Recent developments in improving signal detection and reducing placebo response in psychiatric clinical trials

2011 ◽  
Vol 45 (9) ◽  
pp. 1202-1207 ◽  
Author(s):  
Craig H. Mallinckrodt ◽  
Roy N. Tamura ◽  
Yoko Tanaka
Keyword(s):  
Clinical Trials ◽  
Signal Detection ◽  
Placebo Response ◽  
Recent Developments

Use of a placebo in clinical trials

1998 ◽  
Vol 13 (5) ◽  
pp. 254-263 ◽  
Author(s):  
G Emilien ◽  
JM Maloteaux ◽  
A Seghers ◽  
G Charles
Keyword(s):  
Clinical Trials ◽  
Placebo Response ◽  
Drug Efficacy ◽  
Placebo Treatment ◽  
High Response Rate ◽  
Experimental Methodology ◽  
Necessary Condition ◽  
Control Group ◽  
Placebo Control ◽  
Experimental Drug

SummaryThe use of a placebo control group in the evaluation of a new product is today considered by most as a necessary condition of experimental drug research. Placebo response is an essential consideration in all clinical trials. If not properly controlled, incorrect and dangerous conclusion may be inferred for a product efficacy and safety profile. However, the inclusion of a placebo group in clinical trials in neuropsychiatric research raises several ethical and scientific questions. Whereas in certain indications, such as suicidal patients and severe and psychotic depression, the use of a placebo is generally not accepted, it is difficult to assess drug efficacy. This article discusses the concept of placebo in clinical trials, the occurrence of adverse events after placebo treatment and the high response rate of placebo in neuropsychiatric clinical research. The experimental methodology to adequately control all the factors involved is also analysed and discussed.

scholarly journals Recent Developments in Clinical Applications of Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis and Osteoarthritis

2021 ◽  
Vol 12 ◽  
Author(s):  
Joel Jihwan Hwang ◽  
Yeri Alice Rim ◽  
Yoojun Nam ◽  
Ji Hyeon Ju
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Clinical Applications ◽  
Clinical Settings ◽  
Positive Outcomes ◽  
Joint Function ◽  
Safety And Efficacy ◽  
High Expectations ◽  
Recent Developments

Mesenchymal stem cell (MSC) therapies have been used as cell-based treatments for decades, owing to their anti-inflammatory, immunomodulatory, and regenerative properties. With high expectations, many ongoing clinical trials are investigating the safety and efficacy of MSC therapies to treat arthritic diseases. Studies on osteoarthritis (OA) have shown positive clinical outcomes, with improved joint function, pain level, and quality of life. In addition, few clinical MSC trials conducted on rheumatoid arthritis (RA) patients have also displayed some optimistic outlook. The largely positive outcomes in clinical trials without severe side effects establish MSCs as promising tools for arthritis treatment. However, further research is required to investigate its applicability in clinical settings. This review discusses the most recent advances in clinical studies on MSC therapies for OA and RA.

scholarly journals Navigating the Crossroads of Cell Therapy and Natural Heart Regeneration

2021 ◽  
Vol 9 ◽  
Author(s):  
Stefan Elde ◽  
Hanjay Wang ◽  
Y. Joseph Woo
Keyword(s):  
Cardiovascular Disease ◽  
Clinical Trials ◽  
Cell Therapy ◽  
Cause Of Death ◽  
Natural Regeneration ◽  
Therapeutic Potential ◽  
Myocardial Regeneration ◽  
Heart Regeneration ◽  
Recent Developments

Cardiovascular disease remains the leading cause of death worldwide despite significant advances in our understanding of the disease and its treatment. Consequently, the therapeutic potential of cell therapy and induction of natural myocardial regeneration have stimulated a recent surge of research and clinical trials aimed at addressing this challenge. Recent developments in the field have shed new light on the intricate relationship between inflammation and natural regeneration, an intersection that warrants further investigation.

Placebo Response in Clinical Trials of Bipolar Disorder

2015 ◽  
pp. 585-598
Author(s):  
Bret R. Rutherford ◽  
Steven P. Roose ◽  
Jane M. Tandler
Keyword(s):  
Bipolar Disorder ◽  
Clinical Trials ◽  
Placebo Response

New Developments and Challenges in Rare Genitourinary Tumors: Non-Urothelial Bladder Cancers and Squamous Cell Cancers of the Penis

2017 ◽  
pp. 330-336
Author(s):  
Jeanny B. Aragon-Ching ◽  
Lance C. Pagliaro
Keyword(s):  
Clinical Trials ◽  
Squamous Cell ◽  
Rare Diseases ◽  
Research Funding ◽  
Diagnosis And Treatment ◽  
New Developments ◽  
Effective Care ◽  
Recent Developments ◽  
Urothelial Bladder ◽  
Genitourinary Cancers

The diagnosis and treatment of rare genitourinary tumors is inherently challenging. The Rare Diseases Act of 2002 initially defined a rare disorder as one that affects fewer than 200,000 Americans. The lack of widely available clinical guidelines, limited research funding, and inaccessible clinical trials often lead to difficulty with treatment decisions to guide practitioners in rendering effective care for patients with rare genitourinary cancers. This article will discuss basic tenets of diagnosis and treatment as well as recent developments and clinical trials in rare non-urothelial bladder cancers and penile squamous cell cancers.

Bayesian hierarchical model for safety signal detection in multiple clinical trials

2020 ◽  
Vol 99 ◽  
pp. 106183
Author(s):  
Yafei Zhang ◽  
Shuai Sammy Yuan ◽  
Barry A. Eagel ◽  
Hal Li ◽  
Li-An Lin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Signal Detection ◽  
Hierarchical Model ◽  
Bayesian Hierarchical Model ◽  
Safety Signal ◽  
Bayesian Hierarchical

scholarly journals Placebo Response in Rheumatoid Arthritis Clinical Trials

2019 ◽  
Vol 47 (1) ◽  
pp. 28-34 ◽  
Author(s):  
Katie Bechman ◽  
Mark Yates ◽  
Sam Norton ◽  
Andrew P. Cope ◽  
James B. Galloway
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Kinase Inhibitors ◽  
Placebo Response ◽  
Janus Kinase ◽  
Controlled Trials ◽  
American College Of Rheumatology ◽  
Factor Therapy ◽  
Expectation Bias ◽  
Over Time

Objective.Understanding the placebo response is critical to interpreting treatment efficacy, particularly for agents with a ceiling to their therapeutic effect, where an increasing placebo response makes it harder to detect potential benefit. The objective of this study is to assess the change in placebo responses over time in rheumatoid arthritis (RA) randomized placebo-controlled trials (RCT) for drug licensing authorization.Methods.The Cochrane Controlled Trials Register database was searched to identify RCT of biological or targeted synthetic disease-modifying antirheumatic drugs (DMARD) in RA. Studies were excluded if patients were conventional synthetic DMARD (csDMARD)–naive, not receiving background csDMARD therapy, or were biologic experienced. Metaregression model was used to evaluate changes in American College of Rheumatology (ACR) 20, ACR50, and ACR70 treatment response over time.Results.There were 32 trials in total: anti–tumor necrosis factor therapy (n = 15), tocilizumab (n = 4), abatacept (n = 2), rituximab (n = 2), and Janus kinase inhibitors (n = 9). From 1999 to 2018, there was no significant trend in the age or sex of patients in the placebo arm. Disease duration, swollen joint count, and 28-joint count Disease Activity Score using erythrocyte sedimentation rate at baseline all significantly declined over time. There was a statistically significant increase in placebo ACR50 and ACR70 responses (ACR50 β = 0.41, 95% CI 0.09–0.74, p = 0.01; ACR70 β = 0.18, 95% CI 0.04–0.31, p = 0.01) that remained significant after controlling for potential confounders.Conclusion.There has been a rise in the placebo response in RA clinical trials over the last 2 decades. Shifting RA phenotype, changes in trial design, and expectation bias are possible explanations for this phenomenon. This observation has important implications when evaluating newer novel agents against established therapies.

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