Pharmaceutical manufacturers have long struggled to create an efficient clinical trial process for faster next-phase approval. The root cause of most failures is a lack of necessary efficacy data to support
clinical trial claims. In the article “Gathering Substantial Data for Faster Clinical Trial Approval” found in the latest issue of Journal for Clinical Studies, Moses Zonana and Danahlyn Tamola at Compliance Meds Technologies (CMT) discuss the ways that will contribute to more efficient follow-up of clinical trials resulting in faster clinical trial approval.
Journal for Clinical Studies, with its distinguished editorial advisory board, provides the best practice guidelines for conducting global clinical trials. They are known to be the specialist journal providing bio-pharmaceutical professionals with relevant articles which will help navigate emerging markets. As a company focused on contributing to the optimization of clinical trials, the experts at Compliance Meds Technologies were featured to expose the underlying problem of low efficacy data and how to improve it by applying three key practices to clinical trials.
A study drug, no matter how chemically effective, is insignificant without substantial data for clinical validation. It has been determined that half of drug compounds fail to demonstrate efficacy in clinical trials, which leads to prolonged trial duration, increased study cost, and delayed approval prospects. The underlying cause of low-quality data is empirically linked to patient non-adherence to clinical medication protocol.
The pros and cons of the measurements used for non-adherence were explored in in this article to compare and discuss its evolution. From patient diaries to Medication Electronic Monitoring System (MEMS), The article highlights their features and setbacks to give a better understanding on which will be better for clinical use.
The three key practices to improving adherence in clinical trials are the following:
- Patient Selection – The key to adherence is early and responsive intervention.
- Patient Engagement and Communication– Effective communication is linked to study outcomes including subjects’ participation, recall of information, and adherence.
- Leverage Novel Technologies – Research teams need to seriously consider leveraging novel technologies for medication adherence if certain conditions apply to their clinical trial.
Each of these practices has already proven to make an impact in medication adherence, and by combining the three, allows for a layered solution to a complex issue.
See full JforCS issue: https://issuu.com/mark123/docs/jcs-nov-2017-web_smaller