In drug development, as in much of the rest of today’s technology-dependent world, the servant has become the slave driver. Granted, software is an integral part of any research program. However, technology developed to save time often creates more work for investigators and site staff, ultimately draining the efficiency of our clinical resources.
Software systems can ensure consistency when enrolling patients across hundreds of different investigator sites around the world. They can provide consistent and cost-effective training for site staff. They can streamline the process of ordering study supplies. They can reduce errors in tracking patient information. But the fact that a given trial uses multiple software systems, and that systems differ from one trial to the next, can create bottlenecks and inefficiencies.
Research shows many areas where software is now creating problems rather than driving efficiency. Here are seven examples:
- eCRF requests data that is not consistent with the protocol
- ePRO is confusing to the patient, so data is inaccurate/incomplete and/or site staff functions as “help desk”
- EDC and IRT data fields are not aligned
- Site staff must remember as many as 10 login procedures and passwords per trial
- Vendor help desks/customer service may not be responsive
- Lack of interoperability between systems results in need for manual data input, which takes time and increases opportunity for error
- Systems require human monitoring for incoming data, such as lab reports
Not all problems plague all trials — but Clinical SCORE’s research has identified a number of software problems and their impact on patient recruitment and enrollment as well as other factors that influence success. The first step in removing these roadblocks is identifying them in order to make the changes that will have the most impact. Clinical SCORE helps sponsors and CROs work together more effectively by pinpointing software issues and other areas where they can increase efficiency and better support program success.