Browsing by Subject "Clinical Trials as Topic"
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Item Acute liver failure (ALF) and the ALF study group: a clinical trial network for a rare disease(2020-08-14) Durkalski-Mauldin, Valerie; Fontana, Robert J.; Lee, William M.; Stravitz, R. ToddItem Conflicts of interest in clinical research: lessons from the Minnesota Markingson case(2015-09-08) Brown, E. Sherwood; Reisch, Joan S.; Sadler, John Z.; Wright, J. GregoryThe nationally-publicized Markingson case from the University of Minnesota involved a tragic suicide in the context of a university-based, industry-sponsored clinical trial. A panel of UT Southwestern faculty and staff consider the lessons emerging from the Markingson case, identify areas of risk and opportunities for prevention, and map the multiple layers of policy and practice that could prevent such events in the future.Item The ethics police?: the struggle to make human research safe(2016-01-12) Klitzman, RobertExperiments on human beings have saved countless lives, but sometimes harmed participants. Critical questions thus emerge: how much government should regulate science, and how. Nazi experiments and the Tuskegee syphilis study led the US, in 1974, to establish Research Ethics Committees (or Institutional Review Boards -- IRBs) to oversee human research. But these committees have increasingly been criticized for blocking important studies, while ethical violations continue. Crucial dilemmas thus emerge: whether this system should be changed, and if so, how. In September 2015 President Obama's administration recommended several reforms. Yet we must first understand this system to know how to improve it. Unfortunately, these committees operate behind closed doors, and have received relatively little in-depth investigation. This talk, based on interviews with dozens of IRB leaders, explores how they make decisions, wrestling with conflicts and complexities assessing possible risks and benefits of studies, and deciding how much to trust researchers -- key questions that ultimately affect us all.Item Ethnicity, hypertension, and the Dallas Heart Study(2003-07-17) Victor, Ronald G.Item Impact of National Cancer Institute (NCI)-Mandated Scientific Review on Cancer Clinical Trial Protocol Development(2014-02-04) Ning, Ning; Yan, Jingsheng; Xie, Xian-Jin; Gerber, David E.BACKGROUND: The National Cancer Institute (NCI) requirement that all clinical trials involving cancer patients at NCI-designated cancer centers undergo a scientific protocol review before Institutional Review Board (IRB) review is unique among all medical specialties. Little is known about the impact of scientific review on protocol development. Given heightened interest in the quality and timeliness of oncology clinical trials, we evaluated the scientific review process at an NCI designated center. METHODS: We collected data on all oncology clinical trials that underwent full board review by the UT Southwestern Harold C. Simmons Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. The following data were collected: trial characteristics, PRMC decisions, protocol clarifications and changes requested by PRMC, and subsequent protocol modifications. We analyzed the association between trial characteristics and PRMC protocol modifications using Chi-square testing, Fisher's exact testing, and logistic regression. RESULT: A total of 226 trials were included in our analysis. Of these studies, 23% were institutional (investigator-initiated) trials. Initial PRMC initial decisions were: approved (40%), approved pending response (52%), defer (7%), and disapprove (1%). Across the 226 trials, the PRMC requested 270 changes; total number of requested changes per protocol ranged from 0 (66% of trials) to 17. The number of requested changes per protocol was significantly associated with trial type (mean 0.7 for industry-sponsored versus 3.0 for investigator-initiated; P<0.001) and study year (mean 0.7 in 2009 versus 2.4 in 2013; P=0.03). Forty-nine percent of requested changes applied directly to trial protocols, with the remainder related to consent form (13%) or other documentation (38%). Protocol-related requested changes were as follows: design (53%), intervention (24%), evidence-background-rationale (14%), and population (11%). Compared to those for industry-sponsored trials, PRMC requested changes for investigator-initiated trials were more likely to be implemented (91% versus 83%; P=0.08). A pronounced difference was noted for requested changes related to trial design: among 154 industry-sponsored trials, 28 changes to study design were requested (average 0.2 per trial), and 8 changes (29% of requests) were implemented; among 52 investigator-initiated trials, 39 changes to study design were requested (average 0.8 per trial), and 35 changes (90% of requests) were implemented. CONCLUSION: To our knowledge, this is the first study to evaluate the impact of NCI-mandated scientific protocol review in cancer clinical trial development. While this process appears to have a substantial impact on investigator-initiated trial protocols, effect on industry-sponsored trials is less clear.Item The intersection of academia, community oncology, & clinical trials(2021-08-27) Cole, Suzanne M.Item Meeting the challenges: bringing evidence-based treatment to the pregnant patient(2013-05-14) Brandon, Anna R.Because of the ethical challenges of conducting randomized controlled clinical trials with women who are or may become pregnant, there is insufficient information regarding the risks to the fetus for the majority of prescription medications, leaving pregnant women with a difficult choice between using a medication with an unknown safety profile or suffering from untreated illness. Three major stakeholder groups in perinatal research -- clinical investigators, Institutional Review Board representatives, and pregnant women seeking treatment in a major medical institution -- highlight the limitations of human subjects protections guidelines to address ethical grey areas in research and the need for greater flexibility in accepting women's competence to balance the risks and benefits of research participation for themselves and their fetuses.Item Researchers behaving badly: unreported misconduct in clinical trials(2016-05-10) Seife, CharlesEvery year the Food and Drug Administration inspects several hundred clinical sites performing biomedical research on human subjects. These inspections occasionally reveal evidence of substantial departures from good clinical practice, of research misconduct, and even of fraud. In this talk, Professor Seife will discuss incidents of research misconduct identified by the FDA (and via other means) and examine how frequently these incidents are reported in peer-reviewed journals, and whether unreported incidents are a potential distorting influence on the medical literature. Professor Seife will also examine the forces which are responsible for the frequent failure of research misconduct – even widespread misconduct – to come to the attention of scientists and clinicians.Item Teaching the old dog new tricks: efforts to reform clinical trial design and conduct(2023-01-27) Gerbers, David