There are countless challenges in implementing a global patient recruitment program—different cultures, multiple global gatekeepers, competing timelines and studies, multiple vendors, potentially varying protocols, and different regulatory bodies with different approval timelines and requirements.
When executing a global study, it is inevitable that you will experience delays in site activation, approval processes, and/or enrollment. Adding additional study sites or extending the program timeline is expensive and not always an option. By investing time upfront to organize, plan and build a structure that will mitigate predictable problems, you will be prepared when (not if) something goes wrong.
Centralized Program Management
Traditionally, global patient recruitment programs are coordinated locally by individual country managers. Without a centralized point of contact, each country manager is left to make decisions in a silo. This prevents the sponsor from having full transparency into global study performance and makes identifying and operationalizing efficiencies more challenging.
In order to quickly and successfully coordinate multiple study teams, a centralized core management team is needed. There are many ways to organize your core team, but the key is to include the main players. We have found that when the core team is comprised of a lead sponsor contact, global clinical project managers, and a patient recruitment partner designee, the team performs more efficiently. This core team spans cultures, disciplines and countries, and acts as a liaison between the sponsor and study teams.
Members of the core team are responsible for a single region; each region can consist of up to 15 different countries. It is then the core team members’ responsibility to become experts in their region and build relationships with their country managers to help implement country-specific tactics. When a core team manages and provides guidance to each of the separate study teams, they can assure the strategy is implemented throughout each of the countries. Ensuring efficiencies are identified and shared across internal and external teams, preventing redundancies and setting the program up for enrollment and retention success.
So how does one core team keep multiple studies across different countries organized? Our solution is a clearly defined program charter that eliminates uncertainties by clearly outlining the following:
- Team organization
- Roles and responsibilities
- Escalation plan
- Project specifications
- Country manager communications
- Program Approvals
- Process for deliverable development
- Naming convention for materials
- Translation plan
- Risk mitigation plan implementation (if applicable)
Team Organization
Organizing your team may seem obvious, but it sets the foundation for a successful global recruitment program. This organization provides a precise and efficient way to manage all patient recruitment efforts, retention activities, and communications happening at the country level. Members of the core team can focus solely on their specific region, which allows them to identify, report, and escalate regional learnings or challenges to the larger core team. By organizing your team up front, you ensure that global insights are identified and cascaded to the core team so they can determine how those insights might impact the program as a whole.
Escalation Plan
Once the core team organization is established, an escalation plan should be put in place. To the extent possible, potential challenges should be identified before the program begins.Common problems include anything from staff changes at country level, to removal of country specific tactics. Once you have identified the kind of issues that could arise, sort the issues into categories. Each category will have its own plan and determined point of contact who is responsible for escalating the issue.
By anticipating problems before they arise and developing action plans with assigned point people, you will avoid confusion and potentially costly delays, and your study enrollment will remain on track.
Program Approvals
One of the most complex factors in implementing a global program is the many different approvals and approval timelines that are required for every country. Regulatory timelines vary and are complicated. To manage different approval timelines and requirements the region managers within the core team produce what we call “country regulatory submission packages.” The purpose is to provide country managers at the site level with an overview of all country-specific materials, and recommendations on which items require submission and which do not. Package content varies depending on the program scope; however, they typically include patient- and site-facing materials and outreach and retention tactics.
Preparing customized regulatory packages makes submitting for approvals effortless for the country managers: collecting all materials into one organized document saves the country manager time and ensures all materials are submitted for approvals on time.
Communication is Key
While much of the organization and planning for a global recruitment program will be led by the core team, the effectiveness of the plan depends on ongoing communication and coordination between the sponsor and the core team. Sponsors must commit their time to support the core team and recognize the importance of having a strategic partnership rather than a transactional relationship. Partners that have been granted a strategic seat at the table are empowered to be completely transparent with updates on country and site screening and enrollment rates, while consistently keeping the sponsor updated on trends and their potential implications.
