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Literature DB >> 21533012

Fundamentals of clinical trial design.

Abstract

Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. Issues in trial conduct and analyses should be anticipated during trial design and thoughtfully addressed. Fundamental clinical trial design issues are discussed.

Entities: Chemical Disease Species

Year: 2010 PMID： 21533012 PMCID： PMC3083073 DOI： 10.6030/1939-067x-3.1.19

Source DB: PubMed Journal: J Exp Stroke Transl Med ISSN： 1939-067X

5 in total

1. Duration of symptoms and plasma cytokine levels in patients with the common cold treated with zinc acetate. A randomized, double-blind, placebo-controlled trial.

Authors: A S Prasad; J T Fitzgerald; B Bao; F W Beck; P H Chandrasekar
Journal: Ann Intern Med Date: 2000-08-15 Impact factor: 25.391

2. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee.

Authors:
Journal: Lancet Date: 1996-11-16 Impact factor: 79.321

3. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events.

Authors: Deepak L Bhatt; Keith A A Fox; Werner Hacke; Peter B Berger; Henry R Black; William E Boden; Patrice Cacoub; Eric A Cohen; Mark A Creager; J Donald Easton; Marcus D Flather; Steven M Haffner; Christian W Hamm; Graeme J Hankey; S Claiborne Johnston; Koon-Hou Mak; Jean-Louis Mas; Gilles Montalescot; Thomas A Pearson; P Gabriel Steg; Steven R Steinhubl; Michael A Weber; Danielle M Brennan; Liz Fabry-Ribaudo; Joan Booth; Eric J Topol
Journal: N Engl J Med Date: 2006-03-12 Impact factor: 91.245

4. Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial.

Authors: Hans-Christoph Diener; Julien Bogousslavsky; Lawrence M Brass; Claudio Cimminiello; Laszlo Csiba; Markku Kaste; Didier Leys; Jordi Matias-Guiu; Hans-Jürgen Rupprecht
Journal: Lancet Date: 2004 Jul 24-30 Impact factor: 79.321

5. A randomized trial evaluating Prosaptide for HIV-associated sensory neuropathies: use of an electronic diary to record neuropathic pain.

Authors: Scott R Evans; David M Simpson; Douglas W Kitch; Agnes King; David B Clifford; Bruce A Cohen; Justin C McArthur
Journal: PLoS One Date: 2007-07-25 Impact factor: 3.240

5 in total

12 in total

Review 1. QSAR without borders.

Authors: Eugene N Muratov; Jürgen Bajorath; Robert P Sheridan; Igor V Tetko; Dmitry Filimonov; Vladimir Poroikov; Tudor I Oprea; Igor I Baskin; Alexandre Varnek; Adrian Roitberg; Olexandr Isayev; Stefano Curtarolo; Denis Fourches; Yoram Cohen; Alan Aspuru-Guzik; David A Winkler; Dimitris Agrafiotis; Artem Cherkasov; Alexander Tropsha
Journal: Chem Soc Rev Date: 2020-05-01 Impact factor: 54.564

2. Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study.

Authors: Christian Hoppe; Patrick Obermeier; Susann Muehlhans; Maren Alchikh; Lea Seeber; Franziska Tief; Katharina Karsch; Xi Chen; Sindy Boettcher; Sabine Diedrich; Tim Conrad; Bron Kisler; Barbara Rath
Journal: Drug Saf Date: 2016-10 Impact factor: 5.606

Review 3. Benefit-risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations.

Authors: Bethea A Kleykamp; Robert H Dworkin; Dennis C Turk; Zubin Bhagwagar; Penney Cowan; Christopher Eccleston; Susan S Ellenberg; Scott R Evans; John T Farrar; Roy L Freeman; Louis P Garrison; Jennifer S Gewandter; Veeraindar Goli; Smriti Iyengar; Alejandro R Jadad; Mark P Jensen; Roderick Junor; Nathaniel P Katz; J Patrick Kesslak; Ernest A Kopecky; Dmitri Lissin; John D Markman; Michael P McDermott; Philip J Mease; Alec B O'Connor; Kushang V Patel; Srinivasa N Raja; Michael C Rowbotham; Cristina Sampaio; Jasvinder A Singh; Ilona Steigerwald; Vibeke Strand; Leslie A Tive; Jeffrey Tobias; Ajay D Wasan; Hilary D Wilson
Journal: Pain Date: 2021-09-09 Impact factor: 7.926

Review 4. Strategies for dealing with missing data in clinical trials: from design to analysis.

Authors: James D Dziura; Lori A Post; Qing Zhao; Zhixuan Fu; Peter Peduzzi
Journal: Yale J Biol Med Date: 2013-09-20

5. Enaminone Modulators of Extrasynaptic α₄β₃δ γ-Aminobutyric Acid_A Receptors Reverse Electrographic Status Epilepticus in the Rat After Acute Organophosphorus Poisoning.

Authors: Timothy B C Johnstone; Hilary S McCarren; Jay Spampanato; F Edward Dudek; John H McDonough; Derk Hogenkamp; Kelvin W Gee
Journal: Front Pharmacol Date: 2019-05-24 Impact factor: 5.810

Review 6. A reintroduction of environmental mite allergen control strategies for asthma treatment and the debate on their effectiveness.

Authors: Frank E van Boven; Lidia R Arends; Gert-Jan Braunstahl; Roy Gerth van Wijk
Journal: Clin Exp Allergy Date: 2019-02-11 Impact factor: 5.018

7. Effectiveness and acceptability of cognitive-behavioural therapy based interventions for maternal peripartum depression: a systematic review, meta-analysis and thematic synthesis protocol.

Authors: Danelle Pettman; Heather O'Mahen; Agneta Skoog Svanberg; Louise von Essen; Cathrine Axfors; Oscar Blomberg; Joanne Woodford
Journal: BMJ Open Date: 2019-12-22 Impact factor: 2.692