IN PARTNERSHIP
• Consent forms and processes are often difficult for patients to understand, which can make it more challenging for patients to ask questions
• Many patients are afraid of clinical trials and experimental therapies
Taken together, these insights suggest that clinical trials and the technologies that support them could create a better patient experience by reducing patients’ time burdens, ensuring empathetic connection to providers, making information easy to understand, and assuaging patients’ fears.
This points to the second step in the practice of patient centricity: designing a trial and its technology solutions to meet patients’ needs.
Build the trial designs and tools that make it easier for patients, sites and sponsors to move seamlessly through a trial Sponsors have many tools to design a trial that responds to patient needs – including technologies that can make trials simpler for patients, sites and sponsors. IRT can be one such tool; when technology companies and trial sponsors see interactive response technology (IRT) as supporting a holistic response to patients’ needs, it can become the backbone of an automated patient journey through a clinical trial. Suvoda’s experience with direct-to-patient (DtP) drug shipping demonstrates the potential role of IRT as the foundation of the patient journey. The number of studies we support that include DtP has increased tenfold over the past three years; across those studies, we have seen that IRT touches the patient journey from study entry through therapy completion, and is especially important as a patient connection point in trials with decentralised elements. As the system that randomises patients, signals drug dispensation and manages dispensation reporting, IRT can uniquely provide the technology infrastructure for most tools that support the patient experience.
The biggest challenges Suvoda has faced in implementing DtP are operational. In one of our first DtP trials following COVID-19 shutdowns, our sponsor wanted to move all drugs to ship directly to patients’ homes. Our IRT system could handle this with a few modifications. However, the depot vendor was not set up to ship drugs to hundreds of homes. Suvoda partnered with the depot to identify couriers, train them on
temperature management, and build a process for time-sensitive shipments. By the end of the trial, 100% of the experimental therapy was being shipped directly to patients’ homes. This is one example of a challenge that can emerge when incorporating decentralised elements into trials to better meet patient needs. And we’ve seen that the operational excellence required to deliver high- quality DtP and IRT can be a starting point to solve other operational challenges on the patient journey. In the future, Suvoda sees important opportunities
to leverage our IRT as the foundation of the patient journey. We have a new consent management product that is integrated with IRT as a part of our technology platform. We are advancing our DtP capabilities, offering upfront builds, the ability to toggle DtP on and off in real-time, and tools to manage geographic dispersion of patients. And we are preparing a new eCOA product, also integrated with IRT and our technology platform. Suvoda is optimistic that this suite of tools, built on to the IRT patient platform and integrated with other technologies, can begin to better respond to what we already know about patients’ needs: reducing time burdens, supporting information sharing between provider and patient, and making it easier for patients to accurately report their data. Ultimately, this will make it easier for patients to join and stay in trials.
The big picture payoff of patient centricity: better inclusion and more representative study data Patient centricity holds promise for our industry. But if we want it to pay off, we must be more disciplined at holding a holistic understanding of the patient journey, viewing patient centricity as a mindset and a practice, and building trial designs and tools that respond to patients’ needs. The potential payoff is meaningful and worth it.
Today’s drug development is expensive and slow; it takes an average of nearly $1bn and 12 years to bring a new therapy to market. Many studies struggle to enrol enough patients to test all study outcomes sufficiently, and the patients they do enrol are disproportionately white and male – providing a poor sample of the diversity of the world’s population. If we hope to have a chance of bringing new, potentially life saving therapies to market on meaningful timelines, we have to find ways to make trials move faster, for less resources, and to enrol and retain patients. Patient centricity is at least part of the solution.
Clinical Trial Supply Handbook | 31
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92
