Dear Friends,

 

In 2012 we set out on a mission to improve the treatment landscape for sufferers of ALS and other unsolved, killer diseases. Before that, three years earlier, we had already begun researching the regulations and history of FDA-authorized Expanded Access --the channel through which physicians and patients can access investigational drugs outside of research trials. This included hundreds of interviews with leading experts in constitutional law, patient advocacy, and, also, the organizations that had sponsored the most visible Expanded Access programs in history.   Finding no comprehensive source of knowledge that was focused on Expanded Access we resolved to become that source.  

 

For the last five years WideTrial (formerly ALS Emergency Treatment Fund) has led the national discussion on group-level expanded access and the factors that enable drug developers to engage wider ranges of patients. Also in that time we built the world's first platform for collaboratively sponsored expanded access trials, to make it easier for small companies to make their investigational drugs available to patients and physicians who cannot take part in research trials.

 

It's a big solution to a big problem. And it needs more visibility.

 

Many believe that FDA stands in the way of patients who seek access to unapproved drugs. They are mistaken. It is commercial feasibility that determines whether a company can make its drug available outside of research trials.   On the other end of the spectrum, an equally misinformed narrative is often parroted -one that suggests that Expanded Access trials always work against swift drug development. The intelligent middle ground is the opportunity to launch well-designed data-generating access trials that serve all stakeholders' needs. And WideTrial is here to support that.

 

Last week Clinical Trials Arena published a new paper I wrote on this subject.   I hope you read it, tell me what you think, and share it with anyone interested in improving the conditions for early drug access.  CLICK HERE TO OPEN THIS 3-PAGE REPORT

 

Best wishes, Jess