Clinical trial management in a digital age

Why do clinical trials still rely on paper-based data entry methods when there are so many technologies available to improve trial efficiency? New research published today in Trials provides a case study of integrating technology into trial design for a complex intervention and here, co-authors Cheney Drew and Vincent Poile discuss its impact on efficiency and what they see the future to hold for trial management.

In the recent era of rapidly developing technology, we ask why is it that most trial methodologies still rely on paper-based data collections methods and paper-based processes?

The most widely used methods involve researchers collecting data using paper case report forms. These records are then usually replicated and filed locally with the copies sent to the central research office for transcription by administrative staff into electronic datasets. Processes to check data centrally for accuracy are initiated, with all queries fed back to each research site for clarification and correction.

Similarly, randomization processes are ordinarily completed using paper or telephone based systems. These methods often require staff to be present concurrently at the recruiting and the coordinating site.

In the recent era of rapidly developing technology, we ask why is it that most trial methodologies still rely on paper-based data collections methods and paper-based processes?

These well tested traditional methods can be arduous and time consuming, but necessary to ensure the accuracy of trial data.

Electronic data capture systems are beginning to become an accepted part of clinical trial data management, and are considered efficient in terms of data management requirement.

However, in our experience, clinical trials often do not attempt to effectively leverage available technologies in their trial management processes. To follow Good Clinical Practice and be compliant with required Medicines and Healthcare products Regulatory Agency (MHRA)regulations there are many details to consider and obstacles, which can be difficult to resolve and the time required to initially create these systems is high. Perhaps these are the biggest obstacles to using alternative methods?

We think there are better and more efficient alternatives to manage these processes

Published today in Trials, we report on the use of a web accessible database incorporating randomization and data collection in a multi-site clinical trial of a complex physical activity intervention.

We developed the database specifically to deal with the multiple challenges usually seen in multi-centre coordinated trials and to allow us to ensure monitor fidelity, which is crucial to the delivery of a complex intervention. We used iPad tablets to allow us to control the interaction with our database and leverage the tools available in a mobile device for use within the trial.

Very early on we realized that there were additional benefits resulting from easier communication, including the building of better relationships and retaining engagement with the study researchers at each site. Along with those benefits we also saw confidence in the technology and skill levels rising from increasing efficiency and communication with key team members beyond what we had expected.

Data collection was performed in real time during participant visits using mobile devices. Whilst there is scope for inaccuracies to occur where there is no written paper record, risks were minimized by implementing strict data validations and employing 100% Quality Assurance (QA) on the data at the central site.

Immediate data collection allowed for real time data monitoring resulting in the timely identification and rectification of primary outcome data. Participant completed forms, screening logs and staff training sessions were recorded digitally using the iPad camera and uploaded to the central database using a secure file transfer system, allowing centralized access to these records immediately.

These features required significant input during trial set-up, more than one would usually expect if using more traditional methods; however, this was offset by the significantly reduced time and resource need for data cleaning & management prior to analysis.

The use of this system was of benefit, not only in terms of the efficiency of trial management, but aided in the successful collection of all primary outcome data

Providing research staff at sites with an iPad for data collection allowed the trial team to monitor and assess fidelity of the intervention. Central to this were the Skype sessions with the intervention co-ordinator – something that would ordinarily be problematic if restricted to available equipment in a traditional clinical setting. The perceived investment and trust by staff at each site through provision of the iPad led to high levels of engagement with staff and allowed them to work flexibly.

Importance and impact

The use of this system was of benefit, not only in terms of the efficiency of trial management, but aided in the successful collection of all primary outcome data.

We firmly believe that the ability of research staff to upload visit data immediately and the added function to photograph, and securely transfer participant completed records, contributed to the high rate of return of expected data.

Although a system such as this offers various benefits over traditional paper-based methods important aspects of its implementation should be considered, for example; in areas of poor and no wi-fi or mobile data service coverage, how can you ensure a reliable connection of your device for secure data upload? It is also necessary to have reliable contingencies for ‘mission critical’ processes, such as randomization of primary outcome data collection.

We see electronic data collection tools and integration of digital tools, such as Skype, as the future in clinical trials. They have the potential to improve efficiency and streamline trial processes, something many trialists are striving towards (see this published Trials article and the Trial Forge website).

Future iterations could streamline other facets of trial management such recruitment tracking, safety reporting and the generation of trial reports for management groups. Our experience in the management of ENGAGE-HD through the availability of an associated database was extremely positive and we would urge researchers and trialists to consider how technology can be used to the benefit of all involved in a trial.

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