This program covers the basics of clinical research (how to formulate a research question, select study population, randomization and blinding methods) to statistical methods (data distribution and classification, statistical tests, sample size calculation, survival analysis, missing data and meta-analysis); data collection, monitoring and reporting (include training in manuscript writing); and study designs (observational studies, non-inferior and adaptive designs and randomized clinical trials).
PPCR Program
About Felipe Fregni, MD, PhD, MPH, MEd
Prof. Fregni is an Associate Professor of Epidemiology at Harvard T.H. Chan School of Public Health and an Associate Professor of PM&R at Harvard Medical School. He leads Spaulding Neuromodulation Center, a large clinical research laboratory funded by major NIH grants that are currently investigating techniques to guide and measure neuroplasticity in brain injury. He has been at the forefront of advancing neurorehabilitation science to treat conditions such as stroke, Parkinson’s disease and chronic pain. He holds a MD and PhD from University of Sao Paulo, Brazil and three master’s degrees
from Harvard University. He has more than 440 peer-reviewed publications and has been leading the international training program Principles and Practice of Clinical Research since its foundation in 2007.
Description
Clinical research is vital for advancement in medicine, yet in most medical specialties – and in many countries – its tools are used inappropriately, resulting in invalid results. Furthermore, many clinicians cannot critically evaluate research findings. The purpose of Principles and Practice of Clinical Research (PPCR) is to oer a highly interactive learning environment for clinical research training internationally and to create a global network of clinical researchers to foster future collaboration
in clinical research. PPCR covers the basics of clinical research, including how to formulate a research question, select a study population, randomization and blinding methods; statistical methods (e.g., data distribution and classification, statistical tests, sample size and power calculations, survival analysis, missing data, and meta-analysis); data collection, monitoring and reporting, including training in manuscript writing; and study designs (e.g., non-inferiority and adaptive designs, observational studies and randomized clinical trials). PPCR has been a leading global program in clinical research methods that has trained more than 3,000 participants over the last 12 years.
Format
This program blends live and online interaction via the web and on-site centers. Participants attend weekly three-hour interactive videoconference sessions, which are broadcast live from Boston to centers around the world. Participants may enroll either as part of a site center or individually, if they do not have access to a site center. PPCR consists of 25 weekly lectures taught by distinguished faculty from Harvard T.H. Chan School of Public Health, Harvard Medical School, and Tufts University, amongst other renowned institutions. This program uses the case method to enhance learning. We have developed cases for each lecture, which participants are expected to read and discuss. Each lecture is supplemented by mandatory participation
in online discussions and a poll addressing the week’s topic. Participants are required to complete weekly assignments that emphasize statistical exercises and to work on a group project using an online, interactive Wiki tool. Podcasts and recordings
of the lectures are posted weekly. In addition, we oer two live workshops in Boston where participants can deepen their knowledge and interact with Harvard faculty and other subject matter experts. At the end of the program, participants can attend the 5-Day Immersion Course in Brazil to review and integrate the key concepts learned throughout the program.
Learning Outcomes
During the program, participants will develop skills in two main domains: design and conduct of clinical research, and interpretation and critical understanding of published research. Participants will learn to formulate an appropriate research question, choose an optimal clinical trial design based on ethical principles, accurately interpret results from statistical analyses, collect data appropriately, use the basic functions of a statistical software package, choose appropriate basic statistical tests, run simple statistical analyses, grasp the basic principles of article publication and the reviewing process, and use key tools and concepts to write eective articles. At the end of this program, participants will be able to critically read research papers, understanding the main sources of bias and confounding, as well as the clinical impact of dierent research findings.
Target Audience
Applicants come from all over the world and usually have a graduate degree or a health care professional degree (MD, MPH, biostatistics, epidemiology, nursing, physical and speech therapy, or dentistry). The program is designed to have a critical impact on both clinical scientists and other health care professionals alike.