TY - JOUR
T1 - Standards for design and measurement would make clinical research reproducible and usable
AU - Dickersin, Kay
AU - Mayo-Wilson, Evan
N1 - Funding Information:
59. National Institutes of Health (NIH) (2017) NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials, NOT-OD-17-064. Available at https://grants.nih. gov/grants/guide/notice-files/NOT-OD-17-064.html. Accessed October 27, 2017.
Publisher Copyright:
© 2018 National Academy of Sciences. All Rights Reserved.
PY - 2018/3/13
Y1 - 2018/3/13
N2 - We find standards useful in everyday life and in science, although we do not always follow them. Adopting new standards can be expensive, so there May be a strong incentive to maintain the status quo rather than adopt new standards. The scientific community has many standards encompassing both doing clinical research and reporting it, including standards for design and measurement. Although existing research standards have improved both research and its reporting, we need to unify existing standards and to fill the gaps between steps throughout the research process. Existing gaps include implementation of standards and links between standards for study registration (to know about all studies undertaken), study protocols (to identify the preplanned study design and methods), data collection (to assess outcomes that are important and comparable across studies), dissemination of findings (to know the results of previous studies), data sharing (to make best use of existing data), and evidence synthesis (to draw appropriate conclusions from the body of evidence). The scientific community must work together to harmonize existing standards, to ensure that standards are kept up to date, to check that standards are followed, and to develop standards where they are still needed. A unified system of standards will make our work more reproducible.
AB - We find standards useful in everyday life and in science, although we do not always follow them. Adopting new standards can be expensive, so there May be a strong incentive to maintain the status quo rather than adopt new standards. The scientific community has many standards encompassing both doing clinical research and reporting it, including standards for design and measurement. Although existing research standards have improved both research and its reporting, we need to unify existing standards and to fill the gaps between steps throughout the research process. Existing gaps include implementation of standards and links between standards for study registration (to know about all studies undertaken), study protocols (to identify the preplanned study design and methods), data collection (to assess outcomes that are important and comparable across studies), dissemination of findings (to know the results of previous studies), data sharing (to make best use of existing data), and evidence synthesis (to draw appropriate conclusions from the body of evidence). The scientific community must work together to harmonize existing standards, to ensure that standards are kept up to date, to check that standards are followed, and to develop standards where they are still needed. A unified system of standards will make our work more reproducible.
KW - Clinical trials
KW - Data sharing
KW - Open science
KW - Scientific standards
KW - Systematic reviews
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U2 - 10.1073/pnas.1708273114
DO - 10.1073/pnas.1708273114
M3 - Article
C2 - 29531086
AN - SCOPUS:85043785568
SN - 0027-8424
VL - 115
SP - 2590
EP - 2594
JO - Proceedings of the National Academy of Sciences of the United States of America
JF - Proceedings of the National Academy of Sciences of the United States of America
IS - 11
ER -