Developers pursuing new strategies to improve trial efficiency: Tufts CSDD
The panel, whose members were drawn exclusively from research-based companies, said they had begun collaborating with investigative sites in developing protocols and educating patients about trials before they agree to participate, in an attempt to streamline the trial process.
“The pharmaceutical and biotech industry is facing a crisis in that it needs to develop new drugs more quickly and control expenses,” said Tufts CSDD senior research fellow, Ken Getz.
“Developers understand that substantial operational improvements will more likely flow from new approaches that increase the probability of success, rather than from actions which merely seek to reduce or prevent failures.”
According to Tufts CSDD, more than two-thirds of trial sites fail to meet their patient enrolment targets. And, whereas in 2001 nearly half of all screened patients completed trials, in 2010 that figure plummeted to less than one in four.
Getz says some of the blame may lie in the ever increasing number of procedures patients are subjected to, with the median number per trial sky rocketing by 49 per cent between 2000-03 and 2004-07.
“Improving patient enrolment and controlling the number of procedures could provide substantial benefits,” he said.
The industry leaders convened by Tufts also agreed that communication between sponsors and investigative sites – before, during and after trials – remains critical to the development of good relations.
In addition, medical advisors to help sites better understand trial goals, testing protocols with patients prior to trials, and using electronic medical records to help define and manage data flow, were all agreed by the panel to be of paramount importance to a trial’s success.