Majority of the hospitals have started adopting Electronic Medical Records and the challenges with the adoption process are well known. However, hospitals running clinical trials face extra complications.
EMR adoption is not a simple process and it takes significant amount of time to transfer existing medical records to the online database. During this transition process hospitals have to keep their paper records and maintain electronic records as well. And if this process sounds complicated enough with the amount of double work that it creates, the situation with clinical trials is even worse.
Keeping electronic and paper records at the same time could cause lots of discrepancies between EMR and paper records. The result is that clinical trials teams have to spent lots of time trying to clarify the cause of the discrepancy and verify the information.
The other major issue is that EMRs are not connected in a network and the information that they contain is relevant only for the hospital. As it often happens clinical trials patients are seen by GPs and local hospitals but this information is not available for the treating team. The only way they can obtain such information is by sending official correspondence to GP or local hospital. The result is that there are lot of missing adverse events, concomitant medications and assessments, which are not available for the clinical trials teams.
EMR does not have proper tracking. Current EMRs provide information on changes of treatment but does not provide tracking who has access the information. For example, in clinical trials the physicians are required not just to review lab results but also to have proof they have reviewed them. Because EMRs do not track this information clinical trials teams have to print lab results for physicians to review and sign. This brings everything back to storing huge amounts of paper work.
Majority of the oncology clinical trials require radiology assessments to be done as per RECIST criteria (Response Evaluation Criteria In Solid Tumors). This is not easy to implement in the existing EMR reports so these measurements are usually done on a excel spreadsheets, which are then printed for physicians to review and sign.
These are just few of the issues that clinical trials teams face when implementing EMR. Unfortunately current EMRs are not design to support research and cause increased workload and frustration for hospital staff. But the bigger problem is that they do not provide all the required information for the treating physicians to oversee clinical trials patients’ safety.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 15 Jan 2015