Clinical Trial Methodology

1995 ◽  
pp. 407-417 ◽  
Author(s):  
T. L. Munsat ◽  
D. Hollander ◽  
L. Finison
Keyword(s):  
Clinical Trial ◽  
Trial Methodology ◽  
Clinical Trial Methodology

Clinical trial methodology in rare gynecologic tumor research: Strategies for success

2018 ◽  
Vol 149 (3) ◽  
pp. 605-611 ◽  
Author(s):  
Jubilee Brown ◽  
R. Wendel Naumann ◽  
William E. Brady ◽  
Robert L. Coleman ◽  
Kathleen N. Moore ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Strategies ◽  
Trial Methodology ◽  
Clinical Trial Methodology ◽  
Gynecologic Tumor ◽  
Tumor Research ◽  
Strategies For Success

scholarly journals Psilocybin for depression: Considerations for clinical trial design

2019 ◽  
Vol 3 (3) ◽  
pp. 269-279
Author(s):  
Kelley C. O’Donnell ◽  
Sarah E. Mennenga ◽  
Michael P. Bogenschutz
Keyword(s):  
Clinical Trial ◽  
Trial Design ◽  
Depressive Symptomatology ◽  
Specific Effect ◽  
Clinical Trial Design ◽  
Depressive Illness ◽  
Trial Methodology ◽  
Trial Duration ◽  
Clinical Trial Methodology ◽  
Psychedelic Drugs

Background and aims Given the enormous global burden of depressive illness, there is an urgent need to develop novel and more effective treatments for major depressive disorder (MDD). Recent findings have suggested that psychedelic drugs may have a role in the treatment of depressive symptoms, and a number of groups are in the process of developing protocols to study this question systematically. Given the subjective quality of both the psychedelic experience and depressive symptomatology, great care must be taken when designing a protocol to study the clinical efficacy of psychedelic drugs. This study will discuss many factors to consider when designing a clinical trial of psilocybin for MDD. Methods We provide a thorough review of pertinent research into antidepressant clinical trial methodology and review practical considerations that are relevant to the study of psychedelic-assisted treatment for depression. Results We discuss participant selection (including diagnostic accuracy, exclusion criteria, characteristics of the depressive episode, and the use of concurrent medications), study interventions (including dosing regimens, placebo selection, non-pharmacological components of treatment, and the importance of blinding), trial duration, outcome measures, and safety considerations. Conclusions Careful and transparent study design and data analysis will maximize the likelihood of generating meaningful, reproducible results, and identifying a treatment-specific effect. Meeting the highest standards for contemporary trial design may also broaden the acceptance of psychedelic research in the scientific community at large.

Clearing Up Misunderstandings about Clinical Trial Methodology: A Reply to Barnett et al.'s Commentary on the ACAS Trial

Neurology ◽  
1997 ◽  
Vol 48 (6) ◽  
pp. 1743-1748 ◽  
Author(s):  
L. E. Chambless ◽  
J. D. Hosking ◽  
R. Kronmal ◽  
G. Howard ◽  
V. J. Howard
Keyword(s):  
Clinical Trial ◽  
Trial Methodology ◽  
Clinical Trial Methodology

Field Testing As Clinical Trial Methodology in Periodontics

1992 ◽  
Vol 63 (12s) ◽  
pp. 1064-1071 ◽  
Author(s):  
Kenneth S. Kornman ◽  
Michael G. Newman ◽  
Samuel Holtzman ◽  
James E. Matheson
Keyword(s):  
Clinical Trial ◽  
Field Testing ◽  
Trial Methodology ◽  
Clinical Trial Methodology
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