Evaluation of a tactile breath pacer for sleep problems: A mixed method pilot study.

Sleep problems, like insomnia, are a prevalent condition associated with major health risks. Prevention and treatment of sleep problems are thus essential to preserve physical and mental health. Previous work supports the effectiveness of breathing guidance for sleep problems and recommends breathing exercises as an effective intervention for insomnia. While new technologies can support breathing guidance, such novel devices should be assessed for effectiveness and usability to facilitate implementation and continued use. The current pilot study investigates the acceptability and usability of a mobile tactile breathing device and explores its potential impact on subjective sleep quality. In this mixed-method pilot study, 39 participants tested the breathing device for one month in naturalistic circumstances. We collected their experiences, subjective sleep quality, and feedback regarding the usability of the device and the accompanying app through a survey in a pre-post design. The results show that the breathing device is an acceptable solution for sleep problems and participants particularly appreciate the standalone function and design. Nevertheless, important points of attention, such as the size of the device, were also identified. Explorative analyses suggest that subjective sleep quality improved after using the device and accompanying app. The current study supports the usability and acceptability of a tactile breath pacer and provides preliminary evidence supporting a positive impact of the technology on the sleep quality of participants. Recommendations for developers of breathing technologies and eHealth are devised based on the findings.

Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer.

Although collaborations between academic institutions and industry have led to important scientific breakthroughs in the discovery stage of the pharmaceutical research and development process, the role of multistakeholder partnerships in the clinical development of anticancer medicines necessitates further clarification. The benefits associated with such cooperation could be undercut by the conflicting goals and motivations of the actors included. The aim of this review was to identify and characterize past, present, and future stakeholder partnership models in cancer clinical research through the lens of the European Organisation for Research and Treatment of Cancer (EORTC). Based on the analysis of several landmark EORTC trials performed across the span of three decades, four existing models of stakeholder cooperation were delineated and characterized. Additionally, a hypothetical fifth model representing a potential future collaborative framework for cancer clinical research was formulated. These models mainly differ in terms of the nature and responsibilities of the partners included and show that clinical research partnerships in oncology have evolved over time from small-scale academia-industry collaborations to complex interdisciplinary cooperation involving many different stakeholders.

Sharing of Clinical Trial Data and Samples: The Cancer Patient Perspective.

Introduction: Today, many initiatives and papers are devoted to clinical trial data (and to a lesser extent sample) sharing. Journal editors, pharmaceutical companies, funding agencies, governmental organizations, regulators, and clinical investigators have been debating the legal, ethical, and social implications of clinical data and sample sharing for several years. However, only little research has been conducted to unveil the patient perspective. Aim: To substantiate the current debate, we aimed to explore the attitudes of patients toward the re-use of clinical trial samples and data and to determine how they would prefer to be involved in this process. Materials and Methods: Sixteen in-depth interviews were conducted with cancer patients currently participating in a clinical trial. Results: This study indicates a general willingness of cancer patients participating in a clinical trial to allow re-use of their clinical trial data and/or samples by the original research team, and a generally open approach to share data and/or samples with other research teams, but some would like to be informed in this case. Despite divergent opinions about how patients prefer to be engaged, ranging from passive donors up to those explicitly wanting more control, participants expressed positive opinions toward technical solutions that allow indicating their preferences. Conclusion: Patients were open to sharing and re-use of data and samples to advance medical research but opinions varied on the level of patient involvement and the need for re-consent. A stratified approach for consent that allows individualization of data and sample sharing preferences may be useful, yet the implementation of such an approach warrants further research.

Toward a Tiered Model to Share Clinical Trial Data and Samples in Precision Oncology.

The recent revolution in science and technology applied to medical research has left in its wake a trial of biomedical data and human samples; however, its opportunities remain largely unfulfilled due to a number of legal, ethical, financial, strategic, and technical barriers. Precision oncology has been at the vanguard to leverage this potential of "Big data" and samples into meaningful solutions for patients, considering the need for new drug development approaches in this area (due to high costs, late-stage failures, and the molecular diversity of cancer). To harness the potential of the vast quantities of data and samples currently fragmented across databases and biobanks, it is critical to engage all stakeholders and share data and samples across research institutes. Here, we identified two general types of sharing strategies. First, open access models, characterized by the absence of any review panel or decision maker, and second controlled access model where some form of control is exercised by either the donor (i.e., patient), the data provider (i.e., initial organization), or an independent party. Further, we theoretically describe and provide examples of nine different strategies focused on greater sharing of patient data and material. These models provide varying levels of control, access to various data and/or samples, and different types of relationship between the donor, data provider, and data requester. We propose a tiered model to share clinical data and samples that takes into account privacy issues and respects sponsors' legitimate interests. Its implementation would contribute to maximize the value of existing datasets, enabling unraveling the complexity of tumor biology, identify novel biomarkers, and re-direct treatment strategies better, ultimately to help patients with cancer.