By Zach Hales, Director of Product Management
For at least a decade, life sciences organizations have discussed the need to develop patient-centric services. But what does that mean, really? What are the quantifiable benefits? This article provides some answers.
What is Patient Centricity?
A study published in BMJ Innovations defines patient centricity as “putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family.”In the context of clinical trials, it means prioritizing patients’ needs when developing the protocol.
The FDA supports patient-centered drug development as a way to inform clinical, regulatory, and patient decisions. A patient-centered approach includes gathering patient and caregiver input and implementing approaches that encourage enrollment and participation.
Decentralized clinical trial models are patient-centric by nature because they make participation easier and more convenient for patients. Remote participation also promotes equal access and diverse participation—initiatives that are top of mind for regulators.
What are the Real Benefits of Patient-Centric Trials?
While patient convenience and accessibility are important, some clinical trial professionals debate whether they should overhaul time-tested processes in the name of patient centricity. Will incorporating patient-centric features such as electronic informed consent (eConsent), electronic clinical outcomes assessments (eCOA), and managing direct-to-patient shipping through IRT get you to database lock faster? Will it save you money? Perhaps, in the long run.
A report issued by The Economist Intelligence Unit assessed the impact of innovations in drug development and market access. They conducted a literature review and market research to examine different trial designs in terms of efficiency, likelihood of drug launch, and patient access.
The authors found Phase II and III patient-centric trials were about 20% more likely to succeed than traditional trials. Patient-centric trials took about four months on average to recruit 100 participants compared to about seven months for traditional models.
Patient-centric trials also moved through recruitment faster. Patient-centric neurology and oncology studies recruited 100 participants in about half the time as traditional trials. Rare disease trials recruited 100 participants in about one-fifth of the time of non-patient-centric trials.
The benefits continued after approval. The report found that drugs developed between 2015 and 2017 using innovative trial models such as patient-centric designs were more likely to get added to a formulary by 2018 than drugs developed using traditional approaches.
This data shows that the operational benefits of patient-centric trials stem from improved patient recruitment. By making it easier for patients to participate, clinical trial sponsors can recruit more patients faster, making it more likely they’ll meet enrollment goals. Considering most clinical trials fail to enroll enough patients, success in this area can lead to millions of dollars in savings.
A Patient-Centric Necessity: eConsent
While most businesses use e-signature to ratify agreements, electronic informed consent (eConsent) hasn’t reached the same level of acceptance. Inconsistent regulatory and data privacy requirements between countries has held many sponsors back; however, it’s possible to overcome this hurdle with an understanding of your key markets.
Implementing eConsent keeps a trial moving forward while relieving patient burden. Receiving a large, complicated consent document can overwhelm many patients. Digitizing the process may lessen much of that stress. Patients can review documents at home at their own pace, potentially increasing the odds they’ll sign and move to screening and randomization.
When Suvoda eConsent and IRT are used together, users get full data visibility and control. Study teams can track consents, screening, and randomization in one place, allowing them to move through the process faster. And when mid-study changes happen, the system will prevent dispensation of drug before reconsent, simplifying the process.
Direct Patient Benefit: 被験者への薬剤直接出荷
Many patients who participated in clinical trials at the peak of the COVID-19 pandemic got to experience DTP shipping. Shipping study drugs directly to the patient alleviates the burden of traveling to sites—an advantage for patients who live far away or who are too sick to travel.
However, coordinating DTP shipping makes execution a challenge for many sponsors and CROs. While there’s a lot to consider when planning DTP shipping, your clinical supply chain and IRT partners will help ease the process. Look for partners with extensive experience in DTP as well as the technical capabilities to execute. The benefits in patient retention could be worth it.
Patient-Centric Clinical Trial Essential: eCOA
Sponsors can use technology to reduce the patient burden, recruit in broader geographic areas, and improve operational efficiency. During the pandemic, sponsors had to implement tools such as eCOA, telemedicine, and remote monitoring to keep studies running. Now they’ve become mainstays in many clinical trials.
Replacing traditional paper-based assessments with eCOA increases a study’s patient-centricity by giving patients flexibility. They can complete assessments in the clinic or remotely, using a provisioned mobile device or their own smartphone. eCOA also enables study teams to collect data more frequently without overburdening the patient.When it’s easier for a patient to comply, they may be less likely to drop out.
Operationally, switching from paper to eCOA helps lower the risk of inconsistent or inaccurate data and lessens the workload for site monitors. Study teams can conduct eCOAs using telehealth platforms while meeting fit-for-purpose validation requirements.
However, integrating eCOA into a trial plan isn’t as easy as installing software. Device deployment, returns, resupply, and licensing requirements all add complexity to study set-up.
Suvoda eCOA smooths some of these logistics, offering improved visibility and assessments designed for usability and scalability. With eCOA unified with Suvoda IRT, users can share data, streamline workflows, and better control operational processes. It also means one less system to manage for busy study teams.
Clinical trial sponsors and CROs transitioning to a more patient-centric way of working have several technology choices to make. When evaluating technology vendors, consider companies with patient-centric philosophies and products designed to simplify the clinical trial experience for patients, sites, and sponsors alike.
Director of Product Management