Works matching DE "CLINICAL trial laws"

Results: 246

Dengue vaccines regulatory pathways: a report on two meetings with regulators of developing countries.

Published in:

2011

By:

Mahoney, Richard;
Chocarro, Liliana;
Southern, James;
Francis, Donald P.;
Vose, John;
Margolis, Harold

Publication type:

research

Reducing disparities in the burden of cancer: the role of patient navigators.

Published in:

2006

By:

Fowler, Tisha;
Steakley, Caryn;
Garcia, A. Roland;
Kwok, Jennifer;
Bennett, L. Michelle

Publication type:

journal 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

State Clinical Regulations Service Debuts.

Published in:: Bio-IT World, 2003, v. 2, n. 1, p. 74
Publication type:: Article

Phase I studies in EU: due change in compliance and transparency under the EU clinical trials regulation.

Published in:

2022

By:

De Mey, Christian Martin

Publication type:

Letter

Non-commercial trials on medicines submitted to the Ethics Committee of the University Hospital of Bologna (Italy) along 8 years of activity: time to update rules and recommendations.

Published in:

European Journal of Clinical Pharmacology, 2019, v. 75, n. 10, p. 1415, doi. 10.1007/s00228-019-02706-0

By:

Montanaro, Nicola;
Bonaldo, Giulia;
Proni, Stefania;
Chiabrando, Giacomo;
Motola, Domenico

Publication type:

Article

Practical risk management in early phase clinical trials.

Published in:

European Journal of Clinical Pharmacology, 2019, v. 75, n. 4, p. 483, doi. 10.1007/s00228-018-02607-8

By:

Coates, Simon;
Täubel, Jörg;
Lorch, Ulrike

Publication type:

Article

The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency.

Published in:

European Journal of Clinical Pharmacology, 2015, v. 71, n. 10, p. 1159, doi. 10.1007/s00228-015-1897-9

By:

Pansieri, Claudia;
Pandolfini, Chiara;
Bonati, Maurizio

Publication type:

Article

Ethics Committee Application Procedures in Clinical Trials.

Published in:

Haydarpasa Numune Medical Journal, 2024, v. 64, n. 1, p. 104, doi. 10.14744/hnhj.2022.56667

By:

İlbars, Hilal;
Bebitoğlu, Berna Terzioğlu

Publication type:

Article

House bill would bolster protection of humans in clinical trials.

Published in:: Issues in Science & Technology, 2002, v. 19, n. 1, p. 24
Publication type:: Article

New European Clinical Trial Regulation: The Requirement for Lay Summaries and Its Impact on Medical Communicators.

Published in:

AMWA Journal: American Medical Writers Association Journal, 2015, v. 30, n. 2, p. 60

By:

Brauburger, Katharina;
Sroka-Saidi, Kamila;
Schindler, Thomas M.

Publication type:

Article

Publication Planners and Medical Writers: A Natural Alliance.

Published in:

AMWA Journal: American Medical Writers Association Journal, 2011, v. 26, n. 1, p. 8

By:

Charles, Leslie;
Reidenbach, Faith

Publication type:

Article

BRIEFLY NOTED.

Published in:

AMWA Journal: American Medical Writers Association Journal, 2007, v. 22, n. 4, p. 195

By:

Reidenbach, Faith

Publication type:

Article

Scientific Trials-In the Laboratories, Not the Courts.

Published in:

2018

By:

Bagley, Nicolas;
Carroll, Aaron E.;
Cohen, Pieter A.

Publication type:

journal 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

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

Consequences of Directive 2001/20/EC for investigator-initiated trials in the paediatric population--a field report.

Published in:

2007

By:

Welzing, Lars;
Harnischmacher, Urs;
Weyersberg, Annic;
Roth, Bernhard

Publication type:

journal article

Legal protection of the rights of clinical trial subjects in China.

Published in:

Journal of Biomedical Research, 2018, v. 32, n. 2, p. 77, doi. 10.7555/JBR.32.20170073

By:

Yuanpeng Ren;
Xinrui Jin;
Shan Jiang;
Baisheng Jiang

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

Editorial: Are clinical trial authorisations truly being harmonised?

Published in:

2004

By:

Horton, Linda R.

Publication type:

Editorial

Clinical trials in the pharmaceutical industry: The scope of the research exemption under French patent law -- clarification is still awaited.

Published in:

Journal of Commercial Biotechnology, 2002, v. 9, n. 1, p. 67

By:

Couste, Marina;
Jonqueres, Francois

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

Length and complexity of US and international HIV consent forms from federal HIV network trials.

Published in:

2011

By:

Kass, Nancy;
Chaisson, Lelia;
Taylor, Holly;
Lohse, Jennifer;
Kass, Nancy E;
Taylor, Holly A

Publication type:

journal article

Trial registration for public trust: making the case for medical devices.

Published in:

2008

By:

Sim, Ida

Publication type:

journal article

India mulling stricter laws to curb unethical trials.

Published in:

Nature Medicine, 2012, v. 18, n. 2, p. 182, doi. 10.1038/nm0212-182

By:

Jayaraman, Killugudi

Publication type:

Article

Transparency initiative moves ahead despite official's departure.

Published in:

Nature Medicine, 2011, v. 17, n. 2, p. 141, doi. 10.1038/nm0211-141b

By:

Schubert, Charlotte

Publication type:

Article

News feature: Trials and tribulations.

Published in:

Nature Medicine, 2007, v. 13, n. 3, p. 272, doi. 10.1038/nm0307-272

By:

Mandavilli, Apoorva

Publication type:

Article

European researchers up in arms over new clinical trials edict.

Published in:

Nature Medicine, 2003, v. 9, n. 11, p. 1336, doi. 10.1038/nm1103-1336b

By:

Bosch, Xavier

Publication type:

Article

UK cancer charities concerned about new EU regulations.

Published in:

Nature Medicine, 2001, v. 7, n. 12, p. 1264, doi. 10.1038/nm1201-1264a

By:

Dickson, David

Publication type:

Article

The effect of the European Clinical Trials Directive on published drug research in anaesthesia.

Published in:

Anaesthesia, 2009, v. 64, n. 9, p. 984, doi. 10.1111/j.1365-2044.2009.06011.x

By:

Walker, E.;
Hankins, M. C.;
White, S. M.

Publication type:

Article

The Editor as umpire: clinical trial registration and dispute resolution.

Published in:

2006

By:

Bogod, D. G.

Publication type:

Editorial

Living with the European Clinical Trials Directive: one year on.

Published in:

2005

By:

Hall, Judith E.;
Diaz-Navarro, Cristina

Publication type:

Editorial

SALUD Y ALIMENTACIÓN.

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

Inclusion of patients with severe mental illness in clinical trials: issues and recommendations surrounding informed consent.

Published in:

2006

By:

Welie, Sander P. K.;
Berghmans, Ron L. P.

Publication type:

journal article

Regulatory environment for clinical research: Recent past and expected future.

Published in:

Perspectives in Clinical Research, 2017, v. 8, n. 1, p. 11, doi. 10.4103/2229-3485.198551

By:

Bhave, Amita;
Menon, Suresh

Publication type:

Article

Opinions and perceptions regarding the impact of new regulatory guidelines: A survey in Indian Clinical Trial Investigators.

Published in:

Perspectives in Clinical Research, 2016, v. 7, n. 2, p. 81, doi. 10.4103/2229-3485.179437

By:

Kadam, Rashmi;
Borde, Sanghratna;
Madas, Sapna;
Nagarkar, Aarti;
Salvi, Sundeep;
Limaye, Sneha

Publication type:

Article

Indian Regulatory Update: Jan-May 2014.

Published in:

Perspectives in Clinical Research, 2014, v. 5, n. 3, p. 139, doi. 10.4103/2229-3485.134322

By:

Suvarnapathaki, Kedar

Publication type:

Article

India's next challenge: Rebooting recruitment.

Published in:

2014

By:

Bhatt, Arun

Publication type:

Editorial

Impact of recent regulations.

Published in:

2013

By:

George, Bobby

Publication type:

Editorial

Compensation conundrum.

Published in:

Perspectives in Clinical Research, 2012, v. 3, n. 1, p. 4, doi. 10.4103/2229-3485.92300

By:

Mukherjee, Shoibal

Publication type:

Article

Time Spent for Activation of Non-Profit Studies in Oncology in Italy.

Published in:

PLoS ONE, 2010, v. 5, n. 7, p. 1, doi. 10.1371/journal.pone.0011864

By:

De Feo, Gianfranco;
Signoriello, Simona;
Bryce, Jane C.;
Del Giudice, Antonia;
Canzanella, Giuliana;
Crudele, Federika;
Romano, Fiorella;
de Matteis, Giovanni;
Florio, Manuela;
Falasconi, Fabiano;
Savio, Alfonso;
Giordano, Pasqualina;
Daniele, Gennaro;
Iaccarino, Mario;
Piccirillo, Maria Carmela;
Di Maio, Massimo;
Morabito, Alessandro;
Gallo, Ciro;
Perrone, Francesco

Publication type:

Article

Research and the Privacy Rule: The Chill Is On.

Published in:

Journal of Health Care Compliance, 2008, v. 10, n. 5, p. 35

By:

Brown, Bob

Publication type:

Article

Placebos that harm: sham surgery controls in clinical trials.

Published in:

2002

By:

London, Alex John;
Kadane, Joseph B.

Publication type:

journal article

Developing a nurse-led clinic for patients enrolled in clinical trials.

Published in:: 2011
Publication type:: Journal Article

Drug tests on trial.

Published in:: Chemistry & Industry, 2013, v. 77, n. 4, p. 45, doi. 10.1002/cind.7704_13.x
Publication type:: Article