The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – such as genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop, the central challenge facing trial sponsors is the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.
The data already exists, but in many cases is compartmentalized and stored in incompatible formats, making it difficult to draw actionable insights. Access to specimen data across trials, programs and eras of research is critical to understanding and implementing in-life interventions and more quickly identifying performance issues and their impact.
Below is how one large pharmaceutical company used critical consent data to enable a faster no-go decision and avoid a costly Phase III trial.
Understanding the Challenge
▶ During Phase I and Phase II trials, the company’s promising early stage Alzheimer’s drug was linked to a severe skin reaction among some participants.
▶ In order to determine if there was a predictive marker, in particular a specific genetic association with the affected patients, the company needed to perform additional testing outside the original scope on the trial specimens.
▶ The team would need to execute testing quickly and evaluate data prior to the scheduled Phase III initiation. They needed specimens from all patients with the severe adverse event (SAE), consent information in real-time and to locate, ship and analyze specimens within a 5-day decision window.
▶ Speed was critical because the company was only three months out from incurring the expense of a Phase III trial with a compound that would potentially have limited commercial uptake.
The company had partnered with Global Specimen Solutions (GSS) to manage informed consent and specimen tracking for the program. Informed consent was negotiated, codified and linked to all specimens in GlobalCODE®. Specimen collection was tracked in real time. Working with GSS, the company was able to ensure that there would be broad consent for additional testing of patient specimens as needed.
Rapid Determination of Genetic Association
Because of the SAE, the team needed to investigate whether there was any specific genetic association among the patients who experienced it that would predict the prevalence of the rash in the target population. The results could indicate that the drug was unsuitable for regulatory approval or would have high commercial risk. In this case, it would not advance to a Phase III trial.
In order to perform this additional genetic testing, the company needed to quickly verify which patients had specimens with corresponding consent for genetic analysis that was now needed. They needed to know where those specimens were and had to initiate analysis for a data result return within 5 business days.
Ready Access to Critical Consent Information
Fortunately, the company’s partnership with GSS enabled a quick determination of whether they had sufficient specimens with consent to perform the required genomic testing.
This company utilized GlobalCODE® to find this information and make the decision to proceed with analysis. GlobalCODE® provides access to live specimen data and provides management of codified informed consent and material transfer agreements. Using GlobalCODE®, qualified specimens with appropriate consent can be instantly identified and used without delay. In this instance, GlobalCODE® enabled the company to quickly access critical information confirming authorization to perform additional testing on specimens.
If the informed consent documentation were managed in the traditional way, the site approved consent forms and electronic case report form informed consent collector data would need to be pulled manually from the Trial Master File or from the site (if incorrectly filed) and reviewed. These consent forms are often updated at the investigator site level and even throughout the life of the trial. Performing a manual review of this magnitude would have delayed the initiation of the needed genomic testing by weeks or months and postponed the critical decision on whether to proceed with the Phase III trial.
Timely Decision-Making Enables Rapid Pivot and Saves Money
Using GlobalCODE® to quickly determine patient eligibility for additional testing, the company was able to launch the genetic association study. This study found an association with an HLA marker and the company was able to act on this data within 5 days, instead of months. The company made the decision to discontinue trials on the initial compound and instead pivoted to a back-up compound that did not have the side effect of a rash. This decision saved an estimated $100 million, which would have been spent on a Phase III trial that would have had a low probability of success before it even began.
Harnessing data and enabling valuable and actionable insights to make better, more informed decisions can make a huge difference in potential revenue or achieving the coveted first-to-market designation.
Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory Corporation of America Holdings (LabCorp). Covance recently formed a strategic alliance with Global Specimen Solutions (GSS), giving clients access to a comprehensive and integrated solution that includes GlobalCODE®, snapTRACK® and GSS wraparound services. This alliance enables rapid data cleaning across programs and clinical trial data sources which allow interventions to be made during the clinical trial, impacting overall trial execution and data validity. GlobalCODE® and snapTRACK® are registered trademarks of Global Specimen Solutions, Inc., used with permission by Covance Inc.