Works matching DE "CLINICAL trial laws"

Results: 247

SALUD Y ALIMENTACIÓN.

Published in:: Actualidad Jurídica (1578-956X), 2014, n. 38, p. 260
Publication type:: Article

Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers.

Published in:

2020

By:

Hwang, Thomas J;
Orenstein, Liat;
DuBois, Steven G;
Janeway, Katherine A;
Bourgeois, Florence T

Publication type:

journal article

Master Protocol Trial Design for Efficient and Rational Evaluation of Novel Therapeutic Oncology Devices.

Published in:

2020

By:

Bitterman, Danielle S;
Cagney, Daniel N;
Singer, Lisa L;
Nguyen, Paul L;
Catalano, Paul J;
Mak, Raymond H

Publication type:

journal article

Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT.

Published in:

Bone Marrow Transplantation, 2011, v. 46, n. 3, p. 443, doi. 10.1038/bmt.2010.139

By:

Frewer, L. J.;
Coles, D.;
van der Lans, I. A.;
Schroeder, D.;
Champion, K.;
Apperley, J. F.

Publication type:

Article

A Guideline for Randomized Controlled Trials of Acupuncture.

Published in:

American Journal of Chinese Medicine, 2019, v. 47, n. 1, p. 1, doi. 10.1142/S0192415X19500010

By:

Chen, Haiyong;
Yang, Mingxiao;
Ning, Zhipeng;
Lam, Wing Lok;
Zhao, Ying Ke;
Yeung, Wing Fai;
Ng, Bacon Fung-Leung;
Ziea, Eric Tat-Chi;
Lao, Lixing

Publication type:

Article

Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation.

Published in:

Clinical Trials, 2022, v. 19, n. 5, p. 573, doi. 10.1177/17407745221093812

By:

Wan, Mandy;
Alessandrini, Elisa;
Brogan, Paul;
Eleftheriou, Despina;
Warris, Adilia;
Brüggemann, Roger;
Turner, Mark

Publication type:

Article

A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial.

Published in:

Clinical Trials, 2015, v. 12, n. 6, p. 677, doi. 10.1177/1740774515591983

By:

Cevallos, Myriam;
Züllig, Stephanie;
Christen, Andri;
Meier, Brigitte E.;
Goetz, Martin;
Coslovsky, Michael;
Trelle, Sven

Publication type:

Article

Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.

Published in:

Clinical Trials, 2015, v. 12, n. 5, p. 476, doi. 10.1177/1740774515597698

By:

Smalley, Jaye Bea;
Merritt, Maria W.;
Al-Khatib, Sana M.;
McCall, Debbe;
Staman, Karen L.;
Stepnowsky, Carl

Publication type:

Article

Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials.

Published in:

Clinical Trials, 2015, v. 12, n. 5, p. 485, doi. 10.1177/1740774515597687

By:

Lantos, John D.;
Wendler, David;
Septimus, Edward;
Wahba, Sarita;
Madigan, Rosemary;
Bliss, Geraldine

Publication type:

Article

Did relaxing clinical trial regulation enhance the stock of scientific knowledge in India? Not necessarily.

Published in:

PLoS ONE, 2019, v. 14, n. 01, p. 1, doi. 10.1371/journal.pone.0210163

By:

Rake, Bastian;
Haeussler, Carolin

Publication type:

Article

ClinicalTrials.gov Reporting: Strategies for Success at an Academic Health Center.

Published in:

CTS: Clinical & Translational Science, 2015, v. 8, n. 1, p. 48, doi. 10.1111/cts.12235

By:

O'Reilly, Erin K.;
Hassell, Nancy J.;
Snyder, Denise C.;
Natoli, Susan;
Liu, Irwin;
Rimmler, Jackie;
Amspacher, Valerie;
Burnett, Bruce K.;
Parrish, Amanda B.;
Berglund, Jelena P.;
Stacy, Mark

Publication type:

Article

Demythologising the ‘Liberalisation’ of Clinical Trial Regulations in India: A Practitioner’s Perspective.

Published in:

Science Technology & Society, 2018, v. 23, n. 3, p. 463, doi. 10.1177/0971721818762932

By:

Regal, Brijesh

Publication type:

Article

Clinical research into the ICU: clouds at the horizon, once again.

Published in:

2013

By:

Matei, Mihaela;
Kompanje, Erwin;
Maas, Andrew;
Menon, David;
Lemaire, Francois

Publication type:

Editorial

Clinical research in Italy in adult patients unable to consent: after implementation of the European Union's Directive 2001/20/CE.

Published in:

2007

By:

Wiedermann, Christian J.;
Almici, Mauro;
Mangione, Salvatore;
Giarratano, Antonello;
Mayr, Oswald

Publication type:

journal article

INCREASING TRANSPARENCY OF CLINICAL TRIAL DATA IN THE UNITED STATES AND THE EUROPEAN UNION.

Published in:

Washington University Global Studies Law Review, 2015, v. 14, n. 3, p. 521

By:

Choi, Rebecca

Publication type:

Article

Navigating the Regulatory Pathways and Requirements for Tissue-Engineered Products in the Treatment of Burns in the United States.

Published in:

2021

By:

Belsky, Kimberly;
Smiell, Janice

Publication type:

journal article

The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research?

Published in:

PLoS Clinical Trials, 2006, v. 3, n. 6, p. 1, doi. 10.1371/journal.pctr.0010013

By:

Hartmann, Markus;
Hartmann-Vareilles, Florence

Publication type:

Article

The Non-Admissibility of the Principle of Therapeutic Privilege in Clinical Trials.

Published in:

Pertanika Journal of Social Sciences & Humanities, 2015, v. 23, p. 47

By:

Yuhanif, Y.;
Anisah, C. N.;
Md Rejab, M. D.

Publication type:

Article

Ethical‐legal evaluation of the use of placebo in clinical trials.

Published in:

Journal of Cosmetic Dermatology, 2021, v. 20, n. 4, p. 1348, doi. 10.1111/jocd.13967

By:

Zareba, Renata;
Rysiak, Edyta;
Przylipiak, Andrzej;
Oscilowska, Ilona

Publication type:

Article

Support the 'Access to Cancer Clinical Trials Act' to Ensure Coverage of Routine Patient-Care Costs.

Published in:

ONS News, 2002, v. 17, n. 9, p. 6

By:

Halpem, Ilisa M.

Publication type:

Article

When two plus two must not equal four.

Published in:

BJU International, 2011, v. 108, n. 1, p. E1, doi. 10.1111/j.1464-410X.2011.10416.x

By:

Wyllie, Michael G.

Publication type:

Article

Legal Matters: Research Under Institutional Review Board Approval: A Clinical Means to a Legal End.

Published in:

Alternative & Complementary Therapies, 2007, v. 13, n. 1, p. 44, doi. 10.1089/act.2006.13108

By:

Dumoff, Alan

Publication type:

Article

Strengthening the FDA's Enforcement of ClinicalTrials.gov Reporting Requirements.

Published in:

JAMA: Journal of the American Medical Association, 2021, v. 326, n. 21, p. 2131, doi. 10.1001/jama.2021.19773

By:

Ramachandran, Reshma;
Morten, Christopher J.;
Ross, Joseph S.

Publication type:

Article

Expanding Evidence for Clinical Care of Older Adults: Beyond Clinical Trial Traditions and Finding New Approaches.

Published in:

2021

By:

Steinman, Michael A.;
Boyd, Cynthia M.;
Schmader, Kenneth E.

Publication type:

journal article

Barriers to the conduct of randomised clinical trials within all disease areas.

Published in:

2017

By:

Djurisic, Snezana;
Rath, Ana;
Gaber, Sabrina;
Garattini, Silvio;
Bertele, Vittorio;
Ngwabyt, Sandra-Nadia;
Hivert, Virginie;
Neugebauer, Edmund A. M.;
Laville, Martine;
Hiesmayr, Michael;
Demotes-Mainard, Jacques;
Kubiak, Christine;
Jakobsen, Janus C.;
Gluud, Christian

Publication type:

journal article

Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.

Published in:

2017

By:

Phillips, Adam T.;
Desai, Nihar R.;
Krumholz, Harlan M.;
Zou, Constance X.;
Miller, Jennifer E.;
Ross, Joseph S.

Publication type:

journal article

Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC).

Published in:

2017

By:

Wade, Julia;
Elliott, Daisy;
Avery, Kerry N. L.;
Gaunt, Daisy;
Young, Grace J.;
Barnes, Rebecca;
Paramasivan, Sangeetha;
Campbell, W. Bruce;
Blazeby, Jane M.;
Birtle, Alison J.;
Stein, Rob C.;
Beard, David J.;
Halliday, Alison W.;
Donovan, Jenny L.;
ProtecT study group;
CLASS study group;
Chemorad study group;
POUT study group;
OPTIMA prelim study group;
CSAW study group and ACST-2 study group

Publication type:

journal article

MAIN CHALLENGES AND PROSPECTS OF IMPROVING UKRAINIAN LEGISLATION ON CRIMINAL LIABILITY FOR CRIMES RELATED TO DRUG TESTING IN THE CONTEXT OF EUROPEAN INTEGRATION.

Published in:

Jurisprudence / Jurisprudencija, 2013, v. 20, n. 3, p. 1249, doi. 10.13165/JUR-13-20-3-20

By:

Grebeniuk, Olena

Publication type:

Article

The Essentials of Clinical Trial Management: Addressing Needs for Successful Outcomes.

Published in:

Journal of Medical Evidence, 2024, v. 5, n. 4, p. 338, doi. 10.4103/JME.JME_164_24

By:

Kumar, Gunjan;
Mukherjee, Aparna

Publication type:

Article

Regulatory developments in the conduct of clinical trials in India.

Published in:

Global Health, Epidemiology & Genomics, 2016, v. 1, p. 1, doi. 10.1017/gheg.2015.5

By:

Chaudhury, R. Roy;
Mehta, D.

Publication type:

Article

NIDA's Pharmacologic Calvinism.

Published in:

2016

By:

Macklin, Ruth

Publication type:

Opinion

Changes Need To Be Made To Make Research More Feasible on Scheduled Drugs for Recreational Purposes as Well.

Published in:

American Journal of Bioethics, 2016, v. 16, n. 4, p. 58, doi. 10.1080/15265161.2016.1145286

By:

Brenner, Jay

Publication type:

Article

Research Moratoria and Off-Label Use of Ketamine.

Published in:

American Journal of Bioethics, 2016, v. 16, n. 4, p. 60, doi. 10.1080/15265161.2016.1145285

By:

Segal, Andrea;
Sisti, Dominic

Publication type:

Article

An Ethical Exploration of Barriers to Research on Controlled Drugs.

Published in:

American Journal of Bioethics, 2016, v. 16, n. 4, p. 36, doi. 10.1080/15265161.2016.1145282

By:

Andreae, Michael H.;
Rhodes, Evelyn;
Bourgoise, Tyler;
Carter, George M.;
White, Robert S.;
Indyk, Debbie;
Sacks, Henry;
Rhodes, Rosamond

Publication type:

Article

Urge Overkill: Protecting Deidentified Human Subjects at What Price?

Published in:

American Journal of Bioethics, 2010, v. 10, n. 9, p. 17, doi. 10.1080/15265161.2010.494217

By:

Angrist, Misha

Publication type:

Article

If Children Understand Drawing Straws and Flipping Coins, Research Participants Can Understand Randomization.

Published in:

American Journal of Bioethics, 2009, v. 9, n. 2, p. 19, doi. 10.1080/15265160802657775

By:

Howick, Jeremy

Publication type:

Article

Efficacy and Enlightenment: LSD Psychotherapy and the Drug Amendments of 1962.

Published in:

Journal of the History of Medicine & Allied Sciences, 2014, v. 69, n. 2, p. 221, doi. 10.1093/jhmas/jrs050

By:

Oram, Matthew

Publication type:

Article

Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS.

Published in:

2018

By:

Kim, Jeanie;
Ross, Joseph S.;
Kapczynski, Amy

Publication type:

journal article

Ensuring Respect for Human Research Participants.

Published in:

2016

By:

Doernberg, Samuel N.;
Wendler, David

Publication type:

Opinion

The 50th Anniversary of the Declaration of Helsinki.

Published in:

JAMA: Journal of the American Medical Association, 2013, v. 310, n. 20, p. 2143, doi. 10.1001/jama.2013.281632

By:

Millum, Joseph;
Wendler, David;
Emanuel, Ezekiel J.

Publication type:

Article

RESEARCHER ACCESS TO SOCIAL MEDIA DATA: LESSONS FROM CLINICAL TRIAL DATA SHARING.

Published in:

Berkeley Technology Law Journal, 2024, v. 39, n. 1, p. 111, doi. 10.15779/Z38QF8JK81

By:

Morten, Christopher J.;
Nicholas, Gabriel;
Viljoen, Salomé

Publication type:

Article

Clinical trial registration and reporting: a survey of academic organizations in the United States.

Published in:

2018

By:

Mayo-Wilson, Evan;
Heyward, James;
Keyes, Anthony;
Reynolds, Jesse;
White, Sarah;
Atri, Nidhi;
Alexander, Caleb;
Omar, Audrey;
Ford, Daniel E.;
on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee;
Alexander, G Caleb;
National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee

Publication type:

journal article