In March 2016, experts in the ALS community gathered at the ALS Clinical Trials Guidelines 2016 Workshop, supported in part by MDA. With the aim of improving the testing process for experimental therapies to treat ALS, a multinational group that included neurologists, basic scientists, statisticians, patient advocates, representatives from the pharmaceutical industry, regulatory agencies and patients with ALS revised, updated and expanded the Guidelines for Clinical Trials in ALS/MND that were last revised in 1998.
Updates to the Guidelines take into account numerous scientific advances and have the potential to help future clinical trials in ALS be more efficient and productive.
Now you have the opportunity to contribute to this process and help speed the development of treatments for ALS.
The initial draft of the revised Guidelines is available for public comment beginning today, Aug. 1, and ending on Aug. 31. Public comments are welcomed to ensure that everyone who is interested has an opportunity to provide input.
To read the Guidelines, visit the ALS Clinical Trials Guidelines 2016 Workshop website.
If you wish to make any comments, please email: firstname.lastname@example.org. Be sure to specify to which of eight sections your recommendations refer. All investigators must reach a consensus in addressing your comment or concern.
There is only one drug approved for the treatment of ALS at this time. The generation of new guidelines to direct ALS drug development and clinical trial testing is an important process — one in which you can participate — that will help the ALS community by providing a structure for more effective clinical trials and, in turn, accelerate the development of treatments and cures.