IECRN/Networks for Clinical Research
- What is the IECRN/Networks for Clinical Research?
- What is a clinical research network (CRN)?
- How does the IECRN fit into the NIH Roadmap?
- What is the Core Survey?
- What was the Descriptive Survey?
- What was the Best Practices Study?
- What was the National Leadership Forum?
- Who is coordinating the Project?
- Are there other ways I can get involved in reengineering the clinical research enterprise?
What is the IECRN/Networks for Clinical Research?
The IECRN is the Inventory and Evaluation of Clinical Research Networks. It is a project funded by the National Institutes of Health (NIH) and managed through the National Center for Research Resources (NCRR). The first phase of the project was conducted from September 2004 to July 2006 to develop an inventory of clinical research networks and to conduct an assessment of networks with efficient and effective practices. The second phase of the project, which will be conducted through February 2010, is to continue to develop and maintain the inventory of clinical research networks. The inventory of clinical research networks is available on this web site entitled Networks for Clinical Research and can be accessed from the Home Page. During the first phase of the project there were four components of the IECRN: the Core Survey, the Descriptive Survey, the Best Practices Study, and the National Leadership Forum. The Core Survey verified that the network was an active clinical research network and included brief background questions, such as types of studies being conducted and any focus on special populations. The Descriptive Survey included questions in seven modules (see "What was the Descriptive Survey?" for a list of the modules). The Best Practices Study sought to identify clinical research network practices that contributed to a network's demonstrated success in several areas. A National Leadership Forum was convened on May 31 and June 1, 2006 to summarize the findings of the Descriptive Survey and Best Practices Study and discuss next steps. During the second phase of the project, the Core Survey will continue to be used to collect information on clinical research networks in order to add them to the Inventory.
What is a clinical research network (CRN)?
For the purposes of this project, a clinical research network (CRN) is defined as an organization of clinical sites and investigators that conducts or intends to conduct multiple collaborative research protocols. A CRN must conduct research on human subjects or use data from human subjects that is relevant to improving the quality of human health. Types of studies may include clinical trials as well as epidemiologic, behavior modification, health communication, patient care, medical practice, clinical quality and process improvement research. A CRN must have scientific leadership that either develops or evaluates the concepts or protocols that are brought before it and must include at least three independent participating entities. For a more detailed explanation of a clinical research network, read the definition of a Clinical Research Network using Adobe Acrobat.
How does the IECRN fit into the NIH Roadmap?
The IECRN project is related to Reengineering the Clinical Research Enterprise, a part of the NIH Roadmap initiative aimed at enhancing the efficiency and productivity of clinical research by promoting clinical research networks that can rapidly conduct high quality studies capable of addressing multiple research questions. You can find more information on the NIH Roadmap at www.nihroadmap.nih.gov.
What is the Core Survey?
The "Core Survey" is the term used to identify the brief data collection survey completed by all potential CRNs. This brief survey verifies that the network is an active clinical research network and asks a few questions about the network such as age of network, participating entities, types of studies being conducted, and any focus on special populations. The survey, which should take no more than 15 minutes to answer, can be returned via email, mail or fax. Information from the survey is displayed in responding networks' profiles on the Networks for Clinical Research web site.
What was the Descriptive Survey?
In the first phase of the IECRN project, the Descriptive Survey was a series of survey modules designed to elicit information about the organization and functioning of a random sample of CRNs. The modules covered network management and governance; operations; training and professional development; information technology; data management; recruitment and retention; and financial practices. Parts of the modules were completed in hard copy or online and other parts were administered by telephone to identified network representatives. The results from the Descriptive Study can be found on the Survey and Reports page.
What was the Best Practices Study?
The IECRN project sought nominations for clinical research network (CRN) best practices from fall 2005 through January 2006. Each CRN had the opportunity to nominate itself or another network as a candidate for exemplifying a best practice or best practices in meeting one or more specified outcomes. The project team invited representatives from government agencies such as the NIH Institutes, the Centers for Disease Control, and the Veterans Administration to submit nominations as well.
The nominations were reviewed by a team of clinical research network experts and evaluation specialists who scored the nominees on the basis of demonstrated success in achieving one or more of the stated outcomes. A subset of the networks studied had their practices showcased at the National Leadership Forum. The results from the Best Practices Study can be found on the Survey and Reports page.
What was the National Leadership Forum?
The National Leadership Forum was held on May 31 and June 1, 2006. The Forum served as a venue to present selected findings from the Descriptive Survey and the Best Practices Study. It was an important vehicle for disseminating information about network characteristics and best practices and for formulating recommendations for next steps to take in promoting CRNs. To view the presentations, web casts, and reports from the Forum, go to the National Leadership Forum pages of this web site.
Who is coordinating the Project?
The first phase of the IECRN project was coordinated by Westat with support from Lockheed Martin Aspen Systems, Social & Scientific Systems, and Borland. An Advisory Panel of 12 clinical research network experts also provided consultation to the project team. Westat is coordinating the second phase of the project to continue to maintain and update the inventory of clinical research networks.
Are there other ways I can get involved in reengineering the clinical research enterprise?
The National Heart, Lung, and Blood Institute (NHLBI) is currently developing a Clinical Research Guide to assist current and potential investigators in specific areas:
Organizing a human subjects application
Conducting a study
Maintaining an award
As a result of the recent IECRN National Leadership Forum, a tool kit to include templates and samples for protocols, consent forms, COI policies, report cards and other useful items will be developed. To obtain more information, feel free to contact Victoria Pemberton at pembertonv@nhlbi.nih.gov
