Preclinical efficacy studies in investigator brochures: Do they enable risk–benefit assessment?
Publication Date
April 05, 2018
Authors
Susanne Wieschowski, William Wei Lim Chin, Carole Federico, Sören Sievers, et al
Volume
16
Issue
4
Pages
e2004879
DOI
https://dx.plos.org/10.1371/journal.pbio.2004879
Publisher URL
http://journals.plos.org/plosbiology/article?id=10.1371%2Fjournal.pbio.2004879
Scopus
85046438136
Mendeley
http://www.mendeley.com/research/preclinical-efficacy-studies-investigator-brochures-enable-riskbenefit-assessment
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Mendeley | Further Information

{"title"=>"Preclinical efficacy studies in investigator brochures: Do they enable risk–benefit assessment?", "type"=>"journal", "authors"=>[{"first_name"=>"Susanne", "last_name"=>"Wieschowski"}, {"first_name"=>"William Wei Lim", "last_name"=>"Chin"}, {"first_name"=>"Carole", "last_name"=>"Federico"}, {"first_name"=>"Sören", "last_name"=>"Sievers"}, {"first_name"=>"Jonathan", "last_name"=>"Kimmelman"}, {"first_name"=>"Daniel", "last_name"=>"Strech"}], "year"=>2018, "source"=>"PLOS Biology", "identifiers"=>{"pui"=>"621968038", "pmid"=>"29621228", "doi"=>"10.1371/journal.pbio.2004879", "issn"=>"1545-7885", "scopus"=>"2-s2.0-85046438136", "sgr"=>"85046438136", "isbn"=>"1111111111"}, "id"=>"c279f844-4a20-354b-8d2e-aa6365e309dd", "abstract"=>"Human protection policies require favorable risk–benefit judgments prior to launch of clinical trials. For phase I and II trials, evidence for such judgment often stems from preclinical efficacy studies (PCESs). We undertook a systematic investigation of application materials (investigator brochures [IBs]) presented for ethics review for phase I and II trials to assess the content and properties of PCESs contained in them. Using a sample of 109 IBs most recently approved at 3 institutional review boards based at German Medical Faculties between the years 2010–2016, we identified 708 unique PCESs. We then rated all identified PCESs for their reporting on study elements that help to address validity threats, whether they referenced published reports, and the direction of their results. Altogether, the 109 IBs reported on 708 PCESs. Less than 5% of all PCESs described elements essential for reducing validity threats such as randomization, sample size calculation, and blinded outcome assessment. For most PCESs (89%), no reference to a published report was provided. Only 6% of all PCESs reported an outcome demonstrating no effect. For the majority of IBs (82%), all PCESs were described as reporting positive findings. Our results show that most IBs for phase I/II studies did not allow evaluators to systematically appraise the strength of the supporting preclinical findings. The very rare reporting of PCESs that demonstrated no effect raises concerns about potential design or reporting biases. Poor PCES design and reporting thwart risk–benefit evaluation during ethical review of phase I/II studies.", "link"=>"http://www.mendeley.com/research/preclinical-efficacy-studies-investigator-brochures-enable-riskbenefit-assessment", "reader_count"=>12, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Researcher"=>5, "Student > Postgraduate"=>1, "Student > Bachelor"=>2, "Student > Ph. D. Student"=>1, "Other"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Researcher"=>5, "Student > Postgraduate"=>1, "Student > Bachelor"=>2, "Student > Ph. D. Student"=>1, "Other"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>4, "Biochemistry, Genetics and Molecular Biology"=>1, "Medicine and Dentistry"=>1, "Agricultural and Biological Sciences"=>5, "Engineering"=>1}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>5}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>4}}, "group_count"=>0}

Scopus | Further Information

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