There are a number of common adages that float around the clinical trial industry, which are usually based in some form of
truth:
- Access to patients is the number one problem in clinical research.
- Eighty percent of patients come from 20% of sites, but sponsors keep going back to 100% of sites.
- Monitoring hours are one of the highest costs in a clinical trial.
Laurie Jassenoff, Vice President, Palm Beach Research Center
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These phrases, while sounding cliché, do highlight some of the most frequent and cost-heavy challenges in clinical research
and relate in one way or another to effective clinical trial management. But the questions remain: How do organizations proactively
manage the many different moving pieces and parts of a trial? How can sponsors and CROs alike harvest and institutionalize
information on how to run trials effectively? How can operational managers see useful information across dozens of trials
to keep programs on track and identify potential problems before they happen?
These are the types of problems a clinical trial management system (CTMS) can address. However, it is not always a smooth
and seamless process.
When web-based EDC and automated randomization systems emerged over a dozen years ago it seemed that some of these new systems
might eliminate the need for standalone CTMSs. That has not proven to be the case. The need for CTMS is still important for
sponsors, CROs, and sites.
Many technology systems are touted to include "business intelligence" or digital dashboards and compatibility with other systems.
It's also become common to include compatibility and integration with other data management systems as a core capability of
eClinical systems, but it's more difficult to implement in ways that are meaningful and beneficial to end users.
This was the case with Palm Beach Research Center, an investigation site that conducts Phase I-IV clinical programs. Laurie
Jassenoff, MBA, Vice President of Palm Beach explains, "Today, to get any kind of information on a clinical research program
we have to query a particular database. If we want to look at studies, that's one database. If we want to look at studies
with patients, that's a different database. It takes a lot of extra time and effort. When I log into my bank account I can
view all my accounts at once. It would be great if as a researcher I could sign on to one integrated database with the same
kind of front page to access all the information I need."
And while many systems can integrate with other systems, providing compliance and industry standards capabilities, there are
cost and time considerations to integration that must be accounted for. Because integration can be difficult, many organizations
can end up using different data sources during trial conduct and go through the process of merging data at the end. Janssenoff
says, "for example, it would be a huge time saver if we can enter our source data and it merges with the eCRF."
Palm Beach Research Center is rolling out a CTMS in 2013. "Our goal is for the CTMS to become a huge patient database that
will be able to show cross references of studies and patients, and patients in studies, in addition to having budget information
integrated to show what we are invoicing and what is outstanding." Jassenoff said, "Ideally I'd like to be able to review
this integrated data on my iPad anywhere, any time."
CTMS integrations make a great deal of business sense. The combined data streams provide real-time trial information that
may come from ePRO, IVRS, and EDC systems that roll directly into CTMSs and roll up into a real time view of a trial.
How will CTMS look 10 years from now? That's what vendors and organizations alike are contemplating.
The likelihood seems strong that cloud-based computing will make it easier to provide meaningful dashboards from data across
trials. The resulting information should flow more easily across systems into data warehouses and reporting servers that provide
that actionable knowledge to a variety of stakeholders about the way trials are run.
—Sheila Rocchio, Vice President of PHT Corporation
http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/CRO%2FSponsor/DIY-EDC-Evaluation/ArticleStandard/Article/detail/804827
http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/IT+Articles/Randomization-Revolution-is-Brewing/ArticleStandard/Article/detail/764128
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