Despite the fact that patient recruitment and retention concerns have plagued studies for well over a decade, technology advancements have the ability to reverse this trend by promoting patient participation and decreasing drop-out rates.
It is estimated that just approximately 3% of physicians and patients in the United States engage in clinical trials that lead to new medicines. Patients who are overburdened with too many chores are more likely to drop out of the experiment, For example, a patient dealing with a medical issue may not want to get many alerts, keep an ePRO journal, and sync wearable data to an app every day.
For similar reasons, the site experience may suffer. A sponsor, for example, may employ separate systems for eConsent, electronic Patient Reported Outcomes (ePRO), and televisits, as well as independent electronic data capture (EDC) and clinical trial management software (CTMS) platforms. Inadvertently, this strategy increases site workload. Sites must manually enter metadata (e.g., a patient's ID, a visit schedule) in addition to other patient data if data from these systems is not connected.
Before adding to a patchwork of clinical trial systems, examine if additional technologies would increase patient choice — or ease the load on sites responsible for providing high-quality treatment. The more dependence on human data entry there is, the greater the danger of mistakes. Furthermore, unconnected data and manual processes might cause data availability delays after the research is over.
Why do we need to give patients more options?
The FDA and other regulatory agencies advocate for patient-centered medication development. Patient centricity entails positive, long-term interaction in order to provide the greatest possible patient experience and outcome.
"Patient centricity can be summed up in one word: choice. It's providing a patient with alternatives. It's about making the trial as convenient and comfortable as possible."
People give their time and energy to clinical studies with no assurance of benefit. Their participation and voice are critical to the success of clinical research. Offering patients a choice helps all parties for a variety of reasons, including:
- Individual requirements of patients must be respected. Every patient has different preferences and priorities. If we're asking people to engage in research, it seems only fair to provide options that match their objectives.
- Urge people to participate. One of the most common reasons for patients dropping out of research is inconvenience. Patients are more likely to stay involved in clinical research and participate until the end of the study if they believe they have influence over how they participate. Sponsors may benefit from giving patients the option of participating on-site or remotely.
- Encourage the variety of clinical trials. Companies seeking clearance for new pharmaceuticals will soon be required to submit a diversity strategy for study enrolment in order to boost the number of trial participants from under-represented groups1. Sponsors can reach a greater range of patients by broadening their options. "If you take a one-size-fits-all approach to clinical trials, you risk excluding groups that would otherwise be interested in participating but have different preferences than what you're giving," Davis says.
- Gather more accurate data. Patients will find it simpler to complete ePRO if they are familiar with the device controls and operating system (for example, since they are using their own device). A bad user experience, on the other hand, increases the likelihood of mistakes or missing data points. "Those who are more involved and passionate about participating are more likely to continue with the study, follow the protocol, and produce reliable data," Davis says.
How can sponsors expand patient choice?
Remote participation allows sponsors to enroll patients from a larger geographic region while also accommodating patients who are unable to come to a facility. Similarly, enabling patients to choose between having their testing done at a local lab or at the research location improves patient choice. Additional methods include:
- Start with the eventual goal in mind. Consider the end user's perspective while building patient-centric digital trials. When and how will patients interact with an ePRO app? Can they locate the FAQ section easily? Is it possible for them to obtain a plain-language overview of clinical trial requirements?
- Consider a BYOD strategy. Although provided devices have their place, patients may prefer to utilize a mobile device that they are already familiar with. "We don't need to put gadgets on individuals who already have a superior device in their pocket," Davis contends. Working on a familiar interface allows patients to navigate applications and complete evaluations more easily, minimizing the risk of noncompliance.
- Simplify research participation. While developing a single, user-friendly application, seek to provide patients with all of the information they want in one location.
- Sponsors and CROs place a premium on speed – real-time data availability, quicker study construction times, and shorter time to database lock. While many clinical technology solutions provide effective methods for designing and executing studies, having a heterogeneous set of technologies places an unnecessary strain on sites and diminishes the patient experience. Here are a few places to start:
- Standardize procedures and workflows to build a repeatable model that can be used to the majority of investigations. Although modest adjustments may be required for each attempt, a uniform method will reduce complexity and improve usability.
- Reduce the trial's risk by minimizing the site burden. Disparate, fragmented systems make managing studies and monitoring data throughout the clinical trial lifecycle more complex. The additional training and time necessary to handle various systems places additional demand on site resources. If a protocol incorporates too many systems and software, locations may have to rely on manual methods to achieve deadlines or drop out of research.
- Recruit a cohesive set of solutions. A free-to-site platform reduces the requirement for data to be managed across numerous separate systems. Without the strain of learning new software, locations have more time to focus on their patients. Patient-centered trial platform
Providing patient-centric trials necessitates careful consideration of your organization's security, compliance, and data management aspects. It is also critical to assess the impact on locations and patients. This includes the simplicity of use of an end-to-end system as well as its adaptability to the demands of your trial, independent of how and where it is conducted.
There's a reason for doing things remotely, a rationale for doing things in person, and a case for a mix of both, In order to be genuinely patient-centric, we must provide a variety of options based on where patients reside, how sick they are, and where they are in the trial experience." The platform must be adaptable to all of these scenarios."
How Can Octalsoft Help?
Bringing research closer to the patient can help us make studies more accessible to larger and more diverse patient populations, resulting in more representative study data and more effective medicines and therapies.
Octalsoft has already begun to forge ahead toward the future of decentralized clinical trials with our comprehensive array of eClinical software solutions.
Do you want to know how you can overcome existing clinical trial challenges, accelerate the development of innovative therapies, and usher in a new era of evidence-based medicine that benefits patients worldwide with Octalsoft? Book a Demo with us Now!