As a clinical trial leader, you are likely all too aware that clinical trials take a LONG time, as long as 10 to 15 years to complete all three phases.
- Phase 1 typically lasts less than a year.
- Phase 2 runs for a few months to two years.
- Phase 3 usually takes one to three years.
In 2023, McKinsey & Company determined that 12 years is the average time from nomination to launch of a novel medicine.
What came as a surprise to me – and perhaps to you too – is that the average length of a clinical trial is increasing. McKinsey analysis revealed “the average clinical trial lengthened from 41 to 44 months for Phase 3 trials and from 37 to 41 months for Phase 2 trials” between the years of 2011 to 2015 and 2016 to 2021. As many as 80 percent of clinical trials do not finish on time.
Mid-Study Data Migrations: The Growing Importance
With the average length of clinical trials growing 10 percent for Phase 2 trials and seven percent for Phase 3 trials, the ability to perform mid-study data migrations has become paramount.
Without a doubt, mid-study data migrations are complex. Any two electronic data capture (EDC) systems will have differing ways of storing and structuring data and different interfaces for adding, editing and reviewing the data, requiring data mapping specifications, validation and more. That’s why, until recently, the only practical way to migrate from one EDC system to another was to maintain ongoing studies in the existing system while initiating new studies in the new system.
Once rare, mid-study data migrations of active clinical trials are becoming increasingly common.
That was the impetus for OpenClinica creating, perfecting and proving a process for migrating ongoing studies onto our EDC. To date, we’ve migrated 19 active studies to the OpenClinica EDC.
- In a six-month period, we used the OpenClinica extract, inform and import process to move five active studies for a Top 25 biopharma company.
- In 16 months, we successfully migrated 14 active studies – with 1,700+ patients and 150,000+ forms – for the Imperial College of London.
By success, I mean “any study was offline for no more than three days and not a single data point was dropped,” and our client was thrilled, writing:
OpenClinica is as passionate and as invested in Imperial’s success as we are. Given the thoroughness of their data migration process, I – and our site leaders – are confident that ALL of our study data was migrated during the seamless cutover. Just as importantly, OpenClinica minimized study staff disruptions and maintained regulatory compliance throughout the process.”
Mid-Study Data Migrations: The OpenClinica Process
Allow me to give you a sneak peek into OpenClinica’s process for managing mid-study data migrations. Key components of the data migration process include:
- Testing & Validation
- Data Targets
- Team Definition
- Study Assessment & Identification
- Documentation Needs
- Training
To prepare for a mid-study data migration, we use this readiness checklist.
To learn more about OpenClinica’s proven process for mid-study data migrations of active clinical trials, I encourage you to:
- Download: The Imperial College of London case study, Migrating Data Mid-Study – 14 Studies in 16 Months
- Download: Managing Change in Clinical Trials: A Data Management Playbook
- Contact us: Let’s talk about your migration needs.