Key Operational and Design Considerations in Contraceptive Development

Women and their OB/GYNs can select from an enormous variety of contraceptive products today. This includes multiple categories of contraceptives – oral contraceptives, implants, intrauterine devices (IUDs) or systems (IUSs), injectables, patches, rings, diaphragms and spermicides. Within categories there is usually a choice of multiple products. With contraceptives already available in such variety, it would be easy to assume that opportunities in new contraceptive development are limited. However, many women and OB/GYNs see room for improvement of contraceptives in areas including comfort, convenience, reduction in side effects, methods of device insertion, ease of reversibility and the overall balance of risk vs. benefit.

Forecasts of Increasing Demand for Contraceptive Products

Types of ContraceptiveIn addition, opportunity depends in part on demand. The global need for contraception by married or “in-union” women is projected to increase to 800 million by 2030. Projections vary by region, but the combination of substantial growth in global population in the reproductive years and modest growth in prevalence of contraceptive use means substantial growth in global demand for contraception. A market on such a vast scale always presents opportunities. Both commercial and institutional developers are rising to the occasion with products to meet the needs of women in different geographic regions and with different demographic profiles.

Key Considerations in Phase 3 Contraceptive Trials

Early contraceptive development often progresses through testing of multiple prototypes for devices or doses and formulations for hormonal contraceptives. After selection of the best candidate for phase 3 studies to support marketing submissions, contraceptive developers need to be aware of several design and operational considerations. These include:

  • Will a phase 3 study require a comparator arm or not?
  • How many cycles of exposure will be required in the first year to demonstrate effectiveness?
  • How many subjects must complete treatment for the full study duration?
  • What precision of confidence interval will be required for pregnancy analysis using the Kaplan-Meier estimator or Pearl Index?
  • What factors can exclude cycles from analysis (e.g. backup or emergency contraception, absence of intercourse, missing or incomplete diary)
  • Does an e-diary or a paper diary provide better data, how do costs compare and which type do regulators prefer?
  • Given all the considerations above, what can the operational team do to maximize data quality and likelihood of study success?

Defending the Primary and Secondary Analyses During a Pivotal Contraceptive Trial

Extensive experience in contraceptive trials shows that the project team can do a great deal to maximize the volume and quality of critical data. This includes encouraging close attention to subject retention and patient reminders at investigational sites. A major factor in maximizing data quality is having the biostatistical team review data management plans, CRFs and edit checks to ensure adequate focus on key data and ensuring that clinical monitoring focuses on data critical to the statistical analysis of key endpoints. In addition, the biostatistical team can educate the clinical and data-management teams on the key data fields used in the analysis and their importance to the success of the study.

Attention to such issues will maximize data quality and chances of regulatory approval. And someday, when your product is marketed worldwide, 800 million women and their OB/GYNs may thank you for building a better contraceptive. Investors may thank you as well.

Discuss Contraceptive Development

Health Decisions has extensive experience in contraceptive development for commercial and institutional sponsors. Clint Dart, MS, Head of Data Services, serves as Principal Investigator for Health Decisions in its role as Statistical and Clinical Coordinating Center for the National Institute of Child Health and Human Development (NICHD) Contraceptive Clinical Trials Network. Contact Health Decisions to schedule a conversation with a Health Decisions contraceptive development expert.

2018-08-14T20:59:31+00:00
SUBMIT RFP