Informational needs for participation in bioequivalence studies: the perspectives of experienced volunteers

Koonrungsesomboon, Nut; Potikanond, Saranyapin; Takuathung, Mingkwan Na; Nimlamool, Wutigri; Karbwang, Juntra

doi:10.1007/s00228-019-02738-6

Cited by 3 publications

(2 citation statements)

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“…Direct health benefit, indirect/societal benefit, and post-trial benefit/provision, as well as major foreseeable risk and all adverse effects of the drug, including uncommon adverse effects, were the top five priority items of the IAF/ICF content that the respondents (both child participants and their parents) wanted to know the most. Our finding is consistent with a number of studies indicating that the risks and benefits related to trial participation are frequently perceived to be of most concern from the research participants’ points of view [ 22 , 26 , 27 ]. As such, in pediatric drug trials, information on risks (including infrequent adverse effects) and benefits (including post-trial benefit/provision) should be made a salient feature of an IAF/ICF and described comprehensively.…”

Section: Discussionsupporting

confidence: 92%

What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials

et al. 2022

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Background This study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form (IAF)/informed consent form (ICF) of a pediatric drug trial. Methods A descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item in a questionnaire, by giving a rating scale from 1 (not important) to 5 (very important). Results A total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects (i.e., direct health benefit [mean: 4.71 for child respondents, 4.89 for parent respondents], indirect/societal benefit [mean: 4.65, 4.85], major foreseeable risk [mean: 4.47, 4.78], post-trial benefit/provision [mean: 4.59, 4.74], and all adverse effects of the drug including uncommon adverse effects [mean: 4.53, 4.74]) were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents. Conclusions For pediatric drug trials, risk–benefit information (including direct health benefit, indirect/societal benefit, and post-trial benefit/provision, as well as major foreseeable risk and adverse effects of the drug) should be made a salient feature of an IAF/ICF. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/ICF to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases.

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Section: Discussionsupporting

confidence: 92%

What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials

et al. 2022

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“…30 Although there appears to be agreement on the essential elements of informed consent, the degree of information that an ICF should offer is controversial. [31][32][33] Some critiques express concerns regarding excessive details on certain elements, many of which go beyond what is important to decision-making and may distract potential research participants from more crucial information. 34,35 However, little guidance defines what it means to be ''adequately informed'' in practice.…”

Section: Discussionmentioning

confidence: 99%

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials

Dukaew,

Na Takuathung,

Sakuludomkan

et al. 2023

Clinical Trials

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Background/Aims An informed consent form is essential in drug development clinical trials. This study aimed to evaluate regulatory compliance and readability of informed consent forms currently being used in industry-sponsored drug development clinical trials. Methods This descriptive, cross-sectional study evaluated the informed consent forms of industry-sponsored drug development clinical trials conducted at the Faculty of Medicine, Chiang Mai University, between 2019 and 2020. The informed consent form’s compliance with the three major ethical guidelines and regulations (i.e. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6(R2) Good Clinical Practice; Declaration of Helsinki; and the revised Common Rule) were analyzed. The document length and the readability scores (using Flesch Reading Ease and Flesch-Kincaid Reading Grade) were assessed. Results Of 64 reviewed informed consent forms, the average page length was 22.0 ± 7.4 pages. More than half of their length was mainly devoted to three elements: trial procedures (22.9%), risks and discomforts (19.1%), and confidentiality and the limit of confidentiality (10.1%). Although most of the required elements of the informed consent form content were included in most informed consent forms, we identified four elements with often missing information in the form: aspects of research that are experimental (n = 43, 67.2%), involvement of whole-genome sequencing (n = 35, 54.7%), commercial profit sharing (n = 31, 48.4%), and posttrial provisions (n = 28, 43.8%). Conclusion The informed consent forms in industry-sponsored drug development clinical trials were long but incomplete. Our findings draw attention to ongoing challenges in industry-sponsored drug development clinical trials, where deficient informed consent form quality continues to exist.

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Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)

Moeti

Litedu²,

Joubert

2022

Ther Innov Regul Sci

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Informational needs for participation in bioequivalence studies: the perspectives of experienced volunteers

Cited by 3 publications

References 35 publications

What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials

What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials

Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)

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