Clinical Evaluation of Drug Products

Course objectives

The objective of the course is to introduce the pharmacy student to the conduct of clinical trials and the evaluation of efficacy and safety of new drugs.

General contents and topics

The course will outline practical, ethical and regulatory aspects of the conduct of clinical drug trials in the format of Good Clinical Practice, which is now obligatory in the clinical documentation of new drugs. The randomised controlled trial (RCT) will be the key issue. Basic principles of statistical analysis are presented. Safety evaluation of drug products are also included. Scientific evidence in relation to the practical application of drugs is discussed. Newer and more advanced tools in the evaluation of clinical drug trials will be mentioned.

• Development of new drug products.
• Non-clinical safety evaluation of drug products.
• Statistical methods in the conduct of trials and analysis of data.
• Regulatory aspects of clinical studies.
• ICH-GCP guidelines.
• Ethical aspects of clinical studies.
• Randomised controlled trial (RCT), theoretical and practical considerations.
• Problems and pitfalls of the RCT.
• Cleanfile, drop-outs, withdrawals and protocol violators.
• Clinical measurement in drug evaluation.
• Quality of life in clinical trials.
• RCT in the primary health care.
• Clinical trials in prophylactic activity.
• Aspects of the clinical evaluation of drug trials.
• Scientific fraud and misconduct.
• Analytic tools of Evidence-Based Medicine (EBM).
• Meta-analysis and the Cochrane collaboration.
• Implementation of results of clinical trials in therapeutics.

General information

The 5-day course will comprise a number of lectures followed by discussion and case stories presented by practising doctors and patients.

Duration

27 to 31 May 2002.

Course weight

0.083 STÅ (STÅ = student full-time equivalent) = 4.98 ECTS (European Credit Transfer System).

Course director

Senior Registrar Jens Heisterberg, Gentofte Hospital in Copenhagen, Consultant Jesper Sonne, Department of Clinical Pharmacology at Gentofte Hospital in Copenhagen, and Consultant Hanne Rolighed Christensen, Section of Clinical Pharmacology at Bispebjerg Hospital in Copenhagen.
Contact person at The Royal Danish School of Pharmacy is Professor Sven Frøkjær, Department of Pharmaceutics.

Course fee

Total course fee: DKK 4,800 (including lunch),
of which operating costs amount to: DKK 500.
An additional amount for study materials: DKK 500.

Closing date for application

1 March 2002.

Course capacity

20 participants.

N.B.

Study materials will be handed out. There will be no formal examination, but to complete the course satisfactorily the participants need to take an active part in the course.

The course will only be held in Danish.