• Authored by  Janis Brix, CEO Wigwam

With over 25 years of experience as a CRO and expertise in TB clinical research, Dokumeds has an elaborate network with key stakeholders and clinical sites in TB burden countries and in-depth knowledge of their regulatory framework. The 15 years of dedicated work and experience have enabled Dokumeds to develop a comprehensive risk assessment approach for TB trials site selection. Our experience traverses across multiple realms, including multidrug resistant (MDR), pre-extensively drug-resistant (pre-XDR-TB), extensively drug-resistant (XDR-TB), and HIV-associated TB. Dokumeds operates in and outside Europe and provides services, including:

  • Consultancy in clinical research, submission, and regulatory framework.
  • Consultancy in the microbiology laboratory
  • Medical monitoring and review
  • Feasibility including budget development
  • Clinical site and microbiology laboratory monitoring
  • Site management
  • Pharmacovigilance pre-marketing and post-marketing support.
  • The full scope of Project Management, including site contract development and management

Planning TB trial

Factors such as national disease burden and geographic location are critical during the TB trial planning process. These factors facilitate the clinical trials process by impacting on the speed and capacity of enrollment. Dokumeds has enormous experience and expertise in conducting TB trials that WHO has categorized as TB burden economies. These include the Philippines, South Africa, Russian Federation, Ukraine, Belarus, Republic of Moldova, Romania, and Georgia, among other economies that have reported high levels of TB prevalence.

Key opinion leaders play an instrumental role in the success of clinical trials from local, national, and international levels. Through our partnership with the opinion leaders, we gain access to their valuable expertise in regulatory frameworks, study design requirements, and deep knowledge in TB therapies and research, as well as microbiology labs.

The Increasing Need for TB research

Due to the transformation of TB, there is a need to develop more efficient therapies to combat the new resistant strains. Shorter treatment options are more effective in minimizing non-compliance to treatment by the patients¹.

WHO recommended a shorter standardized treatment regimen for MDR-TB. Studies affirm that such regimens are capable of achieving relapse-free cures in over 85% of patients².

TB is an infectious disease and a public health concern to the global populations now more than ever, courtesy of the COVID-19 pandemic. Therefore, there is a dire need to pursue clinical research in this field to address health concerns. As the scientific community explores options to control and treat the drug-resistant TB strains, collaboration among the stakeholders in the research arena remains critical, especially in high burden countries.

Stakeholders in the research community continue to explore viable TB treatment options, including shortened regimens, vaccines, and new drug combinations to tackle the disease burden. Dokumeds remains steadfast in providing professional support as an infectious disease CRO, particularly in the clinical stage of the drug development process³. To learn more about outsourcing clinical trials for infectious diseases, get in touch with our specialist team today.

References

  1. https://doi.org/10.1183/13993003.00061-2017
  2. https://www.who.int/tb/publications/2019/consolidated-guidelines-drug-resistant-TB-treatment/en/
  3. https://doi.org/10.3390/ijms22020735