Toward a Laboratory Data Interchange Standard for Clinical Trials

Abstract

In 2001, an estimated 2.3 million people in the United States participated in and completed a clinical trial: 750 000 in government-sponsored clinical trials, 850 000 in industry-sponsored Phase I to III clinical trials, and 700 000 in industry sponsored Phase IV clinical trials (1). Major medical center participation in the conduct of clinical trials grew strongly in 2001. More than 65% of academic health centers have established centralized clinical trial offices that encourage and support the involvement of their departments and staff in the conduct of clinical trials (1). Many of the laboratories in those institutions are asked to support investigator participation. Clinical chemistry testing is the mainstay of the drug-safety tests that underlie all clinical trials, and laboratory data derived from tests of both drug safety and efficacy have been estimated to be as much as 60–80% of the data generated during the conduct of clinical trials. Because of this, laboratories are extremely important players in the clinical trial process. Much time and effort is involved in the transfer of clinical trial laboratory data among the parties involved: the reference, performing, or central laboratory; contract-research organization (CRO); pharmaceutical company; and pharmaceutical partners. Some central clinical laboratories are now …