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10.1186/s13063-017-1858-y http://scihub22266oqcxt.onion/10.1186/s13063-017-1858-y C5345177!5345177 !28279205     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=28279205 &cmd=llinks): Failed to open stream: HTTP request failed! 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Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial s conduct and progress: a narrative review |pdf=|usr=}}{{28279205 }} gab.com Text Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial s conduct and progress: a narrative review JO: Trials http://www.kidney.de/pget.php?&tw=1&pmid=28279205 #FOAvip BACKGROUND: Sharing interim data, results or result extrapolations is an important issue that can affect trial integrity. The different ways in which Data Safety Monitoring Boards (DSMBs) share interim results with non-DSMB members and the acceptability of such practices are poorly understood. Our objective was to undertake a narrative review specifically on what kind of interim results, if any, should be shared by the DSMB with non-DSMB members and why. METHODS: We conducted a narrative review using a systematic search strategy of several databases and major health research stakeholders. Literature was included if there was some discussion within the full text about sharing interim trial results with non-DSMB members. RESULTS: About 79.6% (129/162) of included citations were based on author's views, 16.7% (27/162) on research guidelines and 3.7% (6/162) on surveys. The largest group of citations, 73/162 (45%), expresses the opinion or argument against sharing interim results with exceptions. Trailing closely, 71/162 (43.8%) of the included citations support the opinion or argument that interim results should not be shared and should remain confidential with the DSMB. Half of the six surveys support sharing in some capacity, while the other three do not. Eleven circumstances were found that potentially warrant interim result sharing by the DSMB; they relate to (1) usual practices by DSMBs, (2) trial completion threatened, (3) patient safety, (4) regulatory approval and (5) other circumstances. Dominant risks for sharing under these conditions are associated with introducing trial bias. DISCUSSION/CONCLUSION: There was no majority view in the literature. However, the largest group of citations included express the idea that interim results should remain confidential with the DSMB but also acknowledge circumstances when they could be shared with non-DSMB members. Limitations of this review are that (1) the included literature predominately provides personal perspectives, not evidence, and (2) surveys found globally focus on trial monitoring practices lacking detailed information on what specifically to share, with whom and why. More research is needed with the use of a detailed survey of the clinical trial community focused on DSMB sharing interim results, to better understand and guide DSMB interim result sharing practices. Twit Text FOAVip Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial s conduct and progress: a narrative review ????Trials http://www.kidney.de/pget.php?&tw=1&pmid=28279205 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=28279205 #FOAvip English Wikipedia <ref>{{Cite pmid|28279205 }}</ref> Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial s conduct and progress: a narrative review #MMPMID28279205 Borg Debono V ; Mbuagbaw L ; Thabane L Trials 2017[Mar]; 18 (1 ): 120 PMID28279205 show ga BACKGROUND: Sharing interim data, results or result extrapolations is an important issue that can affect trial integrity. The different ways in which Data Safety Monitoring Boards (DSMBs) share interim results with non-DSMB members and the acceptability of such practices are poorly understood. Our objective was to undertake a narrative review specifically on what kind of interim results, if any, should be shared by the DSMB with non-DSMB members and why. METHODS: We conducted a narrative review using a systematic search strategy of several databases and major health research stakeholders. Literature was included if there was some discussion within the full text about sharing interim trial results with non-DSMB members. RESULTS: About 79.6% (129/162) of included citations were based on author's views, 16.7% (27/162) on research guidelines and 3.7% (6/162) on surveys. The largest group of citations, 73/162 (45%), expresses the opinion or argument against sharing interim results with exceptions. Trailing closely, 71/162 (43.8%) of the included citations support the opinion or argument that interim results should not be shared and should remain confidential with the DSMB. Half of the six surveys support sharing in some capacity, while the other three do not. Eleven circumstances were found that potentially warrant interim result sharing by the DSMB; they relate to (1) usual practices by DSMBs, (2) trial completion threatened, (3) patient safety, (4) regulatory approval and (5) other circumstances. Dominant risks for sharing under these conditions are associated with introducing trial bias. DISCUSSION/CONCLUSION: There was no majority view in the literature. However, the largest group of citations included express the idea that interim results should remain confidential with the DSMB but also acknowledge circumstances when they could be shared with non-DSMB members. Limitations of this review are that (1) the included literature predominately provides personal perspectives, not evidence, and (2) surveys found globally focus on trial monitoring practices lacking detailed information on what specifically to share, with whom and why. More research is needed with the use of a detailed survey of the clinical trial community focused on DSMB sharing interim results, to better understand and guide DSMB interim result sharing practices. |*Information Dissemination [MESH] |*Research Design [MESH] |Access to Information [MESH] |Attitude of Health Personnel [MESH] |Clinical Trials Data Monitoring Committees [MESH] |Clinical Trials as Topic/*methods [MESH] |Humans [MESH] |Patient Safety [MESH] |Research Personnel/psychology [MESH] |Risk Factors [MESH] |Stakeholder Participation/psychology [MESH] |Time Factors [MESH]Sharing interim trial results by the Data Safety Monitoring Board with(epmc).pdf DeepDyve Pubget Overpricing