Why are There not More Bayesian Clinical Trials? Ability to Interpret Bayesian and Conventional Statistics Among Medical Researchers

Bray, Ross; Hartley, A.; Wenkert, Deborah; Muehlemann, Natalia; Natanegara, Fanni; Harrell, Frank E.; Wang, Fei; Clark, Jennifer

doi:10.1007/s43441-022-00482-1

Cited by 5 publications

(2 citation statements)

References 12 publications

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“… 19 To overcome the disadvantage of historical controls, the information was appropriately down-weighted according to between-trial variability. At present, this low adoption of Bayesian methods is likely due to a lack of familiarity with Bayesian methods, 20 as well as a lack of willingness to take deviate from frequentist approaches to drug development due to perceived risk. Other methods include the use of external control arms as an alternative to placebo.…”

Section: Discussionmentioning

confidence: 99%

Toward Patient Centricity: Why Do Patients With Inflammatory Bowel Disease Participate in Pharmaceutical Clinical Trials? A Mixed-Methods Exploration of Study Participants

Solitano,

Prins,

Archer

et al. 2024

Crohn's &Amp; Colitis 360

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Background A better understanding of motivations to participate as well as recommendations to reduce barriers to enrolment may assist in design of future clinical trials. Methods We developed a 32-item electronic questionnaire to explore motivations, experiences, and recommendations of inflammatory bowel disease (IBD) patients, who have participated in pharmaceutical clinical trials in a tertiary center in Canada over the last decade. We employed a mixed-methods approach that integrates both quantitative and qualitative research methods. Results We distributed a total of 69 e-mails with surveys and received 46 responses (66.6% response rate). Study participants were mostly male (27/46, 58.7%), non-Hispanic white (43/46, 93.5%), with a mean age of 45.5 years (SD 10.9). Most decided to participate in a clinical trial to benefit future patients (29/46, 63.0%). Half of participants (23/46, 50.0%) reported they were worried about the possibility of receiving placebo, although the majority (29/46, 63.0%) understood they could improve on placebo. The most challenging aspect reported was the number and length of questionnaires (15/46, 32.6%), as well of the number of colonoscopies (14/46, 30.4%). Strategies recommended to increase enrollment were reduction of the chance of receiving placebo (20/46, 43.5%), facilitating inclusion of patients who have failed multiple therapies (20/46, 43.5%), allowing virtual visits (18/46, 39.1%), including subtypes of disease traditionally excluded from trials (16/46, 34.8%) and improving outreach to underrepresented populations (13/46, 28.3%). The vast majority (37/46, 80.4%) reported their experience of participation to be better than expected. Conclusions These results should help inform the design of future clinical trials with a focus on patient centricity.

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Section: Discussionmentioning

confidence: 99%

Toward Patient Centricity: Why Do Patients With Inflammatory Bowel Disease Participate in Pharmaceutical Clinical Trials? A Mixed-Methods Exploration of Study Participants

Solitano,

Prins,

Archer

et al. 2024

Crohn's &Amp; Colitis 360

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“…A major limitation to Bayesian approaches is limited clinician familiarity, and slow adoption of such analyses as being equivalent to frequentist techniques in influencing clinical decision making [84][85][86]. This is despite over a decade of discussion [84] and several recent well publicised re-analyses of critical care studies utilising such techniques, including ANDROMEDA-SHOCK [87] and EOLIA [88].…”

Section: Heterogeneity Of Treatment Effectmentioning

confidence: 99%

Sedation management in the post-COVID era: A personalised, patient-orientated approach

John Glassford,

Shehabi

2024

Clin Crit Care

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Intensive care patients are older, frailer, and more co-morbid than ever before, and remain at risk of a variety of adverse outcomes, both in ICU, and after discharge. Sedation and delirium play an intricate role in this complex system, and it can be difficult to determine if they are a contributor or consequence in any given situation. During the COVID-19 pandemic, the increased frequency of complex ventilatory management, including prone ventilation and neuromuscular blockade, necessitated deep sedation in many cases. In concert with infection control concerns and staffing pressures, the delivery of precision symptom- and patient-oriented sedation has waned in favour of strategies felt to be globally safe. Using the SPICE III study as a lens to understand both the importance of exploring heterogeneity of effect in large, complex RCTs of critically ill patients, and the importance of an individualised approach to sedation in the intensive care unit, we demonstrate the evolution of our understanding of sedation in this challenging environment. By following the principles that define the cornerstones of best contemporary sedation practice we can once more grow beyond the boundaries of clinical practice guidelines in the provision of personalised, patient-orientated sedation in the post-COVID intensive care unit.

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Bayesian Clinical Trials

Clark¹,

Muhlemann²,

Ionan³

2023

Ther Innov Regul Sci

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Why are There not More Bayesian Clinical Trials? Ability to Interpret Bayesian and Conventional Statistics Among Medical Researchers

Cited by 5 publications

References 12 publications

Toward Patient Centricity: Why Do Patients With Inflammatory Bowel Disease Participate in Pharmaceutical Clinical Trials? A Mixed-Methods Exploration of Study Participants

Toward Patient Centricity: Why Do Patients With Inflammatory Bowel Disease Participate in Pharmaceutical Clinical Trials? A Mixed-Methods Exploration of Study Participants

Sedation management in the post-COVID era: A personalised, patient-orientated approach

Bayesian Clinical Trials

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