Drug regimen compliance : issues in clinical trials and by U.A. Meyer, Jean-Michel Metry, Urs B. Meyer

By U.A. Meyer, Jean-Michel Metry, Urs B. Meyer

This precious paintings comprehensively covers all problems with drug routine compliance. In 3 sections--Clinical Trials, sufferer administration, and destiny Aspects--it bargains with an issue of discussion and curiosity.

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Additional info for Drug regimen compliance : issues in clinical trials and patient management

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There are many ways to promote compliance13. To start with, patients must be instructed exactly. The physician and his or her receptionist should explain the treatment regimen and ask the patient to repeat it in his or her own words. Handouts should support the spoken advice. SEQ 0034 JOB WIL8222-002-003 PAGE-0034 CHAP 2 23-40 REVISED 10DEC98 AT 08:21 BY TF DEPTH: 58 PICAS WIDTH 40 PICAS 34 DRUG REGIMEN COMPLIANCE In long-term trials, these written instructions must be handed out at regular intervals.

Meyer Copyright  1999 John Wiley & Sons Ltd ISBNs: 0471971227 (Hardback); 047084633X (Electronic) CHAPTER 2 Design and Analysis of Clinical Trials of Compliance Joerg Hasford University of Munich, Germany At some point, perhaps not in the far future, it will seem as wrong to run a clinical trial without compliance measurement as without randomization. Bradley Efron1 INTRODUCTION The history of compliance is as old as the traditional handing over of medical treatments. Even Hippocrates was aware that ‘patients are often lying when they say they have regularly taken the prescribed medicine’2.

In clinical practice we rely on clinical impression, which gives a similarly inflated view of drug exposure. The only reliable alternative to electronic monitoring is the lowdose, slow-turnover marker, which (as noted earlier) confirms ingestion but cannot show when doses were taken, and requires rather costly formulation and validation steps before it can be used. Another point of criticism of electronic monitoring is the possibility that a patient might systematically open and close the container, and then discard the untaken drug.

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