Those of us who’ve worked in clinical trials for years have a feeling they’re getting more complicated.
But does our gut feel tell us the truth?
From more complicated protocols to increasingly global trials, the answer is yes.
Protocol Designs are more complex
Protocol designs have increasingly included more of the following in addition to standard collections such as blood and liver panels:
- Patient-reported outcome measures
- Collection of comparative effectiveness
- This may require Sponsors to run a “sister study” – that is, a nearly identical study to the original
- Biomarker data
- Some of these call for central reads by academic “vendors”, for whom Sponsor teams must operationalize processes.
An analysis of 9,737 Phase 1-3 clinical trial protocols that received ethics approval from 2001-2005 and 2011-2015 (across all company sizes) found a rapid increase in:
- Number of distinct procedures
- Number of total procedures
- Number of study visits
- A doubling in the number of countries used
- An increase of 63% in the number of sites recruited
Study consequences
There’s further research linking protocol complexity to:
- Longer cycle times
- More protocol amendments (we all love those!)
- Lower patient recruitment and retention rates
All these factors can lead to trial delays.
Cost consequences
Companies are now trying to tighten up protocol designs to reduce amendments and gather only critical data. Hopefully, this will alleviate some strain.
On the other hand, increases in protocol complexity have offset cost savings from procedure and technology efficiencies.
Conclusion
This means that now more than ever, for the sake of trial timelines, data quality, and employees’ mental health, teams need to work smarter, not harder.
At Seascape Clinical, our mission is to help teams reclaim time to run studies efficiently and strategically. To learn more, visit us at www.seascapeclinical.com
Sources
https://www.nature.com/articles/nrd.2017.65
https://www.outsourcing-pharma.com/Article/2018/07/25/Clinical-trials-are-being-delayed-by-the-volume-and-diversity-of-data-collected
