EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations

Boesen, Kim; Gøtzsche, Peter C; Ioannidis, John P. A.

doi:10.1017/s2045796021000147

Cited by 11 publications

(12 citation statements)

References 30 publications

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“…The study's methods are described in the protocol (Boesen et al, 2020) and our first report (Boesen et al, 2021). In brief, we aimed to assess four objectives related to regulatory guidance documents published by the EMA and FDA on how to design pivotal clinical drug trials pertaining to psychiatric diagnoses.…”

Section: Methodsmentioning

confidence: 99%

“…We decided to cross-reference the committee members' industry conflicts to the stakeholder companies (i.e. those companies that submitted feedback during the guideline development) identified in our first publication (Boesen et al, 2021).…”

Section: Identification Of 'Cross-conflicts'mentioning

confidence: 99%

“…In our first report, we reported the results on three of our project's four prespecified objectives: (i) guideline development phases, (ii) stakeholder involvement and (iii) trial design recommendations (Boesen et al, 2021). The fourth prespecified objective in our published protocol (Boesen et al, 2020) was to assess the prevalence of declared industry conflicts of interest among those committee members responsible for drafting the guidelines.…”

Section: Introductionmentioning

confidence: 99%

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Requesting conflicts of interest declarations from the European Medicines Agency: 3-year follow-up status

Boesen,

Gøtzsche,

Ioannidis

2024

Epidemiol Psychiatr Sci

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Aims We have previously described the European Medicines Agency’s (EMA) and the US Food and Drug Administration’s guidelines, each for a specific psychiatric indication, on how to design pivotal drug trials used in new drug applications. Here, we report on our efforts over 3 years to retrieve conflicts of interest declarations from EMA. We wanted to assess potential internal industry influence judged as the proportion of guideline committee members with industry conflicts of interest. Methods We submitted Freedom of Information requests in February 2020 to access EMA’s lists of committee members (and their declared conflicts of interest) involved in drafting the 13 ‘Clinical efficacy and safety’ guidelines available on EMA’s website pertaining to psychiatric indications. In our request, we did not specify the exact EMA committees. Here, we describe the received documents and report the proportion of members with industry interests (i.e. defined as any financial industry relationship). It is a follow-up paper to our first report (http://doi.org/10.1017/S2045796021000147). Results After 2 years and 9 months (November 2022), the EMA sent us member lists and corresponding conflicts of interest declarations from the Committee for Medicinal Products for Human use (CHMP) from 2012, 2013 and 2017. These member lists pertained to 3 of the 13 requested guidelines (schizophrenia, depression and autism spectrum disorder). The 10 remaining guidelines were published before 2011 and EMA stated that they needed to require permission from their expert members (with unknown retrieval rate) and foresaw excessive workload and long wait. Therefore, we withdrew our request. The CHMPs from 2012, 2013 and 2017 had from 34 to 36 members; 39%–44% declared any interests and we judged 14%–18% as having industry interests. For the schizophrenia guideline, we identified two members with industry interests to companies who submitted feedback on the guideline. We did not receive declarations from the Central Nervous System (CNS) Working Party, the CHMP appointed expert group responsible for drafting and incorporating feedback into the guidelines. Conclusions After almost 3 years, we received information, which only partly addressed our request. We recommend EMA to improve transparency by publishing the author names and their corresponding conflicts of interest declarations directly in the ‘Clinical efficacy and safety’ guidelines and to not remove conflicts of interest declarations after 1 year from their website to reduce the risk of stealth corporate influence during the development of these influential guidelines.

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Section: Methodsmentioning

confidence: 99%

Section: Identification Of 'Cross-conflicts'mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Requesting conflicts of interest declarations from the European Medicines Agency: 3-year follow-up status

Boesen,

Gøtzsche,

Ioannidis

2024

Epidemiol Psychiatr Sci

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“…This approach had a rapid and widespread influence on definitions of mental health illnesses through the proliferation of a simple and reliable measurement paradigm. The RDC revolution allowed screening, diagnosis, and treatment to be delivered in a standardized manner by creating consistent, reliable, and reproducible methods that could be generalized across research into populations (Kessler et al 2005, Manea et al 2015, mechanisms, and treatment (Boesen et al 2021, Hyman 2010.…”

Section: History and Aims Of Clinical Measurementmentioning

confidence: 99%

Machine Learning and the Digital Measurement of Psychological Health

Galatzer‐Levy

Onnela

2023

Annual Review of Clinical Psychology

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Since its inception, the discipline of psychology has utilized empirical epistemology and mathematical methodologies to infer psychological functioning from direct observation. As new challenges and technological opportunities emerge, scientists are once again challenged to define measurement paradigms for psychological health and illness that solve novel problems and capitalize on new technological opportunities. In this review, we discuss the theoretical foundations of and scientific advances in remote sensor technology and machine learning models as they are applied to quantify psychological functioning, draw clinical inferences, and chart new directions in treatment.

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“…Bioanalytical method validation was performed according to the US FDA recommendations (Boesen et al, 2021). The selectivity was evaluated by analyzing blank plasma samples, blank plasma samples spiked with standards, and PK samples.…”

Section: Validation Experimentsmentioning

confidence: 99%

Evaluation of herb–drug interactions between compound Danshen dripping pills and clopidogrel based on the pharmacokinetics and pharmacodynamics in rats

Zheng

Zhang

Hou

et al. 2023

Biomedical Chromatography

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Compound Danshen dripping pills (CDDP), a well‐known traditional Chinese medicine, is widely used to prevent and treat cardiovascular diseases. CDDP is usually prescribed in combination with clopidogrel (CLP), but the herb–drug interactions are rarely reported. This study evaluated the effects of CDDP on the pharmacokinetics and pharmacodynamics of coadministered CLP, and ensured the safety and efficacy of their usage. The trial design included a single‐dose administration and multidose test for 7 consecutive days. Wistar rats received CLP alone or CLP combined with CDDP. After the final dose, plasma samples were collected at various time points, and the active metabolite H4 of CLP was analyzed by ultrafast liquid chromatography coupled with triple quadrupole tandem mass spectrometry. The main pharmacokinetic parameters of Cmax (maximum [or peak] serum concentration), Tmax (peak plasma time), t1/2 (half‐time), AUC0–∞ (area under the concentration–time curve from dosing (time 0) to infinite time), and AUC0–t (area under the concentration–time curve from dosing [time 0] to time t) were calculated using the non‐compartment model. In addition, prothrombin time, activated partial thromboplastin time, bleeding time, and adenosine diphosphate–induced platelet aggregation were evaluated for anticoagulation and antiplatelet aggregation activity. In this study, we found that CDDP had no significant effect on the metabolism of CLP in rats. In pharmacodynamic studies, the combination group showed significant synergistic antiplatelet activity compared with the CLP or CDDP groups alone. Based on pharmacokinetic and pharmacodynamic results, CDDP and CLP have synergistic effects on antiplatelet aggregation and anticoagulation.

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EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations

Cited by 11 publications

References 30 publications

Requesting conflicts of interest declarations from the European Medicines Agency: 3-year follow-up status

Requesting conflicts of interest declarations from the European Medicines Agency: 3-year follow-up status

Machine Learning and the Digital Measurement of Psychological Health

Evaluation of herb–drug interactions between compound Danshen dripping pills and clopidogrel based on the pharmacokinetics and pharmacodynamics in rats

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