Tulane University
New Orleans, LA
Program Director: Jaime Palomino, MD
Program Type: Pulmonary Diseases, Critical Care & Environmental Medicine
Abstract Authors: Fayez Kheir, MD, MSCR, Jaime Palomino, MD
RATIONALE
The Accreditation Council for Graduate Medical Education (ACGME) requires that pulmonary and critical care training programs advance fellows’ knowledge of the basic principles of research, including how research is conducted, evaluated, explained to patients, and applied to patient care. Furthermore, most training programs require that each fellow should be involved in a research activity leading to an abstract presentation in a national meeting or a manuscript submission into a peer reviewed journal. The experience on how to best attain such a core requirement in training varies with each institution. Recently, a survey of fellows training in pulmonary and critical care medicine showed an increase from 35% in 2006 to 48% in 2009 among third year fellows doing research.1
EDUCATIONAL STRATEGY
To facilitate the entry of fellows interested in academic medicine into clinical research, our program started supporting a certificate in clinical research through Tulane University School of Medicine since 2012. The curriculum is designed to provide pulmonary and critical care trainees with some fundamentals of clinical research .It provides scholars with an introduction to research design, regulatory issues, statistical concepts and data management.
The certificate curriculum is a one-year program offered during the second year of fellowship for one fellow interested in pursuing an academic career. It consists of 5 courses (13.0 credit hours total) covering basic biostatistics, epidemiological methods, ethics and responsible conduct of research, and protocol writing (Appendix 1). This certificate program is modeled after the Clinical Research Training Courses offered by the National Institutes of Health (NIH) Clinical Center.
RESULTS
This is the third year of the program and so far only 2 fellows had completed the clinical research certificate. We will continue to collect data on the number and quality of scholarly research activities as well as the career fellows chose to pursue after certificate completion during upcoming years.
CONCLUSIONS
By fostering a certificate that emphasizes on basic principles in clinical research, trainees will enhance their knowledge and skills in such a field. In addition, our model can be adapted in a fellowship training program seeking a high standard of training and academic productivity for their upcoming fellows.
REFERENCES
1. Choi AM, Reynolds HY, Colombini-Hatch S, Rothgeb A, Blaisdell CJ,Gail DB. NHLBI workshop: respiratory medicine-related research training for adult and pediatric fellows. Lung 2009; 187:347–366.
Appendix 1: Courses for Clinical Research Certificate
Biostatistics (3 credits)
This course will introduce fellows to statistical methodology in the health field. Topics covered include presentation of data (graphs and tables), descriptive statistics, concepts of probability, estimation of parameters, hypothesis testing, simple linear regression, correlation, and the analysis of attribute data.
Epidemiology (3 credits)
The purpose of this course is to prepare fellows to interpret epidemiologic data and understand and apply epidemiologic approaches to the investigation of health outcomes.
Responsible Conduct of Research/Ethics (1 credit)
This course will cover basic principles of bioethics and their specific application to clinical research. Special attention will be paid to the ethical obligation of the researcher to the participant within the broader framework of patient care and the ethics of caring. Specific challenges of vulnerable populations and research in a global community will also be considered. This course will also cover differences between clinical research and clinical practice, responsibilities regarding data records, data ownership, collaborative and multi-site issues and authorship. Substantive information will be provided about how to conduct clinical research in an ethical manner, especially in the complex and competitive research environment. This course will define research misconduct, falsification and fabrication, with numerous examples to assist in areas that may not be regulatory. Conflict of interest issues present some of the most complex and potentially volatile challenges in the area of clinical research will be covered as well.
Topics in Clinical Research (3 credits)
In this course, fellows will study IRB relations and regulations, discuss the required elements in a clinical research contract and the responsibilities of the clinical researcher, identify effective use of research personnel, and develop negotiating skills to facilitate support for clinical research. The course will also encompass the principle of randomization and “intention-t-treat” analysis in experimental studies, integration of clinical trials and lab support, specimen collections and laboratory problem based learning. A researcher/clinician centric insight into the logistics of technology transfer and intellectual property (IP) development will be studied. The practical aspects of technology transfer in an academic context will be investigated. Discussed topics will include local academic tech transfer policy, related procedures and available resources. Career pathways and opportunities open to the clinical researcher in the academic and private sector will be explored and discussed.
Protocol Design and Writing (3 credits)
Core course discussing the elements of effective research design, including the basic concepts in clinical trials, the main aspects for different types of trials such as proof of principle stage, Phase I, II, III and IV, and understanding good clinical research methodology. Course will introduce and address issues, idea and outline of design methodology that cover planning, conducting, analyzing, and assessing clinical trials. Concepts and principles of study finance, costing and budgeting will be discussed.
