Trial implementation in Mongolia: Collaboration for successful clinical trials
In 2013, when the National Center for Communicable Diseases (NCCD) was approached to participate in STREAM, it was the first international trial of such scope and complexity implemented in Mongolia. Despite this, the site was keen to conduct the trial, given the burden of MDR-TB in the country. The site has now participated in both stages of STREAM, recruiting more than 160 participants, and is well-placed to conduct future regulatory TB trials. This was only possible because the site envisioned the trial as a collaboration among stakeholders.
The site’s commitment to collaboration applied well before participant enrollment began, with initial approvals requiring the site to build understanding and support for the trial across stakeholders. The trial allocated adequate time for this work (about seven months) so sensitization meetings with all key stakeholders could be held, including the Ministry of Health (MoH), the national ethics committee, directors of the NCCD, decentralized health facilities, front line health workers, non-profit organizations supporting TB patients, and donors supporting the national TB program (NTP). The trial team’s long-standing relationships with the MoH and the NTP were essential to the success of those initial meetings and achieving buy-in for the trial.
As the site moved closer to enrolling participants, study team members collaborated amongst themselves to ensure they understood each other’s roles and responsibilities, and were thoroughly familiar with the protocol, as well as logistics and regulatory requirements for the trial. Study team members participated in internal role plays that covered key trial processes like screening and enrollment of participants in line with the protocol, randomization to the trial, packaging and dispensing trial medications, ECG and audiometry assessments, and completing case reporting forms. The study team also trained directly observed therapy (DOT) volunteers, who would play an important role in supporting participants during the trial. This upfront investment to clarify roles and responsibilities and to train the study team helped ensure efficient trial implementation and a positive experience for trial participants.
Collaboration between the trial team and the NTP was important at nearly every stage. Site study staff were drawn from the NTP, helping ensure the trial fully understood patient referral patterns and designed effective recruitment processes. Cooperation was also important for patient management – in particular, arranging DOT options for trial participants that met their needs. The study’s experience with clinical aspects of the shorter regimen, community-based support for participants and retention were shared regularly with NTP colleagues. This conscious focus on knowledge sharing strengthened the relationship between the study and the NTP and helped improve coordinated patient management.
The site took a similar approach to managing regulatory issues collaboratively. Given the country’s history with clinical trials, Mongolia’s regulatory institutions had limited experience with oversight of clinical trials like STREAM. In response, the site invested in regular communications with the ethics committee and regulators to strengthen their working relationship. Regulators were invited to visit the trial site for regular updates and the study team often presented protocol amendments in person to facilitate Q&A. The trial protocol has now been amended five times and regulatory approvals have always been obtained in adequate time to permit uninterrupted trial implementation.
Perhaps the most important collaboration in the trial has been between the study team, and trial participants and family members. For example, the study worked closely with participants to adapt follow up options to participants’ needs. Instead of requiring participants to return to district TB dispensaries for all treatment, participants were offered different options for DOT (at home, at lunch breaks, at family health centers and (in some cases) using video-DOT). The study team credits this flexible approach with ensuring high participant retention at the site.
The final collaboration was between the trial site and the community. With the support of the trial, a community advisory board (CAB) was formed as a coordinating mechanism. The CAB – whose members included people affected by TB and a diverse range of representatives from NGOs and community-based organizations – served as an important bridge between the study and the community. Through the CAB’s work, the study remained aware of the community’s concerns and questions about STREAM, and the community was informed about study progress. This helped build the community’s trust in both the STREAM trial and clinical research generally.
More than seven years after joining STREAM, Mongolia has gained important experience and strengthened critical relationships needed to participate in future clinical trials. This underscores the gains that can be made when stakeholders collaborate with a common purpose.