New and emerging technologies are impacting clinical trials in many ways, but nowhere is that more apparent than in the area of patient centricity. Clinical trials are still plagued by low recruitment rates, retention issues, and poor communication with patients. These are just a few challenges Janssen would like to improve, and it is doing so by taking a three-pronged approach.
“We need to get patients more involved throughout the entire study,” says Tammy Guld, Janssen Clinical Innovation, Global Team Lead and co-chair of the 2019 DPHARM: Disruptive Innovations conference. “We need to ensure their insights and input are considered at the study design phase and throughout the clinical trial process. Their insights need to be embedded into processes throughout the entire sponsor organization.”
One initiative currently underway at Janssen is something the company refers to as the Global Trial Community (GTC). The overall goal is to create better channels of communication with patients, so there is a reciprocal exchange of information before, during, and after the clinical trial experience. A key component of that initiative is the sharing of clinical trial results with the patients themselves, a challenge the industry has spent years trying to overcome.
Regulations that vary by country have certainly been one major hurdle to overcome. There are also debates over what can be shared and what would be considered promotional. There is also some amount of risk aversion in the industry that has kept some companies from wanting to be the first to try this. Whatever the reasons, they have effectively kept patients separated from their trial data.
“We know patients want to be connected and we know they are using social media to be part of various communities,” notes Guld. “GTC is working towards building an environment where we can be a part of that journey with them. We believe the first step of that journey is returning something that we think belongs to them, which is their clinical trial data. GTC will be a platform that supports the patient community. Janssen now has about two years-worth of experience, working across a few countries, in identifying a process to return those results to patients. We also have feedback from patients and investigators on what they most wanted to see.”
Increasing Adherence And Reducing Burden
iSTEP (Integrated Smart Trial and Engagement Platform) is another tool Janssen is using to improve the clinical trial experience for both patients and sites. First announced in 2017, iSTEP is a digital technology that is available as a provision device or BYOD, and integrates medication kit tracking, patient engagement app, and smart medication adherence.
“The tracking feature can relieve the logistical burden on sites while other features, such as push notifications, learning modules, and videos and tutorials will help meet the needs of patients,” states Guld. “These are features that really help connect patients to trials. Medication adherence is a real problem in clinical trials. You cannot obtain good data if patients are not taking their medicines.”
iSTEP also integrates smart blister packs, smart bottles, and smart medications that allow researchers to know when treatments are taken. Guld notes the modules are flexible and sites can choose to use as many as they wish. There is a tailored approach for each therapeutic area. Janssen’s internal innovation team collaborated with Tata Consultancy Services (TCS) to build iSTEP based on TCS’ Connected Clinical Trial (CCT) platform, which is now available for the industry to use.
Real World Data – Where To Next?
Guld believes there has been a real evolution in real-world data (RWD) and its applicability to clinical trials over the last few years. Most of Janssen’s work on RWD has focused on harmonization and utilization of the data.
“When we talk about RWD in the clinical space, we are looking at how we can use electronic health records (EHRs) to support study design, identify patient populations, new sites, and accelerate recruitment,” states Guld. “The privacy of the patients is important. Applying novel approaches, such as federated data management, ensures data privacy by design. The data stay within the hospital firewall and analysis is brought to the data. We are working to scale up these capabilities and use the information to improve study feasibility and optimize operational processes.”
When looking at what can be achieved by mining EHRs, Guld likes to ask, Where to next? There is a lot the industry can do to mine better information from the data it has available. Guld believes the future lies in using AI and machine learning to better identify sites and patients. The industry can now investigate what other data types exist in various countries and therapeutic areas that will give us additional knowledge or information that will help us match the right patient to the right treatment, accomplishing the goal of precision medicine.
Finally, Guld believe the industry needs to continue to focus on how it can better integrate trials into patient’s lives. While progress has been made, she believes it is an area where much more can be done.
“The concept of virtual trials has been discussed for many years,” she adds. “Unfortunately, the concept has not moved forward as fast as we had hoped. There are legal and privacy issues that need to be overcome, and an operational model that needs to be set up. I believe this model will be the future of trials, and we are putting a priority on establishing that model and having it available as an option for our study teams and patients. This model will eventually entail home healthcare visits and the ability to perform remote blood collection with a very small sample.
Tammy Guld will be co-chair and a moderator at DPharm 2019 taking place in Boston on September 17-18, 2019. Click here for more information.