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Forskrifter og veiledninger

Forskrift om kliniske utprøvinger til mennesker (Lenke til Lovdata)
Veiledning til forskrift om kliniske utprøvinger til mennesker
Krav til til farmasøytisk og kjemisk dokumentasjon for legemidler til klinisk utprøving

Se ellers Statens legemiddelverkets Webside for kliniske utprøvninger.

 

Artikkelsamling om klinisk forskning og publikasjoner fra Tidsskrift for Den norske lægeforening 2001:

Ny versjon av Helsinkideklarasjonen
Reidun Førde. Tidsskr Nor Lægeforen 2001; 121: 663
Helsinkideklarasjonen fra Verdens legeforening
Tidsskr Nor Lægeforen 2001; 121: 752
Oversettelsen er godkjent av Den nasjonale forskningsetiske komité for medisin og Den norske lægeforening.
Hva er Helsinkideklarasjonen
Tidsskr Nor Lægeforen 2001; 121: 752
Om å stille kritiske spørsmål til legemiddelindustrien
Knut Arne Holtedahl Eivind Meland Atle Klovning. Tidsskr Nor Lægeforen 2001; 121: 1403-4
Ingen skyr Allmennmedisinsk forskningsutvalg
Dag Solbu Atle Skattebøl. Tidsskr Nor Lægeforen 2001; 121: 2095
Legers forhold til legemiddelindustrien
Hans Petter Aarseth. Tidsskr Nor Lægeforen 2001; 121: 2112
Mot større åpenhet i forskningsetikken
Kari Ronge. Tidsskr Nor Lægeforen 2001; 121: 2209-10
Sponsing, forfatterskap og ansvarlighet
Frank Davidoff Catherine D. DeAngelis Jeffrey M. Drazen John Hoey Liselotte Højgaard Richard Horton Sheldon Kotzin M. Gary Nicholls Magne Nylenna John P.M. Overbeke Harold C. Sox Martin B. van der Weyden Michael S. Wilkes. Tidsskr Nor Lægeforen 2001; 121: 2531-2
Legemiddelindustrien og Vancouver-gruppens nye anbefalinger
Henrik Lund. Tidsskr Nor Lægeforen 2001; 121: 2851
Omkamp om Helsinkideklarasjonen
Hans Petter Aarseth. Tidsskr Nor Lægeforen 2001; 121: 3129
Helsinkideklarasjonen i ny utgave
Hans Petter Aarseth. Tidsskr Nor Lægeforen 2000; 120: 3214

 

Relevante dokumenter fra amerikanske Office of Evaluation and Inspections (under Department of Health and Human Services' (HHS) Office of Inspector General (OIG)):

The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects (OEI-01-00-00190; 09/01)
Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research
(OEI-01-97-00195; 6/00)
Recruiting Human Subjects: Sample Guidelines for Practice (OEI-01-97-00196;
6/00)
FDA Oversight of Clinical Investigators (OEI-05-99-00350; 6/00)
Protecting Human Research Subjects: Status of Recommendations
(OEI-01-97-00197; 4/00)

 

Artikkelsamling om klinisk forskning 2002

Walsh BT, Seidman SN, Sysko R, Gould M.  Placebo response in studies of major depression: variable, substantial, and growing. JAMA. 2002;287:1840-1847 

S. D. Halpern, J. H. T. Karlawish, J. A. Berlin. The Continuing Unethical Conduct of Underpowered Clinical Trials. JAMA. 2002;288:358-362

A. H. Partridge, E. P. Winer. Informing Clinical Trial Participants About Study Results. JAMA. 2002;288:363-5.

C.P. Gross, R. Mallory, A. Heiat, H.M. Krumholz. Reporting the Recruitment Process in Clinical Trials: Who Are These Patients and How Did They Get There? Ann Intern Med. 2002;137:10-16.

Horng, Sam, Emanuel, Ezekiel J., Wilfond, Benjamin, Rackoff, Jonathan, Martz, Karen, Grady, Christine. Descriptions of Benefits and Risks in Consent Forms for Phase 1 Oncology Trials. N Engl J Med 2002 347: 2134-2140

Alison Tonks. A clinical trials register for Europe BMJ 2002;325 1314-1315 http://bmj.com/cgi/content/full/325/7376/1314?etoc

Zelda Di Blasi, Ted J Kaptchuk, John Weinman, and Jos Kleijnen. Informing participants of allocation to placebo at trial closure: postal survey. BMJ 2002;325 1329 http://bmj.com/cgi/content/abstract/325/7376/1329?etoc

D.E. Moerman and W.B. Jonas. Deconstructing the Placebo Effect and Finding the Meaning Response. Ann Intern Med. 2002;136:471-476

N. Dickert, E. Emanuel, and C. Grady. Paying Research Subjects: An Analysis of Current Policies. Ann Intern Med. 2002;136:368-373.

S.L. Coyle. Physician-Industry Relations. Part 1: Individual Physicians. Ann Intern Med. 2002;136:396-402.

S.L. Coyle. Physician-Industry Relations. Part 2: Organizational Issues. Ann Intern Med. 2002;136:403-406.

Kenneth F. Schulz, PhD, MBA; Iain Chalmers, DSc; and Douglas G. Altman, DSc. The Landscape and Lexicon of Blinding in Randomized Trials. Ann Intern Med. 2002;136:254-259.

A. C. Gelijns, S. O. Thier. Medical Innovation and Institutional Interdependence: Rethinking University-Industry Connections. JAMA. 2002;287:72-77.

Karine Morin; Herbert Rakatansky; Frank A. Riddick, Jr; Leonard J. Morse; John M. O'Bannon III; Michael S. Goldrich; Priscilla Ray; Matthew Weiss; Robert M. Sade; Monique A. Spillman. Managing Conflicts of Interest in the Conduct of Clinical Trials. JAMA. 2002;287:78-84.

Paul E. Kalb; Kristin Graham Koehler. Legal Issues in Scientific Research. JAMA. 2002;287:85-91

Hrobjartsson A, Gotzsche PC. Is the placebo powerless? an analysis of clinical trials comparing placebo with no treatment. N Engl J Med. 2001;344:1594-1602

 

 

 

 


Sist endret: 23 March 2003