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Differences in patient characteristics, including age, sex, and race influence the safety and effectiveness of drugs, biologic products, and medical devices. Here we provide a summary of the topics discussed during the opening panel at the 2018 Johns Hopkins Center for Excellence in Regulatory Science and Innovation symposium on Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities. The goal of this session was to provide a brief overview of FDA-regulated therapeutics, including drugs, biologics and medical devices, and some of the major sources of heterogeneity of treatment effects (HTE) related to patient demographics, such as age, sex and race. The panel discussed the US Food and Drug Administration's role in reviewing and regulating drugs, devices, and biologic products and the challenges associated with ensuring that diverse patient populations benefit from these therapeutics. Ultimately, ensuring diverse demographic inclusion in clinical trials, and designing basic and clinical research studies to account for the intended patient population's age, sex, race, and genetic factors among other characteristics, will lead to better, safer therapies for diverse patient populations.

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Antipsychotic medication can be often associated with sexual dysfunction (SD). Given its intimate nature, treatment emergent sexual dysfunction (TESD) remains underestimated in clinical practice. However, psychotic patients consider sexual issues as important as first rank psychotic symptoms, and their disenchantment with TESD can lead to important patient distress and treatment drop-out. In this paper, we detail some management strategies for TESD from a clinical perspective, ranging from prevention (carefully choosing an antipsychotic with a low rate of TESD) to possible pharmacological interventions aimed at improving patients' tolerability when TESD is present. The suggested recommendations include the following: prescribing either aripiprazole or another dopaminergic agonist as a first option antipsychotic or switching to it whenever possible. Whenever this is not possible, adjunctive treatment with aripiprazole seems to also be beneficial for reducing TESD. Some antipsychotics, like olanzapine, quetiapine, or ziprasidone, have less impact on sexual function than others, so they are an optimal second choice. Finally, a variety of useful strategies (such as the addition of sildenafil) are also described where the previous ones cannot be applied, although they may not yield as optimal results.

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Over the last decade, the use of computers and robotics in medicine has increased commensurate with emergent advances in technology. This article largely focuses on the challenges that the U.S. Food and Drug Administration faces when evaluating new technologies for entry into the market. How different categories of devices are categorized and what types of data have been used for regulatory approval or clearance are described. These are compared with expectations that the clinical community may have for these devices. A brief discussion of current regulatory thinking about these types of devices is also included.

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This article briefly describes the US Food and Drug Administration regulatory process for medical devices, focusing on orthopaedic joint device examples. The mission of the Center for Devices and Radiological Health is to promote and protect the health of the public by ensuring that the medical devices that reach US consumers are safe and effective for their intended function. A question and answer section is included as a reference guide for the orthopaedic community to broadly address some common issues related to orthopaedic device constructs, such as hybridization of joint systems, labeling claims, modifications to ultra-high-molecular-weight polyethylene sought by manufacturers to minimize wear and osteolysis, combination products, and the responsibilities of an orthopaedic surgeon. The FDA relies on accurate scientific evidence and regulatory science to determine the safety and effectiveness of orthopaedic joint devices.

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The Food and Drug Administration (FDA) does more than regulate food and drug products. Through its medical device evaluation process, FDA affects every orthopedic surgeon's practice and every orthopedic patient every day. FDA regulations affect the development of each orthopedic device in some way, from the product's inception to its senescence, but the regulatory process and what the FDA's stamp of approval means are not part of the curriculum in medical school or residency. Each device follows a specific pathway from manufacture to physician use and patient care depending on the assessment of risk associated with the device or classes of devices. The evaluation of safety and effectiveness involves a complex process of biomechanical, engineering, preclinical, laboratory, clinical, and epidemiological assessment. How different types of devices get to the patient are reviewed, and the basics of the regulatory process are explained in this paper. Common myths are set straight, and FDA's concerns with "off-label" use are discussed. The role of the orthopedic surgeon in the regulatory process is also introduced.

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STUDY DESIGN: An ex vivo biomechanical study using cadaveric vertebral bodies. OBJECTIVE: To determine how bone mineral density (BMD) affects mechanical strength and stiffness of the vertebral body after vertebroplasty, and to determine how the association between mechanical properties and BMD varies with amount of cement injected. SUMMARY OF BACKGROUND DATA: Adverse events associated with vertebroplasty include cement leakage and adjacent fractures. Understanding effects of bone density and cement volume on mechanical properties may be important clinically to identify the minimum cement volume that will benefit the patient while minimizing risks of adverse events. METHODS: The bone mineral density of 13 vertebral columns from adult white female cadavers was measured with DEXA. Vertebral bodies (n = 126) were assigned to 5 groups based on cement treatment: intact, untreated, 4% fill, 12% fill, and 24% fill. Treated specimens were first loaded asymmetrically to simulate a wedge compression fracture before injection with polymethylmethacrylate cement. Strength and stiffness were measured in axial compression. RESULTS: Only the highest cement dose used (24% fill, 7 mL on average) had an effect on mechanical stiffness or strength. Within this group, stiffness was improved relative to untreated fractures but not restored to prefracture levels, and strength was enhanced beyond intact values. These improvements in stiffness and strength depended significantly on bone density, with highly osteoporotic samples benefitting the least. CONCLUSION: Results suggest that highly osteoporotic patients may receive the least amount of improvement in mechanical properties after vertebroplasty. It is recommended, therefore, that cement volume be restricted to the amount needed for fracture reduction only because there may be a limit to the mechanical benefits that additional cement can offer, depending on patient bone density. Understanding these limitations can potentially minimize risks of adverse events.

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The outcome of surgically treated mucous cysts of the foot is poorly documented in the orthopaedic literature. This study reports on the treatment of mucous cysts of the toes by simple excision and joint debridement. This is in contrast to treatment of similar lesions in the fingers which is often treated by excision of the cyst, joint debridement, and rotational flap. Following this procedure on 15 patients (15 cysts), at a minimum of 2 years postoperatively, only one cyst had recurred at 9 months. All patients were satisfied by the cosmetic appearance of their toe. The authors reviewed the available literature on this condition and suggest that this method of treatment provides good functional and cosmetic results with a minimal rate of recurrence.

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