Clinical trials and the consequent benefits to society are in jeopardy in the United States because of a decline in the ability to recruit patients in a timely manner to trials addressing key clinical issues.

....successful recruitment and retention of participants in clinical trials is critical for improving the efficiency and effectiveness of phase 3 and 4 clinical trials and that action to ensure adequate enrollment is urgently needed.

Too often trial enrollment fails or is significantly delayed, leading to substantial additional costs to the sponsor. Of particular concern is the failure of US trials to meet desired participant enrollment and the trend toward increasing emphasis on recruitment abroad.

En de redenen? Veel te veel formalistisch papierwerk, veel te weinig inzicht in hoe een studie verloopt, te ingewikkelde insluitingscriteria, hele hoge kosten, kortom, de klinische geneesmiddelentank krijgt steeds meer zand tussen haar rupsbanden... 

Dat het anders moet, daarvan zijn velen al lang  overtuigd. Maar dat staat nog niet in de JAMA.

Now is the time to create relationships with clinicians, to maximize federal partnerships, and to streamline regulatory processes to keep the clinical trials system healthy and viable in the United States.

Dat de oplossing ligt in andersoortige studies,  en de EMEA en de FDA eens moeten nadenken waar ze eigenlijk mee bezig zijn, en dat studies antwoorden behoren te geven op daadwerkelijke klinisch problemen, dat horen we helaas nergens.

Bron: Commentary JAMA. 2011;306(16):1798-1799. doi: 10.1001/jama.2011.1544 Strategies for Recruitment and Retention of Participants in Clinical Trials Jeffrey L. Probstfield, MD; Robert L. Frye, MD 

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