Innovation in Chemistry,Manufacturing, and Controls—A Regulatory Perspective From Industry

This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation. There is a desperate need for a consistent form of regulation where global approaches to regulatory strategies can be harmonized, and specific CMC challenges can be dealt with using the appropriate science and risk-based tools. Although these tools are well described in current guidance documents, the specifics of applicability to complex novel modalities can still result in differing regulatory advice and outcomes. The future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization, regulatory education, and industry cooperation through consortia, enabling industry to supply key information to regulators in a transparent yet well-defined manner, and utilizing mutually understood risk-benefit analyses to produce drugs with appropriate safety, efficacy, and quality characteristics.     

Coronary Artery Disease in Patients ≥80 Years of Age

Coronary artery disease (CAD) is a major cause of morbidity and mortality in patients ≥80 years of age. Nonetheless, older patients have typically been under-represented in cardiovascular clinical trials. Understanding the pathophysiology, epidemiology, and optimal means of diagnosis and treatment of CAD in older adults is crucial to improving outcomes in this high-risk population. A patient-centered approach, taking into account health status, functional ability and frailty, cognitive skills, and patient preferences is essential when caring for older adults with CAD. The present systematic review focuses on the current knowledge base, gaps in understanding, and directions for future investigation pertaining to CAD in patients ≥80 years of age.     

Neurobiological Mechanisms of Acupuncture for Some Common Illnesses: A Clinician's Perspective

This paper presents some previously proposed neurobiological mechanisms on how acupuncture may work in some clinical applications from a clinician's perspective. For the treatment of musculoskeletal conditions, the proposed mechanisms included microinjury, increased local blood flow, facilitated healing, and analgesia. Acupuncture may trigger a somatic autonomic reflex, thereby affecting the gastric and cardiovascular functions. Acupuncture may also change the levels of neurotransmitters such as serotonin and dopamine, thereby affecting the emotional state and craving. This mechanism may form the basis for the treatment of smoking cessation. By affecting other pain-modulating neurotransmitters such as met-enkephalin and substance P along the nociceptive pathway, acupuncture may relieve headache. Acupuncture may affect the hypothalamus pituitary axis and reduce the release of the luteinizing hormone in the treatment of polycystic ovary syndrome. In addition, two other approaches to the acupuncture mechanism, the fascia connective tissue network and the primo vascular system, are briefly reviewed. Finally, the idea of true versus sham acupuncture points, which are commonly used in clinical trials, is examined because the difference between true and sham points does not exist in the neurobiological model.     

中俄院校卫勤演习的比较研究

介绍了我校和俄罗斯基洛夫军事医学院的卫勤演习情况,然后针对卫勤演习的构成要素,如演习类型、演习课目、参演对象、演习导调和保障基地等进行了对比分析。在此基础上,从调整参演对象、改变演习时机、改革演习导调、加强基地建设等方面,对我军院校卫勤演习提出了建议。     

我国高等医学院校医学人才培养体制现状调查与分析

目的  为了遵循医学人才培养规律，规范医学人才培养体制，提高医学人才培养质量，探索符合我国实际需求的医学人才培养模式。方法  采用问卷调查法对全国140所高等医学院校进行调查，并对相关调查结果进行分析。结果  ①86.96%的高校对统一规范为“5+3”一体化为主体，同时参加住院医师规范化培训，毕业合格者授予医学博士（MD）学位表示赞成。②76.80%的高校对将“5+3”一体化作为培养全科医生主要渠道的医学博士培养体系表示赞成。③90.40%的高校对通过“5+3+X”一贯制培养授予MD+PhD项目，培养复合型高水平临床医学人才表示赞成。④84.80%的高校对医学学位授予与专科医师规范化培训相脱离，后者应纳入职业培训范畴表示赞成。结论  全面推进落实“5+3”为主体的高素质临床医学相关人才培养模式，将培养目标定位为以满足社会需求的高水平全科医生为主体，加快高层次复合型医学人才的培养体系建设。     

COVID-19 Pandemic: The Role of EMS Physicians in a Community Response Effort

Abstract

The COVID-19 pandemic is a worldwide historical event that will continue to affect nearly every aspect of ordinary life, including affecting our economic, political, and healthcare eco-systems. An effective pandemic response demands a coordinated and integrated response across community healthcare stakeholders, including Public Health and Emergency Management Officials. EMS systems are in a unique position and perform an essential role on the frontlines of COVID-19, including facilitating coordination of response efforts to COVID-19 within their communities while supporting public health mitigation efforts to slow the spread of the SARS-CoV-2. EMS physicians serve their communities at a unique intersection as clinical leaders, population health experts, and advocates. This paper examines and recommends crucial roles for EMS physician leaders as communities work together in pandemic response.     

Hands-On Training in a Digital World: A Novel Simulation-Based Virtual Training Program for Placement and Removal of the Subdermal Contraceptive Implant

ObjectiveThe COVID-19 pandemic necessitated a shift from traditional in-person instruction for learning new technical skills to virtual delivery of medical education training. The objectives of this study were to develop and evaluate a virtual simulation-based training program for Canadian health care professionals (HCPs) on the insertion, localization, and removal of the etonogestrel subdermal contraceptive implant.MethodsA scientific committee of Canadian family planning experts developed a 2-part virtual training program during the COVID-19 pandemic. Core educational content (part 1) was provided in an asynchronous, self-directed, online format. Part 2 consisted of synchronous, simulation-based training using web conferencing. The HCPs were provided with model arms and placebo applicators; the trainers demonstrated implant insertion and removal techniques, and trainees received individual feedback. All trainees were asked to complete an online evaluation upon completion of the program.ResultsBetween September 22, 2020, and December 31, 2021, 83 trainers conducted 565 virtual training sessions. A total of 3162 HCPs completed part 1 of the training program, of whom 2740 had completed part 2 by December 31, 2021. Participants reported high levels of satisfaction with virtual simulation-based training; 96.5% of respondents (1570/1627) agreed that the virtual format was effective. Additional training prior to inserting the implant in clinical practice was requested by 4.5% of respondents (75/1671).ConclusionVirtual simulation-based learning provides effective education and technique training for etonogestrel implant insertion and removal. Online training for implant use can be scaled, as needed, to reach professionals in remote or underserved locations. This virtual training approach may be appropriate for other technical or minor surgical procedures.     

An ethical rationale for perinatal palliative care

Perinatal palliative care has grown out of both an historical necessity in attending to babies in the NICU that face difficult odds of survival, the increasing technology that may avail life-extending, yet technology-dependent, care, and the growth of fetal diagnostic and treatment centers. This review looks ta the history and ethical rationale for making available services from Pediatric and Perinatal Palliative Care to families in the prenatal and postnatal periods caring for a loved one with life-limiting circumstances.