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1 Outline of Presentation Why is there pressure for public use datasets? DCC development of datasets Public Use Datasets (PUDS) J. Michael Dean, M.D., M.B.A. H.A. and Edna Benning Presidential Professor of Pediatrics Vice Chairman for Research, Department of Pediatrics University of Utah School of Medicine Description of two public use data set websites Required agreements for investigators Authorship requirements and restrictions How much do you include? Society of Clinical Trials Pre-Conference Workshop, May 17, 2015 Arlington, Virginia Why did this question arise? Pressure for public use datasets EPA and Airborne Asbestos 1978 through 1990 EPA required REMOVAL of asbestoscontaining materials (ACM) EPA reversed course and acknowledged managing asbestos in place, which remains the current course of management unless building being demolished or renovated Measurement debate Scientific discourse, repeat measurements, led to change of EPA 1
2 Asbestos measurements Endocrine disrupters In the EPA example, there was debate about the measurements The measurement methods could be replicated (actually not) New measurements led to new conclusions, and policy changed This does NOT work with epidemiologic studies or large studies of specific populations (such as TBI, for example) Great Lakes pollutants leading to cancer Pollutants affecting estrogen and testosterone actions, which affect all meaningful aspects of human life, and hence, pollutants were causing a panoply of adverse effects Tulane study in 1996 (McLachlan) showed synergy of toxicity of pesticides -> led to Food Quality Protection Act (1996) and Safe Drinking Water Act (1996) Tulane results were refuted and even the Tulane investigators withdrew their report (1997) Results were refuted; the laws remain on the books Theo Colburn (endocrinologist) More Examples National Cancer Institute and herbicide 2,4-D As the evidence for her theory collapsed, Colborn declared that evidence isn t important: Just because we don t have the evidence doesn t mean there are no effects. NIH Women s Health Study and the Dalkon Shield FDA and Fen-Phen (heart valve damage) In all three instances, serious issues about data management and interpretation of result. All had serious economic consequences. 2
3 Air Quality and Pope Study Congress irked... Congress requested EPA data for 1996 air quality standards and EPA refused to allow access Pope study - telephone survey of 1 million people by 77,000 volunteers, combined with air quality / pollution data EPA: We do not believe... there is a useful purpose for EPA to obtain the underlying data [since the studies were published in peer - reviewed journals]....securing more detail about this information is not necessary as part of EPA s public health standard -setting process new EPA air quality regulations In 1997, Congress evaluated legislation requiring the federal government to make data from federally funded research available to the public. Measure was defeated. Early 1998, passed law to require OMB to study implications of public access to data from federally funded research. Vetoed by Clinton. October 1998 Shelby Amendment to OMB funding:...to require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through procedures established under the Freedom of Information Act. OMB Circular A-110 (1999) Reproducibility of Results Any private citizen can FOIA for data produced with federal funding that has resulted in a published report. Report is published when it appears in a scientific or technical journal, OR when the findings are cited in support of a Federal agency action that has the force and effect of law. Public use datasets should enable other investigators to at least reproduce the statistical analyses of resulting publications. Some statistical methods are trivial to describe, and reproducing those results may not even be interesting Other methods are moderately complex (TBI and CART - there are numerous software settings and judgments) Some methods are extremely complex (genomic pipelines) 3
4 Example of Reproducibility Genomic Signatures Nature Medicine 12(11):1294, 2006, 2008 Predict Breast Cancer Response Cancer Trials Launched Breast cancer trials were launched based on these data Women were stratified according to the sensitivity prediction of the signatures from the Potti paper Keith Baggerly (MD Anderson) was asked to reproduce these results so that the method could be used at MD Anderson for their patients Baggerly could not reproduce the results (the data were, in fact, available) 4
5 149 page supplement to Nature letter to editor, included all statistical code, scripts, and instructions to create the report that repudiated the original Potti paper. Paper retracted in 2011 Publicity on 60 Minutes Clinical trials had actually assigned women to the incorrect sensitivity arms, had the original report even been accurate. 5
6 How does this relate? Maximize Scientific Return on $$ Duke is a pretty good institution - nobody would dispute top tier The only way that the Potti results were refuted was reanalyses of the data, which had been provided in full to other investigators Potti et al actually assisted Baggerly as they tried to reproduce the results The PUBLIC (and Congress) believe this is not rare. Tell me what datasets you have released! Initial evaluation and development Development of Public Use Datasets by the DCC Identify data elements that are sensible; goal is to make the PUDS actually of use Data elements that are not usually missing Create documentation of how data elements are defined Create Excel spreadsheet describing all the data elements that were identified by DCC as candidates Create SAS cross tabulations and frequency tables 6
7 Collaboration with investigator Goals for datasets Materials developed by DCC should be provided to investigator for refinement and discussion DCC goal is not to limit collaboration with investigator, but it IS to limit the amount of time that investigators need to spend on this Estimate that 3 to 6 months of effort goes into getting the data set to the stage where investigator input is valuable, and then hopefully the investigator only needs to spend hours on the process. In current studies, we try to keep ALL manipulations of data within the database, so that releasing the final database will reflect what was done in the study This is not always possible going backwards, as many derived variable constructions are done in SAS or other statistical environments Theoretical Goal: all study data, adverse events, medications, etc. would be released. Not restricted to data used in publications. Example PUDS Website: CPCCRN 7
8 8
9 9
10 Overview for Context Identify Exclusions Documentation: Key Issues If you release a public use dataset, documentation needs to be sufficient so that you do not get asked to support it. In fact, support is expressly denied. Provide annotated CRF or ecrf diagrams, complete definitions, etc. so that the work of creating the PUDS is not wasted. 10
11 Example PUDS Website: PECARN Major study, huge ramifications 11
12 Bronchiolitis Dataset 12
13 Required investigator agreement 13
14 Authorship requirements Actual data... How much do you include? 14
15 Seems easy - but slippery slope. Releasing Code What about statistical code? At least for getting the data into their computer? What about sample scripts so the user can verify that the data were not corrupted? What about the SAS scripts that created the exact tables and figures in the published manuscripts? What about all the derivations of derived variables? What about the dual coding for critical analyses? Do you release both programs? Seems like good idea and we are actually considering how to accomplish release of some of our code Will you then have to explain how the code works? If a DCC has a large library of SAS macros that have been developed over years, are these macros really proprietary information? If you accept the goodness of releasing code, are you obliged to provide it in multiple languages (SAS, STATA, SPSS, R, etc.)? Special Requests Summary Public use data sets have political support at all levels Contacted by esteemed, international expert on a relevant area, who knows that there are some additional data elements that were not included in the PUDS. Example: identification of institutions in multicenter studies How do you handle this, since support of the PUDS is expressly not provided by the DCC? We will lose if we try to block data release (personal opinion) Data use agreements to protect from superfluous requests Data sets represent work product, which supports future network funding We (DCC) work hard to minimize the work load required of investigators, but this is not intended to eliminate the collaboration of the investigator during the process. This is key. 15
16 Thank you for your attention. 16
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