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Meghan McKenzie, Associate Director and Sr. Clinical Program Lead at Genentech, elaborates on her experiences in the field of patient centricity from the perspective of the sponsor.
Our series on patient centricity continues, as we incorporate the Sponsor’s perspective on defining the concept. Genentech has made advancements in patient centricity, as they are applying a variety of pilots to help incorporate the patient’s voice in clinical trials. Meghan McKenzie, Associate Director, Sr. Clinical Program Lead at Genentech, will elaborate on her experiences as a Patient Centricity Team lead. Meghan will be speaking at PanAgora’s Patient Experience Summit April 6-7 held on the Genentech campus.
Moe Alsumidaie: What does patient centricity mean to you?
Meghan McKenzie: Patient centricity is about amplifying and incorporating the patient's voice into the protocol. It is about getting their input before we finalize the protocol, so we can simplify or change the protocol to reduce patient burden. As science gets more sophisticated, protocols become more complex. So, we need to listen to patient concerns and make study design easier, and we also need to simplify studies so that patients can more easily find our trials and stay in them once they qualify. It is also about giving back patient data under some circumstances. We listen to the patient’s needs; we talk to teams and patients and try to merge the gap. Protocols are very scientific, as they are built to answer specific questions about safety and efficacy. But we want to make these protocols more manageable for all patients who are dealing with either acute or chronic diseases.
I am currently leading a Genentech Patient Centricity Team where we partner across the organization with other patient insight groups trying to determine what can be helpful for patients across all disease indications and what is needed specifically for a particular therapeutic area.
It is important to differentiate between diseases and customize the patient centric approach. For example, the concerns of a breast cancer or Lupus patient (often younger women with children) are very different from the concerns of an elderly patient with dry age-related macular degeneration (AMD), a patient who is losing their eyesight and has other comorbidities; a patient’s drive and motivation to be in a trial differ and their concerns as a patient differ. So, we work with study teams to understand where they think patient centricity could have an impact.
MA: Can you elaborate on some pilots or activities involving your Patient Centricity Team?MM: Two of our teams are collaborating with a vendor to establish a portal where we can share letters and surveys with patients who are on the trial. Patients sign an authorization form to opt-in to receive these letters while they're in the trial. We’re using this platform in a non-interventional trial because we want to retain patients in the trial and want to give them something back for their participation. Another program is using the platform as a pure “give back” in a rare disease indication where the protocol is complex. This platform is used to thank patients and includes staff interviews and information on study procedures.
In another example, we are doing mock simulations with patients. For one of our lupus studies, we wanted to understand patient concerns on their disease and patient burden in our screening visit. So, we interviewed a lupus patient during a simple in-house process; one of our Medical Directors pretended to be a private investigator, one of our data managers who was a previous lupus coordinator pretended to be the coordinator, and the patient was taken through the screening visit after her interview. The patient explained to us what was important to her in the disease and what her concerns were. Due to her feedback, we reduced the number of patient reported outcomes from the protocol, and separated the screening visit into two visits. The mock simulation is a simple exercise but even small changes could have big impact for the patient. While we continue to focus on the science, it’s important we gain the patient perspective in order to reduce patient burden as much as we can.
MA: How does Genentech plan to scale these patient centric initiatives across the R&D organization?
MM: We are trying to understand what is going to work across the company vs only at the team level. We host an internal meeting called ‘Breakfast Bites’, that promotes successful pilots and lessons learned from failed. In addition, we also host events with our external partners, such as PanAgora’s Patient Experience Summit, on campus in order to raise awareness about internal initiatives. We have also managed to find some efficiencies in pilots, and mock simulations, so they are easier when we replicate them. We want the barrier to entry to be low so that many colleagues and subject matter experts become interested in contributing towards pilots and innovative initiatives. Teams need to see value in this and that means either changing their perspective, changing their protocol or reducing patient burden. Moreover, if we involve patients in patient centric study design, we are not waiting until Phase II is completed but we are doing it before we even start the Phase I trial, so that the value of the insights will be realized and scaled in later studies. This is how we scale innovative patient centric initiatives across the organization at Genentech.
MA: What will a future clinical trial look like?MM: I see a future where we will be able to rapidly deploy validated, electronic surveys and wireless devices, have more consistency across the industry, and make studies easier for patients, such as having more virtual visits and satellite sites. We'll be collecting data more efficiently by leveraging wireless technology for vital measurements (i.e., EKG, temperature monitoring, and blood pressure). This will allow for some trials to have a larger virtual component where patients are visiting their physician less frequently during trials but still enabling the collection of safety data through local tools (wireless, ePRO diaries, phone visits, perhaps their personal physicians as satellite offices).
Home health services will have more outreach, and sophisticated and trained nursing staff that can help bring the trial to the patient rather than the patient traveling long distances or staying long hours in the clinic. This will also likely reach and attract patients who live far from study sites and reduce study site visit frequency, which ultimately lessens burden on both the patient and the site.
We'd have a patient on every molecule team, early on, giving us insights on patient burden and what is a meaningful change in their disease so we can have confidence that our target product profiles more closely align with what is important to them. We'll have study coordinator consultants by disease indication helping us streamline study site procedures for our protocols.
We’ll have more surrogates for biopsy or other invasive procedures, like circulating tumor DNA from blood so clinical trials are less invasive. Imaging will be even more sophisticated. We’ll be much farther down the road in personalized medicine so our drug manufacturing vendors and facilities will be much quicker; we’ll truly need to bring the drug to the patient, rather than the patient to the drug trial.
I would love to say this would be in five years-can our partners in technology and innovation help us get there? Will we be the strong patient advocates at the table? I would love to hear how others are making patient centricity central to their work. We should pave this road together.
Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.