Metodik inom klinisk läkemedelsprövning och biostatistik

Böcker / Books

• Fundamentals of Clinical Trials, Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger, Springer, 2015
• Björk Jonas, Praktisk statistik för medicin och hälsa: Liber

Helsingforsdeklarationen/Declaration of Helsinki

• WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, World Medical Association: https://www.wma.net/policies-post/wma-declaration-of-helsinki/

ICH riktlinjer / ICH Guidances 

https://www.ich.org/page/efficacy-guidelines

• E8: General Considerations for Clinical
• E4: Dose-Response Information to Support Drug
• E6: Guideline for Good Clinical
• E10: Choice of Control Group and Related Issues in Clinical
• E9: Statistical Principles for Clinical (including addendum E9 [R1])
• E3: Structure and Content och Clinical Study

Läkemedlelsverket Sverige / Medical Products Agency (MPA), Sweden

• Vägledning (version 2) till Läkemedelsverkets föreskrifter (LVFS 2011:19) om kliniska läkemedelsprövningar på människor: https://www.lakemedelsverket.se/sv/lagar-och-regler/foreskrifter/2011-19

Europeiska unionen / European Union 

• REGULATION No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, repealing Directive 2001/20/EC: https://health.ec.europa.eu/medicinal-products/clinical-trials_en#guidelines-on-the-conduct-ofclinical-trials
• 2011/C 172/01: Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’): https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:172:0001:0013:EN:PDF

Europeiska läkemedelsverket/European Medicines Agency

• CPMP/EWP/908/99: POINTS TO CONSIDER ON MULTIPLICITY ISSUES IN CLINICAL TRIALS:
  https://www.ema.europa.eu/en/[documents](https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-multiplicity-issues-clinical-trials_en.pdf)/scientific-guideline/points-consider-multiplicity-issues-clinical-trials\_en.pdf
• EMA/CPMP/EWP/1776/99 Rev. 1: Guideline on Missing Data in Confirmatory Clinical Trials EMA, European Medicines Agency: https://www.tga.gov.au/sites/default/files/2024-06/guideline-missing-data-confirmatory-clinical-trials-ema.pdf 
• CPMP/EWP/482/99: POINTS TO CONSIDER ON SWITCHING BETWEEN SUPERIORITY AND NON-INFERIORITY, EMA, European Medicines Agency: https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-switching-between-superiority-and-non-inferiority_en.pdf

CONSORT

• 2010 Checklist, Explanations and Elaboration document, The CONSORT Group, 2010
  https://www.equator-network.org/reporting-guidelines/consort/
• BMJ, 2010, Artikel med checklista, förklaringar och bakgrund (open access), https://doi.org/10.1136/bmj.c332

Artiklar / Aricles

• Mitra et. al. “Local Change in Urinary Bladder Contractility Following CNS Dopamine Denervation in the 6-OHDA Rat Model of Parkinson's Disease.”, J Parkinsons Dis. 2015;5(2):301-11. doi: 10.3233/JPD-140509.
  https://doi-org.ezproxy.ub.gu.se/10.3233/JPD-1405
• Reference material concerning ANOVA. HyperStat Online Statistics Textbook. LÄNK: HyperStat Online: Introduction to ANOVA
• Donders et. al., “ Review: A gentle introduction to imputation of missing values”, Journal of Clinical Epidemiology 59 (2006) 1087e1091. LÄNK: Review: A gentle introduction to imputation of missing values - ScienceDirect