The Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) is one of 33 Food and Drug Administration (FDA) advisory committees that reviews evidence, hears testimonies, and makes suggestions for or against drug approval to the FDA. Advisory committees typically comprise 10-15 fixed or standing members (BRUDAC has 11 members), including a chairperson. 1 Center for Drug Evaluation, Research. BRUDAC Charter. U.S. Food and Drug Administration. Available at:https://www.fda.gov/advisory-committees/bone-reproductive-and-urologic-drugs-advisory-committee-formerly-reproductive-health-drugs-advisory/bone-reproductive-and-urologic-drugs-advisory-committee-brudac-charter. Published July 11, 2018. Accessed September 24, 2019. Google Scholar Voting members include scientific experts, a consumer representative, and an FDA patient representative; nonvoting members include industry representatives 2 Institute of Medicine, Committee to Study the Use of Advisory CommitteesFood and Drug Administration Advisory Committees. National Academies Press, 1992 Google Scholar ,3 Center for Drug Evaluation, Research. Advisory Committees: Critical to the FDA's Product Review Process. U.S. Food and Drug Administration. Available at: https://www.fda.gov/drugs/drug-information-consumers/advisory-committees-critical-fdas-product-review-process. Published March 11, 2018. Accessed September 24, 2019. Google Scholar (Table 1). Twice per year, committee members meet to hear opinions from patients, patient advocacy groups, pharmaceutical companies, and others about the drug under review. 3 Center for Drug Evaluation, Research. Advisory Committees: Critical to the FDA's Product Review Process. U.S. Food and Drug Administration. Available at: https://www.fda.gov/drugs/drug-information-consumers/advisory-committees-critical-fdas-product-review-process. Published March 11, 2018. Accessed September 24, 2019. Google Scholar Through the information provided by the FDA and the opinions of these speakers, advisory committees present a final recommendation to the FDA. Although the FDA is not required to act on these recommendations, previous studies have found that favorable advisory committee recommendations greatly increase the likelihood of FDA approval. 4 Ciociola AA Karlstadt RG Pambianco DJ Woods KL Ehrenpreis ED FDA-Related Matters Committee of the American College of Gastroenterology. The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process. Am J Gastroenterol. 2014; 109: 1508-1512 Crossref PubMed Scopus (12) Google Scholar Verbatim transcripts of these meetings indicate that some speakers present with financial conflicts of interest (FCOI), even from the drug sponsor. Table 1Description of the FDA approval process, members of BRUDAC, and FDA regulations for FCOIs among BRUDAC committee members and public speakers FDA Drug Approval Timeline* Center for Drug Evaluation, Research. FDA's Drug Review Process: Continued. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-continued. Published September 2, 2019. Accessed November 6, 2019. ,† Office of the Commissioner. Learn About FDA Advisory Committees. U.S. Food and Drug Administration. https://www.fda.gov/patients/learn-about-patient-affairs-staff/learn-about-fda-advisory-committees. Published 2019. Accessed November 6, 2019. Step1: Animal testing Step 3: Phase 1 studies (20 to 80 people included) Step 5: Phase 3 study (300 - 3000 people included) Step 7: NDA Submission Step 9: If approved for review, an FDA review team is assigned to evaluated safety and drug efficacyDrug advisory committee meetings can convene at any time from this step to post-FDA approval Step 11: The FDA inspects the facilities where the drug will be manufactured Step 2: Investigational new drug application created to outline proposed human testing Step 4: Phase 2 studies (80-300 people included) Step 6: Pre-New Drug Application (NDA) period - a time for the drug sponsors and the FDA to meet Step 8: The FDA has a 60 day period to determine if drug will be reviewed Step 10: The FDA reviews information that will be included on a drug's professional labeling Step 12: FDA reviewer will approve the application or provide a response letter Voting and Non-Voting Members of the Bone, Reproductive, and Urologic Drug Advisory Committee (BRUDAC)‡ Center for Drug Evaluation, Research. BRUDAC Charter. U.S. Food and Drug Administration. https://www.fda.gov/advisory-committees/bone-reproductive-and-urologic-drugs-advisory-committee-formerly-reproductive-health-drugs-advisory/bone-reproductive-and-urologic-drugs-advisory-committee-brudac-charter. Published July 11, 2018. Accessed November 6, 2019. -BRUDAC consists of 11 voting committee members including the committee chair which are experts in the fields of bone disease, obstetrics, gynecology, urology, pediatrics, epidemiology, statistics, and others. -The FDA commissioner may select 1 qualified member to represent consumer interests as an additional voting member. -BRUDAC may include 1 nonvoting member who represents industry interests. -The FDA commissioner may select other members from different drug advisory committees to act as temporary voting members when specific expertise is needed that is not found on the current committee or to create a quorum in situations where there is no majority vote. -The FDA commissioner may create temporary subcommittees composed of 2 more BRUDAC members to address specific issues in their areas of expertise; subcommittees make recommendations to the full committee. FDA Regulations of Advisory Committee Members with FCOIs§ FDA Advisory Committees: Financial Conflicts of Interest Overview. US FDA Advisory Committees. https://www.fda.gov/media/87421/download. -According to the FDA, a conflict of interest is when a selected advisory committee member has financial relationships that may impact the individual's work on the advisory committee. -Financial interests include certain relationships, such as the committee member's spouse, minor children, business partners, employer, and organizations in which the individual serves as officer, director, or trustee. Other examples include Stocks; Bonds; Interests through ownership, partnership, LLC; Consulting arrangements Grants or contracts; and employment. -Prior to an advisory committee meeting, committee members selected to serve on the advisory committee must complete the FDA Form 3410 to disclose relative conflicts of interest to the meeting topic. -The FDA then follows the procedures outlined in “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees” to determine whether an advisory committee member's participation in an advisory committee meeting is appropriate. -Appropriate participation by committee members is determined by the FDA who examines if there is a nearly direct correlation between any decision and any expected beneficial effect on the financial interest, instead of speculation that the result will affect the financial interest. Any members with nearly direct correlations with a predicted result cannot be on the advisory committee according to 18 U.S.C. 208(b). -According to 18 U.S.C. 208(b)(3), the FDA can grant a committee member a waiver to serve on an FDA Advisory Committee if the FDA certifies in writing that the need for the committee member's services outweighs the potential for a conflict of interest posed by the financial interest involved. -According to 18 U.S.C. 208(b)(2): The committee member can serve on an FDA Advisory Committee if the FDA determines that the committee member's financial interest falls within an applicable regulatory exemption, listed at 5 C.F.R. 2640, for certain financial interests which are too inconsequential to affect the integrity of the services. FDA Guidelines for Speakers at Open Public Hearings of an FDA Advisory Committee Meeting and Financial Associations with Speakers║ Office of the Commissioner. Guidelines for Speakers at the Open Public Hearing. U.S. Food and Drug Administration. https://www.fda.gov/patients/learn-about-patient-affairs-staff/guidelines-speakers-open-public-hearing-fda-advisory-committee-meeting. Published March 11, 2018. Accessed November 6, 2019. -The FDA asks speakers to disclose any financial association during their presentation related to the drug under review, such as a company paying for transportation. Center for Drug Evaluation, Research. FDA's Drug Review Process: Continued. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-continued. Published September 2, 2019. Accessed November 6, 2019. † Office of the Commissioner. Learn About FDA Advisory Committees. U.S. Food and Drug Administration. https://www.fda.gov/patients/learn-about-patient-affairs-staff/learn-about-fda-advisory-committees. Published 2019. Accessed November 6, 2019. ‡ Center for Drug Evaluation, Research. BRUDAC Charter. U.S. Food and Drug Administration. https://www.fda.gov/advisory-committees/bone-reproductive-and-urologic-drugs-advisory-committee-formerly-reproductive-health-drugs-advisory/bone-reproductive-and-urologic-drugs-advisory-committee-brudac-charter. Published July 11, 2018. Accessed November 6, 2019. § FDA Advisory Committees: Financial Conflicts of Interest Overview. US FDA Advisory Committees. https://www.fda.gov/media/87421/download. ║ Office of the Commissioner. Guidelines for Speakers at the Open Public Hearing. U.S. Food and Drug Administration. https://www.fda.gov/patients/learn-about-patient-affairs-staff/guidelines-speakers-open-public-hearing-fda-advisory-committee-meeting. Published March 11, 2018. Accessed November 6, 2019. Open table in a new tab

This study examines the use of clinical trial registries in systematic reviews published in the top otolaryngology journals and evaluates whether additional studies could have been located for systematic reviews that omitted clinical trial registry searches.

Long-term Risk of Thyroid Cancer After Initially Negative Thyroid Biopsy ResultsThyroid nodules are common, occurring in more than 50% of the general population. 1 Historically, thyroid nodules characterized as benign were followed up indefinitely, often with multiple subsequent biopsies based on growth.Current evidence derived from sampled populations suggests that the rate of malignant neoplasms among benign thyroid nodules after longterm follow-up is low. 2 We used data from an entire population to define the risk of being diagnosed with thyroid cancer in long-term follow-up of individuals with benign thyroid biopsy results.Methods | A cross-sectional analysis of population-based data from a comprehensive administrative health database in Ontario, Canada, was performed.All thyroid biopsies in the province performed from January 1, 1991, to December 31, 2010, were identified from the provincial single payer physician-billing plan and linked to the Ontario Cancer Registry until December 31, 2014, to detect all cases of differentiated thyroid cancer with a follow-up of up to 24 years.Thyroid cancers diagnosed previously or within 1 year after first biopsy were excluded from analyses.

STUDY OBJECTIVE:We aim to investigate spin in emergency medicine abstracts, using a sample of randomized controlled trials from high-impact-factor journals with statistically nonsignificant primary endpoints.METHODS:This study investigated spin in abstracts of emergency medicine randomized controlled trials from emergency medicine literature, with studies from 2013 to 2017 from the top 5 emergency medicine journals and general medical journals. Investigators screened records for inclusion and extracted data for spin. We considered evidence of spin if trial authors focused on statistically significant results, interpreted statistically nonsignificant results as equivalent or noninferior, used favorable rhetoric in the interpretation of nonsignificant results, or claimed benefit of an intervention despite statistically nonsignificant results.RESULTS:Of 772 abstracts screened, 114 randomized controlled trials reported statistically nonsignificant primary endpoints. Spin was found in 50 of 114 abstracts (44.3%). Industry-funded trials were more likely to have evidence of spin in the abstract (unadjusted odds ratio 3.4; 95% confidence interval 1.1 to 11.9). In the abstracts' results, evidence of spin was most often due to authors' emphasizing a statistically significant subgroup analysis (n=9). In the abstracts' conclusions, spin was most often due to authors' claiming they accomplished an objective that was not a prespecified endpoint (n=14).CONCLUSION:Spin was prevalent in the selected randomized controlled trial, emergency medicine abstracts. Authors most commonly incorporated spin into their reports by focusing on statistically significant results for secondary outcomes or subgroup analyses when the primary outcome was statistically nonsignificant. Spin was more common in studies that had some component of industry funding.

Background: Spin is a specific type of reporting bias that misrepresents data and results within randomized controlled trials (RCTs). Because spin may provide a surgeon with an inaccurate representation of trial results, thus misconstruing the surgeons' interpretation thereof and possibly negatively affecting patient care, it is important that spin is identified within publications. The primary goal of our study was to determine the prevalence of spin found within the abstracts of lower extremity joint trials. Methods: Using Google Scholar's H-5 index, we selected the top 20 journals in the orthopedic surgery category. We then conducted a PubMed search on July 2nd, 2018 using the advanced search feature, encompassing all RCTs published in these journals from January 1, 2016 to January 1, 2017. Spin was evaluated using a standardized protocol, using a previously published protocol on the Open Science Network. Results: Our final sample consisted of 46 trials published in 9 of the top 20 orthopedic surgery journals. Spin was found in 27 (58.7%) of the 46 abstracts. Evidence of spin in the abstract results was found in 19 (41.3%) of the 46 articles, and spin in abstract conclusions was found in 15 (32.6%) of the 46 articles. Conclusions: Our study found that a significant number of lower extremity joint RCTs contain one or more form of spin in either their abstract results, conclusions, or both. In addition, our investigation revealed that a sizable portion of these lower extremity orthopedic joint RCTs are not registered or do not report their registration, and funding sources are also underreported. (c) 2019 Elsevier Inc. All rights reserved.