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News Article | April 26, 2017
Site: www.eurekalert.org

Shortening consent documents makes no significant difference to how well potential research participants understand a clinical study, according to a study published April 26, 2017, in the open-access journal PLOS ONE by Christine Grady from the NIH Clinical Center, US, and colleagues. Informed consent is a central tenet of ethical clinical research, but over time the documents used to obtain informed consent from participants have grown longer, more complex, and harder to read. Grady and colleagues developed a "concise" alternative to consent documents used in the multinational START trial, which was shorter by almost 70 percent at 1,821 words. The new document also contained bullet points and tables, and had a simpler reading level. The authors tested these documents with 4,229 HIV-positive participants at 77 sites across the world seeking enrollment in the START trial between 2009 and 2013. The sites were randomly allocated to either the concise or the standard consent documents for participants to review. Participants who reviewed the concise version showed no significant difference in their comprehension, satisfaction, or willingness to volunteer compared to participants who reviewed the standard form. However, comprehension was better when sites mailed the consent forms in advance and when site leaders explained the study to participants in person. One potential advantage of shorter, more concise consent forms, is that they could be reviewed more quick by an ethics committee. This could allow site leaders more time to discuss the important points of the study with their patients before enrollment in the trial, but this theory needs testing. Whilst the study only examined one type of concise document in the context of a single clinical trial, the authors state that it is the largest test to date of modified clinical research consent forms among patients in a real clinical trial setting. They note that their results support continued efforts to make consent forms more efficient. In your coverage please use this URL to provide access to the freely available article in PLOS ONE: http://journals. Citation: Grady C, Touloumi G, Walker AS, Smolskis M, Sharma S, Babiker AG, et al. (2017) A randomized trial comparing concise and standard consent forms in the START trial. PLoS ONE 12(4): e0172607. doi:10.1371/journal.pone.0172607 Funding: This study was funded through National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID) Grants UM1-AI068641 and UM1-AI120197, as well as the NIH intramural program through the Clinical Center. The funder of this substudy, the US National Institutes of Health (NIH), provided support in the form of salaries for some authors [CG, MS], and grant support for some authors [AB, SS, ASW] but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of all authors are articulated in the 'author contributions' section. Genentech Research and Early Development had no role in this study. Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: CG, FH, JT, ED, NP, AP, AS, GT, MS declare no competing interests. AB, SS, SW report receipt of grants. EE reports stock ownership, paid consultancies, Board memberships, and speaking honoraria. There are no commercial or other interests that alter our adherence to PLOS One policies on sharing data and materials.


News Article | April 21, 2017
Site: www.prnewswire.com

The Global Translational Regenerative Medicine market is expected to grow significantly over the forecast period. The Global Translational Regenerative Medicine market was valued at $5.8bn in 2016. Visiongain forecasts this market to increase to $14.5bn in 2021. The market is estimated to grow at a CAGR of 19.9% in the first half of the forecast period and 17.7% from 2016 to 2027. How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new report you find 316-page report you will receive 107 tables and 66 figures - all unavailable elsewhere. The 316-page report provides clear detailed insight into the Global Translational Regenerative Medicine market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Forecasts from 2017-2027 of the leading products in the Global Translational Regenerative Medicine market: - Osteocel Plus - Trinity ELITE - TEMCELL /Prochymal - Apligraf - Dermagraft - Epifix - ReCell - Neovasculgen - Glybera (alipogene tiparvovec) - IMLYGIC (talimogene laherparepvec) • SWOT and Porter's Five Force analysis of the translational regenerative medicine market Visiongain's study is intended for anyone requiring commercial analyses for the Translational Regenerative Medicine Market and leading companies. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 List of Organisations Mentioned in the Report Arthritis Research UK Associazione Infermieristica per lo Studio delle Lesioni Cutanee (AISLeC) [China] Australian Regenerative Medicine Institute Australian Sports Anti-Doping Authority (ASADA) Biomedical Advanced Research and Development Authority (BARDA) British Heart Foundation [UK] California Institute of Regenerative Medicine (CIRM) Cambridge Stem Cell Biology Institute [UK] Case Western Reserve University Catalan Institution for Research and Advanced Studies Center for Biologics Evaluation and Research (CBER) [US] CHA General Hospital [Korea] Cryocenter Saint Petersburg Drugs Controller General of India (DCGI) European Group for Blood and Marrow Transplantation (EBMT) European Medicines Agency Food and Drugs Agency (FDA) [US] Haute Autorité de santé [France] Heriot-Watt University Human Fertilisation and Embryology Authority (HFEA) Institute of Biomedical Research and Innovation Hospital [Japan] International Society for Stem Cell Research (ISSCR) Karolinska Institute [Sweden] Massachusetts General Hospital (MGH) Mayo Clinic [US] Medical Research Council [UK] MiMedx Ministry of Food and Drug Safety, MFDS) [Korea] Ministry of Health, Labour and Welfare (MHLW) [Japan] Ministry of Science and Technology [China] Moorfields Eye Hospital National Tissue Engineering Center (NTEC) [China] New York Blood Center Riken Center for Developmental Biology RUSH University Medical Center [US] Russian Ministry of Healthcare and Social Development Scottish Centre for Regenerative Medicine St. Jude's Children Research Hospital State Food and Drug Administration (SFDA) [China] SUNY Upstate Medical University The Genetico Center [Russia] The StemGen Organisation Therapeutics Goods Administration (TGA) [Australia] UH San Diego Sanford Stem Cell Clinical Center UK Medicines and Healthcare Products Regulatory Agency (MHRA) Universitat Autònoma de Barcelona [Spain] University College London University of Edinburgh MRC Centre for Regenerative Medicine [UK] University of Massachusetts (UMass) Memorial Hospital University of Modena Centre for Regenerative Medicine [Italy] University of Wisconsin US National Institute of Health Wake Forest Institute Wellcome Trust World Health Organization To see a report overview please email Sara Peerun on sara.peerun@visiongain.com


News Article | April 21, 2017
Site: www.prnewswire.co.uk

The Global Translational Regenerative Medicine market is expected to grow significantly over the forecast period. The Global Translational Regenerative Medicine market was valued at $5.8bn in 2016. Visiongain forecasts this market to increase to $14.5bn in 2021. The market is estimated to grow at a CAGR of 19.9% in the first half of the forecast period and 17.7% from 2016 to 2027. How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new report you find 316-page report you will receive 107 tables and 66 figures - all unavailable elsewhere. The 316-page report provides clear detailed insight into the Global Translational Regenerative Medicine market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Forecasts from 2017-2027 of the leading products in the Global Translational Regenerative Medicine market: - Osteocel Plus - Trinity ELITE - TEMCELL /Prochymal - Apligraf - Dermagraft - Epifix - ReCell - Neovasculgen - Glybera (alipogene tiparvovec) - IMLYGIC (talimogene laherparepvec) • SWOT and Porter's Five Force analysis of the translational regenerative medicine market Visiongain's study is intended for anyone requiring commercial analyses for the Translational Regenerative Medicine Market and leading companies. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 List of Organisations Mentioned in the Report Arthritis Research UK Associazione Infermieristica per lo Studio delle Lesioni Cutanee (AISLeC) [China] Australian Regenerative Medicine Institute Australian Sports Anti-Doping Authority (ASADA) Biomedical Advanced Research and Development Authority (BARDA) British Heart Foundation [UK] California Institute of Regenerative Medicine (CIRM) Cambridge Stem Cell Biology Institute [UK] Case Western Reserve University Catalan Institution for Research and Advanced Studies Center for Biologics Evaluation and Research (CBER) [US] CHA General Hospital [Korea] Cryocenter Saint Petersburg Drugs Controller General of India (DCGI) European Group for Blood and Marrow Transplantation (EBMT) European Medicines Agency Food and Drugs Agency (FDA) [US] Haute Autorité de santé [France] Heriot-Watt University Human Fertilisation and Embryology Authority (HFEA) Institute of Biomedical Research and Innovation Hospital [Japan] International Society for Stem Cell Research (ISSCR) Karolinska Institute [Sweden] Massachusetts General Hospital (MGH) Mayo Clinic [US] Medical Research Council [UK] MiMedx Ministry of Food and Drug Safety, MFDS) [Korea] Ministry of Health, Labour and Welfare (MHLW) [Japan] Ministry of Science and Technology [China] Moorfields Eye Hospital National Tissue Engineering Center (NTEC) [China] New York Blood Center Riken Center for Developmental Biology RUSH University Medical Center [US] Russian Ministry of Healthcare and Social Development Scottish Centre for Regenerative Medicine St. Jude's Children Research Hospital State Food and Drug Administration (SFDA) [China] SUNY Upstate Medical University The Genetico Center [Russia] The StemGen Organisation Therapeutics Goods Administration (TGA) [Australia] UH San Diego Sanford Stem Cell Clinical Center UK Medicines and Healthcare Products Regulatory Agency (MHRA) Universitat Autònoma de Barcelona [Spain] University College London University of Edinburgh MRC Centre for Regenerative Medicine [UK] University of Massachusetts (UMass) Memorial Hospital University of Modena Centre for Regenerative Medicine [Italy] University of Wisconsin US National Institute of Health Wake Forest Institute Wellcome Trust World Health Organization To see a report overview please email Sara Peerun on sara.peerun@visiongain.com

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