Owing to the wide range of choices, contraception is not just efficacy driven, but involves a high degree of personal preference. These same preferences influence a woman’s decision to enroll, comply, and complete a contraception clinical trial. Time spent developing a patient profile before trial commencement will save time and costs later.
Our latest infographic shares considerations and best practices in regards to patient recruitment, enrollment and retention of patients in women’s contraceptive trials.
First and foremost, the development of the enrollment patient profile should occur prior to trial commencement and take into consideration the type of contraception being investigated.
Regulatory requirements also influence the patient profile and need for monitoring. Therefore, the plan to address these requirements should be determined during the development of the trial protocol and the approach for recruitment, enrollment, and retention. In fact, the FDA provides specific guidance on the conduct of clinical contraceptive trials and has also identified areas in which specific sampling distribution requirements may be required.
As dropout and withdrawal are inevitable, pre-trial planning should incorporate enrollment monitoring for each of the required characteristics set by the sponsors and regulatory bodies, in addition to contingency planning for additional enrollment and improved retention, should they be required.
The patient profile also guides recruitment, and should aim to include a sample of women that represent the women who will be using the product in “real life”, while balancing the needs of the study to be completed in a timely manner with quality data.