Privacy of Clinical Research Subjects: An Integrative Literature Review with Best Practices

With changes in clinical research practice, the importance of a study-subject’s privacy and the confidentiality of their personal data is growing. However, the body of research is fragmented, and a synthesis of work in this area is lacking. Accordingly, an integrative review was performed, guided by Whittemore and Knafl’s work. Data from PubMed, Scopus, and CINAHL searches from January 2012 to February 2017 were analyzed via the constant comparison method. From 16 empirical and theoretical studies, six topical aspects were identified: the evolving nature of health data in clinical research, sharing of health data, the challenges of anonymizing data, collaboration among stakeholders, the complexity of regulation, and ethics-related tension between social benefits and privacy. Study subjects’ privacy is an increasingly important ethics principle for clinical research, and privacy protection is rendered even more challenging by changing research practice.

The article concludes with suggested best practices based upon the findings.  

Best Practices

• Encourage collaboration - Collaboration among stakeholders is one of the prerequisites for protecting privacy in clinical research.
• Transparency - A well applied, transparent process with properly surveilled procedures ensures compliance with legal guidelines.   
• Reduce tension - The tension between study-subject privacy protection and benefits to society must be eased. This requires, public trust and more flexible privacy rules. But most important is a guarantee of adequate research-ethics training for researchers and clinical-study staff, with solid recognition of the moral rationale behind the regulations.

The full article can be downloaded below.  

Plugging the Gaps in the Continuum of Care

As the U.S. population ages, it becomes increasingly important to keep seniors from falling into the gaps in the continuum of care. With 86 million people expected to reach the age of 65 and beyond by 2050, private sector and community organizations will have to find new ways to collaborate and work together to help care for them.

Continuum of care is a concept involving the overarching system that guides and tracks patients during their life journey through the healthcare system. It spans all levels and intensity of care. There are seven basic categories of continuum services:

1. Extended care
2. Acute hospital care
3. Ambulatory care
4. Home care
5. Outreach
6. Wellness
7. Housing organizations

In a perfect world, the hand-off between each of these organizations and providers would be seamless. This would reduce the chance of hunger and neglect among seniors, of hospital readmission, and of the mismanagement of chronic and acute medical conditions.

The full Forbes article can be viewed at this link.  

Validation and Testing of Fast Healthcare Interoperability Resources Standards Compliance: Data Analysis

As indicated by the JASON report , the implications and benefits from a truly open digital health care architecture are wide ranging, from enabling individual patients to obtain, share, and authorize who can view their data, to population health analytics and research. Currently, data and exchange standards in health care do not adequately ensure out-of-the-box interoperability, chiefly due to the complexity and lack of identical interpretations of the published standards by health IT software developers. Rigorous testing and validation will help move the US health care system in the direction of open, accessible, patient-centric care.

The objective of this research was to examine whether or not the use of validation and test tools, specifically Crucible and Touchstone, had any impact on vendor compliance with the FHIR specification and, by extension, interoperability.

The full article can be downloaded below.  

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice. While randomized clinical trials (RCTs) are the “gold standard” for evaluating the safety and efficacy of new therapeutic agents, necessarily strict inclusion and exclusion criteria mean that trial populations are often not representative of the patient populations encountered in clinical practice. Real-world studies may use information from electronic health and claims databases, which provide large datasets from diverse patient populations, and/or may be observational, collecting prospective or retrospective data over a long period of time. They can therefore provide information on the long-term safety, particularly pertaining to rare events, and effectiveness of drugs in large heterogeneous populations, as well as information on utilization patterns and health and economic outcomes. This review focuses on how evidence from real-world studies can be utilized to complement data from RCTs to gain a more complete picture of the advantages and disadvantages of medications as they are used in practice.

The full article can be downloaded below.  

Genetics has learned a ton — mostly about white people. That’s a problem.

In the future, it’s possible that when you go in for a physical, your doctor will, along with the usual blood pressure test and bloodwork, analyze your genome for health risks lurking in the code of your DNA.

It’s possible your genome will suggest you’re at high risk of developing heart disease. If you are, your doctor may start you on cholesterol-lowering drugs early or could also, maybe, make predictions about what other medications are most likely to work to prevent the disease.

A treatment plan like this — tailored to an individual’s genetic risk — is one of the great promises of “precision medicine.” Whether genomic analysis will ever yield enough useful results to make it possible is a subject of heated debate. If it does pan out, it could be a game changer.

Though, as it stands, the game won’t be changed for everyone: If you’re not white, this new research may fail you.

If the new age of “precision medicine” is going to be equitable, we’ll have to fix this.

There’s an important lesson in diversity and genetics lurking here too. It’s not that people of different ethnic backgrounds have wildly different biology. It’s much more subtle, and fascinating, than that. We need to explore the vast range of human genetic variation: It could end up saving us all.

The full Vox article can be viewed at this link.  

Still Bullish on Blockchain: Experts Give a Lay of the Land

At a healthcare modernization event this week, health IT thought leaders weighed in on where things stand regarding blockchain’s push into healthcare.

Although there are still more questions than answers regarding the impact that blockchain technology will have on healthcare, many health IT experts remain convinced of its promise.

The full Healthcare Informatics article can be viewed at this link.  

How AI is Transforming Clinical Trial Recruitment: Including Best Practices

The medical world is shifting underneath our feet.

To keep up with the rising demands of empowered patients, physicians and pharma businesses regularly test innovative treatments and medicines during rigorous clinical trials.

But one misguided move can trigger a domino effect, such as when the wrong patients are selected for a clinical trial.

Today’s infographic comes to us from Publicis Health, and it highlights why the current model of clinical trial recruitment urgently needs to change.  The article also included some important insights for a patient-based approach, which can yield advantages and added value to recruitment, engagement, and data collection.  

Best Practices

• Omni-channel targeting - Actively reaching out to patients, wherever they are.
• Predictive analytics - Continually refining media channels and messaging to further patient interest
• Ongoing communications - Nurturing relationships with patients, starting with the initial outreach.

The full infographic and article can be viewed at this link.  

How a Pharma Company Applied Machine Learning to Patient Data: Best Practices

The growing availability of real-world data has generated tremendous excitement in health care. By some estimates, health data volumes are increasing by 48% annually, and the last decade has seen a boom in the collection and aggregation of this information. Among these data, electronic health records (EHRs) offer one of the biggest opportunities to produce novel insights and disrupt the current understanding of patient care.

But analyzing the EHR data requires tools that can process vast amounts of data in short order. Enter artificial intelligence and, more specifically, machine learning, which is already disrupting fields such as drug discovery and medical imaging but only just beginning to scratch the surface of the possible in health care.

Let’s look at the case of a pharmaceutical company we worked with. It applied machine learning to EHR and other data to study the characteristics or triggers that presage the need for patients with a type of non-Hodgkin’s lymphoma to transition to a later line of therapy. The company wanted to better understand the clinical progression of the disease and what treatment best suits patients at each stage of it. The company’s story highlights three guiding principles other pharma companies can use to successfully deploy advanced analytics in their own organizations.

Best Practices

• Preliminaries - Generating meaningful hypotheses (and organizational buy-in) requires engaging the right stakeholders
• Richness - The best data set might be a combination of data sets
• Test-and-learn - Feedback loops (many times over) are the key to great results

The fully detailed Harvard Business Review article can be viewed at this link.  

FDA approves new drug to treat influenza

The U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, M.D. “While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination. Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.”

The full FDA news article can be viewed at this link.  

Healthcare Leaders on Unlocking the Value of Disruption: “Digital Innovation Needs to be a Strategic Priority”

Health systems are feeling the pressure from digital disruptors coming into the market along with the increasing demand to be more consumer-focused, noted one healthcare CIO during a recent healthcare innovation conference.

“We are going to be disrupted by Apple and Amazon, if we don’t change,” Adam Landman, vice president and CIO of Boston-based Brigham and Women's Hospital, said during a panel discussion at the FT Digital Health Summit in New York City last week.

At the same time, however, many forward-thinking healthcare executives see digital technology as a tool that can be leveraged to support value-based care with the aim of better patient outcomes at lower cost.

During the FT Digital Health Summit, sponsored by Financial Times Live, a panel of healthcare industry leaders, including Landman, along with Chet Robson, medical director, clinical programs and quality for Deerfield, Ill.-based Walgreens and Nelia Padilla, global lead, digital health at IQVIA, a company that provides technology solutions and contract research services, discussed the role of digital technology in achieving value-based care as well as the significant barriers to adopting digital solutions and the headway their organizations are making with digital innovation.

The full Healthcare Informatics article can be found at this link.