Addictions, ISAP component and participant in the proposed training program. Since 1974, Dr. Rawson has conducted clinical research on various drug treatment techniques, including naltrexone, clonidine, LAAM, and psychosocial models. A major focus of his research and clinical activities has been on the most effective use of counseling strategies in combination with pharmacotherapy for opiate addiction. He has provided training and consultation in addiction treatment to numerous agencies and treatment programs and he has served on several NIDA technical review panels and planning sessions. Dr. Rawson has supervised the training of over 20 mental health professionals who are conducting treatment and research on drug abuse and has chaired the Ph.D. dissertation committee at UCLA for several doctoral candidates.
Walter Ling, M.D., CRETDAP Co-Investigator, is Director of the UCLA ISAP and ITG Co-Investigator; he has conducted research on behavioral and pharmacological treatments for substance abuse for 25 years. He has headed several multi-center projects for the VA and for NIDA. Dr. Ling's research studies began in the early 1970s, with a principal emphasis on pharmacological treatment of opiate addiction. He was involved in the first randomized clinical trials on the efficacy and optimal dosage of LAAM and methadone. Dr. Ling also conducted research on disulfiram in treating alcohol abuse among methadone-maintained opiate abusers and on naltrexone treatment for psychosocially advantaged populations combined with clear and forceful contingencies. Several clinicians who worked with Dr. Ling have continued in the field, and fellows have participated in conducting research and in authorship of articles published in scholarly journals with Dr. Ling.
Steve Shoptaw, Ph.D., CRETDAP Co-Investigator, is a Research Psychologist with the UCLA Neuropyschiatric Institute, and Research Director at the Matrix Institute on Addictions. Dr. Shoptaw is Principal Investigator on the project “Behavior Therapy for Gay Male Methamphetamine Users (1R01 DA11031-01) and also PI on “Behavioral Therapies for Gay Male Stimulant Abusers,” CSAT, (1KD1 12043).
Donnie Watson, Ph.D., CRETDAP Co-Investigator, is Project Director on the Cocaine Rapid Efficacy Study Trial (funded by NIDA), under the auspices of UCLA ISAP. Previously he was Director f the Cork Institute at the Morehouse School of Medicine from 1990 to 1996. Besides medication development trials, his primary focus has been on substance abuse issues among children and adolescents, as well as cultural diversity in addiction research.
Bill Haning, M.D., CRETDAP Co-Investigator, is Associate Dean, Post-Graduate Medical Education, and Director of the Addiction Psychiatry Program and Associate Professor at the University of Hawaii, John A. Burns School of Medicine, Department of Psychiatry. (Dr. Haning will participate in the future “distance training” following Year 1.)Thomas Freese, Ph.D., CRETDAP Training Coordinator and Co-Investigator, is Training Director for ISAP and Friends Research Institute, as well as Project Director on "Behavioral Therapy for Gay Male Methamphetamine Abusers" NIDA Grant #1RO1 DA11031-01). Dr. Freese is also the Program Coordinator of the Substance Abuse Treatment Program at Children’s Hospital Los Angeles, Division of Adolescent Medicine, Los Angeles, CA.
Support
Each fellow is provided with a modest stipend and [more
information needed.]
Training Curriculum
Overview
The program strongly emphasizes training in research
design, methodology, and statistical analysis. Substantive education
focuses on: (1) epidemiology of drug abuse, including related
issues such as HIV/AIDS, (2) etiology of drug abuse, (3) treatment
processes and outcomes in a variety of clinical settings, (4)
methodological issues and techniques in drug abuse research, and
(5) research conducted in clinical settings. Program Director
Newton oversees and guides the training program, with particular
emphasis given to training in methodology and quantitative research
techniques regarding clinical trials research.
The CRETDAP curriculum includes several required courses, as described below. For example, all trainees must complete the series of advanced statistics courses offered in the UCLA Department of Psychology (Biostatistics 416A-C). (Exemptions are allowed if the trainee has had prior training in these statistical applications.) Also during the first year of the program, trainees may audit additional courses that help fulfill the goals and objectives the training program. The audit procedure is informal, simply requiring permission of the instructor. A typical two-year core curriculum is described below:
Year 1
- Advanced Seminar on Substantive Issues in Drug Abuse (469)
- Alcohol and Chemical Dependency: Detection and Treatment (422)
- UCLA Statistics course series (Biostatistics 416A-C / Psychiatry 286A-C)
- Journal Club [Scientific Writing] (402)
- Grand Rounds
- Ethics and Safety Seminars (see Training in Responsible Conduct of Research, below)
- Audit clinical research sites: In Year 1, trainees “audit” ongoing research studies and assist site directors/preceptors at outpatient and inpatient settings in order to gain exposure to various types of ongoing clinical research. Following formal training in good clinical practices, trainees then participate in the practica as described below.)
- Good Clinical Practices Training (assessment instruments, SOPs, human subjects, etc.)
- Designing/initiating research project; develop concept for grant proposalYear 2
- Journal Club [Scientific Writing] (402)
- Grand Rounds
- Practica - hands-on clinical research activities at two supervised sites (generally, one inpatient and one outpatient)
- Research project (with preceptors)
- Preparation and submission of grant proposal
- Preparation and submission of manuscript leading to publication
Clinical Research Training Activities: Practica
The practicum approach. The practicum approach was adopted for this research training program following the example of clinical training as taught in medical school. Thus, in medical school, after two years of basic science classroom teaching (generally now including an "introduction to the patient" hands-on experience), students spend two years as clinical clerks. During this time they learn basic cognitive skills, such as history taking and charting, basic manual skills such as blood drawing and doing a physical examination, and some advanced skills. The importance of each of these skills is emphasized by constant interaction with the team, most of whom are more senior and who have mastered the skills in question. We have designed the practicum to be a shortened version of this experience. Hence, the first year is primarily "basic science" as relevant to clinical trials research, with an auditing component to provide clinical relevance. The second year consists primarily of hands on teaching, during which trainees learn under supervision to apply techniques learned to that point. During the practica, trainees will learn to perform each of the functions necessary to conduct a clinical trial. These functions will vary by site and trial, but will include: subject recruitment and screening, clinical assessment, physical assessment, data collection, adverse event recording and reporting, data entry (using automated systems such as teleforms), data analysis, quality control auditing, and presentation of summary results to sponsoring agencies. By the end of the second year, trainees should not only be able to perform all the functions necessary to conduct a clinical trial, but, more importantly, they should be intimately knowledgeable with tasks delegated to research assistants and coordinators. We believe that this hands on approach, based on the medical model, is likely to produce physicians and others who can effectively conduct clinical research.
Practica format. The practica ensure acquisition of expertise in all phases of clinical research by requiring that trainees participate in the specific tasks involved in conducting a clinical research study. Trainees will rotate in two different clinical research projects (generally one inpatient and one outpatient) in order to become proficient in each of the skills required to do clinical research effectively. A trainee’s practica may occur at the same sites/studies as the Year 1 auditing, but not necessarily. Practica commence in the fourth quarter of Year 1 following coursework, seminars, and auditing of research projects as outlined above; practica occur in an inpatient setting and an outpatient setting, Trainees will be assigned to a preceptor in one of the ISAP-affiliated study sites, usually commencing in an inpatient setting on the UCLA campus at NPH. Preceptors will supervise the trainee, who will in effect become a “sub-investigator” involved in the preceptor’s project, in gaining clinical research experience at all levels in all aspects of the process including: research design, execution, analysis, publication, and the grant writing process. As well as ongoing supervision of clinic processes, the preceptor will hold formal weekly meetings with the trainee in which reviews of training occur and assistance and direction are provided. Trainees will be co-authors on all publications resulting from this training relationship, and they will participate in grant writing. Future “distance training” at sites remote from UCLA will include hands-on practica that are similar in nature to those provided through the program as currently proposed, after preparation of local sites by Training Coordinator Freese.
Trainee-tailored practica. The Program Director (Newton) meets with each fellow soon after entry into the program and assists the trainee in determining the nature of the pre-practica “audit” period that would best serve specific interests. In advance of the formal practica, for the first nine months (three quarters) of Year 1, the trainee audits/assists a study physician/study director in an ongoing clinical research project in order to gain broad experience in inpatient and outpatient settings. Typically, trainees will engage in a rotating preceptorship in which they work with different preceptors to gain breadth of expertise. Subsequently, based on trainee-preceptor compatibility and interests, the Program Director, preceptor(s) and the trainee develop a practica plan. All trainees will achieve a fundamental set of clinical research capabilities as a minimum goal of the program as they audit and then engage in practica in different studies, but a trainee may work with a set of preceptors throughout the duration of the program to accommodate a particular focus. The Program Director meets with the trainees on a twice-monthly basis, and with the preceptor on an “as needed” basis, to monitor progress and to suggest ways to improve productivity.
Contact Information
Please contact Dr. Thomas Newton at tnewton@ucla.edu.