Role of Clinical Pharmacology in Diversity and Inclusion in Global Drug Development: Current Practices and Industry Perspectives: White Paper.

The 2022 United States Food and Drug Administration (US FDA) draft guidance on diversity plan (DP), which will be implemented through the Diversity Action Plans by December 2025, under the 21st Century Cures Act, marks a pivotal effort by the FDA to ensure that registrational studies adequately reflect the target patient populations based on diversity in demographics and baseline characteristics. This white paper represents the culminated efforts of the International Consortium of Quality and Innovation (IQ) Diversity and Inclusion (D&I) Working Group (WG) to assess the implementation of the draft FDA guidance by members of the IQ consortium in the discipline of clinical pharmacology (CP). This article describes current practices in the industry and emphasizes the tools and techniques of quantitative pharmacology that can be applied to support the inclusion of a diverse population during global drug development, to support diversity and inclusion of underrepresented patient populations, in multiregional clinical trials (MRCTs). It outlines strategic and technical recommendations to integrate demographics, including age, sex/gender, race/ethnicity, and comorbidities, in multiregional phase III registrational studies, through the application of quantitative pharmacology. Finally, this article discusses the challenges faced during global drug development, which may otherwise limit the enrollment of a broader, potentially diverse population in registrational trials. Based on the outcomes of the IQ survey that provided the current awareness of diversity planning, it is envisioned that in the future, industry efforts in the inclusion of previously underrepresented populations during global drug development will culminate in drug labels that apply to the intended patient populations at the time of new drug application or biologics license application rather than through post-marketing requirements.

Piriformis syndrome in a patient after cesarean section under spinal anesthesia.

OBJECTIVES: The diagnosis, pathogenesis, and treatment of piriformis syndrome as a cause of persistent buttock and hip pain after spinal anesthesia are presented in this case report. CASE REPORT: A 29-year-old woman presented 5 days after cesarean delivery with sudden onset of pain in the left buttock and left hip radiating to the posterior knee with fever. She was subsequently diagnosed with piriformis syndrome. CONCLUSIONS: Back pain with radiation into the buttocks after spinal anesthesia is frequently attributed to the spinal procedure itself. However, prolonged sitting and weight bearing in the upright position after cesarean delivery can cause sciatic nerve compression at the sacroiliac joint with concomitant irritation, inflammation, and spasm of the piriformis muscle. Piriformis syndrome is frequently underdiagnosed in the obstetric population. Because the diagnosis of piriformis syndrome is based mainly on clinical signs and symptoms, the clinician must have a high index of suspicion.