Study seeks reasons for drop in female investigators

New physicians not engaging in research

For the past five years, the proportion of women physicians conducting clinical research has declined, despite increasing numbers of women graduating from medical school, according to a researcher who has studied trends in clinical research for two decades.

"We're looking at gender disparities among principal investigators, and our intent is to get a better handle on why we're seeing this rate of low involvement among women physicians in clinical research," says Ken Getz, MBA, MS, a senior research fellow at the Tufts Center for the Study of Drug Development at Tufts University in Boston, MA.

Some possible explanations for the decline include the following:

  • In general, the turnover among clinical investigators is at an all-time high, Getz says;
  • Regulatory and financial burdens in conducting research are onerous;
  • Financial rewards in clinical research are not nearly what they were five years ago, Getz adds;
  • It's becoming more difficult to recruit and retain subjects.

"There are many ways that investigators are finding their involvement in clinical research to be a challenge," Getz says.

"For quite some time, a lot of physicians who went into clinical research were physicians who wanted more stimulating ways to supplement their income and, in those days, it was a word of mouth kind of experience," Getz explains. "Back then, if you spoke with enough pharmaceutical companies, you'd land a grant."

Today's research environment is much more competitive, making it difficult for new investigators to succeed, he adds.

"A lot of the investigators who stuck with this business are those who got in many years ago," Getz says. "The average age of the principal investigator (PI) is rising."

Although more women now are entering medical school than in decades past, young physicians are less likely to go into clinical research than they were five years ago, he says.

"Clinical research is very competitive, especially for younger physicians," Getz says. "Unless they have a good handle on their financial operations and have an established practice and can introduce clinical research activity into that practice, they may be more reluctant to get into this new line of business."

One reason why the Tufts Center for the Study of Drug Development is closely following PI trends is related to a growing body of evidence suggesting that the types of patients attracted to clinical research are tied to the gender and ethnicity of the clinician, Getz says.

"As more clinical research targets specific ethnic-based and gender-based communities, the NIH and industry research sponsors need to have a good workforce with a diverse mix of investigators," Getz says.

Getz and his colleagues are collecting surveys from physicians around the country, aiming for more than 1,000 responses as part of a study that is looking for answers to why there is a lack of diversity among investigators.

"There is very little data, surprisingly, to give us even a general sense of the proportion of investigators who are African American, Hispanic, or Asian," Getz says. "The study we're conducting is designed to provide some descriptive and basic information to help us get a handle on the current landscape."

The study also will look at existing barriers to clinical research involvement and how that impacts women and minorities, he adds.

"The survey has been specifically designed to gather representative responses from a variety of ethnic communities and from female physicians," Getz says.

Globalization in clinical research is a trend that's increased partly in response to the problems of finding investigators and research participants in the United States, Getz notes.

Current clinical research forces have made subject recruitment more difficult in recent years, and these forces include stricter eligibility requirements, increasing protocol complexity, and competing studies in the same geographical area and even in the same research clinic, Getz explains.

"There has also been tremendous negative publicity about clinical research, and that has made the lay-public more leery of the clinical research community," he adds. "All of these factors have created challenges in patient recruitment and enrollment."

There are very large populations of patients in developing regions around the world. While American patients are increasingly skeptical of their physicians and medical care, patients in India and other parts of the world continue to place greater trust in their health care providers, Getz says.

And often, for patients in these developing regions, investigational drugs are the first treatment that they can access, so there is high motivation to participate in clinical research, he adds.

"As a result, it is easier to enroll patients from these regions into clinical research studies," Getz says.

When the survey of physicians and research is published early in 2007, it's possible the information could be used to facilitate the development of solutions to the problems of decreasing involvement by women physicians and increasing subject recruitment obstacles, Getz says.

"We are hoping this data will be used to raise awareness of the disparities that exist today, to inform discussion and debate around new policies that will improve the research landscape," Getz says.

The study may help to identify ways to improve physician education about clinical research, and it might influence policies and practices that make getting involved in clinical research more attractive to physicians serving ethnic communities, he adds.

"There's a lot of criticism today that patients from many of these ethnic communities don't have access to investigational treatments because their physicians don't have an interest in conducting the studies," Getz says. "The results from our research might ultimately facilitate greater access to patients who will benefit by these life-enhancing and life-saving treatments."