Decentralized clinical trials are driving speed and engagement
The evolution of clinical research throughout the pandemic, and beyond
There is a new normal in the life sciences industry and decentralized clinical trials are a major part of it. For better or worse, the COVID-19 pandemic forced life sciences organizations around the globe to adapt at an unprecedented scale. Biopharma companies and contract research organizations (CROs) adopted decentralized or digital clinical trials (DCTs) to reduce contact, improve the patient experience and keep studies on track during the pandemic. It’s already clear that the virtual approach of DCTs is benefiting life science organizations. The clinical trial dynamic has shifted. Now DCTs are supported as a legitimate way to execute studies. There have been many improvements to clinical trial operations that range from enhanced patient engagement and site experiences to cost savings and better data integration.
However, obstacles remain. This new clinical trial dynamic merges traditional clinical trial challenges with the challenges of transitioning to digital solutions and decentralized designs. Studies need to be quickly implemented according to security and regulatory standards without putting unnecessary strain on providers and patients. Adopting intuitive solutions can help achieve those goals.
Adapting to the decentralized clinical trials approach
No matter the approach, clinical development will face challenges. The key is to assess and apply flexible, scalable solutions and reduce clinical trial burdens overall.
Traditional clinical trials typically use brick and mortar study sites, which serve as the epicenter of clinical development within a region or geographic location. There is usually a designated investigator team that conducts tests at satellite facilities or conducts direct patient tests with patient-reported outcomes. This approach requires study visits, tests and evaluations to be conducted in-person.
In contrast, study requirements and the patient experience are key to inform decentralized clinical trials designs. For example, in a hybrid clinical trial, some patients might visit a physical site for an electrocardiogram or tumor biopsy, but other patients might participate virtually. In this scenario and others like it, patients typically use a mobile app or other electronic patient-reported outcome (ePRO) solution, in addition to electronic clinical outcome assessment (eCOA) tools to track and report their data.
In some studies, patients undergoing treatment cycles that traditionally require site visits can now have a patient kit or drug shipped directly to their home. For example, clinical study investigators requiring blood or saliva samples to test insulin or cortisol levels can ship sampling kits to patients. Then patients can access a digital platform or virtual healthcare provider that shows them how to conduct the tests via telemedicine. Participants can also discuss their concerns and share data with study coordinators.
Although the benefits of engaging patients closer to their homes are tangible, there are significant hurdles. The coordination of home-based procedures that require a skilled healthcare practitioner is one of the greatest treatment challenges to overcome for a decentralized study. Those challenges can be even harder to overcome if the clinical study includes a large population from multiple locations.
There has never been a more critical time to focus on the patient than now. While the decentralized clinical trial approach is both unique and essential, developing solutions that are scalable, flexible and smarter is going to be essential for long-term success.
Getting ahead of clinical study changes with a flexible protocol
The COVID-19 pandemic forced some study areas to pivot to a decentralized clinical trial approach. Protocol framework and study structure are now required to be robust and include DCT solutions as an integrated option for any future study designs.
Perhaps the greatest challenge in a clinical study is developing a robust and flexible protocol and study design. In late 2019 and early 2020, many organizations had to scramble to convert their traditional clinical studies to a format that complied with pandemic restrictions. Sponsors, CROs and tech companies were forced to find digital and direct-to-patient solutions that could collect data remotely and reduce or eliminate the need for in-person visits.
When pivoting to a decentralized or digital study approach, both the protocol framework and study structure require a dynamic design. A flexible design helps studies adapt to clinical study changes and challenges regardless of the study’s physical location. Due to the typical clinical study considerations, such as patient visit schedules, methodologies and fast drug formulation or investigational new drug approvals, there are additional requirements for executing a successful decentralized clinical trial. For DCTs, study leaders must consider how sustainable remote or tele-visits are, how to keep track of of changing quality and regulatory standards, and how to ensure the clinical study is safe regardless of the setting. Clinical study procedures also vary in how they are conducted, which has the potential to influence clinical results. These differences can introduce variability into critical study endpoints, which ultimately must be considered in the sample-size calculations as well as analysis and monitoring plans.
From study start-up to the last patient interaction, all parts of the study must stay on target to ensure accurate patient results and consistent patient-reported outcomes. The key for moving forward, despite challenges, is to become more agile and efficient, reduce administrative burdens, and promote patient-centricity without compromising clinical study quality or data integrity.
Keeping patients engaged in a virtual environment
Decentralized clinical trials have made impressive improvements in patient engagement and patient retention. Yet, patient engagement and retention are still challenging factors that must be considered carefully as part of study design.
There are many things that can impact patient visits and the quality of data reporting. These issues can become a burden to patients and lead to increased participant drop-out rates, which can ultimately lead to clinical study delays and inaccurate results.
Patient retention remains a serious concern for DCTs despite the integration of direct-to-patient & digital/virtual solutions. Patients can complete online surveys, eFeasibility questionnaires, eConsent, patient diary forms and other protocol-related documents from the comfort of their own device with minimal person-to-person interaction. Then the data can be collected and verified by clinicians in real-time using a virtual technology platform. Overall, a study’s purpose and design complexity should be taken into account when considering patient burden and the feasibility of collecting patient data remotely.
Biopharma companies and large CROs need to work with digital technology and unified solutions to support patient convenience and comfort. For example, a decentralized clinical trial may work with patients in several geographical areas. The study leaders could trace these sites through the use of geofencing technologies that automate reporting through a study app based on location data provided by patient devices, such as cell phones. Thus, investigators could record the time, date, location and type of a medical interaction automatically as long as patients are in an area that supports the system’s geofencing.
Additionally, predictive analytics based on previous studies can help anticipate the behaviors of patients and influence improved data collection and patient retention. Remote patient monitoring can track these trends, which could help investigators identify anomalies before they happen. For example, a study site is expected to have a 30 percent risk rate of adverse events. The rate currently sits at 15 percent, but it is trending to exceed 30 percent. By using predictive analytics and AI, a sponsor could work with investigators and patients to mitigate issues before they occur.
Patient engagement, retention and care are large factors in study success. While decentralized clinical trials often increase patient enablement, there are still considerations and challenges to overcome regarding patient retention and patient engagement. It is necessary to consider patient burdens in study design, protocol-writing, and technology selection to support the study.
Identifying digital solutions that meet your DCT needs
Intuitive, reliable technology is the key to a direct, patient-centric home healthcare model that effectively serves the interests of sponsors, study participants and investigators.
Clinical studies can be disrupted. However, COVID-19 has led to unprecedented burdens. Digital health solutions and unified platforms enabled with smarter technology are emerging as a way to overcome decentralized clinical trial challenges. Technologies such as AI and advanced analytics, virtual study capabilities, and diverse interoperability are considered better solutions for organizations conducting clinical studies. These technologies can help lead to acceleration of studies, improved data integrity and faster adoption among patient and site participants.
Site and patient portals are critical to improving data quality, patient engagement, site engagement and relationships with sponsors, especially for completing online surveys as well as eFeasibility and eConsent documents. Despite some shortcomings, clinical study start-up management solutions can help accelerate site selection and patient recruitment.
There are additional solutions that empower sponsors and CROs to improve the patient experience, create valuable evidence during clinical studies and to recognize more value from the data they collect.
Interest in using life sciences technology to enable decentralized clinical trials and improve traditional trials has exploded since the beginning of the pandemic. Sponsors are discovering that a more patient-centric approach improves study efficacy by applying technology to provide better care, be more responsive to patient needs, and to reduce burdens on both sites and participants.
By using smarter technology, site teams and investigators can devote more time and attention to patient consultation and well-being, even before patient recruitment. Recently, patient engagement has been improved by using community websites that let patients request information about clinical studies ahead of time so they can decide if they want to enroll.
With smarter technology, patients can provide eConsent (video, 01:15) and complete any other documentation virtually without traveling. They can even communicate questions or concerns, which helps build a relationship with the investigator before the clinical study has started. Clinicians reviewing those questions have discovered that answers from patients participating remotely are much more consistent, which led to improved reporting quality.
The new industry standard is here to stay
Decentralized clinical trials are not an anomaly that can be attributed to the current pandemic. Studies conducted in a partially or entirely virtual format are the new industry standard. They reduce sponsor, investigator, and patient burdens by contributing to improved data integrity and supporting study efficiency. Digital clinical study solutions are also scalable. Users can start with something basic and add components as their clinical operations and ambitions grow.
Ultimately, digitally enabled clinical studies offer versatility. They can adjust and pivot as circumstances change as well as reduce the regulatory documentation and logistical challenges associated with such changes. Most importantly, all of these goals can be accomplished while staying laser-focused on a positive patient experience and overall patient wellbeing.