Objective To investigate clinical trialists' opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team. Main outcome measures Support for and prevalence of data sharing through data repositories and in response to individual requests, concerns with data sharing through repositories, and reasons for granting or denying requests. Design and settingResults Of 683 potential respondents, 317 completed the survey (response rate 46%). In principle, 236 (74%) thought that sharing de-identified data through data repositories should be required, and 229 (72%) thought that investigators should be required to share de-identified data in response to individual requests. In practice, only 56 (18%) indicated that they were required by the trial funder to deposit the trial data in a repository; of these 32 (57%) had done so. In all, 149 respondents (47%) had received an individual request to share their clinical trial data; of these, 115 (77%) had granted and 56 (38%) had denied at least one request. Respondents' most common concerns about data sharing were related to appropriate data use, investigator or funder interests, and protection of research subjects. ConclusionsWe found strong support for sharing clinical trial data among corresponding authors of recently published trials in high impact general medical journals who responded to our survey, including a willingness to share data, although several practical concerns were identified.

Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle.OBJECTIVE To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. DESIGN AND SETTINGAll clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. MAIN OUTCOMES AND MEASURESStudies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. RESULTSIn 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer/investigator-initiated postmarket studies, respectively. Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]; ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR, 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively.CONCLUSIONS AND RELEVANCE Among high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval.

Background Industry payments made to physicians by drug and device manufacturers or group purchasing organizations are now reported to the Centers for Medicare and Medicaid Services (CMS) as a part of the Physician Payments Sunshine Act. Initial reports from the program show that orthopaedic surgeons lead all physician specialties in total and average industry payments. However, before further discussion of these payments and their implications can take place, it remains to be seen whether these figures are a true reflection of the field of orthopaedic surgery in general, rather than the result of a few outlier physicians in the field. In addition, the nature and sources of these funds should be determined to better inform the national dialogue surrounding these payments.

Thyroid cancer is among the most common malignancies in the US, with a 3.6% annual increase in incidence over the past 50 years. 1 Treatment regimens for thyroid cancer are wellestablished, with excellent survival outcomes. However, costs of thyroid cancer care can vary substantially by hospital and impose significant financial burdens on patients 2 ; among patients with cancer, bankruptcy rates are highest for those with thyroid cancer. 3 The Centers for Medicare & Medicaid Services (CMS) recently implemented price transparency reforms to promote informed hospital selection by patients and cost-based competition among hospitals. Effective January 1, 2021, hospitals must disclose commercial payer-specific negotiated prices for all items and services. 4 We characterized price availability and variation for thyroid cancer care at National Cancer Institute (NCI)-Designated Cancer Centers.Methods | We performed a cross-sectional analysis of commercial payer-negotiated prices of services for thyroid cancer at NCI-Designated Cancer Centers. We restricted analysis to cancer centers providing adult clinical care and participating in the Medicare Inpatient Prospective Payment System. We reviewed each center's website to extract (as available) prices for 14 services that are integral to thyroid cancer management, including laboratory tests, radiology studies, medical and surgical treatments, and inpatient care (Supplement).To compare prices between centers, we first normalized the median price for each service at each center to the estimated center-specific 2021 Medicare payment amount, which accounts for factors affecting the cost of care delivery (Supplement). 2 We then determined the ratio between the maximum and minimum normalized median prices for each

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Background The FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review tracks, usually without additional supporting clinical data. While orthopaedic devices cleared via the less rigorous 510(k) pathway have been studied previously, devices cleared through the PMA pathway and those receiving postmarket PMA supplements warrant further investigation. Questions/purposes We asked: What are (1) the types of original orthopaedic devices receiving FDA PMA approval, (2) the number and rate of postmarket device changes approved per device, (3) the types of PMA supplement review tracks used, (4) the types of device changes approved via the various review tracks, and (5) the number of device recalls and market withdrawals that have occurred for these devices? Methods All original PMA-approved orthopaedic devices between January 1982 and December 2014 were identified in the publically available FDA PMA database. The number of postmarket device changes approved, the PMA supplement review track used, the types of postmarket changes, and any FDA recalls for each device were assessed. Results Seventy original orthopaedic devices were approved via the FDA PMA pathway between 1982 and

IMPORTANCEWomen comprise an increasing proportion of the otolaryngology workforce. Prior studies have demonstrated gender-based disparity in physician practice and income in other clinical specialties; however, research has not comprehensively examined whether gender-based income disparities exist within the field of otolaryngology.OBJECTIVE To determine whether diversity of practice, clinical productivity, and Medicare payment differ between male and female otolaryngologists and whether any identified variation is associated with practice setting. DESIGN, SETTING, AND PARTICIPANTS Retrospective cross-sectional analysis of publicly available Medicare data summarizing payments to otolaryngologists from January 1 through December 31, 2017. Male and female otolaryngologists participating in Medicare in facility-based (FB; hospital-based) and non-facility-based settings (NFB; eg, physician office) for outpatient otolaryngologic care were included. MAIN OUTCOMES AND MEASURES Number of unique billing codes (diversity of practice) per physician, number of services provided per physician (physician productivity), and Medicare payment per physician. Outcomes were stratified by practice setting (FB vs NFB). RESULTS A total of 8456 otolaryngologists (1289 [15.2%] women; 7167 [84.8%] men) received Medicare payments in 2017. Per physician, women billed fewer unique codes (mean difference, −2.10; 95% CI, −2.46 to −1.75; P < .001), provided fewer services (mean difference, −640; 95% CI, −784 to −496; P < .001), and received less Medicare payment than men

BackgroundA number of research funders, biomedical journals, pharmaceutical companies, and regulatory agencies have adopted policies advocating or mandating that clinical trialists share data with external investigators. We therefore sought to determine whether certain characteristics of trialists or their trials are associated with more unfavorable perceptions of data sharing. To date, no prior research has addressed this issue.MethodsWe conducted an exploratory analysis of responses to a cross-sectional, web-based survey. The survey sample consisted of trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factors in 2011. The following key characteristics were examined: trialists’ academic productivity and geographic location, trial funding source and size, and the journal in which it was published. Main outcome measures included: support for data sharing in principle, concerns with data sharing through repositories, and reasons for granting or denying requests. Chi-squared tests and Fisher’s exact tests were used to assess statistical significance.ResultsOf 683 potential respondents, 317 completed the survey (response rate 46%). Both support for data sharing and reporting of specific concerns with sharing data through repositories exceeded 75%, but neither differed by trialist or trial characteristics. However, there were some significant differences in explicit reasons to share or withhold data. Respondents located in Western Europe more frequently indicated they have or would share data in order to receive academic benefits or recognition when compared with respondents located in the United States or Canada (58 versus 31%). In addition, respondents who were the most academically productive less frequently indicated they have or would withhold data in order to protect research subjects when compared with less academically productive respondents (24 versus 40%), as did respondents who received industry funding when compared with those who had not (24 versus 43%).ConclusionsRespondents indicated strong support for data sharing overall. There were few notable differences in how trialists viewed the benefits and risks of data sharing when categorized by trialists’ academic productivity and geographic location, trial funding source and size, and the journal in which it was published.Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-384) contains supplementary material, which is available to authorized users.