TrialScope is a software company providing clinical trial transparency and compliance solutions.
The company recently announced that it has been selected by GlaxoSmithKline (GSK) to facilitate clinical trial disclosure and transparency – a deal which amounts to more than 1,200 records per year from studies conducted in more than 90 countries.
Under the agreement, GlaxoSmithKline (GSK) will implement two TrialScope solutions, including TrialScope Disclosure Management and TrialScope Transparency Management.
Dan Lehman, vice president, business development, TrialScope, said the addition of GSK is important for several reasons – the most immediate of which is that TrialScope clients now make up more than 40% of the trials being reported on ClinicalTrials.gov.
“With that type of concentration, TrialScope can better monitor the trends related to disclosure and transparency than any other technology supplier focused on the reporting of clinical trial data,” Lehman told us. “Patient ready information is key to ensure our customers are getting the maximum return on investment from their clinical trial efforts.”
“Now, more than ever before, the benefits of performing in patient centric ways are paramount for sponsors,” he added. “Conversely, the risks of poor compliance are becoming magnified.”
Trial transparency trends
Two major trends continue to drive the adoption of TrialScope’s technologies, Lehman said. The first of which is the continued focus on transparency and patient centricity.
“Studies have shown that when trial participants are receiving information regarding their trials in a timely manner and in ‘lay’ summary format, they are more satisfied and more likely to participate in additional trials,” Lehman explained.
“The industry continues to find that enrolling participants is one of the key drivers to successful trials, and sponsors need to ensure that the disclosure of information to clinical trial registries corporate sites are done in an appropriate and efficient manner,” he added, noting that it is important that information remain consistent across various platforms.
The industry also is seeing an increasing amount of “watchdog-type” organizations, which are reviewing trial sponsor work and track-records as it pertains to disclosure and transparency compliance.
“As more and more companies are exposed for non-compliance, it is raising awareness to all that they need to ensure they are not leaving themselves open to the negative publicity and potential fines,” Lehman said.
“We’d like to believe that it is the desire to ensure the better patient experience that is driving the adoption, but we do also recognize that the risks associated with the non-disclosure are helping to push the overall industry forward,” he added.
Ultimately, Lehman said the industry is “truly seeing the need to grow around the trial participants and patients in general.” This will manifest itself in many ways and will be what drives things forward, he said.
“Sharing patient specific information back with the trial participant is definitely something we hear about. There is a lot that must be managed appropriately to ensure it is done correctly,” he added. “Better serving the trial participant and keeping that as the focus leads to a lot of net positives for the trial sponsor.”