A: As an independent research institute, RTI is dedicated to improving the human condition. We answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development.

In the realm of clinical trials, medical and behavioral health care have largely been limited to traditional randomized controlled trial (RCT) designs. RCTs are superb for the acquiring the data for which they were originally designed – efficacy of a treatment in a population. However, for other purposes the utility of RCTs is limited. To illustrate, with greater “precision” in medicine (meaning the application of treatment to more specified types of persons), the RCT requirements for large samples and funding streams generally become less tenable.

Our PersonAlytics^TM idiographic clinical trials (ICTs) approach provides alternatives to RCTs, which are designed to understand within-subject processes that occur in response to a treatment. Under certain conditions (e.g., rare diseases, specific genotypes, early stage drug development, small samples or N=1), ICTs can be used to estimate efficacy. But, perhaps the greatest strength of ICTs is to carefully elucidate how a treatment is affecting individuals as the treatment is delivered and soon thereafter.

A: RTI offers both services and products to help its clients leverage ICT technologies. First, our team has decades of wide-ranging experience in conducting ICTs including drug development for FDA approval, organ transplantation, biosensor-measured outcomes, metabolomics, and psychotherapy (many publications about these studies can be found at: https://personalytics.rti.org/). Second, we provide consultation, collaborative research design, and analytics to support clients’ research and development of treatments and medical devices. Third, we create tailorable software to support patient monitoring and clinical decision-making. One example is Curelator (https://n1-headache.com/), which helps individual patients suffering migraine headaches to identify the triggers/protectors and severity modifiers of his / her migraines; this evidence in turn informs the patient and his / her neurologist of what treatment strategy to pursue in a wholistic and personalized manner. RTI’s software is currently offered as a “white label” product that operates in the background and can be automated for rapid analytics and real-time patient monitoring. RTI is a preeminent non-profit research institution offering expertise across a breadth of health and life sciences, engineering, education and communication sciences, policy, bench science, public health and psychology, environmental sciences, and analytics. Included is RTI Health Solutions, a business unit focused on providing research and advice on clinical, regulatory, market access, and safety programs for pharmaceutical, medical device, and diagnostic companies.

A: I head the PersonAlytics Team of statisticians and software architects at RTI. As a trained Developmental Behavioral Epidemiologist, I also wear several other hats: NIH-funded researcher, statistician, and developer of medical devices. What gets me out of bed in the morning is the anticipation of making new discoveries that can improve people’s lives. So, by continually improving PersonAlytics services and software, I get to help innovators prepare their treatments and devices to improve people’s health and livelihood.

A: RTI’s mission is to improve the human condition by turning knowledge into practice, and our researchers apply this mission across a wide breadth of basic and applied sciences. To illustrate the swath of RTI’s research topics, my own first-hand recent collaborations include developing a virtual exercise regimen for patients recovering from heart attack whose health care coverage for physical therapy has run out; identification of marijuana metabolomics that correspond to level of marijuana-induced cognitive dysfunction; validating a biosensor measure of stress based on electrodermal activity levels to test on-the-job stress-reduction interventions; and a clinical trial that is testing a screening, brief intervention and referral to treatment (prevention) for youth at high risk of early-age substance use that can be used during pediatric well-child check-ups. These few examples of RTI’s innovative research are a miniscule sampling of the swath of health care-related work occurring at RTI.

A: The most pressing short-term challenge for an organization like RTI is to align with the funding priorities of federal agencies to meet societal needs. For example, within drug abuse research the rise of the opioid epidemic has led to shifts in funding from drug abuse prevention to treatment for heroin addiction and overdose. Another example is that the FDA has recently prioritized speeding up the drug development process to more rapidly get innovative treatments to market. As the research funding landscape evolves, organizations must also evolve to respond with high-quality solutions to the most important scientific and societal challenges we are facing.

A: The RTI International team is looking forward to networking with attendees at PMWC. Precision medicine is at the heart of our PersonAlytics efforts. But, for our methods to move forward and have an impact, we need to collaborate with innovators in health care. We hope to foster those collaborations at PMWC.