Health Decisions recognizes the importance of increasing the participation of women in clinical trials in order to identify differences in female response, provide female-specific prescribing information and reduce the number of adverse events experienced by women taking approved medications. Based on Health Decisions’ extensive experience as a women’s health specialty CRO, Project Manager Jessica Kappes, MBA, MT, CCRA offers some observations from women’s health clinical trials, many of which apply to trials enrolling female populations in other indications. Ms. Kappes has nine years of experience as a project manager of studies in areas including women’s health, infectious disease, oncology, endocrinology and psychiatric conditions.
Have you observed any issues of particular importance in conducting studies in women’s health?
Ms. Kappes: Perhaps the most important observation is that women are very busy people and are reluctant to add any burdensome obligations to daily life. Anything that makes involvement in a trial easier will help with enrollment and compliance. The need for childcare and help with transportation are often issues for patients who consider enrolling in a study. Our sites are becoming very creative in addressing these types of patient concerns. In addition, some sites are accommodating subjects with crazy schedules. Some clinics will stay open later in the evenings and offer lunch vouchers, Uber rides and even a weekend option. The flexibility offered by our sites in some of our current studies has helped with enrollment rates. We have also found that women prefer e-diaries or limited diary requirements and that minimizing study visits whenever possible helps with enrollment. For subject retention, it is important for a subject to be able to contact a site when she has a question. Subjects that cannot get their questions answered are more likely to drop out.
What is your experience with recruitment of female patients in general or of female patients for studies in specific indications?
Ms. Kappes: In contraceptive studies, we are generally looking at a younger demographic that is very open to trying different forms of contraception. Women want an option that can be used for longer periods of time, that is comfortable and has minimal side effects. A lot of women like having a non-hormonal option and when investigative products meet those criteria, contraceptive studies can be relatively easy to enroll. Recently, we’ve encountered a new issue in contraceptive studies based on a trend in feminine hygiene. Some women enrolling in these studies are using menstrual cups. Because these products are fairly new to the market, we need to fully understand whether and how these cups might affect the use of contraceptive options like a ring or IUD.
Do studies that require use of double contraceptive methods to ensure that no one gets pregnant discourage enrollment?
Ms. Kappes: In my experience, not at all. Subjects don’t sign up for these studies wanting to get pregnant. They are willing to protect themselves to decrease that risk.
Have you noticed any differences between female and male patients when they consider enrolling in a clinical trial?
Ms. Kappes: My impression is that males are easier to enroll. This may illustrate one of the reasons that it is important to prioritize recruitment of women in trials in all indications. Looking to studies in specific indications, my experience includes studies of both male and female contraceptives. In that area, men are easier to enroll. I think contributing factors include men’s interest in having additional contraceptive options and the ability to control family planning. Male contraception is becoming a very popular topic all around the world.
In studies involving women’s health indications, have you observed any noteworthy differences between studies of drugs and devices?
Ms. Kappes: I think differences in enrollment challenges are more about the level of perceived risk than the type of product. Many device studies are easier to enroll because there is less potential risk or perceived risk involved. You’re not adding a drug to the body or performing an invasive procedure. Diagnostics studies generally involve a minimally invasive procedure (swab, blood draw, urine collection) and then the subject is done. It’s a very easy process for the subject. In addition, sometimes the subject is being compensated for just visiting her regular doctor on a normal schedule. Of course, things are different with studies of surgical devices and studies that require invasive procedures. Things are also different with studies that must enroll patients at times when they are focused on addressing a major concern like a new cancer diagnosis or in situations like pregnancy that may make patients hesitate to try an investigational product. Enrollment can also be more challenging when patients have a bothersome health condition and are informed during the consent process that there is a chance they will be randomized to placebo. We have to think through these types of issues and address them based on the requirements of each study.
For additional information on recruitment of women for clinical trials, please download the Health Decisions white paper, “Addressing the New Imperative to Include Females in Clinical Trials.” Based on Health Decisions’ extensive experience as a women’s health specialty CRO, the white paper includes 35 tips on enrollment of women.