Academic investigator-initiated trials and the challenge of sponsor responsibility: the Cologne Sponsor Model

Georgias, Christine; Grunow, Andrea; Olderog, Miriam; May, Alexander; Paulus, U.

doi:10.1177/1740774512461978

Cited by 10 publications

(9 citation statements)

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“…Academic investigator-initiated clinical trials, or non-commercial experiments, are not exceptional for rare disorders (https://kce.fgov.be/ sites/default/files/page_documents/KCE_246_Public_ funded_clinical_trials_Report.pdf). However these trials require the same legal regulations and Good Clinical Practice (GCP) guidelines (22) as commercial trials, also supervised by a clinical trial coordinator, following Standard Operating Procedures.…”

Section: Introductionmentioning

confidence: 99%

From promising molecules to orphan drugs: Early clinical drug development

Dooms

2017

IRDR

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Section: Introductionmentioning

confidence: 99%

From promising molecules to orphan drugs: Early clinical drug development

Dooms

2017

IRDR

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“…It is especially useful to create a position of a senior lab manager that can count on an attractive salary, so that there is certain continuity in file management [7];PI must assume optimal responsibilities without over-extending in academia;Good symbiosis with referring clinical agencies. This is a continuous process and your work is never done;…”

Section: From Study Design To Delivery Of the Findings: Aim For Perfementioning

confidence: 99%

“…It is especially useful to create a position of a senior lab manager that can count on an attractive salary, so that there is certain continuity in file management [7];…”

Section: From Study Design To Delivery Of the Findings: Aim For Perfementioning

confidence: 99%

Trials and tribulations of conducting medication trials: pediatric bipolar disorder as prototype

Pavuluri

2014

Clinical Investigation

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“…Typical examples are therapeutics optimization, comparison of treatments, proof-of-concept studies, orphan disease studies, pediatric trials, among others. 2,5 Above all, these trials provide robust evidence to enable policymakers to make informed and sustainable policy decisions on public health; lead to scientific communications and publications in scientific journals with high journal impact factors (JIF); help building clinical teams, which are the basis for a research center to be considered of excellence.…”

Section: Introductionmentioning

confidence: 99%

Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials

et al. 2021

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Introduction: The aim of this study was to investigate the Portuguese authorship in publications resulting from trials initiated by the industry or investigators and run in Portugal.Material and Methods: Clinical trials with Portuguese institutions as sponsor or recruiting centers, and registered in four clinical trial registries, in the last 14 years, were assessed. Publications of completed trials, from both the initiative of the industry and investigatorswere screened and compared.Results: The percentage of published trials initiated by industry and investigators was similar (28.0%). However, the percentage of completed investigator-initiated trials (43.6%) was lower when compared to industry trials (69.7%). There was a higher percentage of Portuguese authorship in published investigator-initiated trials when compared with industry-initiated trials (47.1% vs 8.5%, respectively). Moreover, industry-initiated trials with Portuguese authors were published in journals with lower journal impact factor when compared with those published without authorship of Portuguese investigators. Oncology was the therapeutic area with the highest number of clinical trial registrations and publications. However, in publications with Portuguese authors, industry Initiated trials mainly focused on neurology while investigator-initiated trials had a higher number of papers in the fields of gastroenterology and infection diseases. Published trials with Portuguese authorship, initiated by the industry or investigators, also targeted different populations and had different purposes. In both cases, no significant differences were observed in terms of the journal impact factor or in the alignment of the published randomized trials with the respective reporting guidelines.Discussion: When compared with previous publications, this study showed an increasing trend in the number of clinical trials in Portugal, published within similar timeframes, after trial conclusion. Even though both industry and investigator trials are published within the standards for reporting trials, the low number of Portuguese authorships in industry publications might underline the need for invigorating these independent clinical trials in Portugal by capacitating and empowering national clinical research teams.Conclusion: This study confirmed that even though all registered trials had the involvement of Portuguese institutions as a recruiting center, not all the published trials had Portuguese investigators as authors, mainly those initiated by the industry.

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Academic investigator-initiated trials and the challenge of sponsor responsibility: the Cologne Sponsor Model

Abstract: With the combination of central management and support, control and independence of the researchers, our model represents a 'risk-based' system that offers a sensible option that fulfils the requirements of legal regulations and GCP for trials organised within the university environment.

Cited by 10 publications

References 0 publications

From promising molecules to orphan drugs: Early clinical drug development

From promising molecules to orphan drugs: Early clinical drug development

Trials and tribulations of conducting medication trials: pediatric bipolar disorder as prototype

Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials

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