scholarly journals Clinical trials: Are they really useful for clinical decision making?

1996 ◽  
Vol 19 (10) ◽  
pp. 763-764 ◽  
Author(s):  
C. Richard Conti
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Clinical Decision

Beyond the Development of Health-Related Quality-of-Life (HRQOL) Measures: A Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials—Does HRQOL Evaluation in Prostate Cancer Research Inform Clinical Decision Making?

2003 ◽  
Vol 21 (18) ◽  
pp. 3502-3511 ◽  
Author(s):  
Fabio Efficace ◽  
Andrew Bottomley ◽  
David Osoba ◽  
Carolyn Gotay ◽  
Henning Flechtner ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Decision Making ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Cancer Clinical Trials ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Purpose: The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer. Materials and Methods: A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making. Results: Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions. Conclusion: A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.

Important issues in the justification of a control treatment in paediatric drug trials

2016 ◽  
Vol 101 (10) ◽  
pp. 962-967 ◽  
Author(s):  
Lauren E Kelly ◽  
Elin Haf Davies ◽  
Agnes Saint-Raymond ◽  
Paolo Tomasi ◽  
Martin Offringa
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Control Treatment ◽  
European Medicines Agency ◽  
Drug Dosing ◽  
Optimal Dosing ◽  
Dosing Strategy ◽  
Selection Of

ObjectiveThe value of comparative effectiveness trials in informing clinical and policy decisions depends heavily on the choice of control arm (comparator). Our objective is to identify challenges in comparator reasoning and to determine justification criteria for selecting a control arm in paediatric clinical trials.DesignA literature search was completed to identify existing sources of guidance on comparator selection. Subsequently, we reviewed a randomly selected sample of comparators selected for paediatric investigation plans (PIPs) adopted by the Paediatric Committee of the European Medicines Agency in 2013. We gathered descriptive information and evaluated their review process to identify challenges and compromises between regulators and sponsors with regard to the selection of the comparator. A tool to help investigators justify the selection of active controls and placebo arms was developed using the existing literature and empirical data.ResultsJustifying comparator selection was a challenge in 28% of PIPs. The following challenging paediatric issues in the decision-making process were identified: use of off-label medications as comparators, ethical and safe use of placebo, duration of placebo use, an undefined optimal dosing strategy, lack of age-appropriate safety and efficacy data, and drug dosing not supported by extrapolation of safety/efficacy evidence from other populations.ConclusionsIn order to generate trials that will inform clinical decision-making and support marketing authorisations, researchers must systemically and transparently justify their selection of the comparator arm for their study. This report highlights key areas for justification in the choice of comparator in paediatric clinical trials.

scholarly journals Ethical issues in therapeutic use and research in pregnant and breastfeeding women

2021 ◽  
Author(s):  
Ethel Weld ◽  
Theodore Bailey ◽  
Catrionia Waitt
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Historical Perspective ◽  
Clinical Decision Making ◽  
Ethical Issues ◽  
Clinical Decision ◽  
Evidence Based ◽  
High Quality ◽  
Legal Frameworks ◽  
In Pregnancy

Pregnant, or potentially pregnant women have historically been excluded from clinical trials of new medications. However, it is increasingly recognised that it is imperative to generate evidence from the population in whom the drugs are likely to be used in order to inform safe, evidence-based shared clinical decision making. Reluctance by researchers and regulators to perform such studies often relates to concerns about risk, particularly to the fetus. However, this must be offset against the risk of untreated disease or using a drug in pregnancy where safety, efficacy and dosing information are not known. This review summarises the historical perspective, the ethical and legal frameworks which inform the conduct of such research, then highlights examples of innovative practice which have enabled high quality, ethical research to proceed to inform the evidence-based use of medication in pregnancy.

Issues in the Design and Interpretation of Multiple Sclerosis Clinical Trials

2016 ◽  
Author(s):  
Stephen Krieger ◽  
Ilana Katz Sand ◽  
Svenja Oynhausen ◽  
Aaron Miller
Keyword(s):  
Multiple Sclerosis ◽  
Decision Making ◽  
Clinical Trials ◽  
Monoclonal Antibodies ◽  
Clinical Decision Making ◽  
Ethical Issues ◽  
Clinical Decision ◽  
Therapeutic Interventions ◽  
Current Trial ◽  
Oral Agents

This chapter covers important historical, scientific, and current issues in the development of modern clinical trials as well as therapeutic interventions for patients with multiple sclerosis. The chapter includes a review of terminology, methodology, and outcomes employed in clinical trials related to multiple sclerosis. A focus of the chapter is on the limitations of historical and current trial designs, particularly in regard to their application to clinical decision making. This second edition incorporates findings from clinical trials of oral agents and monoclonal antibodies developed for treatment of multiple sclerosis and provides an update on ethical issues in multiple sclerosis clinical research.

Integrating Biomarkers and Targeted Therapy Into Colorectal Cancer Management

2019 ◽  
pp. 207-215 ◽  
Author(s):  
Christopher H. Lieu ◽  
Ryan B. Corcoran ◽  
Michael J. Overman
Keyword(s):  
Colorectal Cancer ◽  
Decision Making ◽  
Clinical Trials ◽  
Targeted Therapy ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Prognostic Indicators ◽  
Molecular Characteristics ◽  
Cancer Management ◽  
The Past

There have been substantial advances in the treatment of metastatic colorectal cancer (mCRC) over the past 15 years. Molecular characteristics of mCRC and identification of specific mutations can serve as predictive and prognostic indicators of disease and response to targeted therapies. When incorporated into clinical decision-making, these biomarkers can serve as critical tools in personalizing therapy to ensure the best outcomes. Additional improvements in the survival of patients with mCRC will be made possible with the identification of new predictive molecular biomarkers and their evaluation using rational and innovative clinical trials.

scholarly journals The comparative efficacy and safety of acupuncture for mild and moderate Alzheimer's disease: A systematic review and network meta-analysis

2021 ◽  
Author(s):  
Nana Han ◽  
◽  
Yang Fang ◽  
Guozhen Zhao ◽  
Bo Ji
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Decision Making ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Clinical Decision Making ◽  
Acupuncture Treatment ◽  
Clinical Decision ◽  
Quality Of Evidence

Review question / Objective: According to the current randomized clinical trials (RCT) of acupuncture therapy for Alzheimer's disease (AD), to evaluate their methodology, the quality of evidence and the report are evaluated and summarize evidence of important outcomes of randomized clinical trials. We aim to provide accurate clinical decision-making for acupuncture treatment of Alzheimer's disease. Condition being studied: According to the current randomized clinical trials (RCT) of acupuncture therapy for Alzheimer's disease (AD), to evaluate their methodology, the quality of evidence and the report are evaluated and summarize evidence of important outcomes of randomized clinical trials. We aim to provide accurate clinical decision-making for acupuncture treatment of Alzheimer's disease.

scholarly journals An ethical relationship with pharma

2018 ◽  
Vol 24 (6) ◽  
pp. 398-401
Author(s):  
Sarmishtha Bhattacharyya ◽  
Susan Mary Benbow
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Royal College ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Ethical Principles ◽  
Pharmaceutical Companies ◽  
The Public ◽  
The Relationship

SUMMARYThis brief article reflects on the relationship between psychiatrists and pharmaceutical companies (pharma), which continues to generate debate and concerns. We suggest that psychiatrists should consider both the biomedical ethical principles and how values guide actions and clinical decision-making in their dealings with pharma. In addition, the Royal College of Psychiatrists should err towards eschewing influences that might be regarded by others as distorting its position, and individual psychiatrists should declare interests that others might regard as competing/conflicting in order to maintain the trust of patients and the public.DECLARATION OF INTERESTS.M.B. practises as an independent systemic psychotherapist. Both authors have undertaken various roles within the Royal College of Psychiatrists and S.B. is involved in recruiting patients for clinical trials.

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