Assessment of Scientific and Ethical Issues in Two Randomized Clinical Trial Designs for Patients With Tourette’s Syndrome: A Model for Studies of Multiple Neuropsychiatric Diagnoses

2005 ◽  
Vol 17 (3) ◽  
pp. 324-332 ◽  
Author(s):  
Donald L. Gilbert ◽  
C. Ralph Buncher
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Ethical Issues ◽  
Tourette's Syndrome ◽  
Tourette’S Syndrome ◽  
Clinical Trial Designs

A multicenter randomized placebo-controlled clinical trial of pramipexole for Tourette's syndrome

2012 ◽  
Vol 27 (6) ◽  
pp. 775-778 ◽  
Author(s):  
Roger Kurlan ◽  
Giovanna Crespi ◽  
Barbara Coffey ◽  
Kirsten Mueller-Vahl ◽  
Stephen Koval ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tourette's Syndrome ◽  
Tourette’S Syndrome ◽  
Controlled Clinical Trial

Patient Access to Experimental Drugs and AIDS Clinical Trial Designs: Ethical Issues

1996 ◽  
Vol 5 (3) ◽  
pp. 400-409 ◽  
Author(s):  
Udo Schüklenk ◽  
Carlton Hogan
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Alternative Treatment ◽  
Ethical Issues ◽  
Treatment Strategies ◽  
Patient Access ◽  
Principal Investigators ◽  
Experimental Drugs ◽  
Trial Protocols ◽  
Clinical Trial Designs

Today's clinical AIDS research is in trouble. Principal investigators are confronted with young and frequently highly knowledgeable patients. Many of these people with AIDS (PWAs) are often unwilling to adhere to the trial protocols. These PWAs believe they are ethically justified in breaching trial protocols because they do not consider themselves true volunteers in such trials. PWAs argue that they do not really volunteer because existing legislation prevents them from buying and using experimental drugs or from testing alternative treatment strategies. Their only access to such agents is participation in clinical trials.

scholarly journals Phase III Precision Medicine Clinical Trial Designs That Integrate Treatment and Biomarker Evaluation

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Mei-Yin C. Polley ◽  
Edward L. Korn ◽  
Boris Freidlin
Keyword(s):  
Clinical Trial ◽  
Drug Development ◽  
Precision Medicine ◽  
Randomized Clinical Trial ◽  
Cancer Genomics ◽  
Clinical Trial Design ◽  
Predictive Biomarkers ◽  
Phase Iii ◽  
Cancer Trial ◽  
Clinical Trial Designs

Recent advances in biotechnology and cancer genomics have afforded enormous opportunities for development of more effective anticancer therapies. A key thrust of this modern drug development paradigm is successful identification of predictive biomarkers that can distinguish patients who might be sensitive to new targeted therapies. To respond to this challenge, a number of phase III cancer trial designs integrating biomarker-based objectives have been proposed and implemented in oncology drug development. In this article, we provide an updated review of commonly used biomarker-based randomized clinical trial designs, with a particular focus on design efficiency. When the efficacy of a new therapy may be limited to a biomarker-defined subgroup, the choice of an appropriate randomized clinical trial design should be guided by the strength of the biomarker’s credentials. If compelling evidence indicates that a targeted therapy is beneficial only in a particular biomarker-defined subgroup, an enrichment design should be used. If there is strong evidence that the treatment is likely to be more beneficial in the biomarker-positive patients but a meaningful benefit is also possible in the biomarker-negative patients, then a properly powered biomarker-stratified design (eg, a subgroup-specific or Marker Sequential Test strategy) would provide the most rigorous determination of the sensitive populations. If the evidence supporting the predictive value of the biomarker is weak and the treatment is expected to work in the overall population, then a fallback design could be used. Careful selection of an appropriate phase III design strategy that integrates evaluation of a new anticancer therapy and its companion diagnostic is critical to the success of precision medicine in oncology.

scholarly journals Ethical dimensions in randomized trials and off-label use of investigational drugs for COVID-19 treatment

2021 ◽  
pp. 147775092110114
Author(s):  
Pooja Dhupkar ◽  
Seema Mukherjee
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Randomized Clinical Trials ◽  
Ethical Issues ◽  
Off Label Use ◽  
Off Label ◽  
Investigational Drugs ◽  
Number Of Patients ◽  
The Impact ◽  
Label Use

Coronavirus disease 2019 (COVID-19) is a fast-developing viral pandemic spreading across the globe. Due to lack of availability of proven medicines against COVID-19, physicians have resorted to treatments through large trials of investigational drugs with poor evidence or those used for similar diseases. Large trials randomize 100–500+ patients at multiple hospitals in different countries to either receive these drugs or standard treatment. In order to expedite the process, some regulatory agencies had also given permission to use drugs approved for other diseases, despite a lack of evidence of efficacy in COVID-19. In this review, we highlight the potential ethical issues that should be addressed during the use of investigational drugs with little prior evidence as a treatment options during a pandemic. We discuss the impact of design of randomized clinical trials using LOTUS trial as an example and that of off-label use of drugs like chloroquine/hydroxychloroquine (CQ/HQ) on the safety of patients during COVID-19. We conclude that the adaptive randomized clinical trial designs offer a flexible and efficient approach, enabling patients to quickly switch to successful treatments, while minimizing the number of patients on standard of care. Randomized clinical trial design should consider blinding of investigators and only representative patients who can provide consent should be included. We also conclude the emergency approvals of drugs should be carefully issued and off-label use should be restricted in pandemics. Streamlined regulatory guidelines for emergency drug use in a pandemic can also help in providing benefit and minimizing harm to patients in the future.

Randomized clinical trial of LigasureTM versus open haemorrhoidectomy

2002 ◽  
Vol 89 (2) ◽  
pp. 154-157 ◽  
Author(s):  
F. F Palazzo ◽  
D. L Francis ◽  
M. A Clifton
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial

Ciprofloxacin is more effective in treating acute pouchitis than metronidazole: A randomized clinical trial

2001 ◽  
Vol 120 (5) ◽  
pp. A453-A453 ◽  
Author(s):  
B SHEN ◽  
J ACHKAR ◽  
B LASHNER ◽  
A ORMSBY ◽  
F REMZI ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial
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