There is an industrywide push for better data exchange to reduce manual processes, improve collaboration, and increase visibility during trials.
One hundred percent of clinical trial sponsors cite the need for better data exchange among study partners, indicating that the industry is pushing for more streamlined trial processes and systems, a survey from Veeva Systems revealed.
The life sciences industry is undergoing rapid innovation and bringing products to market at an accelerated pace, the survey noted. As the pace accelerates, organizations will have a greater need for improved processes and data exchange.
“There is a significant industrywide opportunity to improve study visibility and partner collaboration to speed trial execution,” said Jim Reilly, vice president of Veeva Vault Clinical.
“As more sponsors, CROs, and sites focus on streamlining clinical processes and systems, drug development will become more efficient and stakeholders will be better aligned throughout the trial lifecycle.”
To track the industry’s progress in unifying clinical trial systems and processes, researchers gathered the experiences and opinions of 461 clinical operations professionals from around the world.
The results showed that most clinical trial sponsors have adopted function-specific technologies to improve study execution. Eighty-eight percent of respondents said they use electronic data capture (EDC) during clinical trials, rather than collecting information on paper.
Sixty-nine percent said they utilize electronic trial master file (eTMF), a specialized content management system that holds documents throughout the lifecycle of a clinical trial. Just over half of respondents said they use safety applications to manage clinical trials.
Ninety-seven percent of respondents cited at least one major issue with the technologies they use to manage clinical trials, while 83 percent said they had more than two challenges.
The top two problems, integrating multiple applications (68 percent) and reporting across multiple applications (57 percent), are the direct result of clinical application silos.
To improve these issues, 99 percent of participants said they need to unify their clinical trial systems and processes. Seventy percent said that they want to unify to have better visibility, while 61 percent said they want easier collaboration. Fifty-six percent said they need to unify their systems to improve study quality.
In addition to technological challenges, clinical trial sponsors voiced concerns about data exchange. All respondents reported a need to improve data exchange with their study partners, citing reduced manual processes (71 percent), improved collaboration (66 percent), and increased visibility and oversight (64 percent) as primary drivers.
Currently, clinical trial sponsors use a variety of methods to exchange information with their study partners, including email (78 percent), portals (51 percent), and file share (51 percent).
Participants reported using different methods to communicate with study sites as well, adding more complexity to data sharing and collaboration. Fifty percent of contract research organizations (CROs) and one-third of clinical trial sponsors said they use paper shipments to manage information exchange with study sites.
Forty-four percent of CROs said they use online portals, and 41 percent of clinical trial sponsors said the same.
This host of options for exchanging information significantly impacts the efficiency of clinical trial processes. Ninety-six percent of respondents reported having challenges with the methods used to communicate data during clinical trials, with most citing issues of tracking and reporting (71 percent), misfiled or missing documents (57 percent), and manual document exchange (47 percent).
The survey also showed that the resource-intensive start-up phase of clinical trials is still a slow process. Eighty-six percent of trials experience delays in meeting start-up timelines, which can cost sponsors up to $2 million per month.
Seventy-three percent of respondents said that site contracting and budgeting are the most challenging study start-up processes, while half said that site identification and selection account for delays. Fifty percent of participants said that easier collaboration between sponsors, CROs, and sites is essential to accelerating study start-up.
“This research shows that unifying clinical operations and aligning stakeholders remains an important priority for sponsors and CROs,” researchers said. “While there is work to do, the industry has made progress in moving toward a unified clinical operating model.”
There is great opportunity to reduce system and process fragmentation in clinical trials, and to streamline information exchange among study partners. With modern clinical trial management systems and more unified processes, the industry can eventually reach these goals.
“There is universal recognition that a unified clinical environment is essential to transforming clinical operations – and the industry has made steady progress toward that goal,” researchers concluded.
“The resulting gains in efficiency, visibility, and quality will enable the industry to rethink how studies are conducted – and adopt new and more efficient business models that drive trial performance, simplify data sharing and collaboration, and ultimately, accelerate delivery of breakthrough drugs and treatments to market.”
Date: July 09, 2019