Raising Public Awareness of Clinical Trials: Development of Messages for a National Health Communication Campaign.

Clinical trials are essential for developing new and effective treatments and improving patient quality of life; however, many trials cannot answer their primary research questions because they fall short of their recruitment goals. This article reports the results of formative research conducted in two populations, the public and primary care physicians, to identify messages that may raise awareness and increase interest in clinical trials and be used in a national communication campaign. Results suggested that participants were primarily motivated to participate in clinical trials out of a self-interest to help themselves first.

A Novel Approach to Measuring Efficiency of Scientific Research Projects: Data Envelopment Analysis.

Purpose: Measuring the efficiency of resource allocation for the conduct of scientific projects in medical research is difficult due to, among other factors, the heterogeneity of resources supplied (e.g., dollars or FTEs) and outcomes expected (e.

The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.

Introduction: Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions.

Methods: The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts.

Estimating return on investment in translational research: methods and protocols.

Assessing the value of clinical and translational research funding on accelerating the translation of scientific knowledge is a fundamental issue faced by the National Institutes of Health (NIH) and its Clinical and Translational Awards (CTSAs). To address this issue, the authors propose a model for measuring the return on investment (ROI) of one key CTSA program, the clinical research unit (CRU). By estimating the economic and social inputs and outputs of this program, this model produces multiple levels of ROI: investigator, program, and institutional estimates.

A "three-plus-one" evaluation model for clinical research management.

Clinical research management (CRM) is a critical resource for the management of clinical trials and it requires proper evaluation. This article advances a model of evaluation that has three local levels, plus one global level, for evaluating the value of CRM. The primary level for evaluation is that of the study or processes level.

Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov.

Importance: Clinical trials are essential to cancer care, and data about the current state of research in oncology are needed to develop benchmarks and set the stage for improvement.

Objective: To perform a comprehensive analysis of the national oncology clinical research portfolio.

Design: All interventional clinical studies registered on ClinicalTrials.

AccrualNet: Addressing Low Accrual Via a Knowledge-Based, Community of Practice Platform.

Purpose: Present the design and initial evaluation of a unique, Web-enabled platform for the development of a community of practice around issues of oncology clinical trial accrual.

Methods: The National Cancer Institute (NCI) conducted research with oncology professionals to identify unmet clinical trial accrual needs in the field. In response, a comprehensive platform for accrual resources, AccrualNet, was created by using an agile development process, storyboarding, and user testing.

A virtual national laboratory for reengineering clinical translational science.

Clinical research is burdened by inefficiencies and complexities, with a poor record of trial completion, none of which is desirable. The Clinical and Translational Science Award (CTSA) Consortium, including more than 60 clinical research institutions, supports a unified national effort to become, in effect, a virtual national laboratory designed to identify, implement, evaluate, and extend process improvements across all parts of clinical research, from conception to completion. If adequately supported by academic health centers, industry, and funding agencies, the Consortium could become a test bed for improvements that can dramatically reduce wasteful complexity, thus increasing the likelihood of clinical trial completion.

The importance of doing trials right while doing the right trials.

Effort is being expended in investigating efficiency measures (i.e., doing trials right) through achievement of accrual and endpoint goals for clinical trials.

The prevalence and economic impact of low-enrolling clinical studies at an academic medical center.

Purpose: The authors assessed the prevalence and associated economic impact of low-enrolling clinical studies at a single academic medical center.

Method: The authors examined all clinical studies receiving institutional review board (IRB) review between FY2006 and FY2009 at Oregon Health & Science University (OHSU) for recruitment performance and analyzed them by type of IRB review (full-board, exempt, expedited), funding mechanism, and academic unit. A low-enrolling study included those with zero or one participant at the time of study termination.

Predicting accrual achievement: monitoring accrual milestones of NCI-CTEP-sponsored clinical trials.

Purpose: The need to increase the number oncology clinical trials with sufficient enrollments is a well-known issue, particularly for trials targeting therapeutic applications. It is critical to identify early predictors of eventual study accrual achievement.

Experimental Design: All nonpediatric phase I, I/II, II, and III therapeutic studies supported by the National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP) between 2000 and 2007 (n = 764) were analyzed for accrual performance.

A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.

Purpose: Postactivation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time.

Experimental Design: National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, nonpediatric phase I, I/II, II, and III studies activated between 2000 and 2004 were investigated for an 8-year period (n = 419).

Phase III clinical trial development: a process of chutes and ladders.

Purpose: The Institute of Medicine report on cooperative groups and the National Cancer Institute (NCI) report from the Operational Efficiency Working Group both recommend changes to the processes for opening a clinical trial. This article provides evidence for the need for such changes by completing the first comprehensive review of all the time and steps required to open a phase III oncology clinical trial and discusses the effect of time to protocol activation on subject accrual.

Methods: The Dilts and Sandler method was used at four cancer centers, two cooperative groups, and the NCI Cancer Therapy Evaluation Program.

Openness of patients' reporting with use of electronic records: psychiatric clinicians' views.

Objectives: Improvements in electronic health record (EHR) system development will require an understanding of psychiatric clinicians' views on EHR system acceptability, including effects on psychotherapy communications, data-recording behaviors, data accessibility versus security and privacy, data quality and clarity, communications with medical colleagues, and stigma.

Design: Multidisciplinary development of a survey instrument targeting psychiatric clinicians who recently switched to EHR system use, focus group testing, data analysis, and data reliability testing.

Measurements: Survey of 120 university-based, outpatient mental health clinicians, with 56 (47%) responding, conducted 18 months after transition from a paper to an EHR system.

Steps and time to process clinical trials at the Cancer Therapy Evaluation Program.

Purpose: To examine the processes and document the calendar time required for the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) and Central Institutional Review Board (CIRB) to evaluate and approve phase III clinical trials.

Methods: Process steps were documented by (1) interviewing CTEP and CIRB staff regarding the steps required to activate a trial from initial concept submission to trial activation by a cooperative group, (2) reviewing standard operating procedures, and (3) inspecting trial records and documents for selected trials to identify any additional steps. Calendar time was collected from initial concept submission to activation using retrospective data from the CTEP Protocol and Information Office.

Development of clinical trials in a cooperative group setting: the eastern cooperative oncology group.

Purpose: We examine the processes and document the calendar time required to activate phase II and III clinical trials by an oncology group: the Eastern Cooperative Oncology Group (ECOG).

Methods: Setup steps were documented by (a) interviewing ECOG headquarters and statistical center staff, and committee chairs, (b) reviewing standard operating procedure manuals, and (c) inspecting study records, documents, and e-mails to identify additional steps. Calendar time was collected for each major process for each study in this set.

Processes to activate phase III clinical trials in a Cooperative Oncology Group: the Case of Cancer and Leukemia Group B.

Purpose: National Cancer Institute-sponsored cooperative oncology groups are major sponsors of phase III clinical trials, yet the time and steps required to design and activate such studies has not been well studied. We examine the processes and document the calendar time required to activate such studies opened by the Cancer and Leukemia Group B (CALGB).

Methods: Setup steps were documented by (1) interviewing CALGB headquarters and statistical center staff and committee chairs to discover the steps required to transit from concept development to final study activation, (2) reviewing procedure manuals, and (3) inspecting all study records, documents, and e-mails to identify any additional steps.

Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials.

Purpose: To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites.

Methods: VICC, a National Cancer Institute-designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data.

The physician-patient relationship: the impact of patient-obtained medical information.

We investigate the impact of patient-obtained medical information (POMI) on the physician-patient relationship when patients, as a group, are heterogeneously informed and a physician's interests do not coincide with those of her patients. Introducing additional well-informed patients to the population discontinuously affects the physician's strategy, having no effect unless a sufficient quantity is added. When few patients are well informed, increasing the precision of their information level has no effect on the physician's strategy.