{"content":[{"text":"March 23, 2015","bbox":{"left":0.115333,"top":0.088737,"width":0.13627499999999998,"height":0.020818000000000003}},{"text":"National Institutes of Health/Department of Health and Human Services \n 42 CFR Part 11 \n [Docket Number NIH-2011-0003] \n RIN: 0925-AA52 \n Notice of Proposed Rulemaking","bbox":{"left":0.115333,"top":0.12404,"width":0.618491,"height":0.091576}},{"text":"Dear Director Collins:","bbox":{"left":0.115333,"top":0.230101,"width":0.18631399999999998,"height":0.020818000000000003}},{"text":"On behalf of the Association of Clinical Research Organizations (ACRO,) thank you for \n the opportunity to comment on the Notice of Proposed Rulemaking regarding Clinical \n Trials Registration and Results Submission.","bbox":{"left":0.115333,"top":0.265556,"width":0.751095,"height":0.056159000000000014}},{"text":"As the world's leading, global clinical research organizations (CROs,) ACRO member \n companies provide a wide range of specialized services across the entire spectrum of \n development for new drugs, biologics and medical devices, from discovery, pre-clinical, \n proof of concept and first-in-man studies through post-approval and pharmacovigilance \n research. With more than 110,000 employees engaged in research activities around the \n world, each year ACRO member companies conduct more than 9,000 clinical trials \n involving nearly two million research participants.","bbox":{"left":0.115333,"top":0.336199,"width":0.760562,"height":0.12687899999999996}},{"text":"Improving the utility of ClinicalTrials.gov to raise awareness of available clinical trials \n among patients and physicians with the goal of accelerating patient recruitment is one of \n ACRO’s top policy priorities. We have been working closely with Congress on the 21st \n Century Cures initiative and commend the National Institutes of Health for this timely \n NPRM to address one of the major stumbling blocks to more efficient clinical trials.","bbox":{"left":0.115333,"top":0.47774,"width":0.764647,"height":0.091424}},{"text":"As new technologies and applications are developed to facilitate clinical trials, such as \n the recently introduced Apple ResearchKit, it is imperative that ClinicalTrials.gov be \n brought up to current standards of technology and usability. Without a standardized, \n compatible database, the power of these emerging technologies will never be fully \n realized and clinical trial recruitment will continue to be one of the major impediments to \n the faster development and delivery of new treatments and cures to patients.","bbox":{"left":0.115333,"top":0.5838,"width":0.758474,"height":0.10919000000000001}},{"text":"We see four fundamental shortcomings of the current website: 1) there is insufficient \n information entered to be truly useful for matching patients with appropriate trials; 2) the \n information is not provided in standard terminology format; 3) the site is very difficult to \n navigate and not consistent with current standards for usability and searchability; 4) the \n website currently is not designed for connectivity to electronic health records, which will \n ultimately drive usage.","bbox":{"left":0.115333,"top":0.707475,"width":0.7586109999999999,"height":0.10930300000000004}},{"text":"The NPRM addresses these shortcomings and ACRO has specific recommendations in \n each area, in addition to other subjects where comment is requested. While it is not the \n purpose of the NPRM to discuss necessary funding for proposed changes to \n clinicaltrials.gov, ACRO would be supportive of efforts to ensure the National Library of","bbox":{"left":0.115333,"top":0.831263,"width":0.758664,"height":0.07387300000000008}},{"text":"1","bbox":{"left":0.494788,"top":0.922027,"width":0.008175999999999961,"height":0.015614000000000017}}],"images_bbox":[],"images_bbox_not_text_overlap":[]}