Saturday, September 7, 2013
Aren't There Ever Any Scouts At The Table During Trial Design?
For ALS trials, it seems like the trial designers never seriously consider what happens to their trial volunteers if this stuff really works. It's not like they'll just have to scratch an itch or watch their diets or comb over while they wait to see what's next. They decline quickly. They die.
People with ALS who have volunteered for trials and who perceive improvements during the trials are left hanging out to dry. This all could be avoided with some creative trial design that gives them options to continue on the drug (or the placebo... if it works, they really don't care) before they sign on the dotted line.
Instead we have traditional trial designs and the subsequent cry for Expanded Access Programs after the fact. Perhaps we should get in front of the problem and have trial designers, including patients, talk about what happens to trial volunteers if this stuff really works. Be prepared.
Posted by ALSadvocacy at 7:38 AM