Benefits, Challenges and Best Practices of Clinical Trials: Paper vs. Electronic Data Capture

On February 25th 2015, Clinovo hosted the 10th Session of the Silicon Valley BioTalks at HP’s headquarters in Palo Alto. The attendees consisted of life science industry professionals with the sole intent of discussing the benefits, challenges and best practices of paper-based clinical studies vs EDC based studies. To add a valuable experience to the conversation, the event featured a panel of 4 clinical trials professionals: Ana Pulido Ferrer, CEO of Digitaliza TXT, a leading technology provider for CROs in Latin America with over 20 years of experience, Lyssa Friedman, nation-wide Clinical Development and Operations Consultant at Telomere Diagnostics, Carrie Loebertmann, Manager of Data Management at NAMSA with over 15 years of clinical research experience, and Victor Chen, Director of Clinical affairs at Align Technology, with over 20 years of experience. The panel was remarkably moderated by Clinovo’s Chief Technology Officer, Marc Desgrousilliers.

Marc DesgrousilliersToday, more than 50% of regulated studies are still run on paper. This number rises to about 80% if we include non-regulated studies (i.e. Nutraceuticals, cosmetics, skin treatments, etc.). In this technologically driven age, it seems that the number of trials conducted on paper would be dramatically lower.

Of the event attendees surveyed, 18% are still exclusively using paper, 54% are exclusively using EDC and 28% are using both EDC and paper. The sample of attendees that are still conducting clinical studies on paper is significantly lower than the rest of the world but we still need to understand why the EDC adoption rate isn’t reaching a higher level.

Barriers To Entry Of Electronic Data Capture

The panelists and audience discussed the challenges to using an EDC system and it was determined that there are many barriers to overcome, all of which can be categorized into the following:

• High upfront cost
• Lack of technical knowledge
• Resistance to change

High upfront cost:

It is true that the time spent to build a database on paper is significantly shorter. The most common way of setting up a study with paper is for the sponsor to create CRFs in a document editor, and once approved, print it out and have it sent to the sites.

As a consequence of the CRFs sent to the sites, there are no associated license fees or monthly charges. It is the sites’ responsibility to enter data at their own speed, respectfully.

On average, with EDC, the time it takes to design and setup a database is between 5-8 weeks. This does not take into consideration the rounds of User Acceptance Testing (UAT) to ensure that the database meets the sponsor’s needs. Therefore the decision to select paper over EDC is easier for those in charge of budgets.

Lastly, sourcing programmers to build and design studies can represent an important percentage of the sponsors’ budget considering the salary, the time spent when building the study and the training of the staff and sites on the system. Traditional EDC systems require users to be trained and certified on these platforms. Depending on what system is used, the level if intuition may greatly vary which is why training the internal staff and sites that aren’t used to EDC systems may represent a challenge.

Lack of knowledge:

For a company which has always been conducting paper-based clinical trials, switching to an EDC system can definitely represent an overwhelming step. Indeed, this concept will most likely disrupt their employees’ previous workflow. The users will have to adapt to the new graphical user interfaces (GUI) and new features such as in-system randomization, medical coding and electronically calendaring visits.

Resistance to change:

The final and hardest obstacle to overcome for companies that have historically been using paper is their structural resistance to change. Convincing these companies to change their paper-based processes and introducing EDC as a solution still remains a difficult task. Also, some companies simply cannot adopt EDC due the lack of/unreliable internet connection.

Benefits Of Electronic Data Capture

While discussing the barriers to entry of Electronic Data Capture represented a challenge at the conference, attendees were in agreement that the benefits of EDC easily outweighed those of paper.

The recurring items as to why EDC overshadowed paper were:

• Data quality
• Time reduction
• Long-term cost effectiveness

Data quality

EDC systems allow data to be centrally located and accessible. In most validated systems, users will have live time data access to which they are granted permission to see. The ability to create datasets on this data empowers users to catch any discrepancies or safety issues in real time. In addition, errors can be detected and corrected much earlier in the EDC clinical trial process than with paper-based systems that can only rely on ad hoc mid-study analysis. EDC edit checks are automatic and visible at the time of entry and are therefore resolved immediately, resulting in cleaner data at time of entry in the database.

Study monitors greatly benefit through the use of EDC systems as it helps in speeding up their workflow. Virtual monitoring allows sponsors to view, usually in real time, live analytics such as site enrollment progress, subject statuses and event statuses. In addition, erroneous data is decreased through edit check programming. Edit checks act as a preventative measure by adding logic to questions which ensures that answers are within the expectations of the programmed field. Lastly, Source Data Verification (SDV) greatly increases the time that is spent by monitors approving case books that are ready to be signed off by the Principal Investigator.

Time reduction

Time-reduction with EDC is a very sensitive element as it has a direct impact on the overall study length, obviously, but also on the overall study cost.  The data captured electronically can easily be sent from the sites to the sponsor and vice-versa. This not only saves time on the data transfers but also removes the delay paper-based studies would have due to secondary data entry.

The second time-reduction item when using EDC based clinical trials is the on-site monitoring visits. The frequency and duration of on-site monitoring visits can be dramatically reduced or even entirely eliminated thanks to EDC with online, cloud-based monitoring.

Cost Reduction

The third benefit of EDC adoption concerns one the primary vendor selection point of interest of small to mid-size life science companies, the cost-effectiveness.  All the event attendees agreed upon the fact that EDC was more cost-effective than paper-based clinical studies on the long run.

If you consider the travel budget for site visits, the printing and shipping costs of the paper CRFs and the data query resolution cost, Electronic Data Capture is undoubtedly a more cost-effective solution. That statement applies even better for the long-lasting clinical trials that invest higher amounts of money in these items.

EDC enables early identification of discrepancies or data entry errors, minimizing the time spent by monitors at sites. Estimating that a visit can cost up to $3,000, the total savings for a study with 20 sites can reach $60,000. Virtual monitoring can also help alleviate the travel time and cost as they can view raise any queries to sites and colleagues alike

Future Of Data Collection

During the discussion, many ideas were brought up as to what the future of data capture would be. Some of the assumptions raised have already been integrated by the most up-to-date vendors that want to stay ahead of the competition. Here is a selection of the key areas for major improvements.

Simplified systems for in-house control

Much of the programming that was needed in the past will be taken out of the picture. Vendors will soon be able to build studies with little to no programming experience to get their trials up and running. The power will soon be fully in the sponsors’ hands allowing them to build studies on their own and control everything in-house. This will definitely have a major impact on the cost structure, taking the proprietary license fees out of the picture.

Central systems

The central systems also might have an extremely bright future. The idea that vendors would provide a system with open API’s communicating with other systems is slowly making its way into the data capture market. Vendors already aim at becoming experts in their software to create the best solution that seamlessly integrates with almost all other systems. This would undeniably represent a major step in the data capture systems cooperation but, in the end, would be a major benefit for the patients.

Cloud EDC systems

The “Cloud” gives the ability to access value-added services from anywhere at any time with a level of simplicity, flexibility, and cost-efficiency never seen before. In other words, the Cloud is the idea that you can use a service on-demand, as and when you want, and pay only for what you use. It is becoming critical for the drug development industry to adopt new methods to deal with the ever-growing flows of clinical data. Industry analysts estimate that the data generated by the pharmaceutical industry doubles every six months. However, the drug development industry is still in the early stages of evaluating the applications of Cloud in its field. One of the first applications to come to mind is the use of cloud computing to capture and manage patient’s clinical data across large clinical studies. Many foresee the emergence of “Cloud Data Capture” gradually replacing Electronic Data Capture (EDC), among other eClinical systems.

Integrated ePRO (electronic Patient Reported Outcomes) systems

Technological innovation is also placing the patient at the epicenter of clinical research. Fast-developing ePRO technologies allow patients to report clinical data themselves. The modern ePRO systems are designed to maximize the ease in which patients report their observations. Additionally, they better integrate with eClinical systems to capture and spread relevant clinical data faster to clinical teams. For example, ePRO systems integrate with Electronic Data Capture (EDC) systems to automatically and securely import clinical data from the ePRO directly into the EDC system. This allows a quicker response time in the case of adverse events for example.

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