When sponsors and trial planners stress the importance of selecting the correct trial site, they are not understating the gravitas of the task.
The wrong site could mean too few patients are recruited, or that it does not align with the needs of the study. Consider research from the Tufts Center for the Study of Drug Development that 37 percent of sites under-enroll, and 11 percent can’t even recruit a single patient.
This is a shocking statistic considering how much time and money are invested in trials.
In the quest for more efficient clinical trials, sponsors are always trying to improve their study start-up times. A big part of this is choosing the correct trial site for your needs and activating it.
This is why many sponsors and trial managers are looking to clinical trial management software (CTMS) to speed up the process.
In this post, we explore how the right CTMS can give trial planners and sponsors the edge in site selection.
With better data analytics and cloud-based software, processes can be made more efficient as all team members have standardized tools to process data, Mary Jo Lamberti, Ranjana Chakravarthy and Kenneth A Getz at Applied Clinical Trials write. It also makes access to the trial data easier for all involved.
Tight budgets and tighter regulations makes site selection incredibly important. Time is of the essence and the right decision of which site to choose needs to be make quickly and accurately.
Data must drive site selection to increase the odds of a successful study, Otis Johnson and Helen Yeardley at clinical research organization Icon write. This also requires the integration of “multiple internal and external sources of site and investigator information,” the pair suggests.
Data should include survey responses, site experience, startup cycles and patient enrolment.
To do this, Johnson and Yeardley explain that several industry consortia have been developed to help “aggregate data and make it available for site selection decision making.”
This data, along with the software to make sense of it, allows trial planners to develop a valuable and reliable site selection strategy that focuses on rate limiters in the start-up process and cycle times.
CTMS also adds to the transparency of the site selection process and better tracking capabilities. What the software also does is help gather regulatory and financial data much faster, potentially hastening start-up timelines.
CTMS enables trial staff to analyze data faster and more accurately. It also allows comparison with a great amount of historical data.
It’s the data that presents greater certainty. Consider how best practice, at least historically, suggested that the past performance of a trial site is an accurate indicator of its future performance.
However, “issues such as data availability and wide differences in protocol complexity can complicate interpretation,” researchers at ScienceDirect argue. They say that operational data from a central laboratory will provide a more accurate prediction for future trials.
The researchers reveal how analysis of data from contract research organization Covance's central laboratory operations showed an “in-depth visibility” into the performance of trial sites from many different trials.
The CTMS can account for nuances and differences in study protocols and varying designs. This information gives trial managers insight into which country or countries are best suited to the trial, which sites are optimal, and what number of patients are likely to be recruited at those sites.
The contract research organization (CRO) Parexel also notes the importance of choosing site and country, calling it “paramount for successful and cost effective drug development.”
A CRO can benefit from using CTMS by improving site retention and site monitoring, the team at Ripple Science says.
CTMS helps to manage patient recruitment by providing more accessible ways to reach potential patients, leading to a more patient-centric approach to trial recruitment. The software also automates patient tracking and study task management, as well as site-level registry.
When it comes to clinical site monitoring, the team at Ripple says CTMS works with real-time monitoring of site performance and patient retention. The advantages include savings in time for the site investigator as well as a lightened load in administrative duties.
Cloud-based CTMS is powered by algorithms that accurately predict site performance, Chris Neppes at global data and technology company ERT says.
Centralized, cloud-based site performance databases allow trial planners to collect and compare data from sites’ historical performance relative to other sites. To do so, the software aggregates data based on patient enrolment, site quality and operational efficiency, as well as scoring a site’s “indication and phase specificity,” Neppes explains.
The major gains of a CTMS with this capability, he adds, is that trial sponsors save time and money, while enjoying the benefits of improved data quality, all without disrupting the budget or operations to do so.
To run a successful trial, you need a strategy, Leon Surgeon at data analytics solutions provider Saama, says. It should consider whether or not the site has access to recruitable patients, sufficient infrastructure and is the correct site for the therapeutic condition under study.
Finding patients who will remain enrolled in the trial until it ends is always a challenge. This means selecting patients according to the correct inclusion/exclusion criteria is vital, Surgeon writes. Consider also, once the patients have been recruited, how much work the principal investigator has to do, in terms of checking data accuracy and confirming that protocol is being followed.
To assess, process and record all of this information manually would present a considerable burden on time. Regular CTMS obviously improves this process, but Surgeon suggests AI-based machine-learning software for even more efficient trial management.
AI would have insight for “tweaking the parameters many times” as well as analyzing reports. It would then be able to accurately predict a trial site, and make other important decisions, based on analysis of historical data.
One way to overcome the challenges of incorrect site selection is to opt for a virtual trial.
Also known as site-less or remote trials, Craig Morgan at R+D Magazine says virtual trials “allow patients to transmit remote, real-time data” to the centralized study site (where trial staff work).
CTMS still plays a major role in virtual trials, helping trial staff process the streams of data that patients send in though wearables. This information might include data on sleep duration and quality, blood pressure, blood sugar, activity levels, and heart rate among others.
Virtual trials allow patients to stay at home, “effectively eliminating” selecting, activating and maintaining trial sites, Morgan writes.
Since virtual trials are far from becoming ubiquitous, it’s better to focus on the tools at hand to improve existing protocol. To do this, sponsors and managers need to choose the right software tools, Anais Silva at Applied Clinical Trials writes. The most helpful will filter information regarding site size, location and specialty, and provide access to datasets about past experience and performance.
Despite the availability of effective software tools, the industry has been slow to adopt them, engineer Andy Coravos, cofounder of Elektra Labs, writes. She laments how some research sites still rely on physical protocol binders and paper diaries. However, those trial managers that have embraced the new software have boosted their value-chain, she explains.
Our own ClinPlus CTMS can be installed onsite or accessed via the cloud. It enables fast study setup and gives trial managers the means to create and modify templates for project and site documents, events, milestones, site visit reports and budgets. The integrated monitoring tools, graphical displays and a calendar feature helps trial managers avoid any duplicated data.
The CTMS also accesses information and helps to assemble site and project teams from global contacts and global institution files.
Using a sophisticated CTMS will go a long way in improving the decision-making process when it comes to site selection. Accumulating as much data as quickly as possible and having the technology to determine which of it is relevant is vital for accurate predictions of site performance.
With the right site, more patients will be enrolled and retained, leading to better trial outcomes. Rather than try to beat the odds, sponsors can use CTMS to mitigate the risks.
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