Applied Clinical Trials
In this interview, Kevin Hudziak will expand on Lilly’s initiatives to change the face of clinical trials through patient engagement and education initiatives.
Patient engagement is a popular topic and is becoming more specific, as industry leaders make their mark on
Kevin Hudziak
changing the way we run clinical trials. Of recent, several non-profit initiatives, such as CISCRP and One Person Closer, are promoting clinical trial education with patients. At ExL’s CROWN Congress earlier this year, Kevin Hudziak, innovation lead at Eli Lilly, discussed how the big pharma is changing the face of clinical trials through patient engagement and education initiatives.
Q: The concept of patient engagement is changing. What does patient engagement mean to you?
HUDZIAK: Patient engagement is a process of actively listening and engaging with patients to better understand their healthcare journeys. Patient engagement must be an ongoing process to develop a relationship of honesty and trust. Lilly must focus on the value of patient input to help us design clinical trials that fit better into patients’ lives. We also need to engage more effectively with caregivers and understand their perspectives, as they are critical to supporting the patient on their journey. It is important to point out that new medicines are not possible without the volunteers that participate in trials as well as the physicians and staff that conduct clinical trials. Therefore, it is imperative to involve those individuals more proactively in clinical trial design and execution.
Q: How are patient behaviors changing?
HUDZIAK: Patients and patient communities/advocates are becoming empowered to take a more active role in healthcare, and the digital world is altering the way that people seek healthcare information. Patients are also self-identifying for clinical trials. They are educated and knowledgeable about treatment options. All of these characteristics combined mean that we must adjust effectively to the critical role patients can play in transforming clinical trials in an ever-evolving future state.
Patient awareness of clinical trials has traditionally been quite low, so we need to find ways to actively educate them and provide online resources as they seek options in the digital world, to help them gather information to support the decision that is best for them.
Q: How is Lilly adapting to those changes?
HUDZIAK: Lilly has responded to the empowered patient in several ways.
1. We have developed a website called Lilly TrialGuide to help educate and raise awareness for clinical trials as a healthcare option. On the website, we provide patient-focused content using health literacy principles to ensure that patients can more easily consume and understand the complex information, including therapeutic area specific websites for oncology and Alzheimer’s disease. We have also focused on using storytelling as a critical tool in providing and sharing content that is relevant to patients. As a couple of examples, we are sharing caregiver stories and helping to raise awareness of clinical trials via the Hero’s Journey Art Project.
2. Across the industry, we know that we need to shift the model from one where we bring the patient to the trial to bringing the trial to the patient, fitting the trial within the schedule and the life of patients to make it as convenient as possible. We cannot expect the patient’s caregivers to take, say, six hours of their lives for a visit and occasionally drive them to and/or from the visit. Lilly continues to explore many initiatives around how to conduct trials more remotely, especially when it comes to implementing traditional procedures, such as blood pressure measurements and blood draws. We are trying to develop models where we may be able to do this from a local pharmacy or a local doctor’s office; pharmacies can share the information without making the patients travel 1-2 hours to a study site. There are several initiatives within pharma that look at ways to make a trial more remote. For example, sending the study drug or a device directly to the patient at their home. These initiatives are changing the way that not only patients, but also families and caregivers, can help. However, the timing for when this would become a reality is still uncertain.
3. The most important innovation has not necessarily been technology or websites, but simply talking with patients to better understand their needs. The personal interaction with patients has been a key driver of innovation. Lilly built a Clinical Innovation team with experts from across the pharma industry to think differently and develop solutions to aid patients and caregivers in the decision-making process. For example, we have an active Twitter feed @LillyTrials that allows us to engage with patients and caregivers via tweets and tweet chats.
Q: How’s Lilly improving the connection between patients and sites?
HUDZIAK: A key component of Lilly TrialGuide is connecting patients to research centers conducting Lilly trials. If potential patients locate a promising clinical trial on the website, they can connect with sites directly by navigating to the site contact information on Lilly TrialGuide via the “Connect to Study Center” option. If a patient or caregiver can’t find a trial specific to their needs, we have also created an optional service on Lilly TrialGuide called “Alert Me” that allows site users to sign up to receive email alerts if a trial is added in the future that fits a set of criteria that the user creates in a profile.
We also develop study-specific patient recruitment websites that contain more specific information on individual clinical trials that are actively recruiting. We use digital outreach to help identify potential patients and connect them to the website. The website will often have a simple pre-screener to help them understand if the trial may be right for them. If they pass the pre-screener, the patient can then share their pre-screener results with a clinical trial site near them. Additionally, we are piloting some new concepts to help connect patients to study sites on a couple of clinical trials.
Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.
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