Statement of Principles

Introduction

The Critical Path to TB Drug Regimens (CPTR) is a broad collaboration of pharmaceutical companies; government, regulatory, and multilateral agencies; donors; academia; advocates; and NGOs that aims to accelerate the development of new, safe, and highly effective tuberculosis (TB) treatment regimens with shorter therapy durations. CPTR will form innovative partnerships to significantly accelerate delivery of new TB medicines—an urgent public health need—with the goal of saving millions of lives.

  • TB and Drug-Resistant TB are Major Threats to Global Health: Although it is often thought of as a disease of the past, 1.3 million people die from TB every year. One-third of the world’s population is infected with the TB bacterium, and approximately 8.6 million people develop active disease annually. The rise of drug-resistant TB further exacerbates the global epidemic. Strains of TB that are resistant to all major anti-TB drugs have emerged and drug resistance can be found in every country.
     
    There are an estimated 450,000 global cases of multidrug-resistant and extensively drug-resistant TB each year. Unless these trends are reversed, drug resistance raises the specter of future, untreatable TB epidemics.
  • New TB Drug Regimens are Urgently Needed: Today’s TB drugs are more than 50 years old. The commonly used regimens for drug-susceptible TB are unacceptably long, and treating drug-resistant TB can require 24-30 months of prolonged therapy, plagued by significant side effects. These drawbacks dangerously decrease patient compliance, which significantly contributes to the rise of further drug resistance. Safer and more effective TB drug regimens could sharply reduce the duration of treatment for drug-susceptible and drug-resistant TB. However, given the resilient nature of the bacterium and shortcomings in today’s antibiotics, improved TB treatment will likely require a combination of effective antibiotics that includes more than one new drug.
  • New, Innovative Models are Needed for TB Drug Development: Standard drug development has traditionally required that each new drug be evaluated and approved separately before it is tested in combination with other new compounds. Using this approach, obtaining regulatory approval for a new three- or four-drug combination TB therapy could take more than 20 years. With approximately 3,800 people dying of TB each day, and drug resistance continuing to spread, 20 years is far too long to wait.
  • We Have an Unprecedented Opportunity to Work Together to Overcome these Challenges: Today, a significant number of promising TB drug candidates are in pre-clinical or clinical development. Simultaneously, there is new momentum in global efforts to fight TB, owed largely to government investments in research and clinical trial capacity, increased philanthropic funding, industry commitments, the rise of product development partnerships, and overall increased attention to global health. Now is the time for a new, innovative approach: collaboratively test TB drug candidates in combination early in their development and develop the regulatory science and infrastructure needed for this effort.

Principles

The undersigned partners commit to work together to accelerate the development of new TB drug regimens. Within this initiative, the partners agree to:

  • Encourage information sharing and collaboration among international organizations, industry, and regulatory agencies to innovate and accelerate TB drug development and get important new therapies to patients.
  • Promote the development of new regulatory approaches that support innovative research into TB therapeutics, evaluate new TB drug combinations safely and effectively, and reinforce current guidelines for development of effective drug combinations.
  • Work together, using industry best practices, to test TB drug candidates in combination regimens beginning early in the development process.
  • Create a collaborative coordinating structure to oversee this initiative.
  • Explore creative new funding streams for developing novel combination TB therapies.
  • Advance efforts to utilize existing clinical trial sites for TB while also building clinical trial site capacity for late-stage combination TB drug trials.
  • Support relevant organizations and stakeholders in accelerating procurement of and access to new TB drug therapies for patients in need.

Accelerated development of new TB drug regimens is complex and will require taking acceptable, scientifically based risks balanced with careful ongoing scrutiny. Success will require commitments to work together to ensure that effective TB combination therapies are available in the shortest time possible to those who need them most. If successful, this initiative could serve as a model for future collaborative efforts to develop combination therapies for other diseases.

Please view the Partners page for a listing of all organizations who have signed the Statement of Principles outlining the core values and spirit of the Critical Path to TB Drug Regimens initiative.