Enabling greater clinical trial efficiency

Paula Mchale delves into the world of clinical trials and offers her expertise on how technology could enable better efficiency.

The pharmaceutical industry is under increasing pressure to improve the productivity of drug development and streamline the clinical trial process. In your view, what are some of the factors behind this?

Paula McHale. Today’s biopharmaceutical industry is constantly growing in complexity and scope. The market has become highly competitive to improve product development processes and bring innovative compounds to market more quickly. There are also financial goals to meet as sponsors are expected to conduct their trials more efficiently and as cost effectively as possible.

The growing demands from regulatory agencies to improve patient safety have required sponsors to supervise their trials diligently which has encouraged the use of technology throughout many aspects of clinical trials. Web-enabled technologies have provided sponsors and study personnel with the ability to monitor patient and site activity more closely than in the past, which gives them access to the information required to make decisions quickly throughout the conduct of the trial. This ability to observe study data so closely has also added another level of competition for sponsors because early access to study data makes it possible to adjust future studies and plan accordingly.

Why is it important for companies to maximise the value of clinical trial technologies?

PM. Technology plays a vital role in the effective implementation and management of today’s clinical trials and has enabled greater trial productivity and ultimately faster product development. By maximising clinical trial technologies to their fullest extent, sponsors can improve the visibility of their trials and possibly manage them with fewer resources that can ultimately save time and reduce cost. Sponsors can optimise the use of technologies by integrating systems that share redundant data.

Some of the more advanced technologies converge multiple systems to streamline the data collection process for sites. This not only improves the overall site experience, but eliminates the need to reconcile data from both sources at the end of the study and improves the overall data quality. Utilising technologies in this way can also reduce the time to database lock and speed up the reporting process. Sponsor companies are using technology strategically to run their trials efficiently to achieve critical milestones and significantly reduce high development costs.

What specific solutions and tools can pharmaceutical companies use to ensure their clinical trial data is processed efficiently and effectively?

PM. The biopharmaceutical industry can select from a variety of today’s technologies to increase trial productivity and improve data processing. There’s a wide collection of solutions available to combat some of these initial market challenges, including Electronic Data Capture (EDC), Interactive Voice and Web Response Systems (IVRS/IWRS), Clinical Trial Management Systems (CTMS), Medical Imaging and Electronic Patient-Reported Outcomes (ePRO) solutions.

However, the appropriateness of any particular solution is dependent upon the studies being conducted and the needs of the trial. Dashboards and Portals should always be utilised because they expose study-wide metric data to sponsors and study teams without requiring them to log into each system that is used in their trial. This data helps study teams to easily follow and manage the activity of the sites and shows the progress of the data cleaning process. Systems such as this provide simple access to data collected from all technologies used in the trial and can be useful in monitoring study team performance and CRO activity.

How do you see the management of clinical trial data developing in the future?

PM. Clinical trial technologies have enabled study teams to have ‘eyes’ at the site with more visibility to the data being collected on a day-to-day basis. EDC tools are continuously advancing to provide new and flexible tools to streamline the workflow process and improve the site experience. The desire to conduct deeper analysis of ongoing patient data will require more emphasis to be put on the ability to view, report and export patient data quickly and easily and in multiple formats. Having timely and detailed reporting for each site will allow sponsors to adjust the site monitoring needs based on how well sites perform. In addition, extracting data from electronic health record (EHR) systems will minimise the need for source document verifications (SDV) and reduce the need for frequent monitoring trips.