Try a new search

Format these results:

Searched for:

person:millej17

in-biosketch:yes

Total Results:

41


2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics: A Consensus Conference Report

Benjamin, Ivor J; Valentine, C Michael; Oetgen, William J; Sheehan, Katherine A; Brindis, Ralph G; Roach, William H; Harrington, Robert A; Levine, Glenn N; Redberg, Rita F; Broccolo, Bernadette M; Hernandez, Adrian F; Douglas, Pamela S; Piña, Ileana L; Benjamin, Emelia J; Coylewright, Megan J; Saucedo, Jorge F; Ferdinand, Keith C; Hayes, Sharonne N; Poppas, Athena; Furie, Karen L; Mehta, Laxmi S; Erwin, John P; Mieres, Jennifer H; Murphy, Daniel J; Weissman, Gaby; West, Colin P; Lawrence, Willie E; Masoudi, Frederick A; Jones, Camara P; Matlock, Daniel D; Miller, Jennifer E; Spertus, John A; Todman, Lynn; Biga, Cathleen; Chazal, Richard A; Creager, Mark A; Fry, Edward T; Mack, Michael J; Yancy, Clyde W; Anderson, Richard E
PMID: 33994057
ISSN: 1558-3597
CID: 4876502

2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics: A Consensus Conference Report

Benjamin, Ivor J; Valentine, C Michael; Oetgen, William J; Sheehan, Katherine A; Brindis, Ralph G; Roach, William H; Harrington, Robert A; Levine, Glenn N; Redberg, Rita F; Broccolo, Bernadette M; Hernandez, Adrian F; Douglas, Pamela S; Piña, Ileana L; Benjamin, Emelia J; Coylewright, Megan J; Saucedo, Jorge F; Ferdinand, Keith C; Hayes, Sharonne N; Poppas, Athena; Furie, Karen L; Mehta, Laxmi S; Erwin, John P; Mieres, Jennifer H; Murphy, Daniel J; Weissman, Gaby; West, Colin P; Lawrence, Willie E; Masoudi, Frederick A; Jones, Camara P; Matlock, Daniel D; Miller, Jennifer E; Spertus, John A; Todman, Lynn; Biga, Cathleen; Chazal, Richard A; Creager, Mark A; Fry, Edward T; Mack, Michael J; Yancy, Clyde W; Anderson, Richard E
PMID: 33974449
ISSN: 1524-4539
CID: 4917252

Equitable Access to Research Benefits: Considerations for COVID-19 Vaccine Development and Clinical Trial Crossover [Comment]

Zaidi, Danish; Miller, Jennifer; Varma, Tanvee; Boatright, Dowin; Friesen, Phoebe
PMID: 33616486
ISSN: 1536-0075
CID: 5202472

COVID-19 vaccine research and the trouble with clinical equipoise [Letter]

Friesen, Phoebe; Caplan, Arthur L; Miller, Jennifer E
PMID: 33539728
ISSN: 1474-547x
CID: 5081632

Managing conflicts of interest in pharmacy and therapeutics committees: A proposal for multicentre formulary development

Friesen, Phoebe; Caplan, Arthur L; Miller, Jennifer E
WHAT IS KNOWN AND OBJECTIVE/OBJECTIVE:While many countries have central agencies responsible for formulary development, within the United States, each hospital, health care system, or insurance provider has their own pharmacy and therapeutic committee, leading to both inefficiencies and inequalities across formularies. The number and variety of processes within pharmacy and therapeutic committees also increases the likelihood that conflicts of interest will influence the development of formularies. We sought to determine how such influences could be reduced by reviewing international evidence related to the presence and harms of conflicts of interest in formulary development. METHODS:Several approaches have been taken to reduce the influence of conflicts of interest in pharmacy and therapeutics committee processes, including include disclosure, recusal, exclusion, universal consideration and dual committees. The feasibility of each of these approaches is considered in the context of the United States. RESULTS AND DISCUSSION/CONCLUSIONS:A proposal is drawn from the discussion of various approaches to conflicts of interest in pharmacy and therapeutics committees: multicenter formulary development. WHAT IS NEW AND CONCLUSION/CONCLUSIONS:Multicentre formulary development, where resources are pooled across institutions, may lead to a reduction in the influence of conflicts of interest in pharmacy and therapeutics committee processes in the United States, increasing the chances of including the most safe, efficacious and cost-effective drugs on formularies.
PMID: 31657022
ISSN: 1365-2710
CID: 4163172

Ethical implications of poor comparative effectiveness evidence: obligations in industry-research partnerships [Comment]

Singh, Ilina; Naci, Huseyin; Miller, Jennifer; Caplan, Arthur; Cipriani, Andrea
PMID: 32199476
ISSN: 1474-547x
CID: 4394832

Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices

Miller, Jennifer; Ross, Joseph S; Wilenzick, Marc; Mello, Michelle M
OBJECTIVES:To develop and pilot a tool to measure and improve pharmaceutical companies' clinical trial data sharing policies and practices. DESIGN:Cross sectional descriptive analysis. SETTING:Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015. DATA SOURCES:Data sharing measures were adapted from 10 prominent data sharing guidelines from expert bodies and refined through a multi-stakeholder deliberative process engaging patients, industry, academics, regulators, and others. Data sharing practices and policies were assessed using data from ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms and registries (eg, the Yale Open Data Access (YODA) Project and Clinical Study Data Request (CSDR)), and personal communication with drug companies. MAIN OUTCOME MEASURES:Company level, multicomponent measure of accessibility of participant level clinical trial data (eg, analysis ready dataset and metadata); drug and trial level measures of registration, results reporting, and publication; company level overall transparency rankings; and feasibility of the measures and ranking tool to improve company data sharing policies and practices. RESULTS:Only 25% of large pharmaceutical companies fully met the data sharing measure. The median company data sharing score was 63% (interquartile range 58-85%). Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33% and the median company data sharing score to 80% (73-100%). The most common reasons companies did not initially satisfy the data sharing measure were failure to share data by the specified deadline (75%) and failure to report the number and outcome of their data requests. Across new drug applications, a median of 100% (interquartile range 91-100%) of trials in patients were registered, 65% (36-96%) reported results, 45% (30-84%) were published, and 95% (69-100%) were publicly available in some form by six months after FDA drug approval. When examining results on the drug level, less than half (42%) of reviewed drugs had results for all their new drug applications trials in patients publicly available in some form by six months after FDA approval. CONCLUSIONS:It was feasible to develop a tool to measure data sharing policies and practices among large companies and have an impact in improving company practices. Among large companies, 25% made participant level trial data accessible to external investigators for new drug approvals in accordance with the current study's measures; this proportion improved to 33% after applying the ranking tool. Other measures of trial transparency were higher. Some companies, however, have substantial room for improvement on transparency and data sharing of clinical trials.
PMCID:6614834
PMID: 31292127
ISSN: 1756-1833
CID: 4174702

Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study

Zou, Constance X; Becker, Jessica E; Phillips, Adam T; Garritano, James M; Krumholz, Harlan M; Miller, Jennifer E; Ross, Joseph S
BACKGROUND:Mandatory trial registration, and later results reporting, were proposed to mitigate selective clinical trial publication and outcome reporting. The Food and Drug Administration (FDA) Amendments Act (FDAAA) was enacted by Congress on September 27, 2007, requiring the registration of all non-phase I clinical trials involving FDA-regulated medical interventions and results reporting for approved drugs. The association between FDAAA enactment and the registration, results reporting, and publication bias of neuropsychiatric trials has not been studied. METHODS:We conducted a retrospective cohort study of all efficacy trials supporting FDA new drug approvals between 2005 to 2014 for neuropsychiatric indications. Trials were categorized as pre- or post-FDAAA based on initiation and/or completion dates. The main outcomes were the proportions of trials registered and reporting results in ClinicalTrials.gov, and the degree of publication bias, estimated using the relative risks pre- and post-FDAAA of both the publication of positive vs non-positive trials, as well as of publication of positive vs non-positive trials without misleading interpretations. Registration and results reporting proportions were compared pre- and post-FDAAA using the two-tailed Fisher exact test, and the degrees of publication bias were compared by calculating the ratio of relative risks (RRR) for each period. RESULTS:The FDA approved 37 new drugs for neuropsychiatric indications between 2005 and 2014 on the basis of 142 efficacy trials, of which 101 were pre-FDAAA and 41 post-FDAAA. Post-FDAAA trials were significantly more likely to be registered (100% vs 64%; p < 0.001) and report results (100% vs 10%; p < 0.001) than pre-FDAAA trials. Pre-FDAAA, positive trials were more likely to be published (relative risk [RR] = 1.52; 95% confidence interval [CI] = 1.17-1.99; p = 0.002) and published without misleading interpretations (RR = 2.47; CI = 1.57-3.73; p < 0.001) than those with non-positive results. In contrast, post-FDAAA positive trials were equally likely to have been published (RR = 1; CI = 1-1, p = NA) and published without misleading interpretations (RR = 1.20; CI = 0.84-1.72; p = 0.30). The likelihood of publication bias pre-FDAAA vs post-FDAAA was greater for positive vs non-positive trials (RRR = 1.52; CI = 1.16-1.99; p = 0.002) and for publication without misleading interpretations (RRR = 2.06, CI = 1.17-3.61, p = 0.01). CONCLUSIONS:The enactment of FDAAA was followed by significantly higher proportions of trials that were registered and reporting results on ClinicalTrials.gov and significantly lower degrees of publication bias among trials supporting recent FDA approval of drugs for neuropsychiatric indications.
PMCID:6199729
PMID: 30352601
ISSN: 1745-6215
CID: 5297422

Nivolumab and Ipilimumab Immunotherapy-Induced Colitis and Hepatitis [Meeting Abstract]

Ballecer, Eric; Sy, Alexander; Miller, Jennifer; Mago, Sheena; Sofer, Tova; Malet, Peter
ISI:000464611004286
ISSN: 0002-9270
CID: 3897722

Adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals

Gopal, Anand D; Wallach, Joshua D; Aminawung, Jenerius A; Gonsalves, Gregg; Dal-Ré, Rafael; Miller, Jennifer E; Ross, Joseph S
BACKGROUND:Registration of clinical trials is critical for promoting transparency and integrity in medical research; however, trials must be registered in a prospective fashion to deter unaccounted protocol modifications or selection of alternate outcomes that may enhance favorability of reported findings. We assessed adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and identified the frequency of registrations occurring after potential observation of primary outcome data among trials published in the highest-impact journals associated with US professional medical societies. Additionally, we examined whether trials that are unregistered or registered after potential observation of primary outcome data were more likely to report favorable findings. METHODS:We conducted a retrospective, cross-sectional analysis of the 50 most recently published clinical trials that reported primary results in each of the ten highest-impact US medical specialty society journals between 1 January 2010 and 31 December 2015. We used descriptive statistics to characterize the proportions of trials that were: registered; registered retrospectively; registered retrospectively potentially after initial ascertainment of primary outcomes; and reporting favorable findings, overall and stratified by journal and trial characteristics. Chi-squared analyses were performed to assess differences in registration by journal and trial characteristics. RESULTS:We reviewed 6869 original research reports published between 1 January 2010 and 31 December 2015 to identify a total of 486 trials across 472 publications. Of these 486 trials, 47 (10%) were unregistered. Among 439 registered trials, 340 (77%) were registered prospectively and 99 (23%) retrospectively. Sixty-seven (68%) of these 99 retrospectively registered trials, or 15% of all 439 registered trials, were registered after potential observation of primary outcome data ascertained among participants enrolled at inception. Industry-funded trials, those with enrollment sites in the US, as well as those assessing FDA-regulated interventions each had lower rates of retrospective registration. Unregistered trials were more likely to report favorable findings than were registered trials (89% vs. 64%; relative risk (RR) = 1.38, 95% confidence interval (CI) = 1.20-1.58; p = 0.004), irrespective of registration timing. CONCLUSIONS:Adherence to the ICMJE's prospective registration policy remains sub-standard, even in the highest-impact journals associated with US professional medical societies. These journals frequently published unregistered trials and trials registered after potential observation of primary outcome data.
PMCID:6106722
PMID: 30134950
ISSN: 1745-6215
CID: 3246152