What You Need to Know Before Launching an International Research Project (or Large Clinical Trial): Key Managerial Lessons

Learn key managerial lessons from a large clinical trial to help you plan ahead and avoid hurdles in your projects.

[This post was jointly written by Sara Stanulovic and Mary Mael, project managers at ISGlobal.]

After 6 years, the malaria clinical trial known as BOHEMIA, short for Broad One Health Endectocide-based Malaria Intervention in Africa, is coming to an end. The aim of the trial was to assess whether ivermectin mass drug administration (MDA) could reduce malaria transmission and it took place in two African countries, Mozambique and Kenya. Under BOHEMIA, a door-to-door MDA was conducted, with over 20,000 study participants in each country. It could be considered one of the largest trials of its nature, and with that came immense challenges and a substantial workload for both the researchers and field teams alike.

This short yet concise piece aims to highlight the various managerial lessons learned from this trial, with the hopes of helping future project coordinators and managers think ahead and avoid potential hurdles in their own projects. While some of the lessons learned from BOHEMIA may only be relevant to clinical trials of a similar nature, many insights may also be valuable to observational studies or other international research initiatives.

Setting expectations- Defining a clear understanding of each partner’s role

Before starting a multiple-year collaboration as a consortium, one of the main things to do is to define a clear understanding of each partner’s role. Defining these roles early on will avoid confusion and ensure accountability for deliverables. Some of the questions to ask yourself and the team early on are:

• Who is in charge of supervising which team, work package, and/or task?
• Who handles coordination with external stakeholders, including ethical committees?
• Who manages the safeguarding of local documentation and who ensures that all essential project files are securely stored and easily accessible?

When working as a sponsor with partners in different countries, it is crucial to define how involved the sponsor should be. Without clearly defined roles, the sponsor may unintentionally micromanage or overstep, especially if partners fail to reach agreed-upon milestones.

In addition to clearly defining roles within the consortium, it is helpful to take it a step further to outline the roles and responsibilities of personnel within each partner institution. Creating an organizational chart for the staff of each partner (including the sponsor) at the beginning ensures that each institution is appropriately staffed and that all tasks are clearly assigned.

Sara Stanulovic and Mary Mael.

Find an effective communication method

Once roles and expectations are defined, it is essential to find an effective communication method to set a good pace for the project. Understanding partner institutions' communication preferences and structures is crucial for a successful collaboration. In the BOHEMIA project, Slack proved to be a very effective means of communication, as it offered transparency, and the possibility of real-time follow-up if a message was unanswered.

Understand your partnering institutions

As in all projects, delays are inevitable, and this is no exception when working in a developing setting. Don’t just expect delays—plan for them. One of the significant lessons from BOHEMIA was the importance of understanding intra-institutional rules and processes within partner organizations. For example, what are the timelines for hiring, procurement, and payments and who is in charge of which step within each institution. Not having a clear understanding of how long these processes would take contributed to certain delays in the project and having to find workarounds.

International procurement—start well in advance

Depending on your study, you may need various equipment. For instance, BOHEMIA required many office supplies, entomology equipment, lab and fieldwork material, and study drugs. While some items were easily procurable within the implementing country, some were more difficult to get a hold of, especially in large quantities. Lessons learned from BOHEMIA include:

• Create an exhaustive list of required materials early in the planning phase.
• Determine which items can be procured locally and which require international procurement. Make a timeline for procurement for both the local and international purchasing, allowing plenty of time for delays. Research reliable international suppliers in advance and confirm their shipping capabilities.
• Start the process of obtaining import permits and arranging shipping logistics well in advance. Delays in international procurement are highly probable and it is good to plan for this in advance. This is particularly important for investigational products and drugs.

The BOHEMIA storage room in Mozambique.

Staffing—ensure continuity

Staffing can be another significant bottleneck. Finding skilled individuals for specific roles can take time, and turnover is inevitable in long-term projects. Three of the main lessons learned from this were:

1. Organize the team so that at least one person has sufficient insight into another team member’s work, this will ensure continuity during extended sick leaves or unexpected departures of staff members. It is also helpful to have an accurate and detailed term of reference (TOR) for each position.
2. Regularly save critical project documents in a shared, transparent folder such as the Trial Master File (TMF) or GDrive. This practice ensures that essential files are not lost in emails when employees leave. Archiving of documents is also necessary for audits.
3. Once an employee gives in their notice, immediately advertise the position

Regulatory and Ethical Approvals—be prepared

Ethical approvals are essential in order to be able to start any clinical study. BOHEMIA as previously mentioned was a multi-country project, including sensitive data and involving children which meant it had to receive multiple layers of ethical approvals. Some of the key lessons learned from the BOHEMIA project are:

• Define the focal person to track the submissions to the ethics committees (EC) and regulatory authorities (RA). Create a document for tracking and notify deadlines to the responsible person for drafting/submission.
• Sit down with your partners to map out all required ethical and regulatory approvals.
• Detail the dependencies between committees (super important) and the average response times.
• Be prepared for potential adjustments to the study protocol based on feedback from EC/RA, and factor in times for these modifications.
• Build in sufficient buffer time to account for delays.

Managing a large-scale international clinical trial comes with its fair share of complexities, from defining roles and communication strategies to handling procurement, staffing, and ethical approvals. The lessons learned throughout the six years of the BOHEMIA project taught us the importance of early planning, clear roles and structures, and proactive problem-solving. While each trial or research initiative will have its unique challenges, these insights can help project managers anticipate obstacles and streamline operations. We hope by sharing these key takeaways, your future projects can foster stronger collaborations, enhance efficiency, and ultimately achieve their research goals with greater success.