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Clinical trial registration and reporting: a survey of academic organizations in the United States
Unrestricted Use
CC BY
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Many clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, “The Final Rule” (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations. Methods We conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a “University/Organization” in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis. Results Eligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02–0.25). Because of non-response and social desirability, this could be a “best case” scenario. Conclusions Before the compliance date for The Final Rule, some academic organizations had policies and resources that facilitate clinical trial registration and reporting. Most organizations appear to be unprepared to meet the new requirements. Organizations could enact the following: adopt policies that require trial registration and reporting, allocate resources (e.g., staff, software) to support registration and reporting, and ensure there are consequences for investigators who do not follow standards for clinical research.

Subject:
Applied Science
Health, Medicine and Nursing
Material Type:
Reading
Provider:
BMC Medicine
Author:
Anthony Keyes
Audrey Omar
Carrie Dykes
Daniel E. Ford
Diane Lehman Wilson
Evan Mayo-Wilson
G. Caleb Alexander
Hila Bernstein
James Heyward
Jesse Reynolds
Keren Dunn
Leah Silbert
M. E. Blair Holbein
Nidhi Atri
Niem-Tzu (Rebecca) Chen
Sarah White
Yolanda P. Davis
Date Added:
08/07/2020
Modern Philosophy
Unrestricted Use
CC BY
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0.0 stars

This is a textbook (or better, a workbook) in modern philosophy. It combines readings from primary sources with two pedagogical tools. Paragraphs in italics introduce figures and texts. Numbered study questions (also in italics) ask students to reconstruct an argument or position from the text, or draw connections among the readings. And I have added an introductory chapter (Chapter 0 – Minilogic and Glossary), designed to present the basic tools of philosophy and sketch some principles and positions. The immediate goal is to encourage students to grapple with the ideas rather than passing their eyes over the texts. This makes for a better classroom experience and permits higher-level discussions. Another goal is to encourage collaboration among instructors, as they revise and post their own versions of the book.

Subject:
Arts and Humanities
Philosophy
Material Type:
Textbook
Provider:
BCcampus
Provider Set:
BCcampus Faculty Reviewed Open Textbooks
Author:
Alexander Dunn
Walter Ott
Date Added:
02/06/2015