Results 41 to 50 of about 41,551 (186)

Data Monitoring Committee Usage for Trials Registered on ClinicalTrials.gov

, 2022
Independent Data Monitoring Committees (DMC) play an important role in clinical trial oversight. In 2010 Califf et al. analyzed DMC use for trials registered on ClinicalTrials.gov from 2000-2010, based on voluntary responses to the “Data Monitoring ...
Nora Hutchinson
core   +1 more source

When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL

Trials, 2018
Background Patient and public involvement (PPI) in clinical trials aims to ensure that research is carried out collaboratively with patients and/or members of the public.
Claire L. Vale, William J. Cragg, Ben Cromarty, Bec Hanley, Annabelle South, Richard Stephens, Kate Sturgeon, Mitzy Gafos   +7 more
doaj   +1 more source

A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials

Trials, 2019
Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of ...
Anna Rosala-Hallas, Carrol Gamble, Jane Blazeby, Paula R. Williamson   +3 more
doaj   +1 more source

Subacromial spacers for adults with symptomatic, irreparable rotator cuff tears: the START:REACTS novel group sequential adaptive RCT

Efficacy and Mechanism Evaluation, 2023
Background A balloon spacer is a relatively simple addition to an arthroscopic debridement procedure for irreparable rotator cuff tears. Objective To evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing ...
Metcalfe Andrew, Arnold Susanne, Parsons Helen, Parsons Nicholas, Bhabra Gev, Brown Jaclyn, Bush Howard, Diokno Michael, Elliott Mark, Fox Josephine, Gates Simon, Gemperlé Mannion Elke, Haque Aminul, Hutchinson Charles, Kearney Rebecca, Khan Iftekhar, Lawrence Tom, Mason James, Rahman Usama, Stallard Nigel, Ul-Rahman Sumayyah, Viswanath Aparna, Wayte Sarah, Drew Stephen, Underwood Martin   +24 more
doaj   +1 more source

Guideline on the design and conduct of cystic fibrosis clinical trials: The European Cystic Fibrosis Society–Clinical Trials Network (ECFS-CTN) [PDF]

, 2011
We describe the rationale for disease specific research networks in general as well as the aims and function of the European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) specifically.
S. Conway, Tiddens, H., I. Fajac, T. Lee, F. Dufour, Wagner, T., Conway, S., B. Kassai, Smyth, A.R., Bulteel, V., S. Elborn, Fajac, I., V. Bulteel, Elborn, S., De Boeck, K., Dufour, F., Smyth, A. R.; id_orcid, K. De Boeck, T. Wagner, Lee, T., A.R. Smyth, Serment, I., Kassai Koubai, Behrouz, Smyth, AR., Kassai, B., Sermet, I., H. Tiddens, I. Sermet   +27 more
core   +2 more sources

Online remote behavioural intervention for tics in 9- to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation

Health Technology Assessment, 2023
Background Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online. Objective To investigate the clinical and cost-effectiveness of an online-delivered, therapist- and parent-supported ...
Chris Hollis, Charlotte L Hall, Kareem Khan, Marie Le Novere, Louise Marston, Rebecca Jones, Rachael Hunter, Beverley J Brown, Charlotte Sanderson, Per Andrén, Sophie D Bennett, Liam R Chamberlain, E Bethan Davies, Amber Evans, Natalia Kouzoupi, Caitlin McKenzie, Isobel Heyman, Joseph Kilgariff, Cristine Glazebrook, David Mataix-Cols, Eva Serlachius, Elizabeth Murray, Tara Murphy   +22 more
doaj   +1 more source

Issues in regulatory guidelines for data monitoring committees.

, 2004
As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved.
Kaplan, Richard, Seto, Belinda, DeMets, David, Ellenberg, Susan, Levine, Robert, Stump, David, Fleming, Thomas, Pocock, Stuart, Held, Peter, Rockhold, Frank, Neaton, James, Snapinn, Steve, Dixon, Dennis, Julian, Desmond, Temple, Robert, Siegel, Jay, Packer, Milton, Whitley, Richard, Califf, Robert   +18 more
core   +1 more source

The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961-1990).

PLoS ONE, 2018
BackgroundAfter the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the
Rainer Erices, Andreas Frewer, Antje Gumz   +2 more
doaj   +1 more source

Should data monitoring committees assess efficacy when considering safety in trails in acute stroke? [PDF]

, 2007
The primary role of a trials Data Monitoring Committee (DMC) is to ensure the safety of enrolled patients. In stroke trials, safety is monitored typically by comparing death and stroke specific events between treatment groups.
Wahlgren, Nils-Gunnar, Bath, Philip M.W., Gray, Laura J.   +2 more
core  

Safety profile of oxcarbazepine: results from a prescription-event monitoring study [PDF]

, 2010
Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM.
Layton, D., Shakir, S., Buggy, Y., Fogg, Carole   +3 more
core   +1 more source