11 found
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Stanley H. Shapiro [6]Stanley Shapiro [4]Stan Shapiro [1]
  1.  38
    Clinical Equipoise and Not the Uncertainty Principle Is the Moral Underpinning of the Randomised Controlled Trial.Charles Weijer, Stanley H. Shapiro & Kathleen Cranley Glass - unknown
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  2. Structuring the Review of Human Genetics Protocols.Kathleen Cranley Glass, Charles Weijer, Denis Cournoyer, Trudo Lemmens, Roberta M. Palmour, Stanley H. Shapiro & Benjamin Freedman - 1999 - IRB: Ethics & Human Research 21.
     
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  3.  17
    Monitoring Clinical Research: An Obligation Unfulfilled.Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Cranley Glass & Myriam Skrutkowska - unknown
    The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The (...)
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  4.  12
    Structuring the Review of Human Genetics Protocols Part II: Diagnostic and Screening Studies.Kathleen Cranley Glass, Charles Weijer, Trudo Lemmens, Roberta M. Palmour & Stanley H. Shapiro - forthcoming - IRB: Ethics & Human Research.
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  5.  17
    What Difference Does It Make to Be Treated in a Clinical Trial? A Pilot Study.Charles Weijer, Benjamin Freedman, Abraham Fuks, James Robbins, Stanley Shapiro & Myriam Skrutkowska - unknown
    OBJECTIVE: Pilot study to characterize treatment differences between patients treated in clinical trials and those treated in a clinical setting. Previous studies have shown higher survival rates for participants in trials of cancer therapy. This difference is observed even after rates are adjusted for important covariates such as age and stage of disease. DESIGN: Retrospective chart review. SETTING: Oncology outpatient department in a tertiary care hospital. PATIENTS: Ninety women 18 to 70 years of age with early-stage breast cancer who were (...)
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  6.  6
    Structuring the Review of Human Genetics Protocols Part-III: Gene Therapy Studies.Kathleen C. Glass, Charles Weijer, Denis Cournoyer, Trudo Lemmens, Roberta M. Palmour, Stanley H. Shapiro & Benjamin Freedman - unknown
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  7.  8
    Monitoring Informed Consent in an Oncology Study Posing Serious Risk to Subjects.Myrian Skrutkowski, Charles Weijer, Stan Shapiro, Abraham Fuks, Adrian Langleben & Benjamin Freedman - 1998 - IRB: Ethics & Human Research 20 (6):1-6.
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  8.  6
    A Study in Contrasts: Eligibility Criteria in a Twenty-Year Sample of NSABP and POG Clinical Trials.Abraham Fuks, Charles Weijer, Benjamin Freedman, Stanley Shapiro, Myriam Skrutkowska & Amina Riaz - unknown
    We studied changes in eligibility criteria--the largest impediment to patient accrual--in two samples of clinical trials. Trials from the NSABP (National Surgical Adjuvant Breast and Bowel Program) and POG (Pediatric Oncology Group) were analyzed. After eliminating duplications, the criteria in each protocol were enumerated and classified according to a novel schema. NSABP trials contained significantly more criteria than POG trials, and added precision criteria (making study populations homogeneous) at a faster rate than POG studies. The difference between NSABP studies (explanatory (...)
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  9.  4
    Structuring the Review of Human Genetics Protocols: Gene Localization and Identification Studies.Kathleen Cranley Glass, Charles Weijer, Roberta M. Palmour, Stanley H. Shapiro, Trudo M. Lemmens & Karen Lebacqz - unknown
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  10.  15
    Assessing the Interpretation of Criteria for Clinical Trial Eligibility: A Survey of Oncology Investigators.Charles Weijer, Benjamin Freedman, Stanley Shapiro, Abraham Fuks, Myriam Skrutkowska & Maria Sigurjonsdottir - unknown
    OBJECTIVE: To investigate whether eligibility criteria that exclude the elderly, persons with psychiatric disease, and persons with substance abuse problems from participation in randomized controlled trials (RCTs) are subjective and hence a source of variability in enrolment decisions and investigator uncertainty. DESIGN: Survey questionnaire. PARTICIPANTS: Cancer investigators from the United States and Canada. INTERVENTIONS: Investigators were presented with clinical vignettes from 3 patient categories--eligible, ineligible and uncertain--for each of 5 eligibility criteria--3 subjective and 2 objective--and were asked whether they would (...)
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  11.  11
    Reporting the Study Populations of Clinical Trials. Clear Transmission or Static on the Line?Stanley H. Shapiro, Charles Weijer & Benjamin Freedman - unknown
    In contrast to attempts that have been made to measure the clarity of reporting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this article on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the protocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print between January 1988 (...)
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