A revolutionary new design for clinical trials

Maurizio Fava, an Italian physician migrated to the US, Professor of Psychiatry at Harvard Medical School, and his collaborators at Massachusetts General Hospital present in the May-June 2003 issue of Psychotherapy and Psychosomatics a revolutionary new design for clinical trials, the sequential parallel comparison model.

The placebo response is a major issue in clinical trials for psychiatric disorders. Possible contributing factors to this problem include diagnostic misclassification, issues concerning inclusion/exclusion criteria, outcome measures’’ lack of sensitivity to change, measurement errors, poor quality of data entry and verification, waxing and waning of the natural course of illness, regression toward the mean phenomenon, patient and clinician expectations about the trial, study design issues, non-specific therapeutic effects, and high attrition.

Over the past few decades, researchers have attempted to reduce the placebo effect in a variety of ways. Unfortunately, approaches with very little or no benefit have included restricting enrollment to selected populations, rater training, requirement of same rater, and placebo lead-in phases. Some benefits, although often marginal, have been derived from standardizing diagnostic procedures, managing clinicians’’ overestimation of change, simplification of study visits and assessments, minimizing non-specific, therapeutic effects, extending trial duration, reducing number of sites, increasing the sensitivity of outcome measures, and reducing the number of treatment arms. Thus far, there has been no attempt to develop new study designs aimed at reducing the placebo effect.

We are proposing a novel study design, called ’’Sequential Parallel Comparison Design’’, suitable for double-blind, placebo-controlled trials in psychiatric disorders. This design is aimed at reducing both the overall placebo response rate and the sample size required for such trials. Its usefulness in clinical research needs to be tested empirically. If this study design were to be found to meet its stated goals, this could markedly facilitate the process of clinical development of new compounds for the treatment of psychiatric disorders.

The implications of this new design are discussed in the same issue by Silvana Grandi, Associate Professor of Clinical Psychology at the University of Bologna.

Media Contact

Maurizio Fava, MD alfa

Weitere Informationen:

http://www.karger.com

Alle Nachrichten aus der Kategorie: Health and Medicine

This subject area encompasses research and studies in the field of human medicine.

Among the wide-ranging list of topics covered here are anesthesiology, anatomy, surgery, human genetics, hygiene and environmental medicine, internal medicine, neurology, pharmacology, physiology, urology and dental medicine.

Zurück zur Startseite

Kommentare (0)

Schreib Kommentar

Neueste Beiträge

Researchers break magnetic memory speed record

Advance could lead to new generation of ultrafast computer chips that retain data even when there is no power. Spintronic devices are attractive alternatives to conventional computer chips, providing digital…

Tracing the source of illicit sand–can it be done?

Research presented at the 2020 GSA Annual Meeting. If you’ve visited the beach recently, you might think sand is ubiquitous. But in construction uses, the perfect sand and gravel is…

Location and extent of coral reefs mapped worldwide using advanced AI

Nearly 75% of the world’s coral reefs are under threat from global stressors such as climate change and local stressors such as overfishing and coastal development. Those working to understand…

By continuing to use the site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close