Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs.

There are many differences between Asian regions in terms of the regulatory requirements and operational procedures in conducting international academic clinical trials for the approval of new drugs. The National Cancer Center Hospital in Japan has launched an international investigator-initiated registration-directed trial (IIRDT) in Japan, Korea, Taiwan, and Singapore, aiming at obtaining pharmaceutical approval in participating regions. Differences in regulatory and operational procedures were identified while coordinating the trial. In Japan, regulatory authority reviews should be performed after approval by institutional review boards for IIRDT, whereas in other regions these can be done in parallel. There were disparities in Good Manufacturing Practice-related documents between regions. Several differences were found regarding investigational product (IP) management, specifically concerning labeling, import/export procedures, and customs clearance costs. On the other hand, safety reporting procedures were relatively well-harmonized in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH-E2A). Regions also differed in per-patient costs, due to varying regulations for academic registration-directed trials. In conclusion, the observed differences among Asian regions should be harmonized to facilitate international academic trials in Asia and thus resolve unmet patient needs worldwide. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? International clinical trials have become common because they make it possible to accrue patients faster and obtain new drug approval in wider areas. However, pharmaceutical regulatory differences hinder the efficient conduct of international clinical trials, especially in academia. WHAT QUESTION DID THIS STUDY ADDRESS? We conducted an academic international clinical trial on new drug applications in four Asian countries and clarified pharmaceutical regulatory differences and operational difficulties. WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? The study identified differences between countries in terms of regulatory affairs, institutional review board (IRB) review processes, investigational new drug (IND) dossiers, investigational product (IP) management procedures, and clinical trial costs, while safety reporting procedures were relatively harmonized. Japan utilizes investigator-initiated registration-directed trials, an advanced regulatory system for new drug application by academia, but the other countries do not. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? Harmonization of pharmaceutical regulations and trial initiation procedures, and regulatory reform of clinical trial costs are important to accelerate academic international clinical trials for new drug applications.

"Absurd" Contract Dodge Rejected: Court Lets Cancer Center's Debt-Collection Suit Proceed.

Appeals court denies "free speech" challenge to cancer center's debt-collection suit.

The Influence of the United States Health Care Environment and Reform on Academic Medical Centers.

Academic medical centers (AMC) provide care for most of the underinsured populations of the United States. Their large size and the high acuity of cases make AMCs vulnerable to changes in health care policy. They also are the primary centers for health care research and education and are therefore heavily dependent on federal programs and funding. Since the passage of the Affordable Care Act, AMCs have seen a decrease in the number of patients without insurance. They have also participated in the implementation of alternative payment models, including accountable care organizations, with mixed success.

Is Academic Medicine Ready for Term Limits?

The use of term limits in politics and business has been proposed as a means to refresh leadership, encourage innovation, and decrease gender and racial disparities in positions of power. Many U.S. states and the executive boards of businesses have incorporated them into their constitutions and bylaws; however, studies in politics and business have shown that implementing term limits has had mixed results. Specifically, research in politics has shown that term limits have had a minimal effect on the number of women and minorities elected to office, while research in business indicates term limits do increase innovation. Additionally, term limits may have unintended negative consequences, including inhibiting individuals from developing deep expertise in a specific area of interest and destabilizing institutions that endure frequent turnover in leaders. Given this conflicting information, it is not surprising that academic medical centers (AMCs) in the United States have not widely incorporated term limits for those holding positions of power, including deans, presidents, provosts, and department heads. Notably, a few AMCs have incorporated such limits for some positions, and faculty have viewed these positively for their ability to shape a more egalitarian and collaborative culture. Drawing on studies from academic medicine, politics, and business, the author examines arguments both for and against instituting term limits at AMCs. The author concludes that despite strong arguments against term limits, they deserve attention in academic medicine, especially given their potential to help address gender and racial disparities and to encourage innovation.

The effectiveness of formulary restriction and preauthorization at an academic medical center.

The impact of formulary restriction and preauthorization (FRPA) on prescribing trends was examined over a 5-year period at an academic medical center. Ordinary least squares regression was used to identify hospital units demonstrating statistically significant trends in prescription of restricted agents. Significant decreases in restricted drug use were seen on 2 of 7 medicine units subject to FRPA, whereas a significant increase was seen in 1 of 4 surgical units subject to FRPA.

THE FUTURE OF CARDIOVASCULAR CARE: FROM AFFORDABLE CARE TO THE ACADEMIC MEDICAL CENTER.

We are presently seeing exponential advances in medical knowledge and development of therapeutic and diagnostic tools. We have also begun to experience an historic restructuring of our health care system. But health care costs continue to rise, disparities persist, and the chaotic, disjointed, and often thoughtless discourse in Washington threatens to roll back the prior advances. Improvement in patient care will be severely stymied if the threats to academic medical centers are not countered. This paper will explore our present state through the lens of cardiovascular care. It will 1) examine clinical trends; 2) dissect the value and challenges to the Patient Protection and Affordable Care Act; 3) highlight limitations and alternatives to relying on the federal government; and 4) present the Academic Medical System construct, as a structure designed to retain and advance the academic mission.

Academic Orthopaedic Leadership: Current Challenges and Lessons Learned: AOA Critical Issues.

Health-care reform, market competition, cost containment, and pressure for productivity have dramatically impacted the practice of orthopaedic surgery and academic surgical training. Orthopaedic leaders and training programs are striving to identify and solve these contemporary challenges. Herein, we focus on 4 areas that currently pose important challenges to modern orthopaedic surgical departments and academic hospital systems, including the demanding and evolving skill sets that are required of physician leaders, the effects of the changing medical-legal environment on academic medicine, the impact of increased clinical productivity emphasis on surgical education, and departmental leadership transitions.

Outcomes and associated factors in malpractice litigation involving inferior vena cava filters.

OBJECTIVE: Placement of inferior vena cava (IVC) filters is a controversial focus of medical malpractice. Clinicians currently have little information to guide them regarding key issues and outcomes in litigation. In this retrospective legal case review, we analyzed the factors associated with malpractice actions involving IVC filters. METHODS: The legal databases LexisNexis and Westlaw were searched from 1967 to 2016 for all published legal cases in the United States involving placement of IVC filters. Keywords included "IVC," "inferior vena cava," "filter," and "malpractice." Social Security Disability claims, product liability actions, and hospital employment contract disputes were excluded. RESULTS: There were 310 search results eligible for initial review. After application of exclusion criteria, 29 cases involving medical malpractice were included in final analysis. The majority of excluded cases were insurance disputes and tax revenue cases. Overall, private practitioners were most often sued (11/29 [37.9%]), whereas 24.1% of defendants were academic hospitals (7/29), 20.7% were prisons (6/29), and 17.2% were community hospitals (5/29). The most common specialty named was vascular surgery (8/29), whereas interventional radiologists were named only twice. The most common indications for IVC filter placement were hypercoagulable state (8/29 [29.6%]), recurrent pulmonary embolism (PE; 6/29 [22.2%]), and trauma (5/29 [18.5%]). The most common underlying allegations involved failure to insert IVC filter when indicated (14/29 [48.3%]), intraprocedural negligence (5/29 [17.2%]), and failure to timely remove device (5/29 [17.2%]). Common complications included failure to prevent occurrence of PE (14/29 [48.3%]), device migration (4/29 [13.8%]), and perforation of organs or vasculature (3/29 [10.3%]). Death of the patient occurred in 41.4% of total cases (12/29). In cases in which the patient died, the most common indications for filter placement were trauma (4/12 [33.3%]) and deep venous thrombosis (3/12 [25.0%]), and the most common complication in those patients who died was the failure to prevent a subsequent PE (9/12 [75.0%]). Available verdicts favored defendants (13/14 [92.9%]). In cases with defense verdicts, the most common indications for filter placement similarly were trauma (4/13 [30.8%]) and deep venous thrombosis (3/13 [23.1%)], and the most common complication was failure to prevent PE (9/14 [64.3%]). CONCLUSIONS: Analysis of malpractice cases involving IVC filters revealed key factors associated with litigation. Overall, verdicts favored defendants. Private practitioners were most commonly sued, and the most common reasons for bringing suit were failure to insert filter, intraprocedural complications, and failure to remove filter. Deeper awareness of issues related to malpractice litigation can inform clinical practice and improve patient care and safety.

A Tobacco-Free Medical Campus Policy is Associated With Decreased Secondhand Smoke Exposure and Increased Satisfaction Among Military Medical Employees: Results of a Mixed-Methods Evaluation.

INTRODUCTION: Tobacco control is an ongoing concern for the U.S. Army. Although tobacco use is currently prohibited within all military hospitals and clinics, known as military treatment facilities (MTFs), no such facility had implemented a tobacco-free medical campus (TFMC) policy before 2012. This evaluation examined the effects of one Army installation's TFMC policy implementation at its medical facilities. MATERIALS AND METHODS: Online questionnaires were distributed to medical campus employees, including Active Duty Soldiers, civilians, and contractors, before policy implementation (N = 1,210) and 12 months following policy implementation (N = 1,147). Chi-square analyses, independent t tests, and logistic regression models were utilized to examine pretest/post-test changes in employees' secondhand smoke (SHS) exposure; tobacco use, motivation to quit, and cessation; and health outcomes. Twenty-three focus groups, interviews, and informal discussions with 65 employees and patients were conducted 13 months after initial policy implementation to capture both the intended and unintended policy effects. RESULTS: After controlling for demographic characteristics, the study found that employees had more than twice the odds of exposure to SHS in the workplace at baseline than at 12-month follow-up (odds ratio: 2.06, 95% confidence interval: 1.73-2.46, p < 0.001). Employees also reported a lower prevalence of diagnosis with chronic bronchitis (p < 0.05) at follow up compared to baseline. Although the mean number of sick days taken for respiratory illness decreased over time, results were not significant after controlling for demographic factors. No significant differences existed in tobacco-use prevalence or quit rates among tobacco users over time. Employees reported significantly higher levels of satisfaction with a TFMC policy than the original policy (p < 0.001) though this finding was moderated by smoker status such that smokers reported lower levels of satisfaction with the policy over time. Qualitative findings revealed that the most common policy effect was that the policy caused smokers to change the location of where they used tobacco to off campus. Findings further revealed several unintended policy effects, including safety concerns and greater visibility of smokers in front of the MTF. CONCLUSION: The first Army MTF TFMC policy was associated with reported reductions in SHS exposure and improvements in some short-term health outcomes. The policy had no observed association with tobacco-use prevalence, motivation to quit, or cessation at 12-month follow-up. Focus group participants discussed several positive and negative policy effects. These policies should be expanded and studied in more depth across military installations, and policy makers should plan mitigation strategies to reduce unintended effects. This is an important step in military tobacco control, but additional efforts will be necessary to curb tobacco use within this population.

Outcomes In Two Massachusetts Hospital Systems Give Reason For Optimism About Communication-And-Resolution Programs.

Through communication-and-resolution programs, hospitals and liability insurers communicate with patients when adverse events occur; investigate and explain what happened; and, where appropriate, apologize and proactively offer compensation. Using data recorded by program staff members and from surveys of involved clinicians, we examined case outcomes of a program used by two academic medical centers and two of their community hospitals in Massachusetts in the period 2013-15. The hospitals demonstrated good adherence to the program protocol. Ninety-one percent of the program events did not meet compensation eligibility criteria, and those events that did were not costly to resolve (the median payment was $75,000). Only 5 percent of events led to malpractice claims or lawsuits. Clinicians were supportive of the program but desired better communication about it from staff members. Our findings suggest that communication-and-resolution programs will not lead to higher liability costs when hospitals adhere to their commitment to offer compensation proactively.

Resolving Malpractice Claims after Tort Reform: Experience in a Self-Insured Texas Public Academic Health System.

OBJECTIVE: To describe the litigation experience in a state with strict tort reform of a large public university health system that has committed to transparency with patients and families in resolving medical errors. DATA SOURCES/STUDY SETTING: Secondary data collected from The University of Texas System, which self-insures approximately 6,000 physicians at six health campuses across the state. We obtained internal case management data for all medical malpractice claims closed during 1 year before and 6 recent years following the enactment of state tort reform legislation. STUDY DESIGN: We retrospectively reviewed information about malpractice claimants, malpractice claims, and the process and outcome of dispute resolution. DATA COLLECTION/EXTRACTION METHODS: We accessed an internal case management database, supplemented by both electronic and paper records compiled by the university's Office of General Counsel. PRINCIPAL FINDINGS: Closed claims dropped from 244 in 2001-2002 to an annual mean of 96 in 2009-2015, closures following lawsuits from 136 in 2001-2002 to an annual mean of 28 in 2009-2015, and paid claims from 60 in 2001 to an annual mean of 20 in 2009-2015. Patterns of resolution suggest efforts by the university to provide some compensation to injured patients in cases that were no longer economically viable for plaintiffs' lawyers to litigate. The percentage of payments relating to cases in which lawsuits had been filed decreased from 82 percent in 2001-2002 to 47 percent in 2009-2012 and again to 29 percent in 2012-2015, although most paid claimants were represented by attorneys. Unrepresented patients received payment in 13 cases closed in 2009-2012 (22 percent of payments; mean amount $60,566) and in 24 cases closed in 2012-2015 (41 percent of payments; mean amount $109,410). Even after tort reform, however, claims that resulted in payment remained slow to resolve, which was worsened for claimants subject to Medicare secondary payer rules. Strict confidentiality became a more common condition of settlement, although restrictions were subsequently relaxed in order to further transparency and improve patient safety. CONCLUSIONS: Malpractice litigation risk diminished substantially for a public university health system in Texas following legal changes that reduced rights to sue and available damages. Health systems operating in a low-tort environment should work with policy makers, plaintiffs' attorneys, and patient groups to assist unrepresented patients, facilitate early mediation, limit nondisclosure obligations following settlement, and expedite the resolution of Medicare liens.

[Reform of occupational insurance medical treatment from the perspective of an accident insurance consultant]. / Neuordnung des BG-lichen Heilverfahrens aus der Sicht eines niedergelassenen D­Arztes.

The reform of occupational insurance medical treatment in 2011 also resulted in many changes for occupational insurance consultants in private practice. The transformation of the physicians participating in treatment status (H-Arzt) to accident insurance consultant status (D-Arzt) has resulted in a significant increase in numbers in outpatient fields, which in some cases leads to increased competition. The tentative flexibilization of the conditions for participation of a D­Arzt is welcomed but must be broadened to safeguard the future. The relaxation of obligatory attendance of a D­Arzt is contemporary and is welcomed. The regularly checked obligation for further education initially led to irritation but has now been extensively coordinated with the mandatory further education for contract physicians. As from 1 January 2016 many smaller alterations and specifications in the implementation regulations have been undertaken. The scale of charges for physicians in invoicing with accident insurance companies as with other scales of charges is urgently in need of reform with respect to the performance rating and in particular to the classification.

[New regulations for inpatient treatment of the statutory accident insurance: From the perspective of a university medical center]. / Neuordnung des stationären Heilverfahrens der Gesetzlichen Unfallversicherung: Aus Sicht einer Universitätsklinik.

BACKGROUND: New regulations of the German statutory accident insurance for inpatient treatment have been introduced. The aims of the new regulations are to improve cost-effectiveness and the quality of medical care. The introduction of the injury type catalogue and the severe injuries type procedure (SAV) has led to a concentration of resources. The purpose of these innovations is an increase in the quality of treatment of patients with complex injuries. CONCLUSION: The introduction of the new regulations resulted in a centralization of medical care in order to optimize the quality of treatment of complex injuries from occupational accidents. Hence, the high demands concerning infrastructure and human resources expected of a level one university medical center are taken into account.

After the "Doc Fix": Implications of Medicare Physician Payment Reform for Academic Medicine.

The Medicare Access and CHIP Reauthorization Act (MACRA) introduces incentives for clinicians serving Medicare patients to move away from traditional "fee-for-service" and into alternative payment models (APMs) such as accountable care organizations and bundled payment arrangements. Thus, MACRA creates strong reasons for various teaching clinical services to participate in APMs, not only for Medicare patients but for other public and private payers as well. Unfortunately, different APMs may be more or less applicable to the diverse teaching physician roles, academic clinical programs, and patient populations served by medical schools and teaching hospitals. Therefore, this time of transition will complicate the work of academic clinical program leaders endeavoring to sustain the tripartite mission of patient care, health professional education, and research. Nonetheless, payment reforms promoted by MACRA can reward efforts to reinvent medical education to better incorporate value into medical decision making, as well as to give clinical learners the tools and insights needed to recognize their personal financial (and other) conflicts and navigate these to meet their patients' needs. This post-MACRA environment may intensify the need for researchers in academic medicine to stay independent of the short-term financial interests of affiliated clinical institutions. Health sciences scholars must be able to study effectively and speak forcefully regarding the actual benefits, risks, and costs of health care services so that educators and clinicians can identify high-value care and deliver it to their patients.

Ethics and Regulatory Challenges and Opportunities in Patient-Centered Comparative Effectiveness Research.

The Affordable Care Act includes provisions for the conduct of large-scale, patient-centered comparative effectiveness research. Such efforts aim toward the laudable moral goal of having evidence to improve health care decision making. Nevertheless, these pragmatic clinical research efforts that typically pose minimal incremental risk and are enmeshed in routine care settings perhaps surprisingly encounter an array of ethics and regulatory challenges and opportunities for academic health centers. An emphasis on patient-centeredness forces an examination of the appropriateness of traditional methods used to protect the rights, interests, and welfare of participants. At the same time, meaningful collaboration with patients throughout the research process also necessitates ensuring that novel approaches to research (including recruitment and consent) entail necessary protections regarding such issues as privacy. As the scientific and logistical aspects of this research are being developed, substantial attention is being focused on the accompanying ethics and regulatory issues that have emerged, which should help to facilitate ethically appropriate research in a variety of contexts.

Applications of Cone-Beam Computed Tomography in Oral and Maxillofacial Surgery: An Overview of Published Indications and Clinical Usage in United States Academic Centers and Oral and Maxillofacial Surgery Practices.

PURPOSE: The American Association of Oral and Maxillofacial Surgeons appointed a task force to study the indications, safety, and clinical practice patterns of cone-beam computed tomography (CBCT) in oral and maxillofacial surgery (OMS). The charge was to review the published applications of CBCT in OMS, identify the current position of academic thought leaders in the field, and research the adoption and usage of the technology at the clinical practitioner level. MATERIALS AND METHODS: This study reviewed the CBCT world literature and summarized published indications for the modality. A nationwide survey of academic thought leaders and practicing oral and maxillofacial surgeons was compiled to determine how the modality is currently being used and adopted by institutions and practices. RESULTS: This report summarizes published applications of CBCT that have been vetted by the academic and practicing OMS community to define current indications. The parameters of patient safety, radiation exposure, accreditation, and legal issues are reviewed. An overview of third-party adoption of CBCT is presented. CONCLUSION: CBCT is displacing 2-dimensional imaging in the published literature, academia, and private practice. Best practices support reading the entire scan volume with a written report defining results, patient exposure, and field of view. Issues of patient safety, ALARA ("as low as reasonably achievable"), accreditation, and the legal and regulatory environment are reviewed. Third-party patterns for reimbursements vary widely and seem to lack consistency. There is much confusion within the provider community about indications, authorizations, and payment policies. The current medical and dental indications for CBCT in the clinical practice of OMS are reviewed and an industry guideline is proposed. These guidelines offer a clear way of differentiating consensus medical indications and common dental uses for clinicians. This matrix should bring a predictable logic to third-party authorizations, billing, and predictable payments for this emerging technology in OMS.