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.

Methodological Approaches and Evidence for Effectiveness in Clinical Trials

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
L. Davis
Keyword(s):  
Clinical Trial ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Essential Elements ◽  
Institute Of Medicine ◽  
Trial Methodology ◽  
Clinical Trial Methodology ◽  
Theoretical Reasoning ◽  
Design And Methods ◽  
Controlled Clinical Study

Recent publications by the Institute of Medicine have unearthed several fundamental flaws in clinical trial methodology that, if corrected by the next generation of clinical investigators, can transform the field of mental health intervention research. Using a clinician-friendly approach, Dr. Davis will succinctly review the essential elements of optimal design and implementation of a randomized controlled clinical study. These elements include the need for a hypothesis that has clinical relevance based on sound theoretical reasoning, reasonable and generalizable inclusion and exclusion criteria, feasibility of an enrollment goal and study time-line, and appropriate choice of a comparator intervention and primary outcome. Techniques to reduce the study's costs, risks, and participant burden will be described. Examples from psychopharmacologic, psychotherapy, and vocational rehabilitation trials for the treatment of posttraumatic stress disorder will be discussed. Following the didactic session by the two presenters, the participants will be encouraged to bring forth their own questions regarding clinical trial design for a 45-minute interactive discussion with the presenters. The objectives of the workshop are to improve the participants’ understanding of the goals of clinical trial design and methods to achieve those goals in order to improve their own research techniques, grantsmanship, and abilities to more accurately judge the results of studies presented in the literature.

Reinventing the Wheel in Clinical Trial Design

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
L. Davis ◽  
A. Leon
Keyword(s):  
Clinical Trial ◽  
Treatment Effect ◽  
Trial Design ◽  
Statistical Power ◽  
False Negative ◽  
Clinical Trial Design ◽  
Essential Elements ◽  
Type I ◽  
Institute Of Medicine ◽  
Trial Methodology

Recent publications by the Institute of Medicine have unearthed several fundamental flaws in clinical trial methodology that, if corrected by the next generation of clinical investigators, can transform the field of mental health intervention research. Using a clinician-friendly approach, this workshop will succinctly review the essential elements of optimal design and implementation of a randomized controlled clinical study and the strategies to enhance signal detection. These include minimizing bias in the estimate of treatment effect while maintaining a nominal level of type I error (i.e., false positive results) and maintaining sufficient statistical power (i.e. reducing the likelihood of false negative results). Particular attention will be paid to reducing the problems of attrition and the hazards of multiplicity. Methods to examine moderators of the treatment effect will also be explored. Examples from psychopharmacologic, psychotherapy, and vocational rehabilitation trials for the treatment of posttraumatic stress disorder, depression, and panic disorder will be provided to illustrate these issues. Techniques to reduce the study's costs, risks, and participant burden will be described. Following the didactic session, the participants are encouraged to bring forth their own questions regarding clinical trial design for a 45-minute interactive discussion with the presenters. The objectives of the workshop are to improve the participants’ understanding of the goals of clinical trial design and methods to achieve those goals in order to improve their own research techniques, grantsmanship, and abilities to more accurately judge the results of studies presented in the literature.

Integrating radiomics into clinical trial design

2019 ◽  
Vol 63 (4) ◽  
Author(s):  
Jessica J. Waninger ◽  
Michael D. Green ◽  
Catherine Cheze Le Rest ◽  
Benjamin Rosen ◽  
Issam El Naqa
Keyword(s):  
Clinical Trial ◽  
Trial Design ◽  
Clinical Trial Design

scholarly journals X-change symposium: status and future of modern radiation oncology—from technology to biology

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Stefanie Corradini ◽  
Maximilian Niyazi ◽  
Dirk Verellen ◽  
Vincenzo Valentini ◽  
Seán Walsh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Oncology ◽  
Trial Design ◽  
Rapid Development ◽  
Clinical Trial Design ◽  
Current Status ◽  
Treatment Modalities ◽  
Special Treatment ◽  
Image Guided Radiotherapy

AbstractFuture radiation oncology encompasses a broad spectrum of topics ranging from modern clinical trial design to treatment and imaging technology and biology. In more detail, the application of hybrid MRI devices in modern image-guided radiotherapy; the emerging field of radiomics; the role of molecular imaging using positron emission tomography and its integration into clinical routine; radiation biology with its future perspectives, the role of molecular signatures in prognostic modelling; as well as special treatment modalities such as brachytherapy or proton beam therapy are areas of rapid development. More clinically, radiation oncology will certainly find an important role in the management of oligometastasis. The treatment spectrum will also be widened by the rational integration of modern systemic targeted or immune therapies into multimodal treatment strategies. All these developments will require a concise rethinking of clinical trial design. This article reviews the current status and the potential developments in the field of radiation oncology as discussed by a panel of European and international experts sharing their vision during the “X-Change” symposium, held in July 2019 in Munich (Germany).

scholarly journals Conceptual Framework to Support Clinical Trial Optimization and End-to-End Enrollment Workflow

2019 ◽  
pp. 1-10 ◽  
Author(s):  
Neha M. Jain ◽  
Alison Culley ◽  
Teresa Knoop ◽  
Christine Micheel ◽  
Travis Osterman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Knowledge Representation ◽  
Conceptual Framework ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Prospective Clinical Trial ◽  
Future Trends ◽  
Current State ◽  
Evaluation Strategies

In this work, we present a conceptual framework to support clinical trial optimization and enrollment workflows and review the current state, limitations, and future trends in this space. This framework includes knowledge representation of clinical trials, clinical trial optimization, clinical trial design, enrollment workflows for prospective clinical trial matching, waitlist management, and, finally, evaluation strategies for assessing improvement.

Value of Biomarker Expression for Randomized Clinical Trial Design: One (More) Missed Opportunity

2020 ◽  
Vol 38 (6) ◽  
pp. 649-651 ◽  
Author(s):  
Francisco E. Vera-Badillo ◽  
Andrew J. Robinson ◽  
David M. Berman ◽  
Christopher M. Booth
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Missed Opportunity
Sign in / Sign up

Export Citation Format

Share Document