Works matching IS 17407745 AND DT 2018 AND VI 15

Results: 81

What gives them the right? Legal privilege and waivers of consent for research.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 579, doi. 10.1177/1740774518803122

By:

Baker, Francis X.;
Merz, Jon F.

Publication type:

Article

Effect of two different participant information sheets on recruitment to a falls trial: An embedded randomised recruitment trial.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 551, doi. 10.1177/1740774518803558

By:

Witham, Miles D.;
Band, Margaret M.;
Price, Rosemary J. G.;
Fulton, Roberta L.;
Clarke, Clare L.;
Donnan, Peter T.;
Soiza, Roy L.;
Cvoro, Vera

Publication type:

Article

Global pharmacovigilance regulations: Call for re-harmonization.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 631, doi. 10.1177/1740774518801592

By:

Singh, Ajay;
Twomey, Ken;
Baker, Robert

Publication type:

Article

Developing informed consent materials for non-English-speaking participants: An analysis of four professional firm translations from English to Spanish.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 557, doi. 10.1177/1740774518801591

By:

Brelsford, Kathleen Marie;
Ruiz, Ernesto;
Beskow, Laura

Publication type:

Article

Understanding preferences regarding consent for pragmatic trials in acute care.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 567, doi. 10.1177/1740774518801007

By:

Dickert, Neal W.;
Wendler, David;
Devireddy, Chandan M.;
Goldkind, Sara F.;
Ko, Yi-An;
Speight, Candace D.;
Kim, Scott Y. H.

Publication type:

Article

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 616, doi. 10.1177/1740774518799985

By:

Trask, Peter C.;
Dueck, Amylou C.;
Piault, Elisabeth;
Campbell, Alicyn

Publication type:

Article

Development of an online resource for recruitment research in clinical trials to organise and map current literature.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 533, doi. 10.1177/1740774518796156

By:

Kearney, Anna;
Harman, Nicola L.;
Rosala-Hallas, Anna;
Beecher, Claire;
Blazeby, Jane M.;
Bower, Peter;
Clarke, Mike;
Cragg, William;
Duane, Sinead;
Gardner, Heidi;
Healy, Patricia;
Maguire, Lisa;
Mills, Nicola;
Rooshenas, Leila;
Rowlands, Ceri;
Treweek, Shaun;
Vellinga, Akke;
Williamson, Paula R.;
Gamble, Carrol

Publication type:

Article

Contingency management intervention targeting co-addiction of alcohol and drugs among American Indian adults: Design, methodology, and baseline data.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 587, doi. 10.1177/1740774518796151

By:

Burduli, Ekaterina;
Skalisky, Jordan;
Hirchak, Katherine;
Orr, Michael F.;
Foote, Albert;
Granbois, Alexandria;
Ries, Richard;
Roll, John M.;
Buchwald, Dedra;
McDonell, Michael G.;
McPherson, Sterling M.

Publication type:

Article

Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 624, doi. 10.1177/1740774518795637

By:

Bottomley, Andrew;
Pe, Madeline;
Sloan, Jeff;
Basch, Ethan;
Bonnetain, Franck;
Calvert, Melanie;
Campbell, Alicyn;
Cleeland, Charles;
Cocks, Kim;
Collette, Laurence;
Dueck, Amylou C.;
Devlin, Nancy;
Flechtner, Hans-Henning;
Gotay, Carolyn;
Greimel, Eva;
Griebsch, Ingolf;
Groenvold, Mogens;
Hamel, Jean-Francois;
King, Madeleine;
Kluetz, Paul G.

Publication type:

Article

Recruitment and retention of the Hardest-to-Reach families in community-based asthma interventions.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 543, doi. 10.1177/1740774518793598

By:

Goldman, Hillary;
Fagnano, Maria;
Perry, Tamara T.;
Weisman, Ariel;
Drobnica, Amanda;
Halterman, Jill S.

Publication type:

Article

Triggered or routine site monitoring visits for randomised controlled trials: results of TEMPER, a prospective, matched-pair study.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 600, doi. 10.1177/1740774518793379

By:

Stenning, Sally P.;
Cragg, William J.;
Joffe, Nicola;
Diaz-Montana, Carlos;
Choudhury, Rahela;
Sydes, Matthew R.;
Meredith, Sarah

Publication type:

Article

Comparing two methods for delivering clinical trial informed consent information to older adults: singular versus stepped approach.

Published in:

Clinical Trials, 2018, v. 15, n. 6, p. 610, doi. 10.1177/1740774518793377

By:

O’Hare, Fleur;
Flanagan, Zachary;
Nelson, Mark;
Curtis, Andrea;
Heritier, Stephane;
Spark, Simone;
Zoungas, Sophia

Publication type:

Article

The ethics of uninsured participants accessing healthcare in biomedical research: A literature review.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 509, doi. 10.1177/1740774518792277

By:

Hae Lin Cho;
Danis, Marion;
Grady, Christine

Publication type:

Article

Performance and predictors of recruitment success in National Heart, Lung, and Blood Institute's cardiovascular clinical trials.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 444, doi. 10.1177/1740774518792271

By:

Pemberton, Victoria L.;
Evans, Frank;
Gulin, Jamie;
Rosenberg, Ellen;
Addou, Ebyan;
Burns, Kristin M.;
Gordon, David J.;
Kaltman, Gail D. Pearson and Jonathan R.

Publication type:

Article

Design of non-inferiority randomized trials using the difference in restricted mean survival times.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 499, doi. 10.1177/1740774518792259

By:

Weir, Isabelle R.;
Trinquart, Ludovic

Publication type:

Article

Revisiting isotonic phase I design in the era of model-assisted dose-finding.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 524, doi. 10.1177/1740774518792258

By:

Wages, Nolan A.;
Conaway, Mark R.

Publication type:

Article

Application of multi-state models in cancer clinical trials.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 489, doi. 10.1177/1740774518789098

By:

Le-Rademacher, Jennifer G.;
Peterson, Ryan A.;
Therneau, Terry M.;
Sanford, Ben L.;
Stone, Richard M.;
Mandrekar, Sumithra J.

Publication type:

Article

E-recruitment into a bipolar disorder trial using Facebook tailored advertising.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 522, doi. 10.1177/1740774518784018

By:

Huesch, Marco D.;
Mukherjee, Dahlia;
Saunders, Erika FH

Publication type:

Article

EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 436, doi. 10.1177/1740774518780678

By:

Mooney, Thomas;
Smout, Elizabeth;
Leigh, Bailah;
Greenwood, Brian;
Enria, Luisa;
Ishola, David;
Manno, Daniela;
Samai, Mohamed;
Douoguih, Macaya;
Watson-Jones, Deborah

Publication type:

Article

Rethinking non-inferiority: a practical trial design for optimising treatment duration.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 477, doi. 10.1177/1740774518778027

By:

Quartagno, Matteo;
Walker, A. Sarah;
Carpenter, James R.;
Phillips, Patrick P. J.;
Parmar, Mahesh KB

Publication type:

Article

Lessons learned conducting a multi-center trial with a military population: The Tinnitus Retraining Therapy Trial.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 429, doi. 10.1177/1740774518777709

By:

Scherer, Roberta W.;
Sensinger, Leonora D.;
Sierra-Irizarry, Benigno;
Formby, Craig

Publication type:

Article

Double-blind trials in hyperbaric medicine: A narrative review on past experiences and considerations in designing sham hyperbaric treatment.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 462, doi. 10.1177/1740774518776952

By:

Lansdorp, Nina CA;
van Hulst, Rob A.

Publication type:

Article

Beyond p-values: A phase II dual-criterion design with statistical significance and clinical relevance.

Published in:

Clinical Trials, 2018, v. 15, n. 5, p. 452, doi. 10.1177/1740774518770661

By:

Roychoudhury, Satrajit;
Scheuer, Nicolas;
Neuenschwander, Beat

Publication type:

Article

Abstracts from the SCT 39th Annual Meeting (2018).

Published in:: Clinical Trials, 2018, v. 15, p. S35, doi. 10.1177/1740774518790846
Publication type:: Article

Use of composite outcomes to assess risk--benefit in clinical trials.

Published in:

Clinical Trials, 2018, v. 15, n. 4, p. 352, doi. 10.1177/1740774518784010

By:

Shaw, Pamela A.

Publication type:

Article

University of Pennsylvania 10th annual conference on statistical issues in clinical trials: Current issues regarding data and safety monitoring committees in clinical trials (afternoon panel session).

Published in:

Clinical Trials, 2018, v. 15, n. 4, p. 366, doi. 10.1177/1740774518781849

By:

Dickersin, Kay;
Dixon, Dennis;
Ferris, Frederick;
Goldberg, Judith;
Kimmel, Stephen;
Lachin, John

Publication type:

Article

Proceedings of the University of Pennsylvania 10th annual conference on statistical issues in clinical trials: Current issues regarding Data and Safety Monitoring Committees in clinical trials.

Published in:

Clinical Trials, 2018, v. 15, n. 4, p. 319, doi. 10.1177/1740774518781817

By:

Ellenberg, Susan S.;
Ellenberg, Jonas H.

Publication type:

Article

University of Pennsylvania 10th annual conference on statistical issues in clinical trials: Current issues regarding data and safety monitoring committees in clinical trials (morning panel session).

Published in:

Clinical Trials, 2018, v. 15, n. 4, p. 335, doi. 10.1177/1740774518780434

By:

Davis, Barry;
Kerr, David;
Maguire, Maureen;
Sanders, Corsee;
Snapinn, Steven;
Wittes, Janet

Publication type:

Article

The independent statistician model: How well is it working?

Published in:

Clinical Trials, 2018, v. 15, n. 4, p. 329, doi. 10.1177/1740774518772841

By:

DeMets, David

Publication type:

Article

Modeling adverse event counts in phase I clinical trials of a cytotoxic agent.

Published in:

Clinical Trials, 2018, v. 15, n. 4, p. 386, doi. 10.1177/1740774518772309

By:

Muenz, Daniel G.;
Braun, Thomas M.;
Taylor, Jeremy M. G.

Publication type:

Article

Incidence and impact of withdrawal of life-sustaining therapies in clinical trials of severe traumatic brain injury: A systematic review.

Published in:

Clinical Trials, 2018, v. 15, n. 4, p. 398, doi. 10.1177/1740774518771233

By:

Leblanc, Guillaume;
Boutin, Amélie;
Shemilt, Michèle;
Lauzier, François;
Moore, Lynne;
Potvin, Véronique;
Zarychanski, Ryan;
Archambault, Patrick;
Lamontagne, François;
L&#ger, Caroline;
Turgeon, Alexis F.

Publication type:

Article

Data sharing platforms for de-identified data from human clinical trials.

Published in:

Clinical Trials, 2018, v. 15, n. 4, p. 413, doi. 10.1177/1740774518769655

By:

Huser, Vojtech;
Shmueli-Blumberg, Dikla

Publication type:

Article

Data Monitoring Committees: Current issues.

Published in:

Clinical Trials, 2018, v. 15, n. 4, p. 321, doi. 10.1177/1740774518764855

By:

Fleming, Thomas R.;
Ellenberg, Susan S.;
DeMets, David L.

Publication type:

Article

How to construct an optimal interim report:What the data monitoring committee does and doesn't need to know.

Published in:

Clinical Trials, 2018, v. 15, n. 4, p. 359, doi. 10.1177/1740774518764449

By:

Neaton, James D.;
Grund, Birgit;
Wentworth, Deborah

Publication type:

Article

Expedited and facilitated drug evaluations and evidence of benefit and risk: The cup is half-full.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 235, doi. 10.1177/1740774518771347

By:

Califf, Robert M.

Publication type:

Article

Access versus evidence: The regulators’ dilemma.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 240, doi. 10.1177/1740774518770660

By:

Schilsky, Richard L.

Publication type:

Article

The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 243, doi. 10.1177/1740774518770657

By:

Wallach, Joshua D.;
Ross, Joseph S.;
Naci, Huseyin

Publication type:

Article

Expediting drug development for serious illness: Trade-offs between patient access and certainty.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 230, doi. 10.1177/1740774518770656

By:

Woodcock, Janet

Publication type:

Article

Expedited approval programs at the Food and Drug Administration.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 217, doi. 10.1177/1740774518770653

By:

Begg, Colin B.;
Ellenberg, Susan S.

Publication type:

Article

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 219, doi. 10.1177/1740774518770648

By:

Wallach, Joshua D.;
Ross, Joseph S.;
Naci, Huseyin

Publication type:

Article

A new modeling and inference approach for the Systolic Blood Pressure Intervention Trial outcomes.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 305, doi. 10.1177/1740774518769865

By:

Yang, Song;
Ambrosius, Walter T.;
Fine, Lawrence J.;
Bress, Adam P.;
Cushman, William C.;
Raj, Dominic S.;
Rehman, Shakaib;
Tamariz, Leonardo

Publication type:

Article

LIBERTI: A SMART study in plastic surgery.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 286, doi. 10.1177/1740774518762435

By:

Hibbard, Jonathan C.;
Friedstat, Jonathan S.;
Thomas, Sonia M.;
Edkins, Renee E.;
Hultman, C. Scott;
Kosorok, Michael R.

Publication type:

Article

Reporting non-adherence in cluster randomised trials: A systematic review.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 294, doi. 10.1177/1740774518761666

By:

Agbla, Schadrac C.;
DiazOrdaz, Karla

Publication type:

Article

Prevalence and reporting of recruitment, randomisation and treatment errors in clinical trials: A systematic review.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 278, doi. 10.1177/1740774518761627

By:

Yelland, Lisa N.;
Kahan, Brennan C.;
Dent, Elsa;
Lee, Katherine J.;
Voysey, Merryn;
Forbes, Andrew B.;
Cook, Jonathan A.

Publication type:

Article

Bayesian comparative effectiveness study of four consensus treatment plans for initial management of systemic juvenile idiopathic arthritis: FiRst-Line Options for Systemic juvenile idiopathic arthritis Treatment (FROST).

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 268, doi. 10.1177/1740774518761367

By:

Nigrovic, Peter A.;
Beukelman, Timothy;
Tomlinson, George;
Feldman, Brian M.;
Schanberg, Laura E.;
Kimura, Yukiko

Publication type:

Article

The reporting of harms in publications on randomized controlled trials funded by the “Programme Hospitalier de Recherche Clinique,” a French academic funding scheme.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 257, doi. 10.1177/1740774518760565

By:

Favier, Romain;
Crépin, Sabrina

Publication type:

Article

Beyond total treatment effects in randomised controlled trials: Baseline measurement of intermediate outcomes needed to reduce confounding in mediation investigations.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 247, doi. 10.1177/1740774518760300

By:

Landau, Sabine;
Emsley, Richard;
Dunn, Graham

Publication type:

Article

Increasing the use of mobile technology–derived endpoints in clinical trials.

Published in:

Clinical Trials, 2018, v. 15, n. 3, p. 313, doi. 10.1177/1740774518755393

By:

Herrington, William G.;
Goldsack, Jennifer C.;
Landray, Martin J.

Publication type:

Article

Restricted mean survival time: Does covariate adjustment improve precision in randomized clinical trials?

Published in:

Clinical Trials, 2018, v. 15, n. 2, p. 178, doi. 10.1177/1740774518759281

By:

Karrison, Theodore;
Kocherginsky, Masha

Publication type:

Article

A Bayesian basket trial design using a calibrated Bayesian hierarchical model.

Published in:

Clinical Trials, 2018, v. 15, n. 2, p. 149, doi. 10.1177/1740774518755122

By:

Yiyi Chu;
Ying Yuan

Publication type:

Article