Gatekeepers for pragmatic clinical trials

Whicher, Danielle; Miller, Jennifer E.; Dunham, Kelly M.; Joffe, Steven

doi:10.1177/1740774515597699

Cited by 35 publications

(33 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The pop-up alert study in particular, which would affect clinicians' everyday practice, elicited a wide range of opinions in comparison to the other two studies, highlighting the importance of engaging clinicians during research design and implementation about research being conducted in their practices. After all, clinicians are important gatekeepers for such research efforts [21]. Engaging physicians in study design and implementation could help identify and minimize study burdens while also helping to ensure the clinical relevance of studies.…”

Section: Discussionmentioning

confidence: 99%

Physicians’ perspectives regarding pragmatic clinical trials

et al. 2016

View full text Add to dashboard Cite

Aim: Practicing physicians inevitably become involved in pragmatic clinical trials (PCTs), including comparative effectiveness research. We sought to identify physicians’ perspectives related to PCTs. Methods: In-depth semistructured interviews with 20 physicians in the USA. Results: Although physicians are generally willing to participate in PCTs, their support is predicated on several factors including expected benefits, minimization of time and workflow burdens and physician engagement. Physicians communicated a desire to respect patients’ rights and interests while maintaining a high level of care. Conclusion: Future work is needed to systematically assess the impact of PCTs on clinicians in meeting their ethical obligations to patients and the burdens clinicians are willing to accept in exchange for potential benefits.

show abstract

Section: Discussionmentioning

confidence: 99%

Physicians’ perspectives regarding pragmatic clinical trials

et al. 2016

View full text Add to dashboard Cite

show abstract

“…Successful implementation of PCTs for neonatal research requires that investigators have access to resources such as financial support, institutional infrastructure (clinics, facilities, staff), eligible participants patients, and patient data) and support of the gatekeepers (people or entities with ability to allow or deny access to the resources required to support the conduct of clinical research) [47]. These include research sponsors, regulatory agencies, institutional review boards, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians [47]. The need to address the limited data on safety and efficacy of neonatal medication calls for a need to address challenges related to practical application of the regulatory and ethical paradigms through PCTs [8, 9].…”

Section: Main Textmentioning

confidence: 99%

“…Gatekeepers (sponsors, regulatory bodies and IRBs) should be sensitized on the ethical tensions inherent in neonatal RCTs (including PCTs) related to concern for potential harms associated with neonatal research, as well as to concerns of individuals, groups, and communities affected by the gatekeepers’ decisions, (including need to balance protection from harm and maximization of benefits) [47]. Depending on the research design, the types and targets of PCT interventions and the outcomes, the assessment of the net potential risk (understood as the balance of potential harms and benefits) may vary in different studies [28, 29, 41].…”

Section: Main Textmentioning

confidence: 99%

“…As the balance between protection and access progressively shifts in favor of increasing access to pediatric research in general and neonatal research in particular, it becomes increasingly crucial to ensure the protection for these vulnerable participants [40, 41]. Responsibilities of gatekeepers also include stewardship of financial, human, and other organizational resources needed to ensure ethical inclusion of neonates in research [47]. The fundamental protection for research subjects, namely the informed consent of the parents or guardians before any recruitment, is not reasonable in true emergency situations common in neonatal research, and so modifications of the consent process are necessary [37, 41, 48].…”

Section: Main Textmentioning

confidence: 99%

See 1 more Smart Citation

The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care

Kaye

2019

BMC Pediatr

View full text Add to dashboard Cite

Background Research guidelines generally recognize vulnerable populations to include neonates with the aim of enhancing protections from harm. In practice, such guidance results in limiting participation in randomized clinical trials (RCTs). Yet while medical care of neonates should be based on best research evidence to ensure that safe, efficacious treatment or procedures are used, this seldom happens in contemporary practice. Discussion The compelling need to generate information on effectiveness and safety of procedures and medications that are already in use during neonatal care has led to increase in calls for pragmatic randomized clinical trials (PCTs). This raises ethical concerns as to whether exclusion of the vulnerable populations from research participations constitutes harm. First, neonates are denied access to both potentially beneficial research outputs and an opportunity to generate data on how interventions or medications perform in diverse clinical settings and inform clinical decision-making. Secondly, risks and harms in PCTs may differ from traditional RCTs, and can be reduced by modifications in study designs. The latter may involve assessment of effectiveness of comparable medication, devices or practices (whose safety data is available), randomization at the group level rather than at the individual level, avoidance of invasive and innovative study procedures, reliance on locally available data on relevant patient outcomes, and employment of procedures that tend to meet the criteria of minimal risk for human subject research. Thirdly, informed consent procedures should be modified from those of traditional RCTs, as neonates in traditional RCTs may be vulnerable to different extents in PCTs. Lastly, regulatory and oversight procedures designed for traditional RCT settings need modification, as they may not be translatable, feasible, appropriate or even ethical to apply in PCTs. Conclusion The principle of justice, commonly interpreted as preventing an inequitable burden of research, should also allow fair access to potential benefits from PCTs for neonates and other vulnerable populations. Under certain conditions, prospective randomized trials involving neonates should be ethically permissible to allow inclusion of neonates in research. This may require modification of the research design, consent procedures or regulations for research oversight.

show abstract

“…Those with institutional responsibility for these activities should actively seek the opinions of relevant stakeholders to better understand their interests and priorities. (See Gatekeepers for Pragmatic Clinical Trials 30 in this series of papers for more. )…”

Section: Recommendations: Approaches To Oversightmentioning

confidence: 99%

Oversight on the borderline: Quality improvement and pragmatic research

et al. 2015

View full text Add to dashboard Cite

Pragmatic research that compares interventions to improve the organization and delivery of health care may overlap, in both goals and methods, with quality improvement (QI) activities. When activities have attributes of both research and QI, confusion often arises about what ethical oversight is, or should be, required. For routine QI, in which the delivery of health care is modified in minor ways that create only minimal risks, oversight by local clinical or administrative leaders utilizing institutional policies may be sufficient. However, additional consideration should be given to activities that go beyond routine, local QI to first determine whether such non-routine activities constitute research or QI and, in either case, to ensure that independent oversight will occur. This should promote rigor, transparency, and protection of patients’ and clinicians’ rights, well-being, and privacy in all such activities. Specifically, we recommend: 1. Health care organizations should have systematic policies and processes for designating activities as routine QI, non-routine QI, or QI research, and determining what oversight each will receive. 2. Health care organizations should have formal and explicit oversight processes for non-routine QI activities that may include input from institutional QI experts, health services researchers, administrators, clinicians, patient representatives, and those experienced in the ethics review of health care activities. 3. QI research requires review by an IRB; for such review to be effective, IRBs should develop particular expertise in assessing QI research. 4. Stakeholders should be included in the review of non-routine QI and QI-related research proposals. Only by doing so will we optimally leverage both pragmatic research on health care delivery and local implementation through QI as complementary activities for improving health.

show abstract

Gatekeepers for pragmatic clinical trials

Cited by 35 publications

References 25 publications

Physicians’ perspectives regarding pragmatic clinical trials

Physicians’ perspectives regarding pragmatic clinical trials

The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care

Oversight on the borderline: Quality improvement and pragmatic research

Contact Info

Product

Resources

About