Results 11 to 20 of about 3,635,661 (309)

How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis [PDF]

, 2020
Introduction Adaptive designs offer a flexible approach, allowing changes to a trial based on examinations of the data as it progresses. Adaptive clinical trials are becoming a popular choice, as the prudent use of finite research budgets and accurate ...
Brennan, Alan, Flight, Laura, Hind, Daniel, Julious, Steven, Todd, Susan Todd   +4 more
core   +2 more sources

Cancer Clinical Trials Optimization and Pharmacogenomics [PDF]

, 2012
A critical overview of recent clinical trials in cancer is presented focused on signaling pathways blockers or inhibitors with a view to developing successful clinical trials employing personalized cancer therapies.
I. C. Baianu
core   +2 more sources

Accessing routinely collected health data to improve clinical trials: recent experience of access

Trials, 2021
Background Routinely collected electronic health records (EHRs) have the potential to enhance randomised controlled trials (RCTs) by facilitating recruitment and follow-up.
Archie Macnair, Sharon B. Love, Macey L. Murray, Duncan C. Gilbert, Mahesh K. B. Parmar, Tom Denwood, James Carpenter, Matthew R. Sydes, Ruth E. Langley, Fay H. Cafferty   +9 more
doaj   +1 more source

How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

Digital Biomarkers, 2023
Introduction: Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is limited ...
Brian Perry, Lindsay Kehoe, Teresa Swezey, Quentin Le Masne, Jörg Goldhahn, Alicia Staley, Amy Corneli   +6 more
doaj   +1 more source

Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT [PDF]

, 2011
The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative ...
A Hartmann, A Hemminiki, B Keim, B Moulton, D Coles, D Lacombe, D Schroeder, D van Vyve, F Meunier, I A van der Lans, J F Apperley, K Champion, L Berendt, L J Frewer, LJ Frewer   +14 more
core   +3 more sources

What to do about poor clinical performance in clinical trials [PDF]

, 2002
The performance of individual clinicians is being monitored as never before. Su Mason and colleagues discuss the implications of this for clinical trials and recommend what should happen if during a trial the performance of one clinician or one centre is
Lilford, R., Mason, S., Nicholl, J.
core   +2 more sources

Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative. [PDF]

, 2018
Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to ...
Benjamin, Daniel K, Bradley, John, Corneli, Amy, Farley, John, Greenberg, Rachel G, Jafri, Hasan S, Lin, Li, Nambiar, Sumathi, Noel, Gary J, Roberts, Jamie, Smith, P Brian, Tiernan, Rosemary, Wheeler, Chris   +12 more
core   +2 more sources

Early and Differential Diagnosis of Dementia and Mild Cognitive Impairment Design and Cohort Baseline Characteristics of the German Dementia Competence Network [PDF]

, 2009
Background: The German Dementia Competence Network (DCN) has established procedures for standardized multicenter acquisition of clinical, biological and imaging data, for centralized data management, and for the evaluation of new treatments.
Frölich, Lutz, Gertz, Hermann-Josef, Hampel, Harald, Henn, Fritz, Heuser, Isabella, Huell, Michael, Jahn, Holger, Jessen, Frank, Kornhuber, Johannes, Luckhaus, Christian, Maier, Wolfgang, Pantel, Johannes, Perneczky, Robert, Peters, Oliver, Rienhoff, Otto, Ruüther, Eckart, Schmidtke, Klaus, Schroeder, Johannes, Seuchter, Susanne A., Weih, Markus, Wiltfang, Jens, Wolf, Stefanie   +21 more
core   +1 more source

This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols

Trials, 2019
Background There are limited research and literature on the trial management challenges encountered in running adaptive platform trials. This trial design allows both (1) the seamless addition of new research comparisons when compelling clinical and ...
Francesca Schiavone, Riya Bathia, Krishna Letchemanan, Lindsey Masters, Claire Amos, Anna Bara, Louise Brown, Clare Gilson, Cheryl Pugh, Nafisah Atako, Fleur Hudson, Mahesh Parmar, Ruth Langley, Richard S. Kaplan, Chris Parker, Gert Attard, Noel W. Clarke, Silke Gillessen, Nicholas D. James, Tim Maughan, Matthew R. Sydes, On behalf of past and present members of the STAMPEDE and FOCUS4 Trial Management Group   +21 more
doaj   +1 more source

Neutropenia as an adverse event following vaccination : results from randomized clinical trials in healthy adults and systematic review [PDF]

, 2016
Background : In the context of early vaccine trials aimed at evaluating the safety profile of novel vaccines, abnormal haematological values, such as neutropenia, are often reported.
Aerssens, Annelies, Anemona, Alessandra, Bodinham, Caroline L, Groth, Nicola, Launay, Odile, Leroux-Roels, Geert, Lewis, David, Loulergue, Pierre, Muturi-Kioi, Vincent, Podda, Audino, Saul, Allan   +10 more
core   +4 more sources