Drug trials must accommodate gun-shy women

Leslie Cate is vice president of global access to patients for Quintiles Inc.

Each clinical trial has its own recruitment challenges, but one truism applies to all: A “one size fits all” approach to enrolling patients does not work.

What does work is a customized approach that begins with understanding the issues that keep some women from participating in trials and making sure they are aware of the potential benefits of clinical research.

Some common barriers for patients who are considering enrollment in any clinical trial include nervousness about taking an investigational medicine; concern for the families who may have to help with transportation or otherwise be inconvenienced; fear of jeopardizing their relationship with their current specialist or primary care provider; and the perception that trials are only for people who have advanced illnesses or have run out of other options. A successful recruitment campaign addresses these concerns first.

Our experience indicates that women are generally more tuned in to their health care than are men, perhaps because they are often the lead caretaker of the family. They tend to be more up-to-date on health issues and thoughtful about preventive medicine. They get into the habit of making and keeping regular health care appointments. Also, women tend to form more of a relationship with their health care providers and staff.

Successful recruitment of women -- indeed of all patients -- should ensure that patients are provided with information about the condition and the medicine being studied. They should be provided as many choices as possible within the trial’s framework about how they want to manage their own health care and scheduling of appointments. All patients also need the opportunity to provide feedback, which helps them feel that their opinion counts and that they are part of a study team.

I have found that women who are middle-aged or older tend to be the most altruistic of clinical trial patient populations. They seem to better appreciate the importance they bring to clinical research and that their participation will be valued. These women also are more likely to identify with people who also suffer from the same disease, or support group communities, so these organizations may be a way to reach individuals who may be interested in a trial.

Many support organizations have Web sites and newsletters to provide information for their members and often post clinical trial information that is approved by their boards of directors.

Younger women often respond to a different approach. It is important to advise women of college age who may not be closely tied to regular health care that they will be compensated for their time and travel.

To address established protective protocols, women of childbearing age should be provided with effective reproductive health counseling. Women with young children usually appreciate study sites that provide family-friendly environments, such as playrooms in the waiting areas and healthful snacks for their children.

The Quintiles Global Access to Patients team has learned through a decade of recruiting that no single approach will work. In every case, the best strategy is to consider patients’ needs and tailor programs to meet those needs as well as those of the researchers.