ERT President and CEO Jim Corrigan sat down to speak with PharmaVOICE at DIA 2017. In the interview, he discusses the risks associated with clinical trials, highlights what’s needed to clear the hurdle of paper-based data collection in clinical research, and shares where the eClinical space will be five years from now.
What are biggest challenges sponsors/CROs are facing in executing clinical research / the clinical trial process?
Clinical trials are increasing in complexity every day. Trial sponsors are challenged to keep up in a highly competitive marketplace, and to meet more strict regulatory standards with greater emphasis on trial oversight and patient safety. Complexities have also arisen from regulators’ growing requests for more data, which results in more complex study designs – in some studies, up to 12 endpoints are needed to demonstrate product value.
Simultaneously, clinical trial development timelines, costs and risks are increasing, especially for those sponsors who continue to rely on outdated paper-based data collection methods and trial management processes. Sponsors and CROs need a more tech-focused, innovative way of looking at trial management – one that removes risk and uncertainty as much as possible so that trials can produce data that meets regulatory expectations while remaining on budget and on track.
What do you see as the BIGGEST risk threatening trial success?
Clinical development is notoriously inefficient and getting more complicated every day, with the need to capture more data via more data sources in an environment where study budgets and team members are ever more strained. In this environment, sponsors who continue to rely on outdated, paper-based systems and processes face the biggest risk to their trial success.
Manual, paper-based processes are time-intensive and error-prone, threatening data quality, extending development timelines, and inflating costs. Given the increasing demands on the clinical development function, sponsors can ill afford to operate this way. In fact, those that do may risk falling behind their more progressive and efficient peers.
What do you see as the most promising or exciting advancements in the eClinical space?
Clinical development is becoming more patient-centric, with more tailored outreach and engagement to keep patients in the trial, compliant with treatment regimens, and enable data collection of lifestyle and other ‘circumstantial’ factors that my influence their treatment and/or response to medications. At the same time, advancements in mHealth devices, like activity trackers and continuous glucose monitoring are empowering patients to become more involved in their overall health. These can be integrated with other eClinical solutions, such as eCOA to enable automated data collection and integration with CTMS systems, giving sponsors a more complete picture of patient experiences during clinical development.
Also, new – yet proven – technologies are emerging every day, giving trial leaders the means to streamline and improve clinical development efficiencies and mitigate risks. More precise image analysis software enables more reliable and compliant data capture, especially relevant given regulators’ growing requests for the inclusion of imaging endpoints in clinical development. And, advanced, flexible trial management systems are enabling sponsors to integrate data from all sources such as EDC, IVR, eCOA, and labs and deliver real-time visibility into study progress for greater proactivity, collaboration and responsiveness than ever before.
Where do you see the eClinical space evolving in next 5 years? What is ERT doing to get there?
I see a number of areas that are evolving. The first is that the changing payor and policy maker environment will drive greater demand for endpoints required per study, and will extend the use of post approval real world evidence ― in the form of data collection, integration and analysis, making trials even more challenging for pharma.
Second, the growth of personal health management tools and introduction of new patient engagement technology will enable pharmaceutical companies and CROs to implement new development models to accelerate research and lower cost.
And, finally pharma will continue its pursuit of the triple aim to increase shareholder value. This will drive increasing demand for outsourcing, digitizing processes and simplifying data management, leaving sponsors with greater need for tools and systems that enable better collaboration with their CRO partners.
The most important thing ERT does is to help pharmaceutical companies develop new medical products faster, so they can bring life-changing treatments to the patients who need them more quickly. So we are continually looking for, developing and applying technologies that make it faster, easier and more efficient to collect, share and disseminate trial data – and on a scale that’s needed given the global nature of trials.
We do this via organic product development, acquisition of new technologies, and in partnership with sponsors and others; for example, assessing new technologies in adjacent industries and seeing how they can be harnessed and configured to be used in a clinical trial. All of this enables us to remove risk and uncertainty in clinical development, which helps sponsors move ahead quickly, and with confidence.
Click here for more information on how ERT is helping sponsors and CROs accelerate new product development.
Christine Tobin is Corporate Communications Specialist at ERT