If you google unmet needs in clinical trials in clinical trials – you get 20M hits. If you google “unmet needs in clinical trials” (for an exact match on the phrase) – you get 8 hits. One of the hits is from ICON (the large Irish CRO)
External Control Arms Can Increase Operational Efficiency Of Trials & Lower Costs.
Think about those 8 hits for a moment.
Consider that none of the 8 “unmet needs in clinical trials” relate to the real unmet needs we hear from sites and sponsors (spoiler – none of the unmet needs relate to external control arms).
The top 8 unmet needs of clinical trials according to reality
If we talk to real people (not to social media and search engines), we get a different set of unmet needs:
- Administrative load on sites
- Unfathomable amounts of paper transcription and manual data processing
- Non-interoperable systems
- 30-60 days delay in receipt of data from sites to sponsor EDC
- Another 30-60 days delay in obtaining a precise picture of study protocol compliance, patient safety, and data quality. These are red lights on data and safety issues that come on late. In a best case scenario, the red lights delay completion of the study for the sponsor and impact time to market. In a worst case scenario, late red lights can deny an FDA submission as in the case with the AstraZeneca COVID-19 vaccine.
- Monitoring costs on the order of 30-50% of total study cost
- CRO product and services markups and project management overheads on the order of 50-100%
- Lack of patient diversity in recruitment