Diagnostic research encompasses a wide array of tools, including medical devices, imaging techniques, and laboratory tests, all aimed at assessing the accuracy, safety, and effectiveness of diagnosing diseases or conditions. The primary endpoints in diagnostic trials typically test accuracy metrics such as sensitivity, specificity, and positive predictive value, with outcome measures focusing on diagnostic performance.

Clinical development professionals and research sponsors recognize the intricacies of diagnostic research and the critical need for careful planning and strategic execution. In this blog, we highlight five proven strategies aimed at enhancing efficiency and achieving success across key phases of diagnostic study startup for sponsors.

Background

Since 2017, 1,129 health diagnostic companies have secured substantial investments totaling nearly $20.3 billion, contributing to the dynamic landscape of diagnostic companies and trial startups.¹ The success rate for all clinical trials (including diagnostics) is approximately 7.9 percent,² highlighting the challenges inherent in this burgeoning sector. Consequently, only a small fraction of investigational diagnostic products successfully progress from early phases to regulatory approval. Alongside this entrepreneurial surge, the diagnostic industry witnesses the performance of over 7 billion clinical lab tests annually in the United States alone, emphasizing the critical role diagnostics play in healthcare.³

As the demand for diagnostic services and participation in clinical trials grows, it is crucial to approach diagnostic clinical trials with meticulous care and strategic planning. Recent industry data highlight a concerning trend: the cycle times for site start-up activities (SSU) have surged from a median of 1.5 months to over three months.⁴ This elongation has significantly impacted clinical trial timelines, with nearly half experiencing delays, primarily attributed to sluggish patient enrollment. Our tips identify solutions to this and other key challenges.

Project Start-up Optimization

Establishing a successful project start-up process serves as the bedrock for a successful trial. Prioritizing early interactions with a contract research organization (CRO) and appointing dedicated start-up resources, such as a Premier Research Project Launch Manager (PLM), sponsors can realize seamless coordination and adherence to study timelines. Moreover, with the inclusion of dedicated senior-level diagnostic and MedTech resources, sponsors gain early visibility into study timelines, fostering transparency and bolstering confidence.

Pre-kickoff activities:

Designate a PLM to spearhead cross-departmental coordination, ensuring alignment and progress with start-up activities and timelines across all departments
Arrange meetings with CRO partners to encourage collaborative review of protocols and study designs, facilitating collective alignment and optimizing resource allocation
Coordinate discussions concerning financial and human resource availability and finalize specific study timelines
Access the specialized expertise of senior-level MedTech and diagnostic experts holding certifications in medical device and diagnostic development. With extensive experience spanning all study phases, from inception to FDA submission and responses, these team members ensure studies are steered by invaluable knowledge and insight. Their presence will instill confidence in achieving study milestones and safeguarding successful outcomes

Site Selection

Effective site selection is essential to the success of any study. Sponsors can optimize this process by leveraging their network of sites and past data for data-driven forecasting, swift decision-making, and expedited processes.

Developing Relationships with Diagnostic Sites:

Establishing strong relationships with diagnostic sites is essential. By leveraging past data and experience, sponsors can employ data-driven forecasting to predict enrollment trends accurately
Utilizing a robust understanding of site performance allows device developers to discern which sites are likely to meet enrollment targets and which should be avoided to safeguard study success
Prioritizing sites with efficient start-up times helps ensure that studies remain on track, avoiding unnecessary delays and setbacks

Streamlining the PSSV to SIV Transition:

Expediting the transition from a Pre-Study Site Visit (PSSV) to a Site Initiation Visit (SIV) is crucial. By ensuring a swift 24-hour turnaround, sponsors can focus decision-making and prioritize sites aligned with study objectives
Facilitating real-time communication between clinical research associates (CRAs) and clinical trial leaders (CTLs) allows for immediate assessment and informed decision-making regarding site suitability
By prioritizing efficient communication and processes, developers ensure that site selection aligns with study goals and timelines, ultimately contributing to study success

Effective Budgeting and Contract Negotiation

Achieving a delicate balance between fairness and efficiency in budgeting and contract negotiation is crucial in clinical research. Here are strategies to strike the right balance:

Choose study sites engaged in multiple non-competing studies to maximize enrollment potential and minimize competition. This approach optimizes study budgets, enhancing value while reducing costs
Capitalize on extensive experience by partnering with CROs proficient in establishing fair starting points and negotiating competitive rates for both sponsors and sites
Harness the expertise of legal departments to expedite contract processes, ensuring swift turnaround times without compromising quality
Leverage established relationships with sites and site networks to facilitate efficient negotiations and foster collaborative partnerships

Empowering Team Members

Empowering team members through robust training and communication channels is imperative for successful clinical trials. Regular training sessions, coupled with CTL oversight of CRAs, ensure team members are well-prepared with the requisite knowledge and expertise.

CTLs play a crucial role in ensuring CRAs are well-versed in study intricacies before they proceed to train site staff. They ensure that CRAs possess the necessary proficiency not only to train site staff effectively but also to oversee study conduct with confidence
Training site staff should focus on study protocols and documents, preparing team members with an understanding of the study protocol and procedures
Conducting multiple training sessions at regular intervals provides opportunities for knowledge reinforcement and refinement, enabling team members to stay updated on any protocol or procedure changes

Streamlined Site Start-up and Real-time Tracking

Streamlining site start-up and real-time tracking are pivotal for any study. Sponsors can implement proactive strategies such as centralized site activation processes, utilization of site activation metrics and performance dashboards, and adopting a risk-based monitoring (RBM) approach to prioritize site visits based on risk levels. Additionally, staggered enrollment can mitigate challenges related to study supply limitations, ensuring smooth integration with study operations without compromising efficiency.

Adopt a centralized approach to site activation to streamline processes and expedite site readiness
Use standard templates for essential documents to ensure consistency and accelerate the activation timeline
Collect and leverage site activation metrics and performance dashboards to enable real-time tracking of site progress
Implementing an RBM approach prioritizes site visits based on risk levels, which in turn ensures efficient resource allocation, focusing efforts where they are most needed
To mitigate study supply challenges, sponsors can adopt a staggered enrollment approach to ensure that the sample lab is not overwhelmed, allowing for smooth integration with study operations without compromising efficiency

Moving Forward with Diagnostic Research Success

By implementing these strategies, sponsors can navigate the complexities of diagnostic research with confidence and drive their device innovations forward. At Premier Research, our client-centric approach involves crafting customized start-up objectives for each functional team, aligning efforts to meet your specific site activation goals. With meticulous timeline management, we ensure the prompt initiation of your clinical trials, enabling efficient and effective success. Reach out to Premier Research today to advance your research. Learn more about our services and the future of diagnostic research.

[1] Crunchbase News. (2020, December 17). Health diagnostic startups raised $4.8B in 2020, see new opportunities post-pandemic. Retrieved from https://news.crunchbase.com/health-wellness-biotech/health-diagnostic-startups-raised-4-8b-in-2020-see-new-opportunities-post-pandemic/

[2] Kim, E., Yang, J., Park, S. et al. Factors Affecting Success of New Drug Clinical Trials. Ther Innov Regul Sci 57, 737–750 (2023). https://doi.org/10.1007/s43441-023-00509-1

[3] American Clinical Laboratory Association. (n.d.). Value of lab testing. Retrieved from https://www.acla.com/value-of-lab-testing/

[4] SPE. (2018, January-February). Improving study start-up (SSU) in the clinical trial continuum. Pharmaceutical Engineering, 38(1), 50-55. Retrieved from https://ispe.org/pharmaceutical-engineering/january-february-2018/improving-study-start-ssu-clinical-trail-continuum