Despite the fact that tuberculosis (TB) has been curable, it has become a global epidemic that impacts more people every year than HIV/AIDS. The millions of TB patients worldwide suffer from morbidity, mortality and Social Stigma, which can be referred to as a ‘triad of devastation.’
In recognition of World TB Day on March 24, I think it’s important to recognize just how devastating this disease has become due to the increasing spread of drug resistance, and how the clinical trial industry is working together to provide the healthcare industry and patients with a solution.
Bad news and good
One of the most shocking statistics about this disease is that roughly one third of the world’s population harbors the bacilli in their lungs, which means they have been infected by TB bacteria but are not (yet) ill and cannot transmit the disease. About 10 percent of these people will fall ill with TB in their lifetime, resulting in roughly 1.5 million TB-related deaths every year. A majority of these deaths occur in low and middle-income countries, including Africa, Asia and the Western Pacific, where TB rates are much higher than in developed nations.
The high rate of illness and death related to this disease is due to a confluence of factors. TB requires specialized diagnosis, it is highly contagious due to the inhalation route of transmission, and it tends to hit hardest among high-risk and low-income patient populations who may have limited access to healthcare. Since there is a social stigma attached to the disease, patients are often slow to pursue diagnosis, which further enables the disease to spread.
Even when these patients are diagnosed, the treatment is expensive and extensive, often requiring a year or so of therapy, which results in high levels of non-adherence. This has led to a high rate of resistance, and today, almost half-a-million people have multidrug-resistant TB (MDR-TB), a form of the disease that does not respond to standard treatments, and is difficult and costly to treat.
It’s a grim picture, though it’s not all bad news. There has been some good progress made in recent years to lessen the impact and spread of TB. In 11 of the countries with the highest burden, mortality fell by at least 50 percent between 1990 and 2015.
The annual global number of new cases of TB has been falling slowly but steadily for the past decade, thanks to efforts in support of the World Health Organization’s (WHO) Millennium Development Goal to reverse the spread of the disease by 2015. And last May, governments agreed on an ambitious new 20-year strategy to eventually end the global TB epidemic by 2035. The End TB Strategy focuses on efforts to provide patient-centered care, pursue policies and systems that enable prevention and care, and drive research and innovations needed to end the epidemic and eliminate TB once and for all. The plan includes global impact targets to reduce TB deaths by 95 percent and to cut new cases by 90 percent between 2015 and 2035.
It takes a team
The only way to achieve these global health goals is if the industry works collaboratively, to bring the best science, technology, and data management tools, and best practices in order to bring innovative new diagnostics and treatments to market. Such efforts led to the December 2012 approval of bedaquiline by U.S. Food and Drug Administration (FDA) as part of a combination therapy to treat adults with multidrug resistant pulmonary TB when other treatments are not available. It was the first new TB drug approved in more than 40 years. FDA also granted the drug fast track designation, priority review and orphan-product designation, underscoring the importance it places on bringing new TB drugs to market.
We also have seen exciting innovations in TB diagnostics, including the innovative use of molecular technology for detecting drug susceptibility patterns as well as quick speciation. Immune mediated diagnosis of latent TB is also seeing new landscapes. Moreover, new modalities for better specimen collection is also going to aid diagnosis significantly. Improved diagnostics is now known worldwide to more efficiently detect and begin treating the highly contagious disease.
These developments are just the beginning. There are currently more than a dozen TB drugs in the clinical development pipeline, with several in Phase II and Phase III trials, including exciting innovation in diagnostics and vaccines in the field of TB which has seen a lot of movement in recent years. Q2 Solutions, as a Global Central laboratory, is offering testing services across many geographies including South Africa to support clinical trials for the development of innovative drugs.
While they likely won’t all make it to market, the research holds great promise for TB sufferers, and for the global organizations working to wipe out this deadly disease. However, results will take time. These are long complex trials that require a lot of technical competence by all participating stakeholders. Most of the time, in TB related studies, Laboratory results forms the endpoints – hence selection of the laboratory with appropriate experience, expertize and dedication towards technically challenging, sometimes research based assays as well as Biosafety is important. Furthermore, logistics, data and project management of large and complex TB studies also needs paramount focus. Not only the technical standardization, but also the process standardization is vital for good quality and reliable data for a particular study. Though if we work together and stay focused on the common goal of providing a long-term solution for patients with TB, we can hopefully make World TB Day a thing of the past, and wouldn’t that be a great thing to celebrate?