Patients at the Heart of the Scientific Dialogue: An Industry Perspective

Habr, Dany; Glanares, Brittany Wolf; Schuler, Kris; Chari, Dheepa

doi:10.1007/s40487-023-00220-z

Cited by 3 publications

(1 citation statement)

References 30 publications

(62 reference statements)

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“…As shown in our study, studies with sites in Asia have a significantly higher rate of industry involvement as sole funder. This also puts the onus on the pharmaceutical industry to collaborate with the broader oncology community to implement effective changes [ 32 , 59 ]. Several best practices for biopharmaceutical companies for enhancing ethnic diversity in clinical trials have also been discussed [ 7 ].…”

Section: Discussionmentioning

confidence: 99%

Diversity in Oncology Clinical Trials: Current Landscape for Industry-Sponsored Clinical Trials in Asia

Habr,

Singh,

Uehara

2023

Oncol Ther

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Introduction There has been a growing recognition on the importance of diversity in clinical trials. Existing research has highlighted a significant demographic imbalance. Amidst this renewed focus on diversity, it is crucial to acknowledge that Asia comprises over half of the world’s population. Given the region’s demographic significance, we sought to compare various characteristics and growth rates for trials with sites in Asia against those without any sites in Asia. Methods We performed comprehensive analyses of industry-sponsored phase 2 and 3 oncology trials registered at Clinicaltrials.gov, using drugs or biologics as investigational agents and executed between 1 January 2018 and 31 December 2022. We applied the compound annual growth rate (CAGR) as an analytical tool to track the trial growth rates over this 5-year period. Results We identified 894 industry-sponsored phase 2 and 3 cancer studies with available study location data. Out of these, 415 trials (46.42%) had study sites in Asia. Notably, these trials with sites in Asia were also more likely to be phase 3 trials (39.76% vs 6.47%, p < 0.001), include female and paediatric populations, and be randomised trials. Interestingly, lung and stomach cancers were more commonly studied in these trials, while myeloma was less commonly studied. The number of trial sites for liver cancer was not significantly higher for Asia, even though the incidence of the disease is much higher in this region. Despite an overall declining trend in the number of clinical trials in the last 5 years, we observed a transitional positive increase in the CAGR from 2020 to 2021 for trials with sites in Asia. However, East Asia, specifically China, exhibited a disproportionate overrepresentation in these trials. Conclusions There are notable characteristics of clinical trials with sites in Asia. Comprehending these disparities may aid in the strategic planning to enhance a balanced representation of ethnicities in trials. Supplementary Information The online version contains supplementary material available at 10.1007/s40487-023-00254-3.

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Section: Discussionmentioning

confidence: 99%

Diversity in Oncology Clinical Trials: Current Landscape for Industry-Sponsored Clinical Trials in Asia

Habr,

Singh,

Uehara

2023

Oncol Ther

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Practices and Barriers in Developing and Disseminating Plain-Language Resources Reporting Medical Research Information: A Scoping Review

Pal,

Arnet,

Elger

et al. 2024

Patient

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Background The intent of plain-language resources (PLRs) reporting medical research information is to advance health literacy among the general public and enable them to participate in shared decision-making (SDM). Regulatory mandates coupled with academic and industry initiatives have given rise to an increasing volume of PLRs summarizing medical research information. However, there is significant variability in the quality, format, readability, and dissemination channels for PLRs. In this scoping review, we identify current practices, guidance, and barriers in developing and disseminating PLRs reporting medical research information to the general public including patients and caregivers. We also report on the PLR preferences of these intended audiences. Methods A literature search of three bibliographic databases (PubMed, EMBASE, Web of Science) and three clinical trial registries (NIH, EMA, ISRCTN registry) was performed. Snowball searches within reference lists of primary articles were added. Articles with PLRs or reporting topics related to PLRs use and development available between January 2017 and June 2023 were identified. Evidence mapping and synthesis were used to make qualitative observations. Identified PLRs were quantitatively assessed, including temporal annual trends, availability by field of medicine, language, and publisher types. Results A total of 9116 PLRs were identified, 9041 from the databases and 75 from clinical trial registries. The final analysis included 6590 PLRs from databases and 72 from registries. Reported barriers to PLR development included ambiguity in guidance, lack of incentives, and concerns of researchers writing for the general public. Available guidance recommendations called for greater dissemination, increased readability, and varied content formats. Patients preferred visual PLRs formats (e.g., videos, comics), which were easy to access on the internet and used short jargon-free text. In some instances, older audiences and more educated readers preferred text-only PLRs. Preferences among the general public were mostly similar to those of patients. Psychology, followed by oncology, showed the highest number of PLRs, predominantly from academia-sponsored research. Text-only PLRs were most commonly available, while graphical, digital, or online formats were less available. Preferred dissemination channels included paywall-free journal websites, indexing on PubMed, third-party websites, via email to research participants, and social media. Conclusions This scoping review maps current practices, recommendations, and patients’ and the general public’s preferences for PLR development and dissemination. The results suggest that making PLRs available to a wider audience by improving nomenclature, accessibility, and providing translations may contribute to empowerment and SDM. Minimizing variability among available guidance for PLR development may play an important role in am...

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Publishing clinical trial results in plain language: a clash of ethical principles?

Pal,

Klingmann,

Wangmo

et al. 2024

Current Medical Research and Opinion

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Patients at the Heart of the Scientific Dialogue: An Industry Perspective

Cited by 3 publications

References 30 publications

Diversity in Oncology Clinical Trials: Current Landscape for Industry-Sponsored Clinical Trials in Asia

Diversity in Oncology Clinical Trials: Current Landscape for Industry-Sponsored Clinical Trials in Asia

Practices and Barriers in Developing and Disseminating Plain-Language Resources Reporting Medical Research Information: A Scoping Review

Publishing clinical trial results in plain language: a clash of ethical principles?

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