Let’s face facts.
Far too often, clinical trials are delayed. Associated statistics reveal the troubling impact:
- Roughly 80% of clinical trials are “delayed due to recruitment problems and dropout rates are high”
- 90% of trials end up doubling their original timeline to meet enrollment goals.
- 37% of sites fail to enroll a sufficient number of volunteers and 11% of research sites do not enroll a single patient.
- Trial start-up delays can cost between $600,000 and $8 million for each day that a trial postpones a product’s development and launch.
- Each screen failure rate costs, on average, approximately $1,200.
Why Clinical Trial Start-Up Delays Are Rampant
Undoubtedly, study start-up delays are a major hurdle in clinical trials.
Often driven by paperwork, miscommunication, tech gaps, and lack of coordination, typical bottlenecks to a timely trial start-up are:
- Contract negotiation
- Clinical trial site selection and contracting
- Challenging regulatory environments
- Staff readiness
- Coordinating high numbers of stakeholders across sponsor organization, clinical research organizations (CROs), trial sites, lab providers, patient groups, and more
- Technology decisions made late in the process as well as tech onboarding
- Authority approvals
- Identification and engagement of suitable patients
All of these bottlenecks impact clinical trial timelines, budgets, and trial enrollment goals, leading some to conclude that only 12% of clinical trials are successful.
There is a better way.
Accelerating Clinical Trial Start-Ups with Best Practices & Clinical Trial Technology Solutions
Research sites can overcome these delays through practical best practices supported by modern, site-friendly digital tools like OpenClinica.
In our experience, there are five best practices to accelerate trial start-up:
- Standardize and streamline documentation
- Use digital tools and data-driven strategies to engage and enroll clinical trial participants
- Improve site-sponsor communication early and often
- Centralize training and onboarding
- Adopt clinical trial technology solutions that work for sites, not just sponsors
Increasingly, clinical trials are coupling best practices with technology solutions to speed up execution as well as facilitate real-time collaboration and audit trails. That’s because of the seamless onboarding of modern eConsent and EDC platforms.
In fact, OpenClinica’s EDC was named a top contender in electronic data capture platforms by the Everest Group, a leading global research and consulting firm, because of its high marks in technology capability, customer support, and ease of deployment.
As Nisarg Shah, Practice Director at Everest Group, highlighted:
OpenClinica offers a user-friendly EDC software that requires minimal programming knowledge, featuring single-click publish for mid-study changes, user management, data validation, and query management. OpenClinica’s strong partnership network includes CROs, hospital networks, industry consortia, and academic institutions, with clients appreciating its efficient support services and pricing tailored for their needs.”
Likewise, OpenClinica Randomize is easy to configure and deploy and OpenClinica Recruit enables targeted outreach and faster patient identification to support trials to meet recruitment goals. By the numbers, OpenClinica Recruit has demonstrated compelling results:
- 50,000+ participants enrolled
- 2x faster enrollment
- 3-5x cost reduction
- 250+ therapeutic areas
- 1,200+ studies supported
- 175+ healthcare institution clients
OpenClinica’s integrated suite of clinical trial technology solutions empower sites to accelerate trial start up. Our intuitive, site-friendly interfaces improve the pace of adoption and pre-built templates and workflows reduce build time. Integrated modules, including OpenClinica’s EDC, eConsent and Randomize, minimize back and forth, all of which support rapid site setup with minimal training required.
At OpenClinica, everything we do – advanced clinical trial technology and recruitment solutions – enable clinical trials to minimize start-up delays and improve efficiency and effectiveness. To learn more, watch a short demo of our EDC here.