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.

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.

Introduction

2018 ◽  
Author(s):  
John R. Peteet ◽  
Mary Lynn Dell ◽  
Wai Lun Alan Fung
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Ethics Committees ◽  
Clinical Decision ◽  
Cultural Formulation ◽  
Statistical Manual ◽  
Diagnostic And Statistical Manual ◽  
Dsm 5 ◽  
Religious Professionals ◽  
The Relationship

Historical tensions between psychiatry and religion continue to hinder dialogue and restrict consensus on how to approach areas of overlap in clinical decision making. In Part One, contributors to this volume discuss concerns arising in the general areas of values, religious and psychiatric ethics, diagnosis and treatment, and the work of religious professionals and ethics committees. In Part Two, chapter authors consider these issues as they arise within various subspecialties of psychiatric practice, often using the Jonsen Four Topics (or Four Quadrants) Model. The theme of the relationship between religion and culture runs throughout and is addressed more directly than in the Outline for Cultural Formulation in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

scholarly journals Medical professionalism: Navigating modern challenges

2021 ◽  
pp. 175573802110526
Author(s):  
Nicola Cooper-Moss ◽  
Helen Hooper ◽  
Kartina A. Choong ◽  
Umesh Chauhan
Keyword(s):  
Primary Care ◽  
Decision Making ◽  
General Practice ◽  
Professional Practice ◽  
Clinical Decision Making ◽  
Medical Profession ◽  
Clinical Decision ◽  
Medical Professionalism ◽  
The Public ◽  
General Practice Training

Medical professionalism is an evolving entity, requiring continual development according to shifting societal priorities. The public trust that underpins the medical profession is imperative for maintaining effective partnerships with patients, their families and the wider community. This article provides an overview of what constitutes medical professionalism, including the current protocols and assessments for general practice training. The aim is to improve understanding of the current issues surrounding professionalism in primary care. Fictional case scenarios are used to illustrate modern professional dilemmas and to promote reflection on the complex interacting factors that influence professional practice and clinical decision-making.

Likelihood Ratio, Skull Roentgenograms, and Clinical Decision-Making

PEDIATRICS ◽  
1983 ◽  
Vol 71 (4) ◽  
pp. 672-673
Author(s):  
JOHN M. LEVENTHAL ◽  
ROBERT M. LEMBO
Keyword(s):  
Decision Making ◽  
Likelihood Ratio ◽  
Clinical Finding ◽  
Clinical Decision Making ◽  
Skull Fracture ◽  
Clinical Decision ◽  
Clinical Findings ◽  
Skull Fractures ◽  
Fractures In Children ◽  
The Relationship

To the Editor.— In the February 1982 issue of Pediatrics, Leonidas et al1 examined the relationship between clinical findings and skull fractures in children evaluated with skull roentgenograms to develop reliable criteria for the ordering of roentgenograms in patients with head trauma. In their analysis, the authors used the liklihood ratio (LR) to characterize quantitatively the relationship between a clinical finding and the presence of a skull fracture. As defined by the authors, the LR is that ratio between the probability of a certain clinical finding occurring in the presence of a fracture and the probability of the same clinical finding occurring in the absence of a fracture.

scholarly journals Unravelling the ‘Tangled Web’: Chemotherapy for Tuberculosis in Britain, 1940–70The William Bynum Prize Essay

2015 ◽  
Vol 59 (2) ◽  
pp. 156-176 ◽  
Author(s):  
Clare Leeming-Latham
Keyword(s):  
Clinical Trials ◽  
Best Practice ◽  
Research Council ◽  
Clinical Decision Making ◽  
Medical Research Council ◽  
Bed Rest ◽  
Clinical Decision ◽  
Success Story ◽  
Post War ◽  
The Relationship

AbstractThe introduction and assimilation of chemotherapy to treat pulmonary tuberculosis (TB) during the mid-twentieth century appears at first sight to be a success story dominated by the use of streptomycin in a series of randomised clinical trials run under the auspices of the Medical Research Council (MRC). However, what this standard rhetoric overlooks is the complexity of TB chemotherapy, and the relationship between this and two other ways of treating the disease, bed rest and thoracic surgery. During the late 1940s and 1950s, these three treatment strands overlapped one another, and determining best practice from a plethora of prescribing choices was a difficult task. This article focuses on the clinical decision-making underpinning the evolution of successful treatment for TB using drugs alone. Fears over the risk of streptomycin-resistant organisms entering the community meant that, initially, the clinical application of streptomycin was limited. Combining it with other drugs lessened this risk, but even so the potential of chemotherapy as a curative option for TB was not immediately apparent. The MRC ran a series of clinical trials in the post-war period but not all of their recommendations were adopted by clinicians in the field. Rather, a range of different determinants, including the timing of trials, the time taken for results to emerge, and whether these results ‘fitted’ with individual experience all influenced the translation of trial results into clinical practice.

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.

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