“…Five trial aspects key for the DMC in performing its role were: a large committee of members, including some with extensive DMC experience and others who had broad clinical expertise; clear strategic planning, communication, and responsiveness by the trial principal investigators; data collection and analysis systems able to cope with phases of very rapid recruitment and link to electronic health records; an ability to work constructively with regulators (and other DMCs) to address emerging concerns without the need to release unblinded mortality results; and the use of videoconferencing systems that enabled national and international members to meet at short notice and from home during the pandemic when physical meetings were impossible. …”
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“…We present the results of a survey conducted among the principal investigators (PIs) of the National Institute for Health and Care Research (NIHR) randomized controlled trial on posterior laminectomy with fixation for degenerative cervical myelopathy (POLYFIX-DCM). …”
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“…Patient race/ethnicity information was self-reported in case report forms. As principal investigators (PIs) did not report their own race/ethnicity, a deep-learning algorithm (ethnicolr) was used to predict PI race/ethnicity. …”
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“…Protocol version: 1.2 (Dated: 01 June 2014) Anticipated completion: September 2015 Role of Trial Sponsor: The named sponsor for this investigator-initiated trial was the Director of the Royal Brisbane and Women’s Hospital (RBWH) Safety and Quality Unit (Therese Lee, Phone: +61 7 3646 8111). The principal investigators, SC and MA, are employed by the RBWH Safety and Quality Unit. …”
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“…The knowledge potential generated through this system would aid various principal investigators in well established (but ill funded) research labs by giving them access to bioinformaticians and biologists around the world who are eager be recognized for their contributions. …”
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“…Across every competition, applications with female principal investigators were more likely to integrate sex (odds ratio [OR] 1.60, 95% confidence interval [CI] 1.50–1.63) and gender (OR 2.40, 95% CI 2.29–2.51) than those who identified as male. …”
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“…This initiative will support 8 efficacy trials and 2 exploratory projects, each led by 2 principal investigators. Taken together, the studies address all of the key steps of the HIV prevention and care continuum for youth in the United States. …”
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“…CONCLUSIONS: Although the proportion of female authors is significantly lower than the proportion of male authors in all six categories of authorship analysed, the proportions of male and female last authors are comparable to their respective proportions as principal investigators in the BRC. These findings suggest positive trends and the NIHR Oxford BRC doing very well in gender parity in the senior (last) authorship category. …”
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“…FUNDING: The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The principal investigators (MSA and GAM) had full access to all the data in the study and had final responsibility for the decision to submit for publication.…”
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“…METHODS/STUDY POPULATION: The Johns Hopkins University implemented a Clinicaltrials.gov program solely mandated to assist Principal Investigators (PIs) and other study team members with clinical trial registration and results reporting. …”
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“…Building on previous work, we have identified 13 types of stakeholders whose input can enhance the relevance and uptake of guidelines: Patients, caregivers and patient advocates; Public; Providers of health care; Payers of health services; Payers of research; Policy makers; Program managers; Product makers; Purchasers; Principal investigators and their research teams; and Peer‐review editors/publishers. …”
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“…BLINDING (MASKING): Due to logistical reasons, only principal investigators and the data analyst will be blinded to group assignment. …”
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“…We recruited new community-based research sites and principal investigators (PIs) to mirror historically underrepresented populations and emphasized mentorship of junior sub-Is by seasoned PIs to support enrollment and retention. …”
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“…BLINDING (MASKING): The principal investigators, the statistician and study collaborators will remain blinded from the identity of randomised practices until the end of the study. …”
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“…The scientific programme was further enriched by two scientific special sessions, held by Professor Pier Paolo di Fiore and Dr Giuseppe Testa, Principal Investigators at the IFOM-IEO-Campus and by a bioethical round table on human embryonic stem cell research moderated by Silvia Camporesi, a senior PhD student in the SEMM PhD Programme ‘Foundation of Life Science and their Bioethical Consequences’. …”
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“…A team must have included, at a minimum, one Penn State faculty researcher and one community-based organizational leader as co-principal investigators. In the proposal, the team was asked to describe its preliminary research question, the work to be accomplished during the planning period, anticipated outcome(s) and deliverables, and preliminary ideas for seeking future external funding. …”
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