ePRO Solutions: Should we eliminate paper altogether in clinical trials?

??????????????????????????????????????????According to a study by CenterWatch, if the market continues to adopt ePRO technologies, paper diaries will no longer exist in 10 years. In an increasingly interconnected world, where technology can make data available in real time and increase the quality of collected data, why are we still using paper diaries to collect subject data in clinical trials? 

ARITHMOS looks at potential scenarios in clinical trials using paper vs electronic diaries and provides an example of a respiratory study in which an ePRO solution determined the success or failure of the study outcome. 

 

Quality of Data: Collecting Accurate Data in Real Time

In a paper diary scenario, clinical trial leaders face many challenges including illegible forms and uncompleted questionnaires. This wastes a Data Manager’s time trying to decipher a subject’s diary entries and ask for missing information.  More importantly, paper doesn’t always guarantee an accurate and honest response. The British Medical Journal reports in a pain study example, 45 percent of subjects invented data because they waited until the deadline to fill out questionnaires and had to recall weeks of data.

ePRO takes the burden off the subject and allows clinical trial leaders to have more control over the situation. Devices can be programmed to send reminders to subjects so they fill out diaries with real time data and submit data in real time.

Compliance

Technology has allowed ePRO devices to come in all shapes and sizes – from smartphones to tablets that integrate with Glucometers to spirometric devices that capture respiratory data. These devices have been proven to increase compliance among adults and elderly subjects who can adjust viewing screens and respond to questionnaires with a simple click.

Moreover, studies have demonstrated that subjects have a greater sense of privacy with ePRO devices. Subjects might be hesitant to respond honestly on a paper form knowing that various people will read their answers. In a study on female sexual dysfunction, subjects reported 80 percent more sexual episodes on an eDiary as opposed to a paper diary (cit. CenterWatch).

Reducing Study Timelines, and Inevitably Costs

ePRO solutions can be significantly advantageous for biostatisticians, especially when applying an adaptive approach to a study. Based on accurate and high quality data and data available in real time, biostatisticians can adjust sample size calculations and study endpoints which can potentially save money.

Paper diaries may be a viable option when time is not an issue, however is a time when pharmaceutical and biotechnology companies are struggling to cut trial timelines and costs, this hardly seems a feasible option.

ePROARITHMOS can provide a customized ePRO solution for its customers or work with third party ePRO devices and integrate with the eCRF. Below is an example of an ePRO solution ARITHMOS implemented in a respiratory study which used a hybrid solution:

A CRO contracted ePRO and EDC services for a respiratory study combining eCRF with paper diaries and paper questionnaires. The device was a spirometer with an integrated QoL questionnaire. The study also required a short deadline with external providers for IVRS, laboratory data and ECG and direct upload of spirometry data onto eCRF. Milestones included:

  •  eCRF receiveddata from 2,000 subjects in 14 countries from 207 sites
  • It was easy to identify subjects who experienced problems in using the ePRO and perform the appropriate corrective actions
  • The team was able to have the last query resolved to database lock in 2 days using innovative technology solutions to integrate a spirometric device with EDC
  • Each subject was given a Spirometric device for 1 year, collecting 700 records each. Over 14,000 total records were collected with almost 100% success. Any mishaps were handled immediately due to an alert system.
  • Blind Review Meeting was done 2 days after study completion since all data was immediately available. Without the spirometric device, it would have taken up to 3 months.
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Leveraging Cloud Technology in Pharmacovigilance

healthcare-cloudThis month ARITHMOS hosted its first Pharmacovigilance Day seminar in Milan, Italy. The event focused on modern technology solutions to meet the challenges of pharmacovigilance and collecting patient safety data. Gianluigi Albertini of Arithmos gave a presentation on the cloud computing technology as a solution for pharmacovigilance and discussed how leveraging cloud computing can be an effective and cost-effective solution.

The National Institute of Standards Technology (NIST) defines cloud computing as follows: “Cloud Computing is a model on-demand network access to a shared pool of configurable computing resources (e.g. networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction”.

As a user, this means a company can access services from anywhere via the Internet without hardware/software provisions, installing service applications, maintaining and updating applications or disaster recovery. Resources can be assigned and configured to meet customer usage requirements in terms of functionalities and computer needs. In terms of resource optimization, business investment is better aligned with the service and guarantees a better Return on Investment (ROI).

In terms of time, cloud computing minimizes the time to delivery. Customers should be independent of the service provider in terms of application management which reduces maintenance time.

Pharmacovigilance Systems in the Cloud

edc1Pharmacovigilance applications should be accessed through the internet with minimal IT effort through web browsers with no installation required on a PC. Another option is to publish the application in Citrix with only a plugin to install.

To implement a cloud-based pharmacovigilance system, the application is deployed with a standard validation configuration with changes being applied to meet customer business processes and needs. The changes can be tested before the application is released into production.

Examples of pharmacovigilance systems in the cloud are Oracle AERS and Oracle Argus. Oracle AERS is a cost-effective and ready-to-use solution for managing Adverse Events from capture to reporting. Oracle Argus is a more comprehensive system with configurable workflow, advanced query and reporting functionalities, case import/export and document management.

However, Oracle AERS is not a Software as a Service (SaaS) system. It was developed to be used by personnel within the company LAN. External users cannot connect via VPN to the LAN, and the VPN is not always a stable connection. The best solution would be to publish AERS in Citrix with the plugin installation in order to reduce bandwidth usage.

Oracle Argus, on the other hand, is a native SaaS solution which can be accessed via web browser. After configuration and release, customers can use the application with minimal interaction using the service provider for maintenance.

Oracle AERS has been configured and validated according to a standard pharmacovigilance workflow. Reduced configuration and testing activities accelerate the system deployment with a cost-effective solution, and hosting and maintenance are regularly performed. Regardless of the system used, AERS or Argus, customized reports can be added to the default reporting capabilities of the application. Reports are created by the service provider and accessed via web portals from anywhere.

A cloud computing and SaaS solution is a valuable technological trend for efficient application delivery. The burden on the customer is reduced in terms of hosting and maintenance and the default configuration meets standard business processes. This solution is flexible to changing business and operational needs and guarantees an efficient and cost-effective solution.

EDC System Usage Survey: How Experience Improves User Satisfaction

Arithmos has been conducting an open survey via social media on Electronic Data Capture use among clinical trial professionals to determine what the barriers to use are and why some clinical trial professionals prefer EDC over paper. To date, the survey has 178 respondents in over 25 countries – the majority of participants being Project Managers, Data Managers and Investigators. Here we share some of the results from the survey.

The Electronic Case Report Form (eCRF) is used to capture data on a patient via electronic entry. As opposed to a paper CRF, eCRF can be downloaded on electronic devices, record data in real time and increase patient compliance. So, why are some still hesitant to use eCRF?

survey 1

The majority of respondents are concerned about technical problems. Arithmos also learned through a previous question, that while many clinical trial professionals are comfortable using computers, many are not yet accustomed to using smartphones and tablets or other medical devices for collecting data.

Technology-based barriers can be overcome through training, HelpDesk services, local language support and data security.

The next question was “What are the advantages to using EDC? Check all the apply.”

survey

Therefore, if EDC is posing significant advantages, how can we overcome the barriers to EDC use and make a gradual shift to eClinical trials?

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Therefore, we have learned that technical support, including HelpDesk IT and training support, is critical for EDC acceptance and continuous use. There is an opportunity for more eLearning training and to improve HelpDesk services.

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Arithmos analyzes the PROs and CONs of EDC use and how to overcome barriers to use.

 

The EDC usage survey is still available by clicking here. Feedback and comments on EDC usage is always appreciated as we continue our international survey. For more information on EDC, visit our website which includes an article on ePRO and EDC integration.