Doing it right: Caring for and protecting patient information for US organ donors and transplant recipients.

In the current US organ transplantation system, there are no regulations defining how organ procurement organizations must manage personal data and protect the privacy of donors and recipients. In response to the recent announcement of a major overhaul of the US transplantation system, we describe a practical approach to improving transplant data quality and protecting the autonomy of patients interacting with the system.

Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration.

Importance: Emerging policies drafted by the pharmaceutical industry indicate that they will transparently share clinical trial data. These data offer an unparalleled opportunity to advance evidence-based medicine and support decision-making.

Objective: To evaluate the eligibility of independent, qualified researchers to access individual participant data (IPD) from oncology trials that supported US Food and Drug Administration (FDA) approval of new anticancer medicines within the past 10 years.

Beyond privacy: A deeper understanding of the internet is required to protect digitized trial participants.

Understanding privacy in the digital age requires a deep understanding of the forces driving the internet and the specific resulting harms. To protect patients in digitized clinical trials, we must look beyond the traditional and historical concept of medical privacy.

Continuous Monitoring Using a Wearable Device Detects Activity-Induced Heart Rate Changes After Administration of Amphetamine.

Wearable digital devices offer potential advantages over traditional methods for the collection of health-related information, including continuous collection of dense data while study subjects are ambulatory or in remote settings. We assessed the utility of collecting continuous actigraphy and cardiac monitoring by deploying two US Food and Drug Administration (FDA) 510(k)-cleared devices in a phase I clinical trial of a novel compound, which included the use of an amphetamine challenge. The Phillips Actiwatch Spectrum Pro (Actiwatch) was used to assess mobility and sleep.

Evaluation of Wearable Digital Devices in a Phase I Clinical Trial.

We assessed the performance of two US Food and Drug Administration (FDA) 510(k)-cleared wearable digital devices and the operational feasibility of deploying them to augment data collection in a 10-day residential phase I clinical trial. The Phillips Actiwatch Spectrum Pro (Actiwatch) was used to assess mobility and sleep, and the Vitalconnect HealthPatch MD (HealthPatch) was used for monitoring heart rate (HR), respiratory rate (RR), and surface skin temperature (ST). We measured data collection rates, compared device readouts with anticipated readings and conventional in-clinic measures, investigated data limitations, and assessed user acceptability.

Using digital health to enable ethical health research in conflict and other humanitarian settings.

Conducting research in a humanitarian setting requires quantifiable quality measures to ensure ethical study conduct. Digital health technologies are proven to improve research study quality and efficacy via automated data collection, improvement of data reliability, fidelity and resilience and by improved data provenance and traceability. Additionally, digital health methodologies can improve patient identity, patient privacy, study transparency, data sharing, competent informed consent, and the confidentiality and security of humanitarian operations.

Wearable Devices in Clinical Trials: Hype and Hypothesis.

The development of innovative wearable technologies has raised great interest in new means of data collection in healthcare and biopharmaceutical research and development. Multiple applications for wearables have been identified in a number of therapeutic areas; however, researchers face many challenges in the clinic, including scientific methodology as well as regulatory, legal, and operational hurdles. To facilitate further evaluation and adoption of these technologies, we highlight methodological and logistical considerations for implementation in clinical trials, including key elements of analytical and clinical validation in the specific context of use (COU).

A cybersecurity primer for translational research.

Virtually all health care organizations have had at least one data breach since 2012. Most of the largest data breaches and Health Care Information Privacy and Accountability Act fines could have been prevented by the simplest of strategies. Each researcher must clearly understand his or her responsibilities and liability.

Translational informatics in personalized medicine: an update for 2014.

Many things have changed but much has remained the same as we have seen a dramatic increase in the generation of genetics, genomics and a variety of clinical data leading to increased data density and continued challenges in organizing and managing that data in pursuit of personalized medicine. Simultaneously, we have seen an increase in commercial and open-source solutions, and marked movement toward open sharing of tools and data in public-private partnerships, yet still few examples of traditional companion diagnostics for personalized medicine products. Most encouraging are examples of focused public and private efforts that have resulted in knowledge leading to critical assessment of existing therapies and the development of new therapies.

The global need for education on cancer health.

Non-communicable diseases, such as cancer, diabetes, and chronic cardiovascular and respiratory diseases, remain a major cause of mortality and morbidity worldwide resulting in more than 36 million deaths annually. Of primary importance in the reduction of this pain and suffering is the local use of education to eliminate misconception, enable prevention, reduce the associated social stigmas, and prepare a workforce that can care for its own people as well as feed an economic engine helping to combat the poverty that so often determines the availability and quality of care. The need to develop these local capabilities is especially acute for children, as 80% of pediatric cancer cases occur in low- and middle-income countries, places where the survival rates are lowest.

Translational informatics in personalized medicine.

Personalized medicine is often associated and discussed in the context of advances from the human genome project. It is true that significant breakthroughs and advancement of deep sequencing and other analytical technologies have greatly expanded the pool of available biological data, but integrating this data into medically meaningful knowledge via translational informatics remains an area of opportunity that is far from being fully realized. Significant opportunities remain for informatics to drive progress towards wide use and utility of personalized medicine by focusing and exploitation of multimodal biomarkers, precompetitive data sharing and a balance between high-content data and rich phenotypic data, such as real observational medical outcomes.

Effective knowledge management in translational medicine.

Background: The growing consensus that most valuable data source for biomedical discoveries is derived from human samples is clearly reflected in the growing number of translational medicine and translational sciences departments across pharma as well as academic and government supported initiatives such as Clinical and Translational Science Awards (CTSA) in the US and the Seventh Framework Programme (FP7) of EU with emphasis on translating research for human health.

Methods: The pharmaceutical companies of Johnson and Johnson have established translational and biomarker departments and implemented an effective knowledge management framework including building a data warehouse and the associated data mining applications. The implemented resource is built from open source systems such as i2b2 and GenePattern.