There were numerous articles in February 2018 that covered a wide range of topical issues. Here are five of the best stories you might have missed… (click the headline to finish reading the story)
Patient recruitment is one of the most difficult challenges faced when running clinical trials, and is particularly acute in oncology trials. A considerably low number of 3 percent of potential patients volunteer to participate in oncology clinical trials. The difficulty in recruitment can cause overall delays to such trials. Currently less than 20 percent of studies are on-time, meaning the majority of the trials fail to meet initial plans and expectations.
It must be said that clinical development and clinical trials don’t always operate like clockwork. Clinical data management (CDM) organizations need to evolve continuously to properly respond to an environment that changes rapidly and constantly. Data management departments are facing two forces of change, both internal and external.
The internal changes are originally generated because of the company’s strategies, reorganizations, and differing outsourcing models. The external forces for the change come mainly from market, regulatory and health authorities, from rapid clinical technological development, as well as the associated cost of clinical trial services.
On May 25, the General Data Protection Regulation (GDPR) will come into effect, changing the landscape concerning data privacy. The GDPR seeks to empower EU citizens, strengthening their rights and freedoms.
While the impact the new regulation could have on business processes are unknown, the industry must take steps to ensure it is ready and fully compliant. But what do those steps necessarily entail?
EDC , CTMS , IRT , eTMF, are all acronyms of now-classic analytics software used in clinical trials. Each tool can complete a primary task, with some of these tasks being very complex. These specialties software were created to replace locally-stored paper with multi-flow input/output pathways, now accessible globally via the cloud. Many sponsors initially made their own analytical tools using Excel spreadsheets, but they were often limited in scope, and proprietary formats prevented sharing the content with their vendors.
As the design and execution of clinical trials become ever more intricate and complex, the cost of clinical trials continues to rise exponentially. The manpower and resources it takes to complete many of these processes manually add up to an onerous toll on the industry. Outsourcing models that were once the standard are now burdensome and antiquated. With more of the latest innovations making its presence felt in the industry, what new platform has the potential to disrupt clinical trials as we know it?
PHOTO CREDIT: Rob Nguyen