Considerations for Measuring Pain in Clinical Trials

March 7, 2019

From March 7-10 in Atlanta, GA, advocates, researchers and other representatives from the healthcare industry will meet to discuss the latest in women’s sexual health at the Joint International Society for the Study of Women’s Sexual Health (ISSWSH) and International Society for Sexual Medicine (ISSM) Meeting. This year, several presentations will focus on the significant impact pain has on women’s sexual function.

According to the American College of Obstetricians and Gynecologists, almost three in four women will experience sexual pain during her lifetime. For some, it will be only temporary, but others will face long-term issues. Sexual pain may be a sign of more serious gynecologic conditions – such as endometriosis, a condition affecting more than 380 million premenopausal women worldwide, or uterine fibroids, which may impact more than 2.6 billion women globally. Over 40 percent of surveyed women expressed that good sexual health was highly important to their quality of life, underscoring the importance of continuing research efforts to discover new solutions that address sexual pain.

Beyond sexual wellness,  migraine, tension headache, fibromyalgia, irritable bowel syndrome, and other chronic pain conditions are more prevalent in women. While the reason for this discrepancy is unclear, studies suggest biological, psychological, and sociocultural differences may be contributing factors. As current treatment options for many chronic pain conditions remain limited, addressing pain-related women’s health needs requires new research initiatives.

The
complexities of capturing pain can make the design and analysis of clinical
studies challenging. A trial must be strategically designed to be successful. Key
questions to consideration when designing a trial to measure pain intensity
and/or relief include:

  • What are the study objectives?
  • What is the most appropriate scale?
  • At what frequency will pain scores be measured?
  • How, when, and which rescue medications will be permitted?
  • Are any controls needed to account for subject differences? (e.g., age, culture, sex)
  • What site staff trainings are needed to collect quality data?
  • How will pain-related AEs be defined?

For tips on designing a clinical trial that effectively measures pain, read A Framework for Successful Pain Measurement in Clinical Studies.

Contact Health
Decisions
 to
schedule a conversation with a Health Decisions expert to discuss upcoming
clinical programs in pain management or to meet with us during ISSWSH.

2019-03-13T22:33:16+00:00
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