HD begins (another) new era of supporting vital reproductive health research

By Clint Dart, Vice President, Biostatistics and Programming, Health Decisions

The contraceptive market has changed substantially since the first birth control pill was approved by the US Food and Drug Administration (FDA) in 1960. Past research has led to the availability of new contraceptive methods, and helped to define the focus of future research addressing evolving consumer demand. As we embark on the start of our fourth consecutive appointment as the Statistical and Clinical Coordinating Center (SCCC) for the Contraceptive Clinical Trials Network (CCTN) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a unit of the National Institutes of Health (NIH), we’re taking a moment to reflect on the vital research of the past and consider what the future holds.

Since 1996, Health Decisions has served as the SCCC for the NICHD CCTN, running all NIH-sponsored contraceptive clinical studies. Our work with the NIH and other commercial partners has allowed us to be at the forefront of progress in this space for the last two decades. It’s incredible to look back and see the number of new contraceptive methods that have entered the market because of the commitment of groups like the NIH, non-profit organizations like the Population Council, and a number of pharmaceutical companies. We’ve come a long way since the birth control pill was first approved by the FDA. Options for women have expanded to include pills, injectables, IUDs, patches and emergency contraception. In addition, research is edging closer to a possible contraceptive option for men beyond the condom and vasectomy.

While the expansion of contraceptive options has made a significant difference in how we approach reproductive health, unmet needs still exist that beg for research to continue.

Many of the current options available to women are hormonal contraceptives that, while providing effective birth control, come with potential side effects, such as thromboembolic events, which can be life threatening. The potential for safer methods is motivating much of the ongoing research in contraception. In particular, there is a push for low-hormone or non-hormonal methods that may reduce or eliminate the risk of certain side effects.

Past research has also taught us that the safety and efficacy of a contraceptive can vary by patient population. Weight has been shown to impact the performance of certain contraceptives in clinical study. A more concerted effort is being made to explore the relationship between a high body mass index and the efficacy of birth control so that clinicians can better serve their female patients.

One research area that we’re most excited to be a part of is male contraception. There has been very limited research in male birth control methods, making this a “new frontier” that we can explore – and hopefully revolutionize. Surveys show an eagerness on behalf of men to obtain male contraceptive options that will allow them to share some of the responsibility with their female partners. Early studies of hormone-based birth control pills have been promising. A study of a male contraceptive gel launched in 2018, and results could significantly impact family planning.

As an organization focused on women’s health research, we understand how important contraceptive research is. These products empower women (and men) by giving them greater control over their reproductive health. We look forward to not only supporting the NICHD as the SCCC for the next seven years, but also having the opportunity to work on and learn from all future studies that will expand our understanding of contraception and improve consumer choice.

To learn more about Health Decisions’ experience in contraception, click here.