Preparation phase: This is the development phase where we explore unmet needs, generate hypotheses, create research plans, and design trials. In this phase, patients can advocate for new treatments and advise on clinical study design. The PCDD approach to planning includes consideration of the humanistic attributes of people; this systematic approach to listening and understanding informs the type of data the study will capture, e.g., quality of life metrics, physical functioning, social participation or productivity (absenteeism and presenteeism), or other aspects of patient experiences. Examples of PCDD work in the preparation phase include the following.
Experiment	Learnings
Using clinical outcome assessments (COAs) (including patient‐reported outcomes—PRO instruments) to learn about patient values and needs. The COA data collection can be built into clinical trial plans and used as endpoints in research studies, including clinical trials.	The COA data collection can be built into clinical trial plans and used as endpoints in research studies, including clinical trials.
Using real world data to enhance our understanding of patient lives: gathering de‐identified real world data and analyzing it to complement qualitative stories of patient experiences.	Real world data can be analyzed to increase our understanding of combined qualitative and quantitative patient experiences; this understanding can be used to inform all aspects of the planning phase.

Execution phase: This is the phase where we recruit patients for trials, conduct studies, and seek regulatory approval and guidance. In this phase, patients can help recruit the right patients to trials, advise on making the enrollment process more accessible and participation in trials less burdensome, and provide input to regulators. Examples of PCDD experiments in the execution phase include the following.
Experiment	Learnings
Educating and being transparent about how trials work: Lilly TrialGuide (https://www.lillytrialguide.com/en‐US) is Lilly's customer facing, persistent digital site that provides educational information about clinical research, along with easy to find listings of Lilly's clinical trials. Clinical trials are described in patient‐friendly language and iconography, with clear ways to contact investigator sites in order to learn more about participating in clinical research.	We have discovered/confirmed that patients are most interested in content that showcases the authentic experiences of real patients.
Making trial data collection more convenient: exploration to enable controlled, regulatory‐quality data capture through a variety of wearables to reduce the burden of participation in clinical trials while increasing the types, volume, and accuracy of data captured. Current trial design plans include use of smartphones and wearables to measure movement, ambulatory blood pressure, and sleep latency.	We are wrapping up two studies that measured itching and movement as clinical endpoints—two historically difficult things to measure with great reliability and convenience.
Making trial site visits more convenient: Lilly is partnering with leaders in the field of connected clinical trials to bring mobile technology and high‐touch personal support to provide clinical trial participants choices in how they experience trials. We are working to provide options for in‐home clinical trial visits supported by device capture of data, networks of mobile nurses, and varying other support options. In addition, we are identifying blended models that enable clinical trial visits to occur at any doctor's office, clinics, or local pharmacies.	We will be ready to execute this model on an actual study in the second half of 2017 and will have more data to share in 2018 regarding improved patient access and satisfaction in clinical research.
Making study protocols meaningful to patients: Lilly CoLAB is a process Lilly uses with patients and investigative site personnel to assure that clinical trial protocols are designed for participation by key stakeholders. CoLAB participants work face‐to‐face with study teams to identify and address operational issues with the protocols, using simulation as a means to gather insight and recommendations.	To date, we have executed dozens of CoLABs. We have also engaged many patients for their input in a number of studies, and we are confident that our protocols are becoming easier to execute and participate in.
Engaging with and learning from ePatient advisors: Lilly has sought an active partnership with ePatient leaders to better understand the experiences of their everyday lives, how disease management fits into their lives, and the implications of participation in clinical trials. Recognizing that clinical trial participation is just one part of a complicated journey, people who are living with a disease or new diagnosis are expected to become aware of relevant clinical trials, figure out how to navigate them, and then alter their lives to participate in them. The ePatient advisor role is an effort in working collaboratively to design solutions to improve clinical trials and clinical trial participation.	The ePatient advisor role has brought insights on how increased focus on patient‐centeredness and real world evidence is changing the health care ecosystem and how these trends may affect drug development and has helped in keeping the patient voice front and center in clinical trial innovation. Through further collaboration with patients, we developed a tiered‐consent form for clinical trial enrollment, affording patients access to the level of information they desire while meeting the institutional review boards requirements for informed trial participation.
Showing gratitude to patients: one way that Lilly shows gratitude to participants in clinical trials is by honoring them through The Hero's Journey Art project (https://www.lillytrialguide.com/en‐US/heros‐journey‐art). Clinical trial participants and the clinical trial community express their thoughts and feelings about clinical trials, decorating wooden bricks that are incorporated into 3 large crowdsourced sculptures honoring clinical trial participants.	We recently unveiled the first sculpture at the LiveStrong headquarters in Austin, Texas, in March of 2017. There is a strong, positive sentiment around this activity which can be seen by searching on the tag #herosjourneyart on social media.

Communication phase: This is the phase where we share information on the research process, learnings from our clinical trials, and study what happens in the real world (i.e., in naturalistic settings) with our medications. Examples of PCDD experiments in the communication phase include the following.
Experiment	Learnings
Engaging in social media dialogue with patients: Lilly engages in social media focused on clinical trial innovation through the @LillyTrials Twitter handle and the LillyTrials blog. Topics of social discussion include how to improve clinical research as well as a variety of ways to raise awareness of clinical research. The LillyTrials blog is a home for regular patient guest bloggers to share their perspective on clinical trials, their importance, and how they can be improved. @LillyTrials is an eager participant in the global #WhyWeDoResearch social media campaign, encouraging patients, research staff, and the public to lend their voices toward raising awareness of clinical research and research opportunities.	We have doubled our growth rate of followers and continue to push the bounds of Lilly's use in social media. Our most recent example is our Instagram Story series on the unveiling of Hero's Journey Art at LiveStrong.
Using health literacy principles and best practices in the development of documents such as medication labels, trial enrollment forms, potential risks and side effects information and for translating our scientific evidence into nonbranded health education materials that are clear and meaningful to patients; testing these documents and improving them with patient input.	It is our responsibility to make our communications clear for patients. Using health literacy principles and processes improves patient understanding; patient understanding is essential for successful outcomes.
Gathering and applying patient advice and input on the design and function of medications and devices: to design convenient and successful drug devices, we look for insights into the daily lives of patients to help us understand preferences, limitations, and needs.	This approach can impact everything from medication color, shape, and size to the design of the container that holds the medication; we foresee improved patient outcomes and increased adherence due to greater convenience for patients.