The treacherous study startup journey

Craig Morgan
Head of Marketing, Study Startup

Sponsors and contract research organizations (CROs) face intense pressure to speed clinical trials while boosting operational efficiency, but complex protocols, globalization, ever-increasing regulatory mandates, and paper-based methods have long stymied these efforts. Adding to this dilemma is the low approval rate of investigational drugs and growing development costs, the majority of which is directly attributed to running studies.

Despite the nuances between therapeutic areas the foundational phase of all clinical trials is study startup, which is widely recognized as a costly and perpetual bottleneck. Study startup is a complex business, composed of country selection, pre-study visits, site selection, and initiation, regulatory document submission, budget and contract negotiations, patient recruitment initiatives, and enrolling the first patient.

Today, many companies still track these site selection and activation activities manually using Excel spreadsheets with collaboration done via email siloed in disparate inboxes, reports manually generated based on outdated data, and documents stored on shared drives.

With multiple parties making updates, materials rapidly get out of sync, making it difficult to track the overall status of the project. The same is true as it relates to compliance with regulatory and organizational SOPs – potentially resulting in downstream audit findings and rescue interventions. This lack of real-time insights prohibits the ability to proactively address issues, trapping the industry in an endless and costly reactive cycle.

With spiraling costs and increasing stakeholder demands, it’s critical that studies get off to the right start. This may seem self-evident. But how do we get there?

The lowest hanging fruit is the automation of manual processes, which entails the deployment of eClinical tools. The growth in the eClinical software market is staggering, forecasted to reach $6.8B dollars by 2020 with recent research now doubling that estimate by 2024.

In this environment opportunities abound but none of these systems is a panacea. These tools perform separate functions but serve overlapping user groups and need to be assessed as part of the overall picture of clinical study management, rather than just as one piece of the clinical trial jigsaw puzzle. Fully optimizing the clinical trials process requires practices and tools that streamline operations, automate processes, increase transparency, and improve stakeholder collaboration.

One of the key findings from a recent Tufts Center for the Study of Drug Development (CSDD) research report is a renewed interest by the pharmaceutical industry in study startup with the assignment of dedicated teams and budget.

Forward-thinking industry leaders have been trading in their Excel spreadsheets in favor of custom-built study startup applications. This approach improves starting studies by facilitating the selection, feasibility, and activation of performing sites, budget, and contract negotiations, and the tracking of protocol amendments and regulatory documents.

Clinical trials that get off to a good start are more likely to execute well and finish on-time and on-budget. Technology is the critical enabler. With so many multiple aspects to balance across many stakeholders, from finalizing the protocol to coordinating contracts, selecting sites, recruiting patients, tracking information manually, and in a siloed manner, simply does not work. The stakes are too high and risks too great to have a decision model based on ad-hoc processes and fragmented information.

When that foundation is poorly built, timely re-work may be required or worse - the study may need to be rescued or abandoned altogether. There are multiple elements to this foundation which need to be orchestrated simultaneously to be successful, which amounts to a challenging balancing act. Signals that your trial is not on solid ground may include:

  • Poorly selected sites that are struggling with enrollment/retention of trial subjects
  • Little oversight or transparency with CRO partners
  • Lack of robust risk identification and management processes
  • Lack of benchmarking metrics to gauge progress against or upon which to forecast performance
  • Inability to ensure SOP/regulatory compliance
  • Inability to spot bottlenecks and internal processes that are ripe for optimization

As the industry focuses their efforts to improve study startup, stakeholders are reaching out to providers well-versed in the intricacies of study startup, who have a proven track record. It's not just about speeding up the process; study startup underpins the very foundation of the clinical research value chain, ensuring downstream quality with enhanced data integrity and audit-ready regulatory compliance.

Learn more about optimizing your study startup.

Contact us for a conversation.

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