Antibiotics have long been one of the most important tools in a physician’s arsenal. Since the 1940s, these drugs have significantly reduced illness and death from infectious diseases around the world. Yet rampant overuse and limited new classes of antibiotics have led to a growing epidemic of antibiotic resistant bacteria. The World Health Organization (WHO) reports 480,000 people develop multi-drug resistant tuberculosis each year, and drug resistance is starting to complicate the fight against malaria. In the U.S., antibiotic resistance is responsible for more than 2 million infections and 23,000 deaths each year at a direct cost of $20 billion according to the Center for Disease Dynamics, Economics & Policy (CDDEP).

To help combat this epidemic, the biopharma industry needs to develop a more diverse pipeline of antibiotic treatment options. Unfortunately, the scientific challenge of developing new antibiotics, coupled with limited economic upside, can make it a tough sell for companies considering in which development projects to invest. On average, biopharma companies must enroll 50-300 hospitals to test a new antibiotic, a costly and time-consuming endeavor which may not result in significant returns.

But there is a way to potentially address some of these burdens by taking advantage of networks specifically designed to manage antibiotic trials.

There are many benefits to creating networks to support specific research initiatives. They can eliminate much of the early work spent vetting physicians and healthcare centers. Networks also create an environment of continuous momentum, where centers already have the staff, training and infrastructure to quickly ramp-up for new trials, and can move easily from one program to the next. This benefits the sponsors and CROs by providing rapid access to a network of seasoned sites, and it benefits the sites who can confidently invest in training and infrastructure upgrades knowing that future projects are in their pipeline. All of this efficiency can eliminate months or even years from the research process.

Wellcome Trust, a global charitable biomedical research foundation based in the UK, funds innovative solutions to large health problems such as antibiotic resistance. The organization funded a multi-stakeholder working group to evaluate the practicalities and barriers to creating a global clinical trial network for antibiotic testing, and they met in London in October to discuss their findings with a broader group of experts. I was fortunate to be invited to participate in the workshop, and am excited about some of the ideas that emerged. 

Two approaches

The working group, led by Anthony McDonnell, head of economic research for the Review on Antimicrobial Resistance, identified two key strategies for establishing a clinical trial network, which he and his team outlined in a paper published on the Trust website.  The first is a single global network operated by one entity with a single defined protocol, which they call the “Continuous Master Protocol” model. The advantages of this model include a clear leadership, mission, and operational approach, and a single program management process and governance structure, which creates consistency across sites. 

The second is the “Discontinuous Protocol” model, which would “aim to expand and connect regional networks, so that over time, they are able to take on a global function”. In this model, study sites would be managed together by one or more specialized CROs or existing networks. The authors of the paper felt this model would easier to set up because it takes advantage of existing clinical networks and structures.

During the October event, participants discussed the benefits and challenges of both models, including funding limitations, vetting and training sites, and governance and stakeholder control strategies needed to ensure quality and consistency across sites. The workshop led to many important discussions about how to drive faster and more cost-effective development of new antibiotics, and the role networks can play in achieving this goal.

While there is still much work to be done, we are excited Wellcome Trust is pursuing this goal and allowing us to participate in these discussions. At QuintilesIMS, we have built many networks to address specific research needs, and have seen the time and cost savings that can be achieved when they are managed effectively. We believe the efforts of this working group could have a significant impact on addressing this growing healthcare concern, and look forward to sharing our knowledge and experiences to help make that a reality.

Topics in this blog post: Clinical Trials, Biopharma, Population Health