Results 71 to 80 of about 41,551 (186)

On the Use of Local Assessments for Monitoring Centrally Reviewed Endpoints with Missing Data in Clinical Trials [PDF]

, 2013
Due to ethical and logistical concerns it is common for data monitoring committees to periodically monitor accruing clinical trial data to assess the safety, and possibly efficacy, of a new experimental treatment. When formalized, monitoring is typically
Gillen, Daniel L, Brummel, Sean S
core   +1 more source

Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.

, 1993
The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government.
Enas, GG, Rockhold, FW, Frank W. Rockhold, Gregory G. Enas   +3 more
core   +1 more source

Das Data Monitoring Committee – State of the Art und Perspektiven für die Zukunft

, 2020
HINTERGRUND: Die klassische randomisierte und kontrollierte klinische Prüfung steht mit komplexen Studiendesigns und Disease-Interception-Konzepten vor neuen Herausforderungen.
Fischer, Thomas
core   +1 more source

Mechanism-based modular psychotherapy versus cognitive behavioural therapy for adolescents and young adults with childhood trauma experiences: study protocol for a feasibility trial within the German Center for Mental Health

BMJ Open
Introduction Patients with mental disorders and a history of childhood trauma show an early onset of psychopathology and often a poor response to standard disorder-specific treatments.
Till Bärnighausen, Hanna Zimmermann, Christian Schmahl, Stephanie Bauer, Beate Ditzen, Hans-Christoph Friederich, Markus W Haun, Astrid Berner-Rodoreda, Elisabeth Schramm, Svenja Taubner, Corina Aguilar-Raab, Sabine C Herpertz, Manuel Feisst, Frank Enning, Katja I Seitz, Niklas Schouler, Jan Hundertmark, Maximilian Wilhelm, Svea Franz, Christoph W Korn, Ruben Vonderlin, Eva Vonderlin, Josef Bailer, Elias Bopp, Sophia von Stockert, Laura Tabea Kristalis, Claudia Calvano   +26 more
doaj   +1 more source

Issues in data monitoring and interim analysis of trials. [PDF]

, 2005
OBJECTIVES: To address issues about data monitoring committees (DMCs) for randomised controlled trials (RCTs). DATA SOURCES: Electronic databases. Handsearching of selected books. Personal contacts with experts in the field.
Babiker, AB, Campbell, MK, Parmar, MK, Elbourne, DR, Spiegelhalter, DJ, Darbyshire, JH, Pocock, SJ, Altman, DG, F Clemens, D Spiegelhalter, M Sydes, DAMOCLES study group, Wallace, SA, M Parmar, A Walker, D Altman, Sydes, MR, S McLeer, A Babiker, A Grant, S Wallace, D Elbourne, Grant, AM, Parmar, MKB, S Pocock, Clemens, FJ, McLeer, SK, J Darbyshire, Walker, AE, M Campbell   +29 more
core   +1 more source

Design of an international, phase IV, open-label study of simoctocog alfa in women/girls with hemophilia A undergoing surgery (NuDIMENSION)

Therapeutic Advances in Hematology
Background: Although hemophilia A mainly affects males, carriers (defined as females with hemophilia A, as well as symptomatic or asymptomatic hemophilia A carriers) are at risk of excessive bleeding, particularly during trauma or during surgical ...
Natascha Marquardt, Florian Langer, Katharina Holstein, María Teresa Álvarez Román, Ramiro Núñez Vázquez, Predrag Miljić, Nicolas Drillaud, Laurent Ardillon, Anna-Elina Lehtinen, Rita Carlotta Santoro, Mariasanta Napolitano, Sergio Siragusa, Gillian Gidley, Martina Jansen, Sigurd Knaub, Johannes Oldenburg   +15 more
doaj   +1 more source

Study protocol of a pilot randomised controlled trial assessing the feasibility and acceptability of RecoverEsupport: a digital health intervention to enhance recovery in women undergoing surgery for breast cancer

BMJ Open
Introduction Internationally, breast cancer is the second most diagnosed cancer with approximately 2.3 million people diagnosed each year. 40% will require a mastectomy which has an average length of hospital stay of 1–2 days.
Christopher Oldmeadow, Mitch J Duncan, Penny Reeves, Priscilla Viana da Silva, Rebecca Wyse, Helen Moore, Alison Zucca, Sancha Robinson, Stephen Ridley Smith, Emma Sansalone, Owen Morris, Rebecca Chenery, Lara Riley, Anna Palazzi-Parsons   +13 more
doaj   +1 more source

Policies for study monitoring and interim reporting of results.

, 1987
Interim analyses of comparative trials are necessary in order to monitor for extreme therapeutic results. However, closing studies and reporting results whenever "trends" appear increases the probability of a false conclusion to well over the desired ...
T R Fleming, J R O'Fallon, S J Green
core   +1 more source

The Necessity of Independent Data Monitoring Committee in Domestic Clinical Trials

Korean Journal of Applied Statistics, 2009
In adaptive designs important components of clinical trials may be changed based on the results of interim analysis. Several international guidelines point out that such interim analysis should be performed by independent experts who do not participate in clinical trials when adaptive designs are used in therapeutic confirmatory clinical trials, and if
openaire   +2 more sources

On independent data monitoring committees in oncology clinical trials.

Chinese clinical oncology, 2015
An independent data safety monitoring committee (IDMC) that is established to monitor the safety of participants in a clinical trial has, as its primary purpose, the protection of participants in the trial and the maintenance of the integrity of the trial.
Janet, Wittes, Mark, Schactman
openaire   +1 more source