Results 31 to 40 of about 29,514,683 (309)

‘We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact

Trials, 2017
Background The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor.
Anne Daykin, Lucy E. Selman, Helen Cramer, Sharon McCann, Gillian W. Shorter, Matthew R. Sydes, Carrol Gamble, Rhiannon Macefield, J. Athene Lane, Alison Shaw   +9 more
doaj   +1 more source

Establishing a data monitoring committee for clinical trials.

Shanghai archives of psychiatry, 2014
A data monitoring committee (DMC) is a group of clinicians and biostatisticians appointed by study sponsors who provide independent assessment of the safety, scientific validity and integrity of clinical trials. In the United States, the Food and Drug Administration requires the formation of DMC in all trials that assess new interventions. DMC are also
LIN, Julia Y, LU, Ying
openaire   +2 more sources

A statistical framework for quantifying clinical equipoise for individual cases during randomized controlled surgical trials [PDF]

, 2011
Background Randomised controlled trials are being increasingly used to evaluate new surgical interventions. There are a number of problematic methodological issues specific to surgical trials, the most important being identifying whether patients are ...
Girling, Alan, Girling Alan, Parsons, Nicholas R., Parsons, NR, Alan Girling, Griffin Damian, Girling, Alan J., Yuri Kulikov, Kulikov Yuri, Damian Griffin, Parsons Nicholas R, Griffin, Damian R., Griffin, D, Kulikov, Y, Kulikov, Yuri, Nicholas R Parsons   +15 more
core   +2 more sources

Pharmacokinetic research in children: an analysis of registered records of clinical trials. [PDF]

, 2011
BACKGROUND: Reported off-label/unlicensed prescribing rates in children range from 11% to 80%. Research into pharmacokinetic profiles of children's medicines is essential in the creation of more knowledge on the safety and efficacy of medicines in ...
Rademaker, Carin MA, Viergever, Roderik F, C. M. A. Rademaker, Ghersi, Davina, D. Ghersi, R. F. Viergever   +5 more
core   +1 more source

Accreditation of human research protection program: An Indian perspective

Perspectives in Clinical Research, 2012
With the increasing number of clinical trials being placed in India, it is the collective responsibility of the Investigator sites, Government, Ethics Committees, and Sponsors to ensure that the trial subjects are protected from risks these studies can ...
K L Bairy, Pratibha Pereira
doaj   +1 more source

Trends in mental health clinical research: Characterizing the ClinicalTrials.gov registry from 2007-2018.

PLoS ONE, 2020
While the epidemiologic burden of mental health disorders in the United States has been well described over the past decade, we know relatively little about trends in how these disorders are being studied through clinical research.
Joshua R Wortzel, Brandon E Turner, Brannon T Weeks, Christopher Fragassi, Virginia Ramos, Thanh Truong, Desiree Li, Omar Sahak, Hochang Benjamin Lee   +8 more
doaj   +1 more source

American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials [PDF]

, 2011
Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials.
Matucci-Cerinic, M., Richards, P., American College of Rheumatology,, Robert Landewé, Pamela Richards, Alan Tyndall, Wit, M. de, Siegel, Jeffrey N., John Kirwan, Gillian Hawker, Daniel Aletaha, Simon, L.S., Dougados, Maxime, White, Barbara, Montie, Pamela, Kvien, T.K., Andrew Brown, Funovits, J., Combe, Bernard, Aletaha, Daniel, Tuyl, H.D. van, Tuulikki Sokka, Brooks, Peter, Brown, Andrew, Kirwan, J, Josef S. Smolen, Bathon, J., Suzan Verstappen, Choi, Hyon, Allaart, Cornelia F, Furst, Daniel E., Kaleb Michaud, Heijde, D. van der, van der Heijde, D., George Wells, Cornelia F Allaart, Furst, D., Landewe, R., Josef S Smolen, Brooks, Peter M., Allaart, Cornelia F., Sokka, Tuulikki, Maarten de Wit, David T. Felson, Peter Brooks, Verstappen, Suzan, Boers, M., Choi, H., Khanna, Dinesh, Khanna, D., Aletaha, D., Strand, Vibeke, Bombardieri, Stefano, Kvien, Tore K., Wolfe, F, Boers, Maarten, Stefano Bombardieri, Listing, J., Tugwell, P, Zhang, B., Joan Bathon, Lee S. Simon, Barbara White, Richards, Pamela, Wolfe, Frederick, Sokka, T., Maxime Dougados, Angela Zink, van Tuyl, Lilian H. D., van Tuyl, H.D., Hawker, G., Brown, A., Felson, David T., Paul Emery, Keystone, E., Bathon, Joan, Listing, Joachim, Verstappen, S., Zink, Angela, Combe, B., Michaud, K., Hyon Choi, Wolfe, F., Daniel Furst, Joachim Listing, Funovits, Julia, Gomez-Reino, J., de Wit, Maarten P. T., Emery, Paul, Gomez-Reino, Juan, Wells, George, Jeffrey N Siegel, Lilian H D van Tuyl, Theodore Pincus, Zink, A., Michaud, Kaleb, Marco Matucci-Cerinic, Tyndall, A., Lee S Simon, Keystone, Edward, European League Against Rheumatism,, Landewé, Robert, Emery, P., Julia Funovits, Zhang, Bi, Jeffrey N. Siegel, Maarten Boers, Van Tuyl, Lilian H D, de Wit, Maarten, Pincus, T., Hawker, Gillian, Strand, V., Edward Keystone, Frederick Wolfe, Martin-Mola, E., Pamela Montie, de Wit, M., van Tuyl, L.H.D., Tore K. Kvien, Cornelia F. Allaart, Emilio Martin-Mola, Matucci-Cerinic, Marco, Emery, P, Zhang, Bin, Tyndall, Alan, Bernard Combe, Dougados, M., Kirwan, J., David T Felson, Tugwell, Peter, Allaart, C.F., Brown, A, Juan Gomez-Reino, Vibeke Strand, Tuyl, L.H.D. van, Montie, P., Brooks, P., Peter Tugwell, Kirwan, John, Simon, Lee S., Furst, Daniel, Bombardieri, S., van der Heijde, Desirée, Dinesh Khanna, White, B., Pincus, Theodore, Wells, G., Siegel, J.N., Martin-Mola, Emilio, Tugwell, P., Felson, D.T., Desirée van der Heijde, Smolen, Josef S., Lilian H. D. van Tuyl, Smolen, J.S., Strand, V, Bin Zhang   +156 more
core   +2 more sources

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

Frontiers in Pharmacology, 2017
The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have
Ignacio Segarra, Pilar Modamio, Cecilia Fernández, Eduardo L. Mariño   +3 more
doaj   +1 more source

Adverse events following immunization against SARS-CoV-2 (covid-19) in the state of Minas Gerais

Revista de Saúde Pública
OBJECTIVE To analyze adverse events following immunization (AEFI) against SARS-CoV-2 (covid-19) in the state of Minas Gerais (MG), Brazil. METHODS Epidemiological, descriptive study, with data from e-SUS Notifica (e-SUS Notification) in the state of ...
Roberta Barros da Silva, Thales Philipe Rodrigues da Silva, Ana Paula Sayuri Sato, Francisco Carlos Felix Lana, Josianne Dias Gusmão, Janaina Fonseca Almeida Souza, Fernanda Penido Matozinhos   +6 more
doaj   +2 more sources

Stopping at Nothing? Some Dilemmas of Data Monitoring in Clinical Trials

, 2007
This commentary reviews the argument that clinical trials with data monitoring committees that use statistical stopping guidelines should generally not be stopped early for large observed efficacy differences because efficacy estimates may be exaggerated
Goodman, Steven N.
core   +1 more source