Results 61 to 70 of about 41,551 (186)

Data sharing among data monitoring committees and responsibilities to patients and science.

, 2013
Over the past three decades it has become increasingly recognized that systematic assessment of as high a proportion as possible of relevant research evidence is needed to protect the best interests of patients and the public. For example, this principle
Richard WI Cooke, Douglas G Altman, Altman, DG, Iain Chalmers, Chalmers, I, Owens, N, McHaffie, H, Hazel McHaffie, Altman, Doug, Cooke, RW, Nancy Owens   +10 more
core   +1 more source

Reducing severe breathlessness with dronabinol in the group of patients with severe and very severe chronic obstructive pulmonary disease (BONG): a randomised, double-blinded, placebo-controlled, crossover study in an outpatient clinic in Denmark – a study protocol

BMJ Open
Introduction Cannabis-based medicine may alleviate breathlessness. This study will investigate whether dronabinol, a synthetic form of Δ9-tetrahydrocannabinol (Δ9-THC), reduces breathlessness in patients with severe and very severe chronic obstructive ...
Anders Løkke, Ole Hilberg, Ingeborg Farver-Vestergaard, Kristina Kock Hansen, Sofie Krogh Wolsing, Charlotte Uggerhøj Andersen   +5 more
doaj   +1 more source

Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences

, 2015
Background: The Medical Research Council Guidelines for Good Clinical Practice outlines a three-committee trial oversight structure - the day-to-day Trial Management Group, the Data Monitoring Committee and the Trial Steering Committee.
Conroy, EJ, Harman, NL, Norrie, J, Gamble, C, Lane, JA, Sydes, MR, Lewis, SC, Murray, G   +7 more
core   +2 more sources

Analysis of factors for non-disclosure of information by doctor-investigators in clinical trials in Malaysia [PDF]

, 2017
In clinical trials, the need to obtain patient’s consent by way of informed consent has been mandatorily imposed as a way to protect the patient as subject.Unfortunately, many studies have shown that the doctor-investigators had failed to disclose full ...
Abdullah, Nor Anita, Megat Latif, Hairuddin, Yusof, Yuhanif, Che Ngah, Anisah, Md Desa, Md Rejab   +4 more
core  

Challenges to Data Monitoring Committees When Regulatory Authorities Intervene. [PDF]

, 2016
New pharmaceutical agents are best evaluated in randomized, controlled clinical trials in which both the safety of participants and the adequacy of conduct are monitored by an independent data monitoring committee as described in reports from regulatory ...
Swedberg, Karl, Rouleau, J., Borer, Jeffrey S, Borer, J. S., Pocock, Stuart, Rouleau, Jean, Swedberg, Karl,, Pitt, B., Pitt, Bertram, Pocock, S.   +9 more
core   +1 more source

Phase 2 study design and analysis approach for BBT-877: an autotaxin inhibitor targeting idiopathic pulmonary fibrosis

BMJ Open Respiratory Research
Introduction Proof-of-concept (POC) studies are vital in determining the feasibility of further drug development, primarily by assessing preliminary efficacy signals with credible endpoints.
Tamera J Corte, Lisa Lancaster, Jin Woo Song, Toby Maher, Peter M George, Jeong Yun, Kyungjin Kim, Mordechai Reuven Kramer, Jimin Cho, Luisa Fernanda Sather, Jin Hyuk Jung, Sujin Jung   +11 more
doaj   +1 more source

Inadequate cancer pain management in Italian clinical trials [PDF]

, 2011
Pain treatment in Italy is far from being optimal. In order to improve this situation, the reporting of a complete assessment of pain in the clinical record became compulsory by law.
Valentina Maggini, Alessandro Mugelli, Ersilia Lucenteforte, Carlo Tomino, Raffaella Maione, Valentina Fabbroni   +5 more
core   +1 more source

Regulation for the Translation of Gene and Cell Therapy into Medical Practice in East Asian Countries

Регуляторные исследования и экспертиза лекарственных средств
SCIENTIFIC RELEVANCE. Currently, the Russian Federation lacks a comprehensive regulatory framework for the use of gene and cell therapy (GCT) products. There is no standard for conducting clinical trials for purposes other than marketing authorisation in
E. V. Melnikova, V. A. Merkulov, O. V. Merkulova   +2 more
doaj   +1 more source

EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents

BMJ Open
Introduction The identification of type 1 diabetes at an early presymptomatic stage has clinical benefits. These include a reduced risk of diabetic ketoacidosis (DKA) at the clinical manifestation of the disease and a significant reduction in clinical ...
, Melanie Gündert, Anette-Gabriele Ziegler, Peter Achenbach, Olga Kordonouri, Agnieszka Szypowska, Ezio Bonifacio, Parth Narendran, Christiane Winkler, R Ribeiro, Sandra Hummel, Przemysława Jarosz-Chobot, Emanuele Bosi, R Lahesmaa, K Casteels, M Peakman, P Jarosz-Chobot, O Kordonouri, Chantal Mathieu, Vito Lampasona, J F Raposo, H Hyöty, F Pociot, João Filipe Raposo, R Berner, R Bergholdt, E Bonifacio, Flemming Pociot, B Petersen, J Van Rampelbergh, L Overbergh, B Van der Schueren, V Lampasona, C Winkler, R Coelho, O Cohen, C Mathieu, E Bosi, Stefanie Arnolds, Lut Overbergh, Zdenek Sumnik, A Koralova, G Sebastiani, Luisa Hoffmann, Mirjam Kohls, Regine Bergholdt, Bianca K Hoefelschweiger, Jurgen Vercauteren, P Gillard, J Vercauteren, A G Ziegler, P Achenbach, F Haupt, S Hummel, T Pieber, J Mader, S Moitzi, S Del Prato, B Torbeyns, Z Sumnik, O Cinek, V Neuman, B Berka, J Antvorskov, J H Klaebel, J E Laiho, F Reschke, T von dem Berge, A Hommel, A Loff, G Gemulla, N Zubizarreta, L Piemonti, F Dotta, A Szypowska, K Karczewski, E Niemoeller, M Baccara-Dinet, K Fogh, M I Buompensiere, C Hurtado del Pozo, E Latres, G Agiostratidou   +82 more
doaj   +1 more source

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

, 2015
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
core   +1 more source