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The purpose of proposed research is to assess if the low quality (certainty) evidence is more often revised than high quality (certainty) evidence in subsequent studies. Answering this question is of great importance for the practice of medicine as well as for EBM. If the results based on low quality evidence are often overturned this would provide further scientific support for EBM urging practitioners to be extremely cautious in acting on very/low quality evidence as such practice would likely result in greater harm. However, if we do not observe the expected relation between quality of evidence and probability of the results being overturned, then the entire process of evidence appraisal and possibly EBM reasoning would need to be re-examined in conjunction with the current process of approval of health interventions for the use in clinical practice.

Simulation logic for the administrative process associated with industry-sponsored clinical trial activation. Abbreviations: CDA/NDA, confidential disclosure agreement or non-disclosure agreement; CT, clinical trial; DSR, USF’s Division of Sponsored Research; PI, principal investigator. Figure SI2. Administrative procedure involved in the opening of clinical trials managed by the Office of Clinical Research at the University of South Florida. At the level of granularity, the process for activating an industry-sponsored clinical trial at USF comprises 30 steps, 11 decisions, 4 loops, and 8 participants. Abbreviations: CDA/NDA, confidential disclosure agreement or non-disclosure agreement; CTA, clinical trial agreement; OCR, USF’s Office of Clinical Research; P&L, USF’s Patents and Licensing; PI, principal investigator; SRA, OCR’s Senior Research Assistant; WIRB, Western Institutional Review Board. Figure SI3. Analysis of system capacity. Increasing the number of clinical trials arriving at the Office of Clinical Research. Slight increase will cause statistically significant delays to clinical trial activation, increase idle time, and queue lengths. Abbreviations: CTs, clinical trials. Figure SI4. Analysis of key participants’ capacity under increased workload. Effect of personnel addition under an increased demand scenario of 28 clinical trials per month average. At least two new employees must be assigned to OCR in order to maintain the baseline system performance. Abbreviations: CTs, clinical trials. *Baseline scenario. Figure SI5. Analysis of other participants’ capacity. Reducing response time from participants outside USF’s Office of Clinical Research. Reducing response time would not have a statistically significant (95 % confidence) effect on average activation time, idle time, and queue length. Figure SI6. T test comparing the mean duration of Contract Negotiation with and without data of those clinical trials still in process. Figure SI7. T test comparing the mean duration of Budget Negotiation with and without data of those clinical trials still in process. (DOCX 3073 kb)

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