ReadMe File File Name: Zarin_Tse_Ross_2015_NEJM_Figure_1.csv Description: Percentages of trials registered on ClinicalTrials.gov and initiated in 2014 by 80 high-volume Lead Sponsors estimated to be subject to two proposed Federal results reporting policies: (1) Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 801, Notice of Proposed Rulemaking (NPRM) [79 FR 69565, Nov. 21, 2014] (https://federalregister.gov/a/2014-26197) and (2) the National Institute of Health (NIH) Draft Policy on Registration and Results Submission of NIH-Funded Clinical Trials Issued for Public Comment (Draft NIH Policy) [NIH Guide Notice NOT-OD-15-019, Nov. 19, 2014] (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-019.html). High-volume registrants is defined as academic medical centers or other non-profit organizations with 10 or more registered trials in the sample. Definitions of Column Headings: A (#): Rank order ascending by Column C (“% FDAAA/NPRM and/or DRAFT NIH Policy”) B (Lead Sponsor): Name of organization that oversees implementation of study and is responsible for data analysis. (http://prsinfo.clinicaltrials.gov/definitions.html#LeadSponsor). C (% FDAAA / NPRM and/or Draft NIH Policy): Percentage of registered trials estimated to be subject to at least one (either or both) of the Federal results reporting policies. D (% FDAAA/ NPRM Only): Percentage of registered trials estimated to be subject to FDAAA/ NPRM only. E (% Draft NIH Policy Only): Percentage of registered trials estimated to be subject to the DRAFT NIH Policy only. F (% FDAAA/ NPRM & Draft NIH Policy): Percentage of registered trials estimated to be subject to both of the Federal results reporting policies. G (Total Trials Registered): Denominator for the preceding percentages. Data Processing Steps: The following algorithms were used to estimate trials subject to FDAAA/NPRM and Draft NIH Policy using ClinicalTrials.gov protocol data elements as defined at http://prsinfo.clinicaltrials.gov/definitions.html. FDAAA/NPRM Algorithm: Records listing an “Interventional” Study Type (http://prsinfo.clinicaltrials.gov/definitions.html#StudyType), Not “0” or “1” for Study Phase (http://prsinfo.clinicaltrials.gov/definitions.html#StudyPhase), at least one Intervention Type (http://prsinfo.clinicaltrials.gov/definitions.html#InterventionType) as “Drug,” “Biologic” (or “Genetic”), or “Device” (or “Radiation”), at least one Facility Country (http://prsinfo.clinicaltrials.gov/definitions.html#FacilityCountry) as “United States” or Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) Status (http://prsinfo.clinicaltrials.gov/definitions.html#INDApp) as “Yes” [not available publicly], and a Primary Completion Date 9 http://prsinfo.clinicaltrials.gov/definitions.html#PrimaryCompletionDate) (if missing, Study Completion Date (http://prsinfo.clinicaltrials.gov/definitions.html#LastFollowUpDate)) as “January 2008” or later. Draft NIH Policy Algorithm: Records listing an “Interventional” Study Type (http://prsinfo.clinicaltrials.gov/definitions.html#StudyType) and at least one NIH Institute or Center for Collaborators (http://prsinfo.clinicaltrials.gov/definitions.html#Collaborators). Point of Contact: Deborah A. Zarin, M.D., National Library of Medicine, Bethesda, MD (dzarin@mail.nih.gov)