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Abstract: Protocol design complexity, and associated study volunteer burden, negatively impact patient recruitment and retention as well as overall research and development productivity. Complex protocols reduce the willingness of potential clinical trial participants to enroll and reduce retention rates. There have been few systematic assessments of protocol design characteristics to determine the burden placed on study volunteers, although such an assessment would offer a compelling opportunity to optimize trial designs and improve recruitment and retention performance. To be useful, an assessment would need to be patient-centric, and focused on the factors that influence participation throughout the clinical trial. Such an assessment would also need to accommodate the unique cost-value trade-off compared with current treatment patterns that each participant makes when choosing to participate and remain in a clinical trial. This article proposes a new methodology to quantify patient burden: the clinical trial patient friction coefficient (PFC). A case example is provided to illustrate the utility of the PFC. A number of applications for the PFC are envisioned: standardizing patient burden assessment to evaluate clinical trial design feasibility, shedding light on the impact of patient burden on clinical trial economics and performance, and conducting sensitivity analyses to identify factors that most reduce patient burden and improve the performance and efficiency of clinical trials. Key words

"We Design for Good Design thinking is in our genes. For decades, IDEO has pioneered the human-centered design approach to solving complex problems.  In 2010, IDEO asked-how might we open up our method, enabling people everywhere to spark innovation where it's needed most? Our answer: OpenIDEO."

"Galileo is a website (designed by UC San Diego Design Lab) where people design and run their own experiments with their community. Anyone curious about their lifestyle and health can use this website; No prior knowledge is needed as the website guides people through the different steps of creating an experiment. After creating their experiment, people can it reviewed from two members who'll help them improve their experiment. Finally, people can invite others to participate in their experiment and begin it for a week when sufficient people join their experiment. By comparing their experiences an experiment, people provide researchers cues to build associations between lifestyle and health."

"Want to see your sleep data at the Helsinki Design Museum? ŌURA is proud to be participating in "Enter and Encounter", a joint exhibition by Helsinki Design Museum and the Finnish Association of Designers Ornamo. This unique exhibition celebrates contemporary Finnish design and Finland's centenary anniversary. As part of the exhibition, we are happy to invite 100 active ŌURA users to share their sleep data and participate in the media installation "How did you sleep last night?"."

Recommended by Gina Soloperto. Dr. BJ Fogg founded the Behavior Design Lab at Stanford University, where he directs research and innovation. In addition, he teaches industry innovators how to use his models and methods in Behavior Design. The purpose of his research and teaching is to help millions of people improve their lives.

"Center for Health Design, Director: Eliah Aronoff-Spencer The Center for Health Design's mission is to foster human-technology teamwork in healthcare by taking a people-centered approach to health's greatest challenges. We work with global stakeholders, from village innovators, community volunteers and patient advocates to researchers, clinicians, government and industry. Together we aim to solve the "wicked" health problems that require not just singular scientific advances but innovation in multidisciplinary and distributed teamwork."

"Late last week, Carnegie Mellon University (CMU) and Lumen Learning jointly issued a press release announcing their collaboration on an effort to integrate the Lumen-developed RISE analytical framework for curricular materials improvement analysis into the toolkit that Carnegie Mellon announced it will be contributing via open licenses (and unveiling at the Empirical Educator Project (EEP) summit that they are hosting in May)."

"Applying the principles of human-centered design to real-world health care challenges, from drug packaging to early detection of breast cancer."

Click through to hear an 8 minute interview with Austin Durant, citizen experimenter and founder and chief fermentation officer, Fermenters Club and Vineet Pandey, lead designer and developer, Galileo. "Ever wonder if kombucha, the fermented tea drink, is actually good for you? Like many food and drinks touted as healthy, there hasn't been much scientific research to rely on and you'd just have to come to your own conclusions. Now a tool out of UC San Diego is empowering regular citizens to design experiments to test hypotheses and recruit participants, becoming scientists themselves. The tool is called Galileo and encourages participants to test their intuitions by asking questions like, can a vegan diet improve energy levels? Or does drinking coffee every day reduce the quality of sleep?"

"N-of-1 or single subject clinical trials consider an individual patient as the sole unit of observation in a study investigating the efficacy or side-effect profiles of different interventions. The ultimate goal of an n-of-1 trial is to determine the optimal or best intervention for an individual patient using objective data-driven criteria. Such trials can leverage study design and statistical techniques associated with standard population-based clinical trials, including randomization, washout and crossover periods, as well as placebo controls. Despite their obvious appeal and wide use in educational settings, n-of-1 trials have been used sparingly in medical and general clinical settings. We briefly review the history, motivation and design of n-of-1 trials and emphasize the great utility of modern wireless medical monitoring devices in their execution. We ultimately argue that n-of-1 trials demand serious attention among the health research and clinical care communities given the contemporary focus on individualized medicine. Keywords: clinical equipoise, early-phase trials, individualized medicine, n-of-1, remote phenotyping, single patient trial, treatment repositioning, wireless health"

"While citizen science is gaining attention of late, for those of us involved in community-based public health research, community/citizen involvement in research has steadily increased over the past 50 years. Community Health Workers (CHWs), also known as Promotores de Salud in the Latino community, are critical to reaching underserved populations, where health disparities are more prevalent. CHWs/Promotores provide health education and services and may also assist with the development and implementation of community- and clinic-based research studies. Recognizing that CHWs typically have no formal academic training in research design or methods, and considering that rigor in research is critical to obtaining meaningful results, we designed instruction to fill this gap. We call this educational initiative "Building Research Integrity and Capacity" or BRIC. The BRIC training consists of eight modules that can be administered as a self-paced training or incorporated into in-person, professional development geared to a specific health intervention study. While we initially designed this culturally-grounded, applied ethics training for Latino/Hispanic community research facilitators, BRIC training modules have been adapted for and tested with non-Latino novice research facilitators. This paper describes the BRIC core content and instructional design process."

he UC San Diego Design Lab works on major societal issues, such as large-scale education, automation, healthcare, visualization of complex phenomena and data, social interactions, citizen science, and the ethical issues that are of ever-increasing importance.

"Digital Twins and the Emerging Science of Self: Implications for Digital Health Experience Design and "Small" Data"

"Galileo Design and Run Experiments with people from around the world "

Galileo Design and Run Experiments with people from around the world N=1 Cohort Participants - Set up your account and create your first N=1 experiment.

"The MOST POWERFUL LED Therapy Lights PlatinumLED Therapy Lights emit the highest amount of irradiance than any other LED therapy light on the market today!  This delivers more power with deeper penetration than any other light is capable of. Thanks to our many years designing and producing ultra-high power LED panels, we're able to bring clinical grade LED therapy to the home or medical office user."

The Center for Innovation is an Internal Service Organization led by Director, Nicholas J. Webb. The Center provides a wide range of resources to Faculty, Students, Alumni and Staff. Our mission is to drive the best innovations in Student Experience Design (SXD), Disruptive and Enterprise Innovation, while concurrently supporting all of our Innovators across the University. Through our partnerships across Industry, Education and Philanthropy our principal mission is to deliver exceptional value to all we serve. Services that we provide include the following:

Download the Mydatahelps app -- "When your heart beats faster than usual, it can mean that you're coming down with a cold, flu, coronavirus, or other viral infection. That's the conclusion of recent medical research. So wearable devices that measure your resting heart rate-made by Apple, Fitbit, Garmin, and others-might help scientists spot viral outbreaks, and also give you more insight into your own health. At Scripps Research, we've designed DETECT (Digital Engagement & Tracking for Early Control & Treatment), a study that will monitor your heart rate and allow you to record symptoms like fever or coughing."

"Sitting in freezer at Boston Children's Hospital is a drug you won't find anywhere else. It's called milasen, and the 18 g that the hospital custom-ordered nearly 2 years ago should last for decades. That's because milasen was designed to treat a single patient-a now 8-year-old girl named Mila Makovec. Milasen was built on decades of work on a class of drugs called antisense oligonucleotides. But after Boston Children's Hospital scientist Timothy Yu diagnosed Mila with a never-before-seen genetic mutation, he took only 10 months to go from idea to injection. It's a record-shattering sprint in the typical drug-development marathon, and an unprecedented degree of personalization for a chemical drug."