Study says the industry needs a template for clinical trial monitoring
A lack of clear guidelines on clinical trial monitoring is a challenge for the industry according to the team behind a new model designed to help sponsors and CROs keep tabs on drug studies more effectively.
The researchers - from University College London, UK – developed the proposed plan after analysis of multiple clinical trial monitoring schemes revealed the lack of uniformity and wide range of approaches being taken.
According to the authors “Although regulators like the MHRA emphasize the importance of monitoring and there is a great interest in risk-based monitoring of clinical trials, there has still been a lack of clear guidance regarding the minimum contents of a trial monitoring plan template.
“As a result, there has been a wide range of variation in monitoring practices among the UK academic trial units (17). This research study further highlighted this issue by reviewing 31 monitoring plans received from UK clinical trial units (CTUs), which showed a wide range of differences between plans.”
To address this lack of uniformity the authors propose a clinical trial monitoring plan (TMP) template that they say will benefit sponsors, contract research organizations (CROs), patients and healthcare systems in general.
They write the TMP template is designed to enable “the completion of high-quality clinical trials that are evidence-based, efficient, and effective. CTUs can improve their monitoring practices and standardize the way monitoring is performed by implementing the TMP template.
“Furthermore, research participants can have confidence that their participation is being carefully monitored to ensure that their data or any samples provided are treated with confidentiality, integrity, and respect and that their rights and well-being are protected.”
They add that the template has the potential to improve the transparency and completeness of TMPs for the benefit of investigators, trial participants, future patients, and healthcare systems around the world.
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