Background: In recent years, a number of studies have shown that clinical drug trials financed by pharmaceutical companies yield favorable results for company products more often than independent trials do. Moreover, pharmaceutical companies have been found to influence drug trials in various ways. This paper provides an overview of the findings of current, systematic studies on this topic.
Methods: Publications retrieved from a systematic Medline search on this topic from 1 November 2002 to 16 December 2009 were independently evaluated and selected by two of the authors. These publications were supplemented by further ones found in their references sections.
Results: 57 publications were included for evaluation in Parts 1 and 2 of this article. Published drug trials that were financed by pharmaceutical companies, or whose authors declared a financial conflict of interest, were found to yield favorable results for the drug manufacturer more frequently than independently financed trials whose authors had no such conflicts. The results were also interpreted favorably more often than in independently financed trials. Furthermore, there was evidence that pharmaceutical companies influenced study protocols in a way that was favorable to themselves. The methodological quality of trials financed by pharmaceutical companies was not found to be any worse than that of trials financed in other ways.
Conclusion: Published drug trials that are financed by pharmaceutical companies may present a distorted picture. This cannot be explained by any difference in methodological quality between such trials and trials financed in other ways.
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http://dx.doi.org/10.3238/arztebl.2010.0279 | DOI Listing |
Am J Respir Crit Care Med
January 2025
University of Utah, Division of Cardiovascular Medicine, Department of Medicine, Salt Lake City, Utah, United States.
Rationale: Guidelines recommend patients with pulmonary arterial hypertension (PAH) be referred to pulmonary hypertension (PH) centers, but little is known about where care is actually delivered in the United States (US).
Objectives: To use prescription patterns to estimate the proportion of PAH care delivered at US PH centers and explore factors associated with location of care.
Methods: This retrospective study analyzed claims from the Komodo database in adults who received ≥1 PAH prescription between March 2021 and February 2022.
Crohns Colitis 360
January 2025
Janssen Global Services, LLC, Horsham, PA, USA.
Background: Despite a wide range of available treatments, there is limited evidence as to why significant numbers of Crohn's disease (CD) patients do not achieve disease remission or continue to have residual symptom burden. We aimed to quantify the impact of this suboptimal treatment on patient symptom incidence and severity, quality of life (QoL), and work impairment.
Methods: Data were derived from the Adelphi Real World CD Disease Specific Programme, a cross-sectional survey of CD patients and their treating physicians in France, Germany, Italy, Spain, the United Kingdom, and the United States between January 2020 and March 2021.
Crohns Colitis 360
January 2025
Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, IN, USA.
Background: Exit interviews with patients who completed the Phase 3 VIVID-1 mirikizumab clinical trial for moderately-to-severely active Crohn's disease explored the content validity of bowel urgency, stool frequency, and abdominal pain patient-reported outcome measures and perceptions of meaningful within-patient change and remission in these key Crohn's disease symptoms.
Methodology: Cognitive debriefing explored patient understanding of the bowel urgency numeric rating scale (Urgency NRS), Crohn's Disease Activity Index: Stool Frequency (CDAI-SF) and Abdominal Pain (CDAI-AP), and patient global rating/impression of severity/change (PGRS/PGIC). Perceptions of meaningful change and remission were explored qualitatively.
Mult Scler
January 2025
NYU MS Comprehensive Care Center, Department of Neurology, New York University Grossman School of Medicine, New York, NY, USA.
Background: In the DISCOMS (DISCOntinuation of disease-modifying therapies (DMTs) in multiple sclerosis (MS)) randomized clinical trial, we could not demonstrate that discontinuing MS DMTs in older, stable adults was not inferior to continuing DMTs. Relapses were rare in both groups, and most new disease activity was one to two new brain magnetic resonance imaging (MRI) lesions unassociated with clinical changes.
Objective/aims: Describe results of the DISCOMS extension study.
Med Res Rev
January 2025
Key Laboratory of Advanced Drug Preparation Technologies, Ministry of Education, School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou, Henan, China.
Targeted protein degradation (TPD) has emerged as a significant therapeutic approach for a variety of diseases, including cancer. Advances in TPD techniques, such as molecular glue (MG) and lysosome-dependent strategies, have shown substantial progress since the inception of the first PROTAC in 2001. The PROTAC methodology represents the forefront of TPD technology, with ongoing evaluation in more than 20 clinical trials for the treatment of diverse medical conditions.
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