We discussed how technology can help address challenges common to women’s contraceptives trials, especially with regards to compliance, in our webinar, Trials in Women’s Health: Best Practices to Drive Time and Cost Savings for Your Women’s Contraceptive Clinical Trial.
However, while technology such as electronic diaries may make it easier to report data, compliance still ultimately relies on the subject. This led to a great question from one of our webinar attendees: “How much non-compliance with product and/or reporting do you typically allow before discontinuing patients? One instance, two, three?”
In my experience, setting and tracking compliance is dependent on the type of product being tested. For products used at the time of sexual activity, I typically recommend that compliance be monitored based on the number of sexual acts that occur without appropriate use of the product. For example, most protocols require a minimum compliance of 70% appropriate use. Therefore, if a subject falls below 70% after a set number of sexual acts (perhaps four to five instances), the subject would be non-compliant.
For products that are more pharmacological, I recommend setting level of compliance based on a timeframe and not on the number of sexual acts. Therefore, compliance should be monitored after a certain number of weeks, or after the first 28-day cycle.
However, regardless of the type of product being tested, I suggest that the first offense of non-compliance result in re-education and counseling for both the site and subject on product compliance expectations. It’s important to keep in mind that non-compliance with either the drug/product or the documentation of use, endpoints, side effects, and sexual activity limits the ability to evaluate the success or failure of the product.
At the second offense of a subject below 70% compliance, the subject should be discontinued. Participants who are habitually non-compliant must be withdrawn from the study, which can affect the study duration as new participants are recruited to ensure an adequate number of quality data points. Trials that continue with poor quality or missing data run the risk of being re-run after their initial completion.
However, even if compliance is met, doubts can still remain as to how accurate the data may be, as was demonstrated by another excellent follow-up question we received during the webinar: “How confident should the sponsor be with the reported number of sex acts reported?”
The primary endpoint of a women’s contraceptive trial is one thing—that a woman has the potential of becoming pregnant. This really requires only one act, but most trial protocols require a minimum of two acts per month to be compliant. Compliance is affected by similar participant characteristics as those that affect recruitment and retention. Age, employment status, socioeconomic status, family status, external commitments, marital status, relationship status, and frequency of sex can all influence how diligent a person is with product use and recording.
The type of person who may be more committed and conscientious is also one that may not be willing to take a chance on a contraceptive of unknown efficacy and therefore not likely to participate. This may result in a sample of women who do not possess the characteristics associated with better compliance. Therefore, it’s important to do due diligence when enrolling people in your study. At the end of the day, there is no way to actually confirm patient-reported data, so you’ll have to take their word for it.
That said, in my experience managing women’s contraceptive trials, I’ve never felt like the data being reported was false, and the important thing is that women are actually being exposed to risk of pregnancy, which ultimately requires sexual activity.
For more information on best practices to drive down cost and time savings during your women’s contraceptive clinical trials, feel free to watch the recorded webcast, read the eBook, and download the infographic.