Article Blog April 1, 2019

A Better Way to Manage Clinical Trial Risk

As the clinical trial landscape increases in complexity, traditional clinical risk management solutions have become insufficient to meet the needs of most sponsors.

It’s really no wonder that reactive methods aren’t as effective as they once were, because sponsors (and CROs) have a lot more moving parts to deal with:

  • Since the year 2000, clinical R&D spending has nearly tripled
  • Half of all sponsors currently use three or more different outsourcing models
  • Sponsors use an average of 5.4 different technology solutions per study
  • 25% of all drug applications include data from international sites

As a result of these trends, new issues and inefficiencies are causing expensive trial delays:

  • Inability to identify underperforming sites
  • Missing and inconsistent data
  • Under-reporting of adverse and severe adverse events
  • Lack of insight into prohibited medications
  • High query rates
  • Inability to investigate protocol deviations
  • Poor subject compliance

Most Sponsors Are Interested in Improving Risk Management

The good news is that sponsors recognize the importance of effective oversight. In a poll we conducted with the Tufts Center for the Study of Drug Development, sponsors indicated that they wanted better oversight to manage risk more effectively, achieve compliance, increase productivity, and improve study performance. There’s definitely an appetite among sponsors to change the status quo.

Reasons Sponsors are Interested in Oversight


In a recent webinar I led, entitled Traditional Methods of Clinical Risk Management Are Breaking Down, the majority of attendees (73%) said that their organization’s top risk management priority is to develop a broader focus to achieve good clinical practice as defined by ICH E6(R2) guidance.

New Risk Management Methods Are Needed

Sixty-four percent of the webinar attendees said that the biggest obstacle to meeting risk management objectives was the absence of standardized approaches to monitor and assess risk.

This is consistent with what we’re hearing across the industry, and the Quickpoll we did during the webinar created a nice segue into a success story that showed how a mid-market biotech company—with 11 studies and eight data feeds across three CROs—used Comprehend technology to approach risk management more proactively.

Our initial conversations with the people at this company revealed that they were struggling with the following issues:

  • A lack of data transparency and standardization
  • Insufficient oversight of outsourced trials
  • Delayed responses to data quality issues

These problems were leading to various missed milestones, which were extending the company’s average time to complete a Phase 3 study to 30 months. The company had to spend nearly $700K each month a study was delayed—and the delays were causing the firm to miss out on tens of millions of dollars of revenue—so they came to us for help compressing their problem areas and accelerating their studies.

We helped the company get its data house in order, so stakeholders could gain a real-time understanding of what was working well and what wasn’t. We helped them standardize reporting methods and remove the need to manually reconcile spreadsheets. And we gave them ways for every team member, from the top down, to analyze relevant data at the study, site, and portfolio levels, get alerted to issues earlier, and collaborate through a built-in, fully auditable task management system.

In the end, we were able to help this company cut its delays nearly in half (46%), for a 10.4% average total trial timeline reduction.

Mid-Market Case Study


You Can Better Manage Your Clinical Trial Risk—with the Right Data, the Right Analytics, and the Right Actions

Sponsors around the world are finding that they can change their processes for greater trial performance and reduced risk, without changing their vendors or data systems.

Effective risk management is a continuous journey that begins with an understanding of your data, continues with tools for analyzing and acting on that data, and ends with trials that stick more closely to timelines.

For more information on using technology for more effective risk management, watch our webinar now. If you like what you see and need help putting these solutions in place, call Comprehend at 650-521-5449 or request a demo.

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