Clinical Drug Development

CLINICAL TRIALS - MANDATORY LITERATURE

• WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/Compulsory*
• European Medicines Agency, ICH Topic E3: Structure and Content och Clinical Study Reports, EMA, https://www.ema.europa.eu/en/ich-e3-structure-content-clinical-study-reports-scientific-guidelineCompulsory*
• European Medicines Agency, ICH Topic E4: Dose-Response Information to Support Drug Registration, EMA, https://www.ema.europa.eu/en/ich-e4-dose-response-information-support-drug-registration-scientific-guidelineCompulsory*
• European Medicines Agency, ICH Topic E6: Guideline for Good Clinical Practice, EMA, https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guidelineCompulsory*
• European Medicines Agency, ICH Topic E8: General Considerations for Clinical Studies, EMA, https://www.ema.europa.eu/en/ich-e8-general-considerations-clinical-studies-scientific-guidelineCompulsory*
• European Medicines Agency, ICH topic E9: Statistical Principles for Clinical Trials, EMA, https://www.ema.europa.eu/en/ich-e9-statistical-principles-clinical-trials-scientific-guidelineCompulsory*
• European Medicines Agency, ICH topic E10: Choice of Control Group in Clinical Trials, EMA, https://www.ema.europa.eu/en/ich-e10-choice-control-group-clinical-trials-scientific-guidelineCompulsory*
• 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., EU, http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1497947926249&uri=CELEX:32014R0536Compulsory*
• DIRECTIVE 2001/20/E, laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, EU, https://ec.europa.eu/health/human-use/clinical-trials/directive_enCompulsory*
• 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), EU, http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1497948126522&uri=CELEX:52011XC0611(01)Compulsory*
• Consort 2010 Checklist, Explanations and Elaboration document, The CONSORT Group, 2010, CONSORT hemsidaCompulsory* (Click on CONSORT 2010 - CONSORT Checklist for the web version of the chekclist with explanations)
• Moher, David, CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, The BMJ, https://www.bmj.com/content/340/bmj.c869Compulsory*

CLINICAL TRIALS RECOMMENDED LITERATURE

• Friedman, Lawrence M. et al., Fundamentals of Clinical Trials, 5th ed. 2015., Cham, Springer International Publishing, 2015
• Friedman, Lawrence M.; Furberg, Curt C.; DeMets, David L., Fundamentals of clinical trials, 4. ed., New York, Springer, cop. 2010
• Sundström, Johan; Lind, Lars, Handbok i biomedicinsk forskning, Första upplagan, Stockholm, Liber, [2015]
• Lemne, Carola; Lafolie, Pierre, Handbok för kliniska prövare, 6:1, Studentlitteratur, 2009
• Läkemedelsverket, Läkemedelsverkets föreskrifter (LVFS 2011:19) om kliniska läkemedelsprövningar på människor, Institutionen för medicinska vetenskaper, 2016, Läkemedelsverkets föreskrifter (LVFS 2011:19) om kliniska läkemedelsprövningar på människor (link to "föreskrifter" and "vägledning")
• Anehus, Siw et al., Handbok i genomförande av en klinisk prövning: praktisk tillämpning av lagar och regler med fokus på monitering, 1. uppl., Lund, Studentlitteratur AB, 2012

STATISTICS - RECOMMENDED LITTERATURE

• Machin, David; Campbell, Michael J.; Walters, Stephen John, Medical statistics: a textbook for the health sciences, 4th ed., Chichester, Wiley, 2007
• Bring, Johan; Taube, Adam, Introduktion till medicinsk statistik, Lund, Studentlitteratur, 2006
• Körner, Svante; Wahlgren, Lars, Statistisk dataanalys, 5. uppl., Lund, Studentlitteratur, 2015
• CPMP/EWP/908/99: POINTS TO CONSIDER ON MULTIPLICITY ISSUES IN CLINICAL TRIALS, EMA, European Medicines Agency, http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003640.pdf
• EMA/CPMP/EWP/1776/99 Rev. 1: Guideline on Missing Data in Confirmatory Clinical Trials, EMA, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf
• CPMP/EWP/482/99: POINTS TO CONSIDER ON SWITCHING BETWEEN SUPERIORITY AND NON-INFERIORITY, EMA, European Medicines Agency, http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003658.pdf
• HK, Ramakrishna., Medical Statistics: For Beginners, Singapore, Springer Singapore, 2017 (https://link-springer-com.ezproxy.its.uu.se/book/10.1007%2F978–981-10–1923-4#about)

PHARMACOKINETICS - RECOMMENDED LITTERATURE

• Birkett, D. J., Pocket guide: pharmacokinetics made easy, 2nd ed., North Ryde, N.S.W., McGraw-Hill Australia, 2010

* Compulsory