Challenges of patient recruitment for invasive aspergillosis trials.


Ribaud P.

Date: 16 February 2007


The main challenge in patient recruitment for invasive aspergillosis (IA) trials is to include a maximum number of patients for a minimum length of time, bearing in mind that the final objective is to improve the prognosis of patients with IA. Theoretically, all that is needed is a good drug and a good strategy. The analysis of patient recruitment rates in the most recent important trials of fist line and salvage therapy of IA shows that they are quite low, ranging from two to 18 patients per month, despite high numbers of participating countries and investigators. Several difficulties are encountered: IA is not a frequent disease and inclusion criteria may well exclude patients with true aspergillosis. Competing IA trials and concomitant non IA protocols are often conducted at the same center. Conversely, large numbers of patients (hundreds) are mandatory in the frequently chosen ‘non-inferiority’ trials. Considering the fact that a significant number of IA cases are not diagnosed premortem, new diagnostic methods should be developed to allow an early diagnosis and thus increase the number of treatable patients. Furthermore, the choice of other endpoints for assessing antifungal activity could decrease the duration of studies and, hopefully, the number of needed patients.

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