The process of clinical research is extensive and extremely expensive. If we consider traditional models, a lot of this expense (in time and money) can be attributed to data collection.
Novartis conducted a study on their paper-based clinical trials and found that printing costs could run up to $50,000 for a study involving 500 patients. Additionally, the traditional paper-based approach to data entry takes significant time. Not accounting for human error, completing paper CRFs and double data entry take up a lot of time. Mistakes caused by human error are inevitable and corrections can eat up a lot of time.
In the face of significant logistical challenges, electronic data capture (EDC) developed as a must have in order to keep pace with the demands of large scale, more complex studies. Unfortunately, our industry is not one that is known for being agile and EDC implementation took nearly 20 years.
Even with EDC systems, data captured at a research site still needs to be transcribed. This process isn’t efficient and puts an even greater strain on your clinical research staff.
According to CenterWatch’s own analysis, most investigative sites now have to deal with a dozen different software solutions that aren’t compatible. Sponsors and CROs are providing more technology solutions, but these aren’t making things easier for the site’s staff.
This is just one reason eSource should be considered as a viable solution. They reduce investigator site workloads, and much more. Direct data capture at the point of generation virtually eliminates the need for source data verification and improves data quality. Fewer tasks translate into faster study completion.
eClinicalHealth Ltd developed ClinPal as a patient-centric platform, but in reality it can be used to provide an all-in-one solution for investigative sites. In fact, as an eSource solution, it can already handle both traditional clinical trial and virtual clinical trial models.
Since it was designed with patient engagement in mind (meaning that workflow is set up to support how a patient moves through a clinical trial, beginning with recruitment), ClinPal captures data from investigators and patients in the same way. This platform requires a single instance login and patients are even provided with their own account and login. This means that patient profiles aren’t tied to a specific trial within the platform.
“By putting patient engagement at the heart of clinical development, we facilitate and accelerate study success,” says Douglas Bain, eClinicalHealth’s CEO and Co-founder. “It’s our goal to give every clinical trial participant access to a dedicated online resource, regardless of the size and type of the trial. That’s why we’ve ensured our platform is easily scalable whether you’re running a 10-patient investigator-led study or a 30,000-patient mega-trial. While some studies will only need a self-service online trial information page and pre-screening tool, others can benefit from a full-service model covering the whole participant lifecycle.”
Accuracy is the name of the game when it comes to Clinical Ink’s SureSource platform. Like ClinPal, they also wanted to provide a solution that offers end-to-end data capture. Investigative sites who use this eSource platform can download their standalone app to make electronic data capture during patient visits even more seamless.
Unlike ClinPal, SureSource offers a different interface for site users and patients. Sites work from a tablet-based interface that can be customized to better meet their specific needs. Patients interact via a mobile app. Additionally, the SureSource platform incorporates four distinct products:
Workflow can be designed to match study-specific needs or site-specific processes. It can integrate other data collected from multiple mHealth devices, such as vital signs measurements weight and other biometrics.
Medidata is another leading provider of eSource solutions. In fact, they’ve developed a vertical SaaS platform (known as the Medidata Clinical Cloud) that is geared towards life science companies and their patients. With the Medidata Clinical Cloud, source data can be seamlessly integrated across electronic medical records, electronic health records and other eSource systems.
While eSource is still expanding, there are many sites that are using this platform already. The Medidata Clinical Cloud contains billions of clinical records from more than 2 million patients that have participated in nearly 10,000 clinical studies.
How Does eSource Reduce Site Burden and Improve Timelines?
The best eSource platforms have been developed to be easy-to-use and highly automated. They’re designed to be easy to implement so that sites no longer have any excuse to rely on paper source data capture.
How much more efficient would your site be if it only took minutes to capture data for real-time monitoring instead of weeks??
Remember that eSource platforms have been designed to be an all-in-one solution (site-facing and patient-facing), so investigative sites can use them to:
- Track compliance and other performance metrics in real time
- Improve between-visit patient management (reduce the number of required visits and increase efficiency on site)
- Offer electronic informed consent forms and educational study materials that are more patient-friendly
- Provide study reminders and specific instructions for participants
From a sponsor’s perspective, eSource platforms are extremely valuable in their ability to reduce human error. Investigative sites can use them to improve their protocol executions and provide sponsors with high quality data at a quicker rate.
They can provide instructions that managers can use to improve workflow efficiency and communication between staff and patients. This reduces workload stress and means that your staff can provide a better level of care. This is also extremely valuable as this keeps patients more engaged. A greater level of engagement (especially in remote studies) leads to more adherence, better compliance and higher quality data from participants.
According to feedback that Clinical Ink has received, here’s what investigative sites have to say about eSource solutions:
- 71% said implementing eSource reduced their workload by more than 30%
- 29% said less than 30% but more than nothing
- Everyone said it reduced their workload in some way
- Reported that eSource allowed their staff to spend more time with their patients and on recruitment efforts
Despite these compelling benefits, there are significant challenges that eSource providers still face. Specifically speaking, they’ve found that stakeholders can be hesitant since eSource is still something that isn’t widely recognized in our industry.
On top of that, EDC solutions often fell short of their potential. It’s understandable that sites are wary when approached with yet another technology solution. However, adoption will continue to grow as the benefits of eSource are more widely communicated within the research community.
In many ways, the rise of eSource solutions mirrors the widespread adoption of digital technology solutions in other industries that are reliant on data analysis. For instance, banking in the modern world could never operate efficiently if it was to return to a paper-based system.
Welcome to Clinical Research Trends, a new blog dedicated to providing breaking news on clinical trial recruitment, patient engagement, new technology and noteworthy trends. With this blog, we are working to provide clinical research organizations, sponsors and leading service providers with critical news and industry updates on a regular basis. If you want to learn more about the latest trends in clinical trial recruitment and drug development, you’ve come to the right place.