IBM have launched a clinical trial study design tool that aims to reduce the cost and time it takes to complete trials by standardising protocols and automating access to real-world patient data.
One of the issues with clinical trials is that they are extremely costly and any change to the protocols at any point of the trial can result in extra costs of on average half a million dollars. For instance a single protocol amendment to the third phase in a clinical trial can extend the running time by several months and significantly increase the financial cost.
Big Blue believes that its IBM Study Advance tool will help researchers reduce the number of amendments they make during trials and reduce the pipeline timeframe for drug treatments.
Rob DiCicco, PharmD, Deputy Chief Health Officer, IBM Watson Health commented in a release that: “Currently, 80% of trials experience delays in recruiting and one out of four amendments were considered completely avoidable. Breakdowns in the clinical trial process, including issues caused by study design decisions, may potentially delay access to life-changing therapies for patients. IBM Study Advance aims to remove the barriers in clinical development to help researchers efficiently bring necessary therapies to patients.”
The Study tool – IBM Study Advance – was unveiled at the 11th annual summit for clinical ops executives, which is taking place in Florida.
IBM Study Advance
A key part of the tool is its creation of standard protocol templates and version control capabilities. These help to create logs that have high traceability which allows you keep track of any changes made to the trial.
IBM notes that they: “Facilitate the authoring process for your team and help you strategically access the right data assets to eliminate guesswork when it comes to key protocol development decisions, such as evaluating the impact of inclusion and exclusion criteria on the eligible patient population.”
Interestingly IBM says that the service will also open up access to commercial and claims data gleamed from the patient profiles of over 89 million people that are part of US sponsored healthcare beneficiaries.
IBM state that using its Marketscan offering researchers can: “Track patients longitudinally over multiple years even when they switch plans and includes a strong depth of patient-level detail that reflects the true continuum of care.”