Identifying the Issue
Patient processes are the largest item in the research budget. We can review the process in two main stages: patient recruitment and retention.
Research patient recruitment contains the following processes:
1. Patient screening
2. Achieving patient consent
3. First visit and randomization
For patient screening, many methods are used, such as associations, social media, written and visual marketing, etc. Still, the most common method is working directly with healthcare centers and their comprehensive patient archive. For example, in Turkey, medical faculties are chosen for their familiarity to research culture and broad portfolio of patients, particularly in rare diseases.
A health center’s archive brings great opportunities along with big challenges. Maintaining quality in an ongoing archive is an important issue. However, archival quality is increasing, in part, due to malpractice concerns. Since the widespread use of hospital information systems (HIS), there have been significant improvements.
In addition, archive screening requires an effort and financial cost. The process is labor-intensive and considered to be unappealing. Junior residents, students, medical secretaries and site coordinators generally execute this screening, with unsatisfactory performance. The reasons vary according to the scanner: The main reasons are a lack of medical knowledge and an insufficient knowledge of the research protocol.
Most of the staff execute the screening based on one or two criteria and thus may skip eligible patients for various reasons. Unfortunately, with this manual screening method effectiveness and sensitivity cannot be evaluated with any precision.
Furthermore, with manual screening it is difficult to reach current patient records. Manual screening will take days, perhaps weeks, to perform. A lack of controls and an inability to cover the whole institution’s archive are added major concerns.
Solution Suggestion: IT Support
Nearly 30% of the time dedicated to clinical trials is spent on patient recruitment and enrollment, while 37% of all sites in a given trial fail to meet their enrollment targets and more than 10% never enroll a single patient. As electronic technologies have redefined many processes in various industries, it is clear that such enhancements are also needed in clinical research.
Electronic Health Records (EHRs) may leverage the speed and quality of the patient recruitment process. The pharmaceutical industry and healthcare organizations are looking for an interoperable platform that utilizes real-time data from EHRs for clinical research, in compliance with relevant legal, ethical, regulatory, privacy protection requirements and policies.
There is no question that recruiting patients for global clinical trials through traditional means alone is challenging, time-consuming and expensive. However, integrating an intelligent system to the available HIS would help to scan the entire online data in seconds and, in turn, boost success rates. This is certainly incomparable to the manual process that requires days of extensive efforts.
With such systems, data could be analyzed fast and efforts to reach eligible patients would be reduced to the minimum.
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