In December of 2012, the FDA gave Transparency Life Sciences approval to proceed with a Phase 2 trial studying the effectiveness of lisinopril (blood pressure drug) in patients suffering from multiple sclerosis. This trial will be the first to use both remote monitoring and crowd sourcing in an effort to explore alternative approaches to clinical trial design and increase flexibility.
This is exciting news and represents a milestone in the clinical trial space. The potential for cost savings is significant for a trial with fewer site visits required versus a more traditional clinical study model. Pharmaceutical companies also stand to realize such benefits as the reduction of geographical limitations, an increase in the quality and quantity of data, and increased patient safety.
MedCityNews has a nice write up of this recent news, including a discussion of some of the potential challenges posed by this type of approach to clinical trial monitoring. If the estimates provided in this article are accurate, using robust remote monitoring, study costs can be dramatically decreased by approximately 70%.
At Clinipace, we have seen firsthand how a technology-amplified service delivery model (through the use of our proprietary TEMPO eClinical platform) can transform clinical trials, mitigating the need for costly, unnecessary site visits.
If this subject is of interest, please join me on Thursday, February 28th, 2013 @ 11:30am EST for an interactive panel discussion entitled Mitigating the Challenges of Clinical Trial Monitoring: A Technology-Amplified Approach. It will examine the many benefits of a technology-amplified, real-time, risk-based approach to monitoring including:
- Ensure integrity of trial data and patient safety
- Optimize trial efficiency and quality
- Streamline sponsor, CRO, and trial site team interaction