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Fortuna Eruditis Favet in Global Clinical Studies

Kristin Ludwig
PRINCIPAL SOLUTION CONSULTANT

Planning for and conducting a clinical trial presents many challenges associated with study design, patient safety and outcome determination. Choosing where to conduct a global clinical trial is a critical strategic decision that can impact an entire drug development program. When it comes to planning country selection, Fortuna Eruditis Favet (“fortune favors the prepared mind”).

Conducting clinical trials in places with unfamiliar regulatory pathways, cultural differences, and limited infrastructure is highlighting the value of technology that streamlines key bottlenecks allowing stakeholders to better adhere to established timelines and budgets.

Many factors must be taken into account when selecting countries, however, the relative importance of each factor will vary depending on trial design, therapeutic area under investigation, and overall development strategy.

Have you ever wondered what the impact of country selection has on overall clinical trial costs and timelines? Are you selecting the “right” countries to participate in your clinical trials?

These questions are often pondered by clinical researchers but rarely vetted during the clinical planning process. Research organizations are facing growing pressure from stakeholders to speed the process of drug development, while balancing the clinical and operational impact that country selection may have on their trial. They are also challenged by often changing internal and external study startup processes, regulatory requirements, and economics shifts that can occur throughout the planning cycles.

What if I included sites from Taiwan and Hong Kong in my trial versus just including sites from Japan in my APAC country mix? How would this impact timelines and costs? Will I be able to achieve the same enrollment targets needed? What if I selected Eastern European sites instead of Western European sites? Will I be able to enroll faster or find more patients at a reduced cost? What if I include sites from emerging countries in my trial? How will these impact my country regulatory approval timelines?

Research organizations need a way to be able to quickly conduct this type of scenario planning and cost analysis before country and site selection activities begin. This cost analysis should be conducted early in the study planning process in order to drive the downstream risk assessment and site selection process.

Identifying key criteria to be used in country selection and incorporating this into the planning cycles should become standard practice. Some examples of key country selection criteria:

  • Regulatory timelines to achieve country approvals
  • Number of submissions required to achieve country approvals
  • Complexity of country applications
  • Availability of the “right” sites within the country to be selected
  • Availability of the “right” subjects within the country and sites to be selected – and how this might impact enrollment metrics (patients/site/month) within that country.
  • Competitive trials within the country to be selected (and how this may impact the enrollment metrics for that country)

Additionally, operational and timeline metrics should be included in the country selection criteria including:

  • Complexity (time/effort) to develop the country application for regulatory approval
  • Time/duration for completing the application for regulatory approval
  • Time/duration of obtaining regulatory approval once the application is submitted
  • Number of submissions required per country
  • Additional country related requirements to consider including:
    • Drug/product supply chain availability & management (will drug depots/licensing/importing be required?)
    • Lab sample management (what is process, frequency and cost related to managing the lab samples for the study?)
    • Screen failure and drop rates and how these will impact overall patient counts and timelines to complete all required subject visits to achieve the statistical objectives for the trial.

Finally, cost implications should be factored into country selection. Some examples of key cost assumptions to be understood include:

  • Costs for country regulatory oversight
  • Costs for country medical oversight
  • Cost for country regulatory submissions
  • Patient grant costs: country procedure cost analysis based on the protocol required procedures and standard of care for your subjects within that country
  • Screen failure rates and how these will impact costs and screening timelines
  • Withdrawal/drop-out rates and how these will impact costs and timelines.
  • Average billing rates for resources conducting clinical trial work in the country
  • Costs related to the timeline assumptions mentioned above including:
    • Timeline for country approval
    • Timeline for site approval within the selected country
    • Timeline for enrollment completion and subject visit completion
  • Costs for lab sample management (shipping & handling)
  • Costs for translations required for the country (may include multiple languages)
  • Costs for CRAs/monitors traveling to the sites that need to conduct onsite monitoring visits and query resolution
  • Costs for other site related fees (IRB/EC including initial submission and annual renewals)

Conducting a thorough cost and timeline analysis during the early planning cycles will ensure all of the above assumptions and associated impacts on costs and timelines are thoroughly understood when selecting countries to participate in a trial. Additionally, incorporating real-time performance metrics and actual costs based on selected countries will aid in future scenario planning cycles.

Country selection is inextricably linked to patient recruitment and retention, which is why a data-driven approach to country planning is of paramount importance, which should be routinely conducted at the outset of clinical trial planning efforts. By utilizing this approach, which takes into consideration proprietary institutional knowledge and influencing factors an optimal country mix can be realized.

If you would like to discuss strategies for optimizing country selection for clinical trials, please contact us.

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