Clinical trials are designed to evaluate the safety and efficacy of new drugs and medical devices. But for decades, researchers and patients have noticed one positive side effect: improved health care delivery.
For many patients, participating in a clinical trial leads to better medical care and treatment, which is called Clinical Research as an Option of Care (CRAACO). This is because clinical trials have different resources than general clinics or community hospitals, providing a stronger network of caregivers, clinical skills, and support to meet individual patient needs.
For those with rare or complex diseases with few or no treatment options, CRAACO may be one of the only ways to improve conditions or extend life. We also know that when research options are provided to patients, it translates into greater confidence and hope, as well as improved health outcomes while accelerating medical research.
During the Covid-19 pandemic, the paradigm shift towards more patient-centered, technology-enabled decentralized clinical trials (DCTs) also presents an opportunity to enhance patient care during clinical trials. By strategically selecting and deploying technology products designed to improve the patient experience, researchers can digitally create more patient-caregiver touchpoints while reducing the number of outpatient visits and minimizing the overall impact on their daily lives. distractions, thereby bringing greater value to the participants.
CRAACO’s translation for mixed environments
During the pandemic, DCTs have become necessary to maintain patient and provider safety while ensuring critical clinical research continues during the lockdown. This experience proves that DCT brings powerful new value to all involved – and most importantly, patients benefit from more flexible trial participation options supported by technology solutions.
The use of electronic consent (eConsent) products, telehealth services, direct-to-patient delivery of medications, electronic clinical outcome assessments (eCOAs) and other decentralized operational technology solutions allow sponsors to enhance the patient experience while expanding their geographic reach. For patients, this means their zip code is no longer a major barrier to participation in the study, as they turned their home into a hub for health care delivery and data collection during the trial.
When paired with the new DCT model, CRAACO has a huge impact on people’s lives — because it enables more patients to participate in research when other existing interventions don’t work. Individuals receive a higher level of care because their physicians are able to contact them at a more frequent cadence when communication is limited to on-site visits compared to traditional trial models.
In a DCT setting, patients may be asked to complete more routine tasks than traditional site-based trials, such as entering biometrics or completing a diary. However, many see this as an improvement over the traditional model that requires time-consuming in-person visits to hospital sites on a regular basis — sometimes an hour or more away from their home. For this reason, the DCT research team has sufficient resources to support patients 24/7 via the chat function or call center.
With more trial data flowing directly and regularly into research databases, the model also supports improved safety compared to traditional models that only collect health metrics and research data during site visits, as risk signals are detected in real time.
Trial Execution: Using Digital Tools to Deliver Better Patient Care
The goal of today’s clinical operations leaders is to reduce the burden of participation while creating a highly engaging, patient-centric trial experience that ultimately accelerates actionable insights and brings new drugs and devices to market faster. Enter Clinical Technology Solutions.
Our industry has experienced rapid growth in deploying products such as eConsent, wearables, eCOA, telehealth, and chat support, all implemented to improve patient outcomes during trials. Here are more insights into how some of these tools work and benefit patients:
- eCOA: The eCOA platform intelligently automates and captures the patient experience through robust and reliable electronic measures. The use of this technology provides real-time insights, informs trial progress and presents results. This increases patient engagement, which essentially improves care.
- Electronic Consent: A few years ago, the first step in a clinical trial was receiving an Informed Consent Form (ICF), a long and complex form that made it difficult for patients to understand what they were signing up for — making clinical trials scary for many . Today, eConsent makes it easier for patients to understand what is involved in a clinical trial, highlighting the strengths and weaknesses of multimedia learning tools that can better support patients through the consent process, leading to improved retention rates.
- Connected Devices: As telemedicine becomes increasingly important, connected digital medical devices play an even more critical role by reducing the burden on patients. For example, health data can be collected using an Apple Watch or other actigraphy device and entered into the trial’s central data repository, reducing the number of in-person patient assessments in the field and shortening the time of patient site visits. Connected devices accelerate trial results by simplifying medical device selection and deployment to collect and analyze data.
A new era in healthcare
The Covid-19 pandemic has increased our global population’s understanding and awareness of clinical trials. We also learned that it has a positive effect on increasing awareness and interest in participating in clinical trials.
This openness provides exciting opportunities for the biopharmaceutical industry to engage with the patient community and accelerate research. But to capitalize on this opportunity for greater engagement, we as an industry must consider the patient experience—their burden of participation and their health outcomes—at every decision point. Technology-enabled trials must become a permanent part of clinical research because they can improve efficiency, speed, scale, and delivery of care.
Photo: Warchi, Getty Images
