A clinical trial's operational efficiency depends on a solid oversight and response mechanism. Without vigilant monitoring, patient safety, data integrity, and the overall health of your trial come into jeopardy.
Why Do So Many Clinical Trials Fall Behind? Clinical trials are not immune to missed deadlines and cost overruns. However, with proper advance planning, you can up the odds of success and avoid major glitches. Our studies show that about 33% of all clinical trials are behind schedule at any given moment. These trials under-perform due to operational failures; meaning, they’re behind schedule, over budget, or the data produced lacks the quality needed to support an approval.
In our rescue white paper, 3 Measures to Overcome Operational Failures, we explain our ROI concept. Early in a trial, intervention provides dramatic benefits for minimal cost. An assessment or review may be all that’s needed to get a study back on track.
Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.
IBM is the leading healthcare technology organization in the world. Recently, they wrote a case study on how Biorasi was able to remove the obstacles and optimize its efforts in running clinical trials.
Every year, tens of thousands of clinical trials are initiated. Every year, thousands of initiated those trials falter, and, if corrective action isn’t taken, some may fail to produce usable data. In an analysis conducted by the Biorasi research team, we discovered that a full third of trials slated to complete within the next year have already passed their predicted completion date. Given the magnitude of the problem, there is not nearly enough light being shed on this pervasive issue by the industry. In this first white paper in our series, we want to attempt to characterize the scope of the problem facing the drug development industry, and make a case for early, proactive intervention in faltering clinical trials.
Global studies are notoriously complicated with language barriers, time zone differences, and oft-contradictory regulations. These business challenges are exacerbated, not only working with multiple, but unique cultures. Biorasi encountered this scenario when we were brought in to rescue a complex clinical trial being run in the US and Japan.
Site selection is one of the most crucial parts of planning a study. Ensuring that sites are performing up to par while a trial is underway is equally important but often neglected. Biorasi was asked to assist in a phase II trial of stem cell therapy for traumatic brain injury (TBI).
Every clinical trial comes with its own unique challenges. Sometimes the biggest challenge faced by a […]
An outside rescue expert can bring a fresh set of eyes to a troubled study and help you identify the true root causes of the failure. They can also find more cost-effective and efficient ways to implement some of the strategies you were planning to implement internally, resulting in a net savings.
The costs associated with missed milestones and timeline extensions are significant and can derail the trial entirely. Less than 10% of drug candidates reach approval, with sponsors often incurring the costs associated with failed clinical trials, or trials that are behind schedule. Playing the “blame-game” while a clinical trial fails will only slow down the rescue process and increase these costs. It is paramount that sponsors and CROs are proactively monitoring trial progress and working together to address issues as they arise.
Strict Processes Rescue Complex MS Trial: Biorasi’s Project Management-first Approach Allows Rapid Feasibility and Site Startup to Meet Critical Deadlines
