Press Releases

	Intensive summer program helps physicians build clinical research careers Survey of graduates identifies factors associated with success obtaining NIH funding
	The American Federation for Medical Research Says Daschle Must Cure Clinical Research Crisis if Change Is to Take Hold in U.S. Health Care System
	The Real Crisis in U.S. Health Care is not Insurance Coverage

Intensive Summer Program Helps Physicians Build Clinical Research Careers Survey of Graduates Identifies Factors Associated with Success Obtaining NIH Funding

BOSTON – Graduates of the Program in Clinical Effectiveness (PCE), which has trained almost 1,900 physicians to be clinical investigators since 1986, have achieved significant success in receiving grant support from the National Institutes of Health (NIH) and other funders, along with other accomplishments considered key to establishing a research career. A report on the PCE – a joint program of Brigham and Women’s Hospital (BWH) and Harvard School of Public Health (HSPH) with strong input from the Massachusetts General Hospital (MGH) – from a team of investigators at the three institutions appears in the April issue of Academic Medicine, along with several other articles addressing the NIH vision for clinical and translational research.

“Our survey found that graduates of the Program in Clinical Effectiveness have been able to successfully obtain grant funding, publish, gain promotions, negotiate protected research time and rise to leadership roles in public health, academic medicine and the private sector,” says Mary Ellen Goldhamer, MD, MPH, an MGH physician and PCE graduate who led the study. “As far as we know, the PCE is the original and largest program focusing on clinical research training for physicians and is distinctive in providing research training – with a particular emphasis on clinical trials, clinical epidemiology and health services research – concurrent with clinical training.”

The authors note that the number of physician investigators is dropping nationally due to factors such as heavy educational debt, the lengthy training required, and the challenges of securing grant funding along with time to conduct research. But at the same time, research focused on translating basic scientific discoveries into clinical treatments is more important than ever.

“The scientific knowledge gained through unraveling the genome and deciphering cellular mechanisms in great detail has not led to commensurate improvement in disease prevention and treatment,” says study co-author Daniel E. Singer, MD, associate director of the PCE and director of the General Medicine Fellowship at MGH. “Information generated from clinical trials is often not widely applied to producing safer and more effective medical care. Physician-researchers knowledgeable about biology, clinical medicine and population health who are trained in rigorous research methods are essential to conduct the studies needed to speed translation of knowledge into beneficial medical and public health advances.”

Established in 1986, the PCE is an intensive six-and-a-half week summer program based at HSPH that includes core courses in epidemiology and biostatistics along with electives. The epidemiology course requires students to prepare and submit a grant proposal as the final course project, and several electives have added a similar requirement in recent years. Many participants have gone on to pursue advanced degrees after completing the PCE. Most of the almost 1,500 physicians who completed the program during its first two decades enrolled during their post-residency fellowship training.

The Academic Medicine paper describes results of a 20th anniversary survey sent to all PCE graduates in 2006. The survey was designed to evaluate graduates’ success and identify features predicting who would achieve successful NIH funding. Among the almost 1,000 graduates responding to the survey, 65 percent indicated that their epidemiology grant proposal led to an actual research project; and of those studies, 64 percent were published and 43 percent received funding. In recent years, real-world projects applying course concepts have been required for completion of elective courses, which led to published studies for 30 percent of all graduates, 14 percent of whom received funding for the projects.

Overall, 34 percent of survey respondents reported receiving NIH support, and 63 percent received support from nonfederal sources. Nearly one-third of respondents are currently academic researchers pursuing investigations in epidemiology, clinical trials and health services. Factors most predictive of future success in obtaining NIH funding were being age 40 or less when attending the PCE, being a generalist rather than a specialist and publishing a PCE coursework project.

“Certainly older enrollees achieved federal funding success as well, but it could be that older participants are more likely to have distracting personal and professional responsibilities that compete with a research career,” Goldhamer notes. “The favorable impact of being a generalist was unexpected and may simply reflect that generalists enrolled in the PCE as part of dedicated research fellowships, while some of the specialists were taking a research component of largely clinical fellowships. The association between publishing PCE research projects and NIH grant funding suggests that the opportunity to pursue real-world practical projects during clinical research training, coupled with close mentoring, can serve as a springboard to a career as an independent investigator.”

Goldhamer is an instructor in Medicine at Harvard Medical School (HMS), and Singer is a professor of Medicine at HMS and professor in the Department of Epidemiology at HSPH. Additional co-authors of the Academic Medicine article are E. Francis Cook, ScD, of HSPH, co-director of the PCE; Amy Cohen, HSPH; David Bates, MD, MSc, Brigham and Women’s Hospital, director of the PCE; Roger Davis, ScD, Beth Israel Deaconess Medical Center; and Steven Simon, MD, MPH, Harvard Pilgrim Health Care, the senior author of the study. The study was supported by a National Research Service Award and by the Program in Clinical Effectiveness.

Massachusetts General Hospital (www.massgeneral.org), established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.

Harvard School of Public Health (www.hsph.harvard.edu ) is dedicated to advancing the public's health through learning, discovery, and communication. More than 400 faculty members are engaged in teaching and training the 1,000-plus student body in a broad spectrum of disciplines crucial to the health and well being of individuals and populations around the world. Programs and projects range from the molecular biology of AIDS vaccines to the epidemiology of cancer; from risk analysis to violence prevention; from maternal and children's health to quality of care measurement; from health care management to international health and human rights.

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THE AMERICAN FEDERATION FOR MEDICAL RESEARCH SAYS DASCHLE MUST CURE CLINICAL RESEARCH CRISIS IF CHANGE IS TO TAKE HOLD IN U.S. HEALTH CARE SYSTEM

AFMR Pledges Full Organizational Support to Daschle and Obama Administration to Mitigate U.S. Clinical Research Crisis

BOSTON, Dec. 11, 2008 – The American Federation for Medical Research (AFMR) announces its full support of Former Senate Majority Leader Tom Daschle’s appointment to the post of Health and Human Services secretary. Mr. Daschle will serve as President-elect Obama’s top administration official to overhaul the nation's health care system.

As a result of its work since 1940, the AFMR believes firmly that improving clinical research in the U.S., which weakened significantly during the Bush administration, is a lynchpin to achieving sustainable change in the U.S. health care system. The AFMR pledges the full support of its human resources, medical expertise and scientific knowledge to Mr. Daschle and the Obama administration for the advancement of clinical research, including its leading U.S. physician members and Nobel laureates who have made significant contributions to modern medicine and patient care through clinical research.

“Medical science and the U.S. health care system cannot progress without clinical research,” said Dr. Alan Buchman, president of the AFMR and a prominent physician in gastroenterology. “Yet our nation has neglected the advancement of clinical research – that which involves patients directly – which can prevent disease, lead to more effective disease treatments, medical breakthroughs for chronic diseases, and cut the astronomical costs and inefficiencies that plague our health care system. Mr. Daschle has the opportunity to fix this fundamental issue early on, which will have an enormous positive ripple effect on the rest of the health care system,” said Buchman.

The U.S. clinical research crisis stems from two primary issues:
1) Federal budget cuts for the NIH, particularly in funds spent on clinical research and the education and training of future clinical investigators and physician-scientists, and 2) Lack of support for future physician-scientists, whose job it will be to bring modern medicine and quality patient care to future generations.

According to the Centers for Disease Control and Prevention, chronic diseases account for seven out of 10 deaths in the U.S. and for 75% of every health care dollar spent each year. Yet federal funding for clinical research has decreased in recent years, and funding that has been apportioned, has gone mainly to basic research rather than clinical research – the only kind of research that generates disease-specific breakthroughs and patient treatment alternatives.

The NIH budget for the current fiscal year, $29.2 billion, represents a $329 million increase over last year, but the actual growth for NIH programs is much less because $200 million of the increase was earmarked for the Department of State Global HIV/AIDS fund. When the $200 million is subtracted from the budget, the actual increase in NIH programs is reduced to just $133 million (0.5%) over last year. It is not yet known how the FY 2009 budget will be impacted, although the statement accompanying the signed bill from President Bush indicated his intention to submit an FY 2009 budget proposal that will "once again restrain spending."

One program impacted by the tightening of the NIH budget is the Clinical Translational Science Award program (CTSA) – the NIH-supported clinical research program intended to speed the translation of scientific discovery to the treatment of patients. As a result of the cuts, the NIH is unable to fully fund the evolution and expansion of the CTSA program, which has become a critical training and research structure for junior investigators.

Another alarming issue is the growing scarcity of human resources in the clinical research field. The current generation of physician investigators is aging rapidly and there aren't enough investigators to replace them because support for new investigators entering the field has decreased significantly in recent years.

According to the NIH, the average age of physician scientists in 1980 was 39. By 2015, the average age is expected to be 52. If action is not taken now, the U.S. will face a critical shortage of qualified physician investigators within the next decade, creating a massive knowledge gap between aging physicians and the next generation of physicians.

“The cost of not advancing research and training future physician scientists is one that will be paid by the entire world. The United States is a global feeder pool of physician scientists,” said Buchman. “A further breakdown in clinical research and failure to revitalize the physician-scientist workforce of the future will impact medical breakthroughs, treatments and critical training throughout the world. The pharmaceutical industry cannot be counted on to undertake clinical research alone, and from an economic standpoint, clinical research dollars are being focused away from the U.S. and concentrated on China and India.”

The AFMR is an international, multi-disciplinary association of physician scientists engaged in all areas of patient-oriented clinical, translational and laboratory research. The organization promotes understanding of advances in the prevention, diagnosis and treatment of disease, facilitates the exchange of ideas and information among physicians and investigators concerned with the treatment of disease and works to improve public health by fostering research across medical disciplines through public policy initiatives and educational programs. The AFMR also works to develop future generations of clinical researchers through its own programs, while encouraging public, private, and governmental investment in such initiatives.

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The Real Crisis in U.S. Health Care is not Insurance Coverage

Obama Must Solve Clinical Research Crisis before Tackling Other Health Care Issues