There is a growing tendency, as part of the R&D costs reduction, to give clinical trials teams more responsibility of trial management and reduce the onsite monitoring. Some hospitals have adapted very quickly to the new approach but some struggle and find it more difficult.
Sometimes clinical trials teams express their concerns about this new model because they rely on Clinical Research Associates to tell them what was not done correctly or if there are data entry errors. The main reasons for these concerns are the high workload and turnover in hospitals.
On the other hand some Clinical Research Associates also have expressed their concerns regarding the new model and the limited ability to check if the data is correct.
Do we have trust issues?
Some clinical trials teams may feel abundant and that they do not receive support from pharma companies and CROs as they used to. As a result they feel less confident in running clinical trials. Clinical research teams in pharma companies and CROs also have their concerns that less onsite monitoring will result in more data issues and protocol deviations that could potentially affect the final statistical analysis.
What can we do to overcome these challenges?
Pharma companies can help this new model of remote monitoring by implementing the following:
- Clear protocol design and supporting materials that will help the clinical trials teams in hospitals to follow the treatment protocols.
- Clear case report form design, which will help clinical trials teams to enter all required data without extensive training. This will also allow new team members to easily get used to data entry and study requirements.
- Adequate training regarding remote monitoring requirements and expectations for both, hospital staff and pharma teams.
Hospital staff can also make some adjustments to accommodate the new monitoring model:
- Clinical trials teams have to speak up if they have difficulties following the protocol and request more support if they struggle.
- Teams have to develop proper handover process to assure that all new team members are aware with protocol requirements.
- It is important that during the initial set up process the team has properly evaluated the physician and nursing time required to conduct the study.
- Clinical trials teams have to develop back up plan in case of unexpected resource issues during the study.
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 3 Nov 2014