Breaking bad: decreasing clinical trial queries in imaging trials
Veronica Ludensky of Millennium Pharmaceuticals and Abraham Gutman of AG Mednet, discuss the need for change within the image-based clinical trial industry. They will explore how technology can dramatically increase the overall quality, accuracy and consistency of a submission and how workflow enforcement, customized submission tools, automated edit checks and site-side quality control are where innovation will continue to advance the image-based clinical trial industry.
Clinical development in the pharmaceutical business is challenging because the industry as a whole does not readily accept technology innovation.
It took Electronic Data Capture (EDC) almost 10 years to catch on as an industry standard. Change is scary for people, practices and industries. Resistance to change is normal, but it's especially counterproductive to an industry that is focused on making improvements for patients' lives by getting quality drugs to market faster.
And then there is the issue of the quality of the clinical trial data. For years, the clinical trial industry has continued to face the challenge of preventable human errors caused by outdated standards. According to industry research, more than half of all image-related clinical trial queries result from preventable human errors, causing an average delay of up to seven weeks. Not only are sponsors losing time, money and data, but they risk losing patients.
Consider, for example, the assembly and submission of imaging timepoints for a clinical trial. Sites are asked to:
- Make sure images are de-identified;
- Complete transmittal forms to make sure the information is in line with the images and meta-data;
- Remove any patient identifying information before the courier picks up the CD; and,
- Wait for the core lab to review the images before they know if there is a problem.
This process is flawed. There are too many chances for someone to misread handwriting on the forms, for the data to not be properly de-identified, for incomplete anatomy or for the images not to be compliant with the required imaging charter.
"...more than half of all image-related clinical trial queries result from preventable human errors, causing an average delay of up to seven weeks"
These errors continue to delay the trial process and impact ongoing patient participation. Hopefully, with more open minds in the industry and the willingness to embrace new technology, there is a great opportunity to dramatically reduce delays and improve data quality at the source. So why the wait?
The sponsor's view:
I have seen these challenges first hand through my experience in different roles of the clinical trial process. Whether it's on the sponsor side or from the CRO perspective, excitement and acceptance of innovative technologies is an uphill battle at best and a non starter at worst.
Trials are getting longer, more complicated and more expensive. There are more vendors in trials, more imaging endpoints, biomarkers and other complexities. As a result, multiple vendors want to offer different services through innovation, and it is incumbent upon the sponsor to guide the process and decide what to change or add.
Despite this evolution, the cardinal rule everyone still seems to follow is: don't mess with the clinical site. Don't upset the applecart. Just let the site do things how they like to do it; how they've been doing it for decades.
This creates conflict with innovative projects, ideas and technology that pharmaceutical companies are working to implement. These new ideas often bring more complexity and we need the clinical sites to participate. We shouldn't be afraid to have honest conversations with sites about what we want to change and how we plan to innovate.
"We shouldn't be afraid to have honest conversations with sites about what we want to change and how we plan to innovate."
There are challenges associated with imaging data in clinical trials. Whether its clinical data or lab data, the information captured within an image is large and complex.
Most imaging labs, despite the complexity of imaging data, still rely heavily on couriers. We rely on the clinical site coordinators to take that disk or hard copy image, put it in an envelope, and send it to the core lab. Many have replaced couriers with simple e-transfer solutions resulting in faster data transfer, but not better data.
When the imaging core lab receives the data and realizes that some of the information is incorrect and inaccurate, the project manager has to go to the trial site for more information and / or imaging. This pony express query process is a never-ending game that I hope, as an industry, we stop playing soon.
The only way to break the cycle is with an industry mandate. A new cardinal rule.
"The only way to break the cycle is with an industry mandate. A new cardinal rule."
We need to go beyond simply sending data via a courier, or even via the web. We need to get better about workflow enhancement. We need to make sure the site not only uploads the image online but also utilizes built-in quality control tools that detect errors at the source, before it's even sent to the core lab.
Instead of being afraid of upsetting clinical sites, let's give them new power. Let's give them more control over what they're doing. At the end of the day, they will thank us for it.
As sponsors, we need to drive the change. We must mandate technological innovations, and work with our sites to help them succeed. The result will bring more efficient clinical trials, less time dealing with preventable queries, and reduced risk of losing valuable data and patients along the way.
About the authors:
Abraham Gutman is President and CEO of AG Mednet. Abraham Gutman has had a long career in global technology management. Prior to founding AG Mednet in 2005, he founded and served as president and CEO of Emperative, Inc., a telecommunications software startup. Emperative, the creator of a proven carrier-class provisioning engine, was a venture-backed enterprise with more than $35 million in capital from lead investors including Greylock and Pequot Ventures. Gutman later sold the company to AT&T.
Prior to founding Emperative, Mr. Gutman led the team designing customer care, provisioning and trouble ticketing systems for the nascent broadband operations of Continental Cablevision, then one of the top three cable operators in the U.S. Earlier, he was CIO of The Liberman Group, an international conglomerate focused on the telecommunications and agriculture industries. There, he was responsible for the management of the conglomerate's global information and strategic technologies and systems in nine countries in the Americas, Europe and Asia.
Mr. Gutman holds a Bachelor of Arts degree in Computer Science from Cornell University and a Masters in Computer Science degree from Yale University.
Veronica Ludensky is a Senior Manager, Outsourcing Management at Millennium: The Takeda Oncology Company. Veronica joined Millennium in 2011 and a Clinical Outsourcing Lead for two global Oncology programs, as well as being a group SME for Central Imaging and IRT Services. Prior to her time at Millennium Veronica worked for PAREXEL International (including Perceptive Informatics, Inc./Clinphone) as a Regional Director of Business Operations. Her areas of responsibility have covered adoption and impact of new technologies for the drug development process and outsourcing of central medical imaging, interactive voice/web systems (IVR/IWR), electronic data capture (EDC), electrocardiogram (ECG/EKG), clinical trial management system (CTMS) services, and various other eClinical solutions.
Veronica received her MBA at Babson College, with a concentration in Global Management and holds a BA in Biology from Boston University.
Closing thought: What are the challenges associated with imaging data in clinical trials?
