A Problem in NIH and Federally Funded Prostate Cancer Interventional Clinical Trials.

BACKGROUND: Obesity, diagnosed in 41.1% of African American (AA) men, is a risk factor for prostate cancer (PCa) recurrence, progression, and increased mortality. Obesity is associated with aggressive PCa only in AA men and not White American (WA) men. The overall health of AA PCa patients is also more likely to be adversely affected by comorbid type 2 diabetes (T2D), often an outcome of obesity and a cause of reduced odds of PCa survival. This evidence suggests that preventing and controlling comorbid obesity and T2D in AA men diagnosed with PCa should be a research funding priority. AIM: The aim of this study is to determine if federally funded PCa clinical trials controlled T2D and obesity. METHODS: Completed interventional PCa clinical trials conducted in the USA, funded by the NIH or other federal agency, which included males aged 18-64 years, and reported study protocols were included in the study. We examined the intervention modalities used in the trials to determine if any attempted to control obesity and T2D. RESULTS: Fifty-eight trials met the study inclusion criteria. Of these 11 were excluded from the analysis as they did not report AA men. A total of 5802 men participated in the remaining 47 trials. Of these, 917 (15.8%) were AA and 4885 (84.2%) were WA men. Forty (85.1%) trials used pharmaceutical medication therapies or other clinical procedures. None of the medications or clinical procedures used were indicated for treatment of obesity and T2D. 5 (10.6%) trials addressed treatment preferences, survivorship, coping, function, and incontinence among PCa patients. Only 2 (4.25%) trials examined weight loss and diet. CONCLUSIONS: None of the completed federally funded PCa clinical trials that included AA men used methods to control T2D. Only an insignificant number (4.25%) attempted to control obesity. This gap in therapeutic optimization to control these comorbid conditions indicates a critical area in need of federal funding priority.

Inclisiran: A First-in-Class siRNA Therapy for Lowering Low-Density Lipoprotein Cholesterol.

OBJECTIVE: To review the current pharmacology, pharmacokinetics/pharmacodynamics, safety, and efficacy of inclisiran in lowering lipid levels. DATA SOURCES: A PubMed (from December 1, 2014 to April 15, 2022) and ClinicalTrials.gov search was conducted using ALN-PCSsc, ALN-60212, PCSK9si KJX-839, and inclisiran. Additional articles were identified by hand from references. STUDY SELECTION AND DATA EXTRACTION: We included English-language articles evaluating inclisiran pharmacology, efficacy, or safety in humans for lowering low-density lipoprotein cholesterol (LDL-C). DATA SYNTHESIS: Inclisiran is a novel small interfering RNA-based therapy administered as a twice-yearly subcutaneous injection. By binding to the messenger RNA (mRNA) precursor of proprotein convertase subtilisin/kexin type 9 (PCSK9), inclisiran inhibits expression of the PCSK9 gene, resulting in increased recycling and expression of LDL receptors and decreased levels of LDL-C. Like PCSK9 inhibitors, inclisiran was associated with a comparable extent of LDL-C reduction in several phase II/III trials. Compared with placebo, inclisiran was found to have similar adverse events except for injection-site reaction. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Currently, inclisiran lacks data on clinical outcome improvement or long-term safety. However, it may play a role in patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk equivalent if optimal LDL-C cannot be achieved by statins and PCSK9 inhibitors cannot be tolerated. The drug may be used for heterozygous familial hypercholesterolemia. CONCLUSION: Inclisiran is an effective and safe medication for lowering LDL-C levels. Additional data regarding efficacy on cardiovascular outcomes and long-term safety profile with inclisiran are needed.

An ethics-based approach to global health research part 4: Scholarship and publications.

Disseminating research findings from global health collaborations is essential to advancing science. However, there are a number of ethical considerations and potential challenges to address to ensure thoughtful and non-exploitative reporting. The factors include the benefits and risks to publication, authorship criteria or values, and the accessibility of forums or journals in which to pursue publication. This paper provides commentary related to planning for writing, communicating intentions to publish, obtaining permissions to publish, risks in internationally collaborative work, authorship principles, and journal selection. Authors' and editors' knowledge of experienced individuals from both pharmacy literature, medical fields, and general publications is incorporated to provide an assessment of risks and benefits of publication of international global health research.

Current Practices in Global/International Advanced Pharmacy Practice Experiences: Preceptor and Student Considerations.

The objective of this article is to describe the key areas of consideration for global/international advanced pharmacy practice experience (G/I APPE) preceptors, students and learning objectives. At the 2013 Annual Meeting of the American Association of Colleges of Pharmacy (AACP), the GPE SIG prepared and presented an initial report on the G/IAPPE initiatives. Round table discussions were conducted at the 2014 AACP Annual Meeting to document GPE SIG member input on key areas in the report. Literature search of PubMed, Google Scholar and EMBASE with keywords was conducted to expand this report. In this paper, considerations related to preceptors and students and learning outcomes are described. Preceptors for G/I APPEs may vary based on the learning outcomes of the experience. Student learning outcomes for G/I APPEs may vary based on the type of experiential site. Recommendations and future directions for development of G/IAPPEs are presented. Development of a successful G/I APPE requires significant planning and consideration of appropriate qualifications for preceptors and students.

Current Practices in Global/International Advanced Pharmacy Practice Experiences: Home/Host Country or Site/Institution Considerations.

International outreach by schools and colleges of pharmacy is increasing. In this paper, we provide current practice guidelines to establish and maintain successful global/international advanced pharmacy practice experiences (G/I APPEs) with specific recommendations for home/host country and host site/institution. The paper is based on a literature review (2000-2014) in databases and Internet searches with specific keywords or terms. Educational documents such as syllabi and memoranda of understanding (MoUs) from pharmacy programs were also examined. In addition, a preliminary draft was developed and the findings and recommendations were reviewed in a 90-minute roundtable discussion at the 2014 American Association of Colleges of Pharmacy Annual Meeting. Recommendations for the host country include travel considerations (eg, passport, visa, air travel), safety, housing, transportation, travel alerts and warnings, health issues, and financial considerations. For the home country, considerations for establishment of G/I APPE site (eg, vetting process, MoU, site expectations) are described. The paper is a resource for development of new G/I APPEs and provides guidance for continuous quality improvement of partnerships focusing on G/I pharmacy education.