In the late 20th and early 21st centuries, concern grew among scientists, clinicians, and public policymakers regarding the direction of clinical research. Over the previous five decades, the scientific community had benefited from significant progress in the realm of basic science research, backed by the public's long-term investment in it. The concern over clinical research stemmed from the idea that scientific discoveries of these past generations were not being appropriately translated. This was addressed with numerous targeted initiatives, including the Clinical Research Roundtable at the Institute of Medicine in June 2000. This initiative identified four major challenges to the progress of clinical research: (1) enhancing public participation in clinical research, (2) funding, (3) an adequately trained workforce, and (4) developing information systems (1). The last challenge mentioned, and the focus of this section, highlights the idea that the use of information technology (IT) and standards not only improves healthcare delivery, accuracy, and patient safety (2) but also advances clinical research.
Information technology has now been integrated into every phase of clinical research. Physician–investigators use IT to assist in designing of hypotheses and protocols, identifying and recruiting research subjects, implementing data collection instruments, training research staff, ensuring regulatory compliance, and generating timely reports (1,3). IT applications have been tailored to both research and clinical systems; both have influenced the world of clinical research with considerable overlap (Figure 2–1) (4).
Information technology systems supporting the translational research enterprise. CPOE, computerized physician order entry; EMR, electronic medical record. Reproduced, with permission, from Payne PRO, Johnson SB, Starren JB, Tilson HH, Dowdy D. Breaking the translational barriers: The value of integrating biomedical informatics and translational research. J Investig Med. 2005;53(4):192-200.
Clinical IT systems have made an enormous impact on clinical research and study design (5). Specifically, hypothesis development and study preparation have been enhanced by the ability to perform literature searches using tools such as PubMed (6). Cohort identification and study recruitment have been enhanced by data-mining tools, and decision support systems, including clinical trial alert systems, have helped identify study candidates (7,8). The electronic medical record has streamlined clinical data collection from research participants, reduced redundant data entry, and helped identify patients who qualify for clinical investigations; in addition, computerized physician order entry has allowed accurate tracking of therapies prescribed and delivered to study patients (9,10).
In addition to clinical IT systems, several research-specific IT systems have been developed that have led to increases in data and research quality. These are now being implemented in clinical research studies at growing rates (6,11). Table 2–1 outlines some of the research-specific IT systems and their utility in clinical research (12–16).