Effective Clinical Trials (eCT) continue to be the most commonly used model in today’s clinical trials. However, there is an alternative approach – The Empowerment Model. We often refer to this model as ePRO, eConsent, eCOA, or decentralized clinical trials. The Empowerment Model replaces the one-size-fits-all approach with a partnership model. It allows each party to maximize opportunities and minimize associated risks and costs.
Meet the eCOA Clinical Trial Empowerment Model
According to Medable, “The acronym eCOA stands for electronic Clinical Outcomes Assessment.” It is a new partnership model for maximizing efficiency. It also optimizes cost savings and control over clinical trial data. This empowerment model allows enterprises, sponsors, CROs, and CMOs to work together.
Combined, they’ll make the clinical trial supply chain process more efficient and effective. It will do this by supporting the needs of industry partners. This model delivers better patient outcomes and much more. It also ensures that clinicians meet regulatory compliance requirements.
So if you’re asking what’s the difference between eCOa and ePRO? Then you should know that DDC, eCOA, ePRO, and eConsent are the technologies that make up the eCTM platform. Though they have similarities, each has its function.
- DDC stands for Data Capture. It refers to capturing patient information, integrating it with clinical trial data, and storing it securely in the cloud.
- eCOA stands for Electronic Consent. It refers to electronically collecting and managing consent from patients and site staff.
- ePRO stands for Electronic Patient-Reported Outcomes (ePROs). It refers to the ability to collect patient-reported outcomes through an online survey or other devices such as a tablet or phone.
The Current State of Clinical Trials
Clinical research is a $200 billion dollar per year industry. Unfortunately, only 4% of the industry’s proceeds go to patients. This is due to the high costs associated with clinical trials. These inconsistencies lead us to seek out new models for conducting clinical trials. These new empowerment models will increase efficiency, reduce costs, and increase patient involvement.
How Do Decentralized Clinical Trials Work?
It is a type of Clinical Trial in which one or more sites participate without a central location. In contrast, a Centralized Clinical Trial puts a single entity over participating sites. This entity directs how each site should operate and collect data. Decentralized Clinical Trials make overseeing activities much easier to scale.
Why This is Partnership Model That Works
The Empowerment Model offers a unique set of advantages. These benefits include:
Efficiency – Decrease In Hiring Personnel
One of the biggest challenges for CROs is providing better value. This model makes clinical trials more efficient by taking on the burden so specialists can focus on delivering care.
Cost – Real-Time Data Capture
Paper-based reporting systems aren’t just obsolete; they’re expensive. However, real-time data capture costs less than 10% of what traditional clinical trials cost.
Control – Give Frontline Employees Full Control Over the Trial Process
Control is a critical aspect of running successful clinical trials. Many executives, pharmaceutical licensing firms, and investors need more tools to manage what happens on the ground. The Empowerment Model prioritizes these needs during complex drug studies.
Compliance – Real-Time Reporting of Designated Events
Companies must report specific events during trials to comply with Clinical Trials regulations. Reporting events on a real-time basis gives regulators immediate insights. That way, they can take action if there are any problems as they happen.
Flexibility – Faster Decision Making and Trial Closure
Flexibility is a crucial component of success in clinical research studies. Empowered by blockchain technology, eCOA gives control back to stakeholders. Now they can adapt faster at a much lower cost with increased security.
The future of healthcare will be a combination of centralized and decentralized care delivery models. Together, they’ll leverage value-based care to drive efficiency. They’ll also promote transparency into costs and outcomes.