Biomedical Data Science, Artificial Intelligence, and Ethics: Navigating Challenges in the Face of Explosive Growth.

Advances in biomedical data science and artificial intelligence (AI) are profoundly changing the landscape of healthcare. This article reviews the ethical issues that arise with the development of AI technologies, including threats to privacy, data security, consent, and justice, as they relate to donors of tissue and data. It also considers broader societal obligations, including the importance of assessing the unintended consequences of AI research in biomedicine.

Developer Perspectives on Potential Harms of Machine Learning Predictive Analytics in Health Care: Qualitative Analysis.

Background: Machine learning predictive analytics (MLPA) is increasingly used in health care to reduce costs and improve efficacy; it also has the potential to harm patients and trust in health care. Academic and regulatory leaders have proposed a variety of principles and guidelines to address the challenges of evaluating the safety of machine learning-based software in the health care context, but accepted practices do not yet exist. However, there appears to be a shift toward process-based regulatory paradigms that rely heavily on self-regulation.

Stronger regulation of AI in biomedicine.

Regulatory agencies need to ensure the safety and equity of AI in biomedicine, and the time to do so is now.

Not in my AI: Moral engagement and disengagement in health care AI development.

Machine learning predictive analytics (MLPA) are utilized increasingly in health care, but can pose harms to patients, clinicians, health systems, and the public. The dynamic nature of this technology creates unique challenges to evaluating safety and efficacy and minimizing harms. In response, regulators have proposed an approach that would shift more responsibility to MLPA developers for mitigating potential harms.

Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.

Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups.

A systematic review and meta-analysis of pregabalin preclinical studies.

Despite large efforts to test analgesics in animal models, only a handful of new pain drugs have shown efficacy in patients. Here, we report a systematic review and meta-analysis of preclinical studies of the commercially successful drug pregabalin. Our primary objective was to describe design characteristics and outcomes of studies testing the efficacy of pregabalin in behavioral models of pain.

Assessment of Pregabalin Postapproval Trials and the Suggestion of Efficacy for New Indications: A Systematic Review.

Importance: After a drug receives regulatory approval, researchers often pursue small, underpowered trials, called exploratory trials, aimed at testing additional indications. If favorable early findings from exploratory trials are not promptly followed by confirmatory trials, then physicians, patients, and payers can be left uncertain about a drug's clinical value (clinical agnosticism). Such findings may encourage the off-label use of ineffective drugs.

A meta-analysis of threats to valid clinical inference in preclinical research of sunitinib.

Poor study methodology leads to biased measurement of treatment effects in preclinical research. We used available sunitinib preclinical studies to evaluate relationships between study design and experimental tumor volume effect sizes. We identified published animal efficacy experiments where sunitinib monotherapy was tested for effects on tumor volume.

Patient time costs and out-of-pocket costs in hepatitis C.

Background: Hepatitis C virus (HCV) infection is associated with substantial costs to patients, their caregivers and society.

Aims: We evaluated time costs (time spent seeking healthcare) and out-of-pocket (OOP) costs for patients with HCV and their caregivers.

Methods: We measured costs for 738 HCV outpatients in a tertiary-care clinic using a patient-completed questionnaire.

Health utilities and psychometric quality of life in patients with early- and late-stage hepatitis C virus infection.

Background And Aim: Hepatitis C virus (HCV) infection is associated with impairment in health-related quality of life (HRQOL). The purpose of this study was to evaluate HRQOL across the HCV disease spectrum using preference-based (utility) and non-preference-based (psychometric) methods, adjusting for sociodemographic factors and co-morbidity.

Methods: Hepatitis C virus patients (n = 751) were recruited from several tertiary care settings in Vancouver, Canada for this observational, cross-sectional cohort study.

Untapped ethical resources for neurodegeneration research.

Background: The research community has a mandate to discover effective treatments for neurodegenerative disorders. The ethics landscape surrounding this mandate is in a constant state of flux, and ongoing challenges place ever greater demands on investigators to be accountable to the public and to answer questions about the implications of their work for health care, society, and policy.

Methods: We surveyed US-based investigators involved in neurodegenerative diseases research about how they value ethics-related issues, what motivates them to give consideration to those issues, and the barriers to doing so.

Reducing barriers to ethics in neuroscience.

Ethics is a growing interest for neuroscientists, but rather than signifying a commitment to the protection of human subjects, care of animals, and public understanding to which the professional community is engaged in a fundamental way, interest has been consumed by administrative overhead and the mission creep of institutional ethics reviews. Faculty, trainees, and staff (n = 605) in North America whose work involves brain imaging and brain stimulation completed an online survey about ethics in their research. Using factor analysis and linear regression, we found significant effects for invasiveness of imaging technique, professional position, gender, and local presence of bioethics centers.