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10.1136/bmjopen-2020-047341 http://scihub22266oqcxt.onion/10.1136/bmjopen-2020-047341 34158302!8228572!34158302     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=34158302&cmd=llinks): Failed to open stream: HTTP request failed! 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Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials |pdf=|usr=}}{{34158302}} gab.com Text Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials JO: BMJ Open http://www.kidney.de/pget.php?&tw=1&pmid=34158302 #FOAvip OBJECTIVES: In an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of 'virtual' clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic. DESIGN: We applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials. SETTING: All trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021. OUTCOME MEASURES: The primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019-February 2020) compared with the 10 months following (May 2020-February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants). RESULTS: CDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19. CONCLUSIONS: These findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants' COVID-19 diagnosis. Twit Text FOAVip Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials ????BMJ Open http://www.kidney.de/pget.php?&tw=1&pmid=34158302 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=34158302 #FOAvip English Wikipedia <ref>{{Cite pmid|34158302}}</ref> Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials #MMPMID34158302 Marra C; Gordon WJ; Stern AD BMJ Open 2021[Jun]; 11 (6): e047341 PMID34158302show ga OBJECTIVES: In an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of 'virtual' clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic. DESIGN: We applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials. SETTING: All trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021. OUTCOME MEASURES: The primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019-February 2020) compared with the 10 months following (May 2020-February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants). RESULTS: CDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19. CONCLUSIONS: These findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants' COVID-19 diagnosis. |*COVID-19/epidemiology[MESH] |*Telemedicine[MESH] |Biomedical Research/*instrumentation[MESH] |COVID-19 Testing[MESH] |Clinical Trials as Topic[MESH] |Humans[MESH] |Observational Studies as Topic[MESH] |Pandemics[MESH] |SARS-CoV-2[MESH]Use of connected digital products in clinical research following the C(epmc).pdf DeepDyve Pubget Overpricing