In this Q&A, Nan Zhang MD PhD, Vice President of Global Central Lab and Biomarker Services at Frontage, speaks on the role of analytical and central laboratories in providing accurate laboratory data and seamless logistics services.

Chronic pain affects millions of Americans, with a prevalence higher than heart disease, cancer, and diabetes combined. Chronic pain resulting in osteoarthritis and cancer is often treated with opioid medications. Opioid medications can provide short-, intermediate-, or long-acting analgesia. Hydrocodone is one of the currently approved formulations available in IR and ER forms. Extended-release forms are formulated as both combination products with acetaminophen or non-steroidal anti-inflammatory drugs or single-entity drug. All currently approved oral opioids have limitations, including continued concern about abuse and misuse in the intended patient population. Like other opioids used in analgesia, hydrocodone can be abused and is subject to criminal diversion. A number of the abuse-deterrent formulations in development and available on the market utilize hard-to-crush tablet technologies. Frontage possesses wide experience in running studies with controlled substances. Frontage provided full support in developing the protocol, revising study methodology, developing full package for IRB submission, including Informed Consent Form.

Programs that need to include women in their FIH (first in human) studies will find that successful enrollment of women is achievable; however, it requires a concerted effort, with the correct strategies and proper support. In this paper, we explore the challenges in recruiting women for FIH studies and present a set of practices that have proven successful in improving the recruitment rates of women for these studies.