How One Pharma Company Is Embracing Digital Technologies
By Ed Miseta, Chief Editor, Clinical Leader
The increased demand for hybrid and decentralized approaches to clinical trials has increased the use of digital devices and other tools that will make studies more patient centric. Sanofi is one of the companies leading the way in getting devices into the hands of patients. The company has spent the last 10 years evolving a model designed to improve the patient experience in trials. Today Sanofi’s development programs are 100% informed by patients and technology plays a big part in it.
In October 2022, Terttu Haring, head, Clinical Innovation Office at Sanofi, and Victoria DiBiaso, global head, patient informed development & health value translation joined Clinical Leader Live to discuss the company’s new patient centered R&D organization and its use of emerging technologies. In this Q&A, Haring discusses the company’s use of technology and how tech solutions are helping to make trials more patient centric.
Ed Miseta: Why is it important to incorporate consumer devices into clinical trials?
Critical in all of this is making sure patients have options. For example, some patients may say they want apps on their personal smartphone or tablet. But there are other patients who do not want to have any medical apps on a personal device or one that they use for work. In those instances, we will provide them with a device. Our focus is on enabling every patient to take part in a study.
Miseta: Can you talk about any challenges the company faced when incorporating these devices into clinical trials?
Haring: One of the biggest challenges we face is determining what device is the best fit for a study. When one of our internal teams comes to me wanting to use a digital device, the first question I always ask is, what is it that you want to know or that you want to measure? That question starts the journey of identifying the right device for the study. That initial question will then lead to others. Someone might want to know the day-to-day activity of a patient, but do they want to know the number of steps the patient took, or do they want to know the number of hours they were active? Or do they want to know the number of hours the patient is not active? Do they want to know the radius around a home that a patient will cover in a day? Answering those questions is a challenge but they help us determine what device will best measure the data we hope to collect.
Although this may sound obvious, you also need to go through real-life testing. That testing can be conducted with patients or volunteers. I remember one time when we had a whole team of Sanofi employees walking around with all sorts of devices. That is one way for us to determine what it means to ask patients to make that same commitment.
I would also caution that sometimes you must expect or anticipate the unexpected. For example, we once tested a sleep device that was placed under the mattress. When reviewing the readout, we noticed a strange heart rate. We later learned the daughter of the patient was sick and crawled into the same bed. The device recorded the heart rate of the daughter instead of the patient. That was a real eye opener for us. You might think you are being patient focused, but as soon as the patient walks out the door, you lose a lot of control. Care needs to be taken to ensure you are measuring what you really want to measure.
Miseta: Many companies are now using devices to collect physical measurements directly from patients. Can you discuss how Sanofi might be using those devices?
Haring: We think about digital data collection in terms of three different purposes. One is to enable safety monitoring at home and to enable decentralization of trials without losing the safety oversight. That would certainly include patient activity tracking. The second purpose is making sure we can take the trial into the patient's home regarding endpoint data collection. For example, the measurement of various physiological processes. The third purpose is value creation. We want to know if the product we are developing will add value to the patient's life and quality of life.
In all three of these categories, you can include activity tracking for safety. I want to know the number of hours a patient is mobile for decision-making and enablement of home healthcare. In some of our trials we have activity tracking not for the number of steps but for balance and gait and other disease-specific features. What we often care the most about is the impact of the disease on a patient's life. That is one area where eDiaries are a big help. If we can measure that a patient is able to have a bigger radius around their home, that could be a good indicator of value for patients and payers. For me, the bigger concern is always what we are trying to measure and the best device to use.
Miseta: Are you aware of any burdens these devices place on the patients using them?
Haring: Absolutely. We are not operating in an ideal world. It is a burden simply to ask a patient to complete a questionnaire once a day, to complete a diary card, or to come to the clinic. It's also a burden to wear devices on your body or to upload data on connected devices. But if we believe in the cause, and if we believe we are doing the right thing to produce better clinical development and better drugs for patients, then that is a trade-off we have to choose. Although these devices can create burdens, we can do our best to minimize them and ensure the burdens do not become an exclusion factor especially for diverse patient populations.
Miseta: If you want to use a digital device in a Phase 3 trial, when does validation typically occur?
Haring: You need to start early. I work closely with Victoria (DiBiaso) because planning starts with our strategy for that disease area. Depending on the disease area, there are different types of purpose and objectives. If we want to use a digital endpoint as a primary endpoint in a Phase 3 trial, it can take up to five years to validate the endpoint and get regulatory authorities to accept it.
Even if you want to use a digital assessment in a Phase 3 trial as a secondary endpoint you must start early. There are two ways of doing that. One way is to build specific observational, non-interventional studies to test and validate a device or endpoint in devices. We have been speaking to regulators about doing that. The other way is using Phase 1 and Phase 2 trials to validate the device you want to use. We are also doing that. We run validation studies where the patients are asked to use a device both in the clinic and at home. We collect data to demonstrate that an assessment has the same validity inside and outside the clinic, which can also take years.
Miseta: Sanofi is committed to offering patients a single interface to connect with investigator and sponsor data. Why is that so important to patients?
Haring: When it comes to technology, consumers have gotten used to going through one interface. We are used to doing our grocery shopping through one app and taking care of our banking and credit cards through one app. We are even getting used to accessing our healthcare provider and our healthcare data through a secure system that connects directly with the hospital. So, for me, this is something that we must do. We need to provide that same level of experience and service for patients engaged in clinical trials.
Today, patients interact with their investigator and study nurse, they make appointments and change appointments, they arrange for medicines to be picked up or delivered, and more. Four years ago, we were thinking about how we could be ready for the future, and we knew it would include more digital assessments, devices, and technology. We felt we needed to provide patients with a single point of entry. We started with an ambitious drawing on a whiteboard of what we wanted for patients. We wanted patients to be able to access data but also be able to access videos about the study procedures, have information to show to loved ones, be able to change an appointment, schedule deliveries, and upload data all through one interface. We call it an Integrated Patient Platform. I can't disclose more details about it now, but we recently had a kickoff meeting and the first patients will be using it in the spring of 2023.
Click here to see the entire discussion with Terttu Haring and Victoria DiBiaso.