Patient Centricity: Improving Study Outcomes in Small Pharma

Patient centricity has been a big focus over the past few years within the biopharmaceutical industry, especially with large enterprises. Today, smaller biopharmaceutical enterprises are implementing new patient centricity techniques to improve study outcomes and reduce time to completion. In this interview, Rashieda Gluck, Senior VP, Global Clinical Operations, at Aurinia Pharmaceuticals, will discuss how patient centricity techniques are benefiting smaller biopharmaceutical companies.

Moe Alsumidaie: What are Aurinia’s therapeutic areas of focus?

Rashieda

Rashieda: Aurinia’s mission statement is, "reaching people and changing lives." Aurinia has a few different clinical programs in place. Our main clinical program is studying our lead candidate, Voclosporin, in the treatment of patients who have lupus nephritis. It is currently in Phase III trials. We also focus on Focal Segmental Glomerulosclerosis (FSGS), and dry eye syndrome.

MA: You recently completed enrollment for the Lupus Nephritis Phase III study ahead of schedule. How did you achieve this milestone?

Rashieda: Recruitment was a team effort. We had over 100 clinical sites across twenty-nine countries. It was a concerted effort from our clinical team, as well as our CRO partners who worked very hard to engage sites, increase awareness for patients as well as the publicon lupus nephritis, and encourage recruitment through those means. Our success in completing study recruitment was attributed to relationshipswe have built with our sites, CRO partners, and advocacy groups on both the national and regional level-on the national side, Lupus Foundation of America, Lupus and Allied Diseases Association, Lupus Research Alliance, NKF National Kidney Foundation. They helped increase awareness about the study, our clinical program, and encouraged enrollment into the study. For example, we worked closely with The Lupus Foundation and The Lupus Research Alliance. We also worked with groups, such as MyHealthTeams, which had social networks within the lupus population, to let people know about our clinical programs. We used websites and social media to reach patients and ran a grass-roots campaign, where we visited sites and talked to the clinicians tohelp them understand our program and how our clinical study could potentially benefit patients. 

MA: What do you recommend other study leaders do to improve patient centricity? 

Rashieda: We focus on patient centricity at Aurinia by understanding the patient journey in our clinical programs. It begins with looking at the therapeutic area you are studying and understanding what patients who suffer from the disease being studiedgo through. Then asking how you can make participating in your clinical study a little bit easier for them. You have to look at some of the difficulties; do they have young families, are they working, and how easy is it for them to get to the clinic? By understanding patient profiles, you can optimize your clinical protocols to adjust to patient lifestyles, such as the number of visits, and procedures, and the amount of time that needs to be spentaway from their families and work. For example, can procedures be done in a way that would decrease needed travel? Alternatively, can procedures be planned around timelines that allow for patient visits before or after work? Could providing childcare at the clinic, or offering coffee or refreshments to the caregiver staying with the patient through the entire visit ease a burden? These are little tweaks that are very simple, but are often forgotten. These changes not only benefit the clinical program but also, impact your patients in a way that could be easier for them, which translates to improved recruitment, retention, and adherence.

MA: What are the best practices, and how do you build effective relationships with sites? 

Rashieda: In a multi-national trial, you have to take cultural considerations from a patient and site perspective into account. Understanding how the disease, the treatment, or the procedures impact the patients from a cultural perspective makes a difference in choosing campaigns, and running and designing effective recruitment and retention strategies. From a site perspective, spending the time to understand what is happening at the site and making sure that the relationships you build with your site are solid, are important tactics to be successful in your clinical program.

MA: As a smaller biopharmaceutical enterprise, what factors do you look for when selecting vendors?

Rashieda: You look for companies who are willing to partner with you truly. When you are a small company, you need to look for your CRO or vendor partners that flexibly allow you to effectively oversee projects as needed. When you are small, you cannot afford to outsource all tasks. We work in a partnership on all levels with our CROs. The understanding we have with them is that they can come to us, and we support them as much as they support us, whether it is on a clinical or management level. We also work to incorporate risk-sharing early in the study via milestones that can benefit the CRO team. Such milestones can be recruitment that is completed early or databases that are locked early. We incorporate the CRO in our culture and team, so we celebrate successes together. We also make it very clear early on that our CRO partners are the face of Aurinia, so they are an extension of our team. By incorporating culture, our partners feel more involved and accountable in achieving study milestones.

Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.