Author: Marc Weinberg MBA, Senior Director, RTSM
Many studies rely on manual methods of randomization and trial supply management (RTSM), but increasing complexities are changing what works. Modern study designs and global supply chains require more flexible, responsive, and user-friendly solutions, especially for early-phase studies.
We all know the clinical research landscape has experienced seismic shifts since 2020 – pandemics have that ability. However, the impact of those changes didn’t end once the lockdowns were over. Clinical trials are still experiencing threats. Study managers need to understand how those factors may prevent them from being successful.
- Supply chain shortages
- As of the end of 2021, 87%  of life sciences companies are still dealing with pandemic-related supply chain issues
- International conflict and shipping restrictions are causing additional supply chain issues
- Staffing issues
- Turnover rates for clinical research associates (CRAs) are at: 30%, which is more than 50% higher than the average 
- The demand for research professionals is increasing. The number of open positions across the industry went up by 9.3% last year 
- Nearly half of job candidates who accepted a job in 2021 had three or more  offers to consider
- Financial strains
- Study leadership is feeling the squeeze
- Around 90%  of CEOs say inflation will have a significant impact on their business in 2022
- Protocol complexity
- Phase I protocols are the most complex, with the highest mean number of distinct procedures (36) and total procedures (253) carried out 
- Study design drives RTSM complexity. Things like multiple treatment arms, single or double-blinded design, and adaptive randomization impact trial timelines and introduce new challenges
- Early phase trials may be subdivided into different methodologies, forming a tangled knot instead of two or three clear tracks
- Protocol amendments
- Phase I
- From 2018-2020, there was a 7% increase in Phase I protocol amendments (57%, up from 52%) 
- The average number of substantial amendments in Phase I also increased to 2.4 amendments per protocol from 1.8  amendments
- Phase II
- Roughly 78% of Phase II trials have at least one substantial amendment 
- The average number of substantial amendments increased to 2.7 in 2018-2020 from 2.2 in 2013-2015 
- Phase I
Is your early phase study feeling the squeeze of some of these constraints? Watch our on-demand webinar as Medrio experts explain why it is time to rethink the status quo around randomization and supply management and how Medrio’s RTSM can support your next clinical trial.
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