Author: Marc Weinberg, MBA, Senior Director of RTSM
Protocol amendments are a standard part of the clinical trial process, they can be disruptive but often necessary. Regardless of the trial stage, therapeutic area, or industry and the rigor of protocol design, there are likely going to be adjustments made to the protocol – and that’s not a bad thing. However, your ability to minimize the disruption caused by mid-study changes will depend on the agility of your study’s partners and the technology in play. Manual solutions for tracking randomization and trial supply likely won’t be able to properly keep up with study designs or unanticipated changes. An RTSM solution is adaptive and flexible, and it can help you uncover the best ways to handle protocol amendments.
Understanding the Impact of Protocol Amendments
Trial complexity is increasing, and protocol amendments aren’t just a fact of conducting research today – they are becoming more common:
- From 2018 to 2020, almost 70 percent of Phase III trials had at least one substantial amendment, up from 66 percent in the period from 2013 to 2015.
- In that same period, the percentage of Phase II protocols requiring amendments moved to 78 percent from 77 percent in the previous period.
- Phase I protocol amendments also became more common. Nearly 60 percent of these early-phase studies required a protocol amendment, up from 2.2 in the period 2013 to 2015.
Oncology or rare disease studies are approximately twice as likely to experience a protocol amendment than non-oncology trials – and these protocol amendments come with a cost. Changing the average protocol will cost an average of $450,000 and depending on the study phase, delay the study an average of 30 days.
Are protocol amendments inevitable?
Many protocol amendments are the result of the technology-enabled transparency as studies progress and the benefits of modern trial technologies to make adjustments and modifications that will improve the trial. However, the technologies and service providers engaged can help to minimize the disruption of the amendment.
- Before the introduction of eClinical solutions, the ways to obtain data mid-trial took a significant period of time and required more than one individual (possibly across multiple functional teams).
- Data was reviewed in a very manual fashion which increased overall analysis time and effort.
- eClinical introduced new solutions and methods of not just obtaining data and performing analysis but also allowing team members to make better decisions based on the “story” of the data.
- When changes are needed, customers introduce a protocol amendment and can more rapidly produce data from analysis to support the changes compared to, say, a decade or two ago.
When customers are able to use data in a more accurate, faster way than ever in supporting those humans participating in the trial and those that can benefit from that therapy’s eventual approval for use.
What will make a difference in how a sponsor or CRO is able to navigate a protocol amendment is what support they have from their vendors. At Medrio, we have completed over 6,200 studies with over 1.5 million participants, garnering a 98% satisfaction rate. We’ve read, reviewed and adjusted many protocols.
“Compared to RTSM vendors we’ve worked with in the past, Medrio has been much more thorough. You came to the table with a clear understanding of our protocol…We really appreciate the effort you put in.”
– Global, Full-Service CRO
Medrio’s Fearless Approach to Amendments
Medrio’s RTSM solution and experienced team make protocol amendments a fearless endeavor:
- Medrio EDC and Medrio RTSM offer a single sign-on experience, and data flows in real-time from RTSM into EDC. Real-time data allows for real-time decision-making and keeps your study data easy to consume and evaluate.
- Medrio’s easy-to-learn and easy-to-use RTSM empowers staff to shorten their learning curves to prevent errors and support study continuity.
- Medrio builds a collaborative relationship with our RTSM customers. We pride ourselves on being responsive and customer-focused, from the pre-sales process through study closeout.
- Our pre-sale discussions and protocol reviews allow us to proactively build flexibility into the platform to adapt to needs that will arise later in the study. When unexpected changes are required, Medrio is extremely responsive and remains customer-focused throughout the process of making changes.
Mitigate Trial Supply Risk with RTSM
If you have an upcoming trial that you are interested in incorporating RTSM, connect with us. We’ll perform a protocol review and ensure all aspects of your protocol have been considered in your RTSM solution before you start your clinical trial. While we can’t eliminate the need for certain amendments, Medrio RTSM can help you minimize delays by making sure you have the supplies your study requires when you need them.
References
- Getz, K., (2022, Mar 1). Doubling Down on Protocol Amendments and Deviations. Pharmaceutical Outsourcing. Retrieved 6 Oct 2022.
- Miessler, J. (2022, January 20). No end in sight for trial complexity, CSDD report reveals. Center Watch. Retrieved September 15, 2022.
