A Real-Time Screening Alert Improves Patient Recruitment Efficiency

The scarcity of cost-effective patient identification methods represents a significant barrier to clinical research. Research recruitment alerts have been designed to facilitate physician referrals but limited support is available to clinical researchers. We conducted a retrospective data analysis to evaluate the efficacy of a real-time patient identification alert delivered to clinical research coordinators recruiting for a clinical prospective cohort study. Data from log analysis and informal interviews with coordinators were triangulated. Over a 12-month period, 11,295 were screened electronically, 1,449 were interviewed, and 282 were enrolled. The enrollment rates for the alert and two other conventional methods were 4.65%, 2.01%, and 1.34% respectively. A taxonomy of eligibility status was proposed to precisely categorize research patients. Practical ineligibility factors were identified and their correlation with age and gender were analyzed. We conclude that the automatic prescreening alert improves screening efficiency and is an effective aid to clinical research coordinators

Using EHRs to integrate research with patient care: promises and challenges

Clinical research is the foundation for advancing the practice of medicine. However, the lack of seamless integration between clinical research and patient care workflow impedes recruitment efficiency, escalates research costs, and hence threatens the entire clinical research enterprise. Increased use of electronic health records (EHRs) holds promise for facilitating this integration but must surmount regulatory obstacles. Among the unintended consequences of current research oversight are barriers to accessing patient information for prescreening and recruitment, coordinating scheduling of clinical and research visits, and reconciling information about clinical and research drugs. We conclude that the EHR alone cannot overcome barriers in conducting clinical trials and comparative effectiveness research. Patient privacy and human subject protection policies should be clarified at the local level to exploit optimally the full potential of EHRs, while continuing to ensure participant safety. Increased alignment of policies that regulate the clinical and research use of EHRs could help fulfill the vision of more efficiently obtaining clinical research evidence to improve human health

Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial

This paper describes the rationale and design of the vanguard for the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS), a multicenter, randomized, controlled trial of a patient preference‐based, stepped care protocol for persistent depressive symptoms after acute coronary syndrome (ACS). The overall aim of the vanguard phase was to determine whether the patient-preference, stepped care protocol, which is based on the intervention used in the recent Coronary Psychosocial Evaluation Studies (COPES) trial, was feasible in patients with recent ACS who were recruited from 5 geographically diverse sites. Innovative design features of this trial include randomization to either initial patient-preference of treatment or to a referred care arm in which the primary care provider decided upon care. Additionally, delivery of psychotherapy was accomplished by telephone, or webcam, depending upon patient preference. The vanguard phase provides estimates of eligibility and screening/enrollment ratios, patient acceptance of screening, and retention. In this report, we describe the innovative features and the baseline results of the vanguard phase of CODIACS. The data from this vanguard study will be used to finalize planning for a large, phase III clinical trial designed to evaluate the effect of treatment on depressive symptoms, coronary events, and death

Nine-Year Effects of 3.7 Years of Intensive Glycemic Control on Cardiovascular Outcomes

In the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, ∼4 years of intensive versus standard glycemic control in participants with type 2 diabetes and other cardiovascular risk factors had a neutral effect on the composite cardiovascular outcome, increased cardiovascular and total mortality, and reduced nonfatal myocardial infarction. Effects of the intervention during prolonged follow-up were analyzed

Emerging concepts in biomarker discovery; The US-Japan workshop on immunological molecular markers in oncology

Supported by the Office of International Affairs, National Cancer Institute (NCI), the "US-Japan Workshop on Immunological Biomarkers in Oncology" was held in March 2009. The workshop was related to a task force launched by the International Society for the Biological Therapy of Cancer (iSBTc) and the United States Food and Drug Administration (FDA) to identify strategies for biomarker discovery and validation in the field of biotherapy. The effort will culminate on October 28th 2009 in the "iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer", which will be held in Washington DC in association with the Annual Meeting. The purposes of the US-Japan workshop were a) to discuss novel approaches to enhance the discovery of predictive and/or prognostic markers in cancer immunotherapy; b) to define the state of the science in biomarker discovery and validation. The participation of Japanese and US scientists provided the opportunity to identify shared or discordant themes across the distinct immune genetic background and the diverse prevalence of disease between the two Nations

Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: Design and methods

© 2007 Elsevier Inc. All rights reserved. Most patients with type 2 diabetes mellitus develop cardiovascular disease (CVD), with substantial loss of life expectancy. Nonfatal CVD contributes greatly to excess healthcare costs and decreased quality of life in patients with diabetes. The current epidemic of obesity has raised expectations that CVD associated with type 2 diabetes will become an even greater public health challenge. Despite the importance of this health problem, there is a lack of definitive data on the effects of the intensive control of glycemia and other CVD risk factors on CVD event rates in patients with type 2 diabetes. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is a randomized, multicenter, double 2 - 2 factorial design study involving 10,251 middle-aged and older participants with type 2 diabetes who are at high risk for CVD events because of existing CVD or additional risk factors. ACCORD is testing the effects of 3 medical treatment strategies to reduce CVD morbidity and mortality. All participants are in the glycemia trial, which is testing the hypothesis that a therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level of \u3c6.0% will reduce the rate of CVD events more than a strategy that targets an HbA1c level of 7.0%-7.9%. The lipid trial includes 5,518 of the participants, who receive either fenofibrate or placebo in a double-masked fashion to test the hypothesis of whether, in the context of good glycemic control, a therapeutic strategy that uses a fibrate to increase high-density lipoprotein cholesterol and lower triglyceride levels together with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) to lower low-density lipoprotein cholesterol will reduce the rate of CVD events compared with a strategy that uses a statin plus a placebo. The blood pressure trial includes the remaining 4,733 participants and tests the hypothesis that a therapeutic strategy that targets a systolic blood pressure of \u3c120 mm Hg in the context of good glycemic control will reduce the rate of CVD events compared with a strategy that targets a systolic blood pressure of \u3c140 mm Hg. The primary outcome measure for all 3 research questions is the first occurrence of a major CVD event, specifically nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Upon the expected completion of participant follow-up in 2009, the ACCORD trial should document for the first time the benefits and risks of intensive glucose control, intensive blood pressure control, and the combination of fibrate and statin drugs in managing blood lipids in high-risk patients with type 2 diabetes