This week marks the 3rd annual Clinical Trials Awareness Week hosted by the Coalition for Clinical Trials Awareness (CCTA). Raising awareness about clinical trials helps to find volunteers to participate in research. Evidence derived from clinical trials is critical to inform medical care and future treatment guidelines. Participants in a trial gain access to break-through treatment options and they are given special care from the clinical research team who closely monitor a trial patient’s progress.

Surprisingly 37% of trial sites fail to meet their enrollment goals[1], which means that trials are delayed or canceled or provide inconclusive results. Poor trial performance significantly impacts Research & Development productivity and patients’ access to innovative treatment options. For example, in life threatening diseases such as cancer only 3% of patients are enrolled in clinical trials[2].

Several barriers exist that negatively influence trial recruitment. This includes:

  • Lack of awareness and time: Treating physicians have limited awareness to the clinical trials available and on average only five minutes per patient to discuss treatment options and potential clinical trials.
  • Trial process complexity: The process for clinical trials have become time consuming and the eligibility criteria has become increasingly more complex. For example, the median number of trial inclusion criteria increased more than three times between 1995 and 2005, making it difficult for a research team to find matching patients[3].
  • Unstructured patient data: Patient data residing in disparate systems is typically in an unstructured format, making it difficult to find eligible patients.

Clearly there is a need to improve the clinical trial recruitment process that will increase efficiencies to connect the researchers, doctors and patients, in order to improve participation in clinical trials. This will advance medicine and help find better treatments for patients.

Granting patients access to optimal treatment

The “Center for Biomarker Research in Medicine” (CBmed GmbH, Graz, Austria) together with their scientific partner, the University Hospital Graz, face similar challenges on a daily basis. The number of diabetic patients searching for best treatment options at the University Hospital Graz has increased tremendously. To gain further knowledge about how to best personalize treatment, clinical trials are required. However, a highly laborious and time consuming patient screening process hinders the objective of including more patients into recruiting clinical trials.

To increase efficiency and to grant more patients access to their clinical trials, CBmed is tapping the potential of in-memory computing on an open platform, digitizing their recruitment process. From this pilot project, CBmed expects to transform their entire process; from a centralized study department to a decentralized workflow including 24/7 access to trial data as well as a reliable continuous search for eligible patients.

Optimizing patient and trial matching

At SAPPHIRE NOW 2017, Prof. Herald Sourij, MD, Associate Professor and Principal Investigator will share his insights on a new application SAP is currently co-developing together with CBmed and the University Hospital Graz.

The application will  focuses on finding eligible patients for an investigator-initiated or industry-sponsored trial and aims to optimize the patient eligibility screening and recruitment process in clinical trials to address some of the challenges mentioned above. Key features and functionalities of the planned solution could be:

  • Trial data model to store all trial relevant information including inclusion and exclusion criteria
  • Create trial manually or import trial details automatically from clinicaltrials.gov to reduce manual entry
  • Intuitive structuring of complex trial criteria in a harmonized and computable format
  • Apply common ontology standards to harmonize eligibility criteria and patient data
  • Include the ability to enter criteria tolerance to improve eligible patient screening results
  • Automatic matching with patient data from electronic medical records (EMR)
  • Alerts within clinical workflow to notify doctors that their patient is potentially eligible for a clinical trial

To serve the patient and to optimize future patient care should always be at the center of attention. Therefore, the key of this new offering  is to improve collaboration, time and efficiency gains for all end-users, so that physicians and study nurses can focus more on the most important task: serving the patient.

For more details, please view or attend https://sessioncatalog.sapevents.com/go/agendabuilder.sessions/?l=153&sid=46777_467755&locale=en_US

[1] Tufts Centre for the study of drug development, Impact Report, Vol 15 Number 1, Jan-Feb 2013 http://csdd.tufts.edu/files/uploads/jan-feb_2013_ir_summary.pdf

[2] https://www.ncbi.nlm.nih.gov/books/NBK50895/

[3] http://www.appliedclinicaltrialsonline.com/why-are-cancer-clinical-trials-increasing-duration

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