ABSTRACT
AIM: Identify solutions to the most important policy barriers to the clinical adoption of next-generation sequencing. MATERIALS & METHODS: Four-round modified policy Delphi with a multistakeholder panel of 48 experts. The panel deliberated policy solutions to (previously reported) challenges deemed most important to address. RESULTS: The group advocated using consensus panels to promote consistency in payer policies and to standardize test reporting, and favored making genomic data-sharing a condition of regulatory clearance, certification, or accreditation processes. They were split on the role of US FDA. CONCLUSION: Panelists found common ground on solutions for health plan coverage policy consistency, data-sharing, and standardizing reporting, but were sharply divided on the role of the FDA in mitigating risks to patients.
ABSTRACT
This research aims to inform policymakers by engaging expert stakeholders to identify, prioritize, and deliberate the most important and tractable policy barriers to the clinical adoption of next generation sequencing (NGS). A 4-round Delphi policy study was done with a multi-stakeholder panel of 48 experts. The first 2 rounds of online questionnaires (reported here) assessed the importance and tractability of 28 potential barriers to clinical adoption of NGS across 3 major policy domains: intellectual property, coverage and reimbursement, and FDA regulation. We found that: 1) proprietary variant databases are seen as a key challenge, and a potentially intractable one; 2) payer policies were seen as a frequent barrier, especially a perceived inconsistency in standards for coverage; 3) relative to other challenges considered, FDA regulation was not strongly perceived as a barrier to clinical use of NGS. Overall the results indicate a perceived need for policies to promote data-sharing, and a desire for consistent payer coverage policies that maintain reasonably high standards of evidence for clinical utility, limit testing to that needed for clinical care decisions, and yet also flexibly allow for clinician discretion to use genomic testing in uncertain circumstances of high medical need.
ABSTRACT
Patient advocacy organizations (PAOs) are nonprofit groups that represent patients and families affected by a significant medical condition or disease. We review some of the different approaches that humanities and social researchers use to study PAOs. Drawing on this recent scholarship, we describe some contemporary patient groups and explore how PAOs can collaborate with biomedical researchers to advance genomic science. We highlight research that aims to describe how PAOs are contributing to multiple aspects of biomedical research, including study design, definition of research goals, data collection and analysis, dissemination of results, and research funding. We also describe several challenges that genomic researchers may encounter in collaborations with PAOs. Throughout our review, we focus on the manner in which new PAO roles challenge traditional boundaries between researchers and subjects, thereby redefining the relationship of patients to science. We consider how this shift may affect our view of scientific collaborations and impact genomic researchers in the future.
