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Outsourcing Tuberculosis Clinical Trials

March 10, 2021

Dokumeds is a CRO highly experienced in TB clinical research and during 25 years in business, the company has established close relationships with clinical sites and key opinion leaders in high TB burden countries, and has gained deep expertise in the regulatory landscape of such countries. Dokumeds has developed a highly robust methodology of risk assessment for site selection in TB trials, which is based on our 15 years of dedicated and continuous work in this field. Our experience includes projects in multidrug resistant (MDR), pre-extensively drug resistant (pre-XDR-TB), extensively drug resistant (XDR-TB) and HIV-associated TB, in Europe and outside of Europe, where we provided the following services:

  • Feasibility including Budget development
  • Regulatory support, submission and consultancy
  • Full scope of Project Management, including site contract development and management
  • Medical monitoring and Medical review 
  • Pharmacovigilance pre-marketing and post -marketing support
  • Microbiology laboratory consultancy 
  • Clinical site and microbiology laboratory monitoring 
  • Site management, including Clinical research coordinator service

Planning a tuberculosis clinical trial

When planning a TB clinical trial, the geographic potentiality and national disease burden are key factors which will impact the capacity and speed of enrollment, resulting in a successfully completed clinical trial. WHO reports the whole list of high TB burden countries, in which Dokumeds has a proficiency to perform TB trials. Dokumeds has TB research experience in Philippines, South Africa, Russian Federation, Ukraine, Belarus, Republic of Moldova, Romania, Georgia and other countries that suffer from a high level of TB prevalence. 

Key opinion leaders are considered to be an accompanying factor which has an influence on the clinical trial success at the international, national, and local levels, in order to ensure regulatory requirements and study design considerations. Our CRO maintains close relationships with TB treatment experts, local and regional microbiology labs, which enables to consolidate knowledge about the local healthcare system and TB treatment organization.

Emerging need of tuberculosis research

Now more than ever, there is a need for improved TB treatment options, to combat the threat of more resistant strains of TB. In particular, treatment regimens with shorter treatment duration will relieve the pressure of patient compliance and thus reduce the risk of an incomplete treatment course¹. In their recent Consolidated Guidelines on Drug-Resistant Tuberculosis (DR-TB) Treatment, the WHO recommended to treat MDR-TB with a standardized shorter regimen, as studies have shown that such regimens are capable of achieving relapse-free cure in over 85% of patients². 

TB continues to present a substantial global burden of disease, and especially now with the Covid-19 pandemic challenging the previous progress against TB, it is especially important that clinical research in this field continues. As current and future efforts look towards controlling and treating the most dangerous drug resistant TB (MDR-TB, pre-XDR-TB, XDR, XXDR, Total DR-TB) strains, researchers will need to collaborate with partners experienced in the conduct of TB research in high burden countries. Research continues in new treatments, such as shortened regimen treatments, new drug combinations, vaccines and mycobacteriophages, where Dokumeds would be eager to provide professional support for the clinical stage of drug development³. 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

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