We recently discussed taking women’s contraceptive clinical trials global in our webinar, 7 Best Practices to Drive Time and Cost Savings for Your Women’s Contraceptive Clinical Trial.
Global enrollment for clinical contraception trials can result in increased recruitment and potentially better compliance and engagement, particularly in underserved countries with population control concerns and limited access to contraception or affordable contraception. In fact, at the moment, nearly 600 clinical trials are being conducted globally for the development or validation of contraceptive methods in both men and women.
However, managing a multinational contraceptive clinical trial does not come without its challenges. We asked our webinar attendees to share their perspective on the most difficult challenges to manage.
The results of our poll:
- 14% said, “FDA data point and patient enrollment requirements”
- 14% said, “Developing accurate patient profile”
- 7% said, “Lack of globally standardized products”
- 0% said, “Drug importation limitations”
- 65% said, “All of the above”
With a lack of globally standardized products and varying standards of care among countries, perhaps it doesn’t come as much of a surprise that more than half of our attendees selected “All of the above”. However, I’ve seen a lot of success with clinical trials held outside the United States as long as the country selection makes sense for the study you’re trying to run and for the product you’re developing.
Therefore, it is important to keep in mind the following:
- The FDA may require that a specific proportion of the data points and/or participants be enrolled in the US for a product that will be used in the US, to ensure appropriate demographic characteristics.
- The development of the patient profile should also take this into consideration — drug metabolism may differ in other ethnicities, physical characteristics may not reflect those of US women, and the evaluation of the “typical” vs “perfect” use of a drug may depend on cultural differences.
- In some countries, particularly in the developing world, there are cultural gender rules that do not allow women to have independent decision-making or economic abilities regarding contraceptive use.
- Religion can have a profound effect on the acceptability of birth control use, and this can affect enrollment in some countries.
- Access to universal health care may limit enrollment because there is no need to access free contraception through a clinical trial.
- A lack of globally standardized products may result in products that are being used as standard care in the US, but are not approved by the regulatory bodies in other countries. In this case, the drug is considered an investigative drug, with obvious implications to the protocol.
- Limitations may exist in the ability to import specific drugs into other countries, and this may depend on the structure (e.g., democracy or dictatorship) and restrictions by the government for importing goods.
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 and be on the lookout for the related eBook and infographic. If you’d like to be alerted when they become available, please leave your contact information in the comments section below.
Darcy Forman is the senior director of project management at Clinipace.