The Food and Drug Administration and pragmatic clinical trials of marketed medical products

Anderson, Monique; Griffin, Joseph C M; Goldkind, Sara F.; Zeitler, Emily P.; Wing, Liz; Al‐Khatib, Sana M.; Sherman, Rachel E.

doi:10.1177/1740774515597700

Cited by 22 publications

(21 citation statements)

References 34 publications

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“…In addition, concerns have been raised that Food and Drug Administration (FDA) regulations may also apply to some ROMP studies and, if so, may limit what consent approaches IRBs can approve. 10-11 In the absence of clear guidelines, IRB professionals have expressed uncertainty about where ROMP should fit within the existing regulatory scheme. 12 …”

Section: Introductionmentioning

confidence: 99%

A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices

Kraft¹,

Cho²,

Constantine

et al. 2016

Clinical Trials

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Background/Aims In the context of research on medical practices, which includes comparative effectiveness research and pragmatic clinical trials, empirical studies have begun to raise questions about the extent to which institutional review boards’ (IRBs) interpretations and applications of research regulations align with patients’ values. To better understand the similarities and differences between these stakeholder groups, we compare and contrast two surveys: one of IRB professionals and one of patients, which examine views on consent for research on medical practices. Methods We conducted online surveys of two target populations between July 2014 and March 2015. We surveyed 601 human subjects research professionals out of 1500 randomly selected from the Public Responsibility in Medicine and Research (PRIM&R) membership list (40.1% response rate), limiting analysis to the 537 respondents who reported having had IRB experience. We also surveyed 120 adult patients out of 225 approached at subspecialty clinics in Spokane, Washington (53.3% response rate). Our survey questions probed attitudes about consent in the context of research on medical practices using medical record review and randomization. The patient survey included three embedded animated videos to explain these concepts. Results A majority of IRB professionals distinguished between consent preferences for medical record review and randomization; ranked clinicians as the least preferred person to obtain participant consent (54.6%); and viewed written or verbal permission as the minimum acceptable consent approach for research on medical practices using randomization (87.3%). In contrast, most patients had similar consent preferences for research on medical practices using randomization and medical record review; most preferred to have consent conversations with their doctors rather than with researchers for studies using randomization (72.6%) and medical record review (67.0%); and only a few preferred to see research involving randomization (16.8%) or medical record review (13.8%) not take place if obtaining written or verbal permission would make the research too difficult to conduct. Limitations of our post hoc analysis include differences in framing, structure, and language between the two surveys and possible response bias. Conclusions Our findings highlight a need to identify appropriate ways to integrate patient preferences into prevailing regulatory interpretations as IRBs increasingly apply research regulations in the context of research on medical practices. Dialogue between IRBs and research participants will be an important part of this process and should inform future regulatory guidance.

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Section: Introductionmentioning

confidence: 99%

A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices

Kraft¹,

Cho²,

Constantine

et al. 2016

Clinical Trials

View full text Add to dashboard Cite

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“…The study investigator must ensure the study staff are trained and experienced, treat only appropriate study subject's and collect clinical trial data in a manner allowing appropriate evaluation of product effects on the human subject. Many authors [2][3][4][5][6] Monitoring trial activities to ensure patient safety and data integrity and to ensure all adverse events are reported and followed until resolution or other protocol-driven endpoint 10. Auditing trial activities to ensure study compliance and data quality Although the good clinical trial practices listed above may be the same for food and drug trials, many details differ between food and drug trials.…”

Section: Similarities Between Food and Drug Clinical Trialsmentioning

confidence: 99%

“…Favorable and unfavorable evidence should be considered. 6. As an example, the FDA drafted a guidance document to help infant formula manufacturers develop and substantiate truthful and not misleading claims [10].…”

Section: The Us Federal Trade Commission (Ftc) Has Primarymentioning

confidence: 99%

Similarities and Difference between Clinical Trials for Foods and Drugs

Jl¹

2017

Austin J Nutri Food Sci

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“…Manufacturers should demonstrate that a reusable device's materials will not release any toxic byproducts after repeated use and reprocessing. Materials should also be evaluated for their capacity to retain unacceptable levels of reprocessing chemical residuals as a result of any recommended cleaning, disinfection, or sterilization procedures [138]. If there is a potential for toxic byproducts or residuals, then manufacturers of both critical and semi-critical devices should perform extra biocompatibility testing on these potential threats [139].…”

Section: Effect Of Different Materials On a Device's Biocompatibilitymentioning

confidence: 99%

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Reifschneider

2018

Preprint

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The U.S. Food and Drug Administration ("FDA") regulates all medical devices in the United States. As part of its regulatory duties, the FDA provides guidance documents on various regulatory topics as mandated by the U.S. code of federal regulations. Since 2015, the FDA has begun to issue many substantial revisions to their guidance documents that directly affects the regulatory framework on biocompatibility, reprocessing, and sterilization.These regulatory issues are of paramount importance for many companies because of the potential high costs involved in changing their internal design, controls, manufacturing, and quality systems. This master’s thesis examines the various changes made by the FDA in recent years on the inter-related topics of biocompatibility, reprocessing, and sterilization. Some of the major changes by the FDA involve an increase in the importance of chemical characterization, a reduction in the use of animal testing, a requirement for an independent validation of the user instructions for reusable devices, and increased usability testing.The principal reasons for these major policy changes by the FDA are shown to be the major device scandals that recently involved duodenoscopes, metal-on-metal hip implants, and vaginal surgical mesh implants. Along with several other regulatory failures that made national news headlines in the United States, the FDA began to revise several of their previous medical device guidances. The information from this master’s thesis can be used by medical device developers and manufacturers, especially when they are located outside of the United States and lack sufficient regulatory affairs resources to provide independent advice and recommendations on these important FDA changes. A thorough analysis is made of the new FDA guidances to clarify several potentially difficult questions for medical device manufacturers, specifically the following: (1) "Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", (2) "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and (3) "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". This master’s thesis is intended to provide not only an overview of the current FDA requirements, but to function as a guide for both researchers and engineers to improve their medical device design and development process.

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The Food and Drug Administration and pragmatic clinical trials of marketed medical products

Cited by 22 publications

References 34 publications

A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices

A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices

Similarities and Difference between Clinical Trials for Foods and Drugs

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

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