History

The Asthma Clinical Research Network (ACRN) was established in 1993 by the Division of Lung Diseases (DLD), National Heart, Lung and Blood Institute (NHLBI). The objectives of this multi-center program are to conduct multiple well designed clinical trials for rapid evaluation of new and existing therapeutic approaches to asthma and to disseminate laboratory and clinical findings to the health care community. From 1993 to 2003, ACRN consisted of six Clinical Centers and one Data Coordinating Center (DCC). In September 2003, after a national competition, NHLBI re-awarded ACRN for another 5 years with eight Clinical Centers and one DCC to continue pursuit of the same objectives.

Organization

Administratively, the main governing body of the ACRN is its Steering Committee. The Steering Committee consists of the Principal Investigator from each Clinical Center, the Principal Investigator from the DCC, a Chairman who is not an Investigator, and a Project Scientist from the NHLBI. The following figure displays the locations of the ACRN participants.

Responsibilities of the Steering Committee include the following:

1. identifying important research questions
2. selecting topics for investigation
3. designing and developing protocols
4. facilitating the conduct and monitoring of protocols
5. participating in the analysis and interpretation of data
6. preparing manuscripts
7. assuring timely reporting of study results to the scientific community

Prior to implementation, an ACRN protocol must be approved by its Protocol Review Committee (PRC). The PRC consists of clinical scientists, basic scientists, and biostatisticians who are not associated with any other ACRN activity. After a protocol has been approved, patients are recruited, enrolled, and monitored at the eight Clinical Centers. The DCC provides overall scientific, data management, and administrative coordination during the progress of the trial. The Data and Safety Monitoring Board (DSMB) is another independent committee whose function is to oversee ongoing trials. The DSMB is empowered to stop an ACRN trial for any reason concerning safety and/or efficacy, and it also reviews the final outcomes of the study.