The Real Benefits of Patient-Centric Clinical Trials

By Zach Hales, Director of Product Management

Snapshot 

• Importance of Patient-Centric Trials: Patient-centric trials prioritize patients' needs in trial design and execution. This approach is supported by regulatory bodies like the FDA and EMA and has been shown to improve trial success rates and speed up recruitment. 

• Quantifiable Benefits: Data from The Economist Intelligence Unit indicates that patient-centric trials are about 20% more likely to succeed and recruit participants faster than traditional trials.¹  

• Technological Enhancements: Tools like AI chatbots, eConsent, and eCOA (electronic clinical outcome assessment) can help enhance patient engagement and compliance.  

• Future Directions: Embracing patient-centric approaches can simplify the clinical trial experience and improve data integrity. This approach not only benefits patients but also contributes to better scientific outcomes and operational efficiencies for sponsors and CROs. 

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, and shares examples of solutions from the Suvoda platform and beyond that can help sponsors and CROs be more patient-centric in their trials. 

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.”² In the context of clinical trials, it means prioritizing patients’ needs when developing the protocol and trial tools. 

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. For example, patients who are offered choices on how they want to participate in a clinical trial—whether it’s in a remote, hybrid, or decentralized clinical trial model—could then choose what’s most convenient for them.  
  

What are the real  benefits of patient-centric trials? 

While patient convenience is important, some clinical trial professionals question whether changing established processes to achieve patient-centricity is necessary. However, a report by The Economist Intelligence Unit presented data in favor of patient-centric approaches.¹  

The report found that Phase II and III patient-centric trials–those that consider or include patients in trial design and execution–were about 20% more likely to succeed compared to traditional trials.¹ Recruitment was also faster—patient-centric trials took around four months to recruit 100 participants, versus the seven months needed in traditional models. In neurology, patient-centric trials recruited 100 participants in roughly half the time compared to traditional methods.¹  In rare disease trials, patient-centric trials recruited 100 participants in one-fifth the time.¹ 

Furthermore, patient-centric trials continued to show benefits post-approval. Drugs developed with patient-centric designs between 2015 and 2017 had better success being added to formularies by 2018.¹ These data suggest that patient-centric practices can result in faster enrollment, cost savings, and getting drugs to patients facing diseases more quickly.   

AI & chatbots: A new communication model 

AI and chatbots are becoming essential tools for enhancing patient engagement and support. JAMA Internal Medicine published an evaluation of AI and physician responses to patient questions. In this evaluation, licensed healthcare professionals were three times more likely to rate AI responses to questions as “good” or “very good” compared to physician responses, both in terms of quality and empathy.³ 

Sites and sponsors can adopt AI assistants or chatbots to handle frequently asked questions (FAQs) and provide immediate responses to patient concerns, such as questions about the treatment, potential side effects, and visit schedules. This immediate feedback can help support in sharing information and reducing patient worries, potentially leading to a more positive trial experience. 

eConsent: Higher trial comprehension & retention rates 

Digital documentation is now commonplace and may be an important tool to center clinical processes around patient needs. In a Suvoda survey of the general population in the US and UK, a majority were comfortable reading and signing documents digitally. eConsent tools allow patients to review and sign consent documents at their own pace, potentially increasing their willingness to participate and stay in the studies.

When Suvoda eConsent is used alongside IRT, site teams have one fewer tool to manage, and study teams gain full visibility to and control over their data, streamlining consent, screening, and randomization processes. At the same time, mid-study changes are simplified, as the system can ensure no drug is dispensed before reconsent. 

eCOA: Higher participation flexibility and compliance 

Electronic clinical outcome assessment (eCOA) is another tool that helps to reduce patient burden. A robust eCOA platform can also capture complex outcomes information and harness those data to help sponsors make more informed decisions. 

eCOA increases study flexibility by allowing patients to complete assessments electronically in the clinic or remotely on their devices, as opposed to paper-based assessments. This simple change—when well implemented—increases patient compliance and data accuracy, while reducing patient dropout rates and site workload.

Solutions like Suvoda eCOA help to tackle problems sites and sponsors face when using paper-based patient reported outcomes. Suvoda eCOA can help sponsors maintain data accuracy, facilitate more timely patient reporting, and adhere to data privacy and compliance regulations. When unified with IRT as part of the Suvoda platform, study teams benefit from better data integrity, improving the chances of clinical trial success.  

Moving forward with a more patient-centric future 

CROs and sponsors transitioning onto a more patient-centric approach in their trials can benefit from partnering with technology vendors with similar philosophies and products to simplify the clinical trial experience for everyone involved.  

Fit-for-purpose technology and partners can help sponsors to run their trials more efficiently, provide a positive, patient-centric experience, and more quickly bring potentially life-saving medicine to patients who need them critically. 

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Resources

^{1“The Innovation Imperative: The Future of Drug Development Drug Development,” Economist Intelligence Unit, May 8, 2019, https://druginnovation.eiu.com/.} 

2 Guy Yeoman et al., “Defining Patient Centricity with Patients for Patients and Caregivers: A Collaborative Endeavour,” BMJ Innovations 3, no. 2 (March 24, 2017): 76–83, https://doi.org/10.1136/bmjinnov-2016-000157.  

3 John W. Ayers et al., “Comparing Physician and Artificial Intelligence Chatbot Responses to Patient Questions Posted to a Public Social Media Forum,” JAMA Internal Medicine 183, no. 6 (June 1, 2023): 589, https://doi.org/10.1001/jamainternmed.2023.1838. 

Author

Zach Hales
Director of Product Management
Suvoda