Taking Clinical Trials to the Next Level

January 23, 2012

Dean Robert Alpern: 333 Cedar Street

333 Cedar Street is a monthly letter from Dean Robert J. Alpern, MD, Ensign Professor of Medicine, on topics of interest to the Yale School of Medicine community. Write to Dean Alpern at 333cedar@yale.edu.

Clinical research at Yale is moving forward rapidly with a major clinical trials recruitment campaign, branding initiative, and new system for data and trials management.

To the School of Medicine Community,

Last summer, the Institute of Medicine convened a working group of experts to tackle the problems that hinder clinical trials of new drug candidates nationally. These obstacles range from slow or insufficient accrual of study subjects, uneven representation in certain segments of the population, delays related to regulatory requirements, and the often fragmented way in which trials are undertaken. In recent years, there has been a shortfall in volunteers for many clinical trials, not just at Yale but at academic research centers around the world, and particularly among minorities, adolescents, and cancer patients.

The working group distilled a list of core elements for successful trials that includes focusing on patient accrual, investing in community outreach and education, building systems to deal with the complex research landscape, and communication effectively. For the past several years, the School of Medicine has been focusing on these and other goals, including a major clinical trials recruitment campaign titled "Help Us Discover." The goal of the campaign, which begins today, is to increase the number of participants in the more than 400 open clinical studies at Yale.

Faculty and staff at the Yale Center for Clinical Investigation (YCCI) have focused their efforts on:

  • Developing a new website, yalestudies.org, along with posters, brochures, newspaper ads, transit ads, and community health fairs, in cooperation with stakeholders within the medical school, Yale-New Haven Hospital, the university, and our surrounding neighborhoods and towns.
  • Engaging community organizations to help explain the clinical research process, the safeguards that protect participants' rights and safety, and the benefits of participation to potential study volunteers.
  • Providing templates to advertise studies and raising awareness of the "clinical research brand" at Yale, to make it easier and less costly for investigators to recruit patients. This includes arranging bulk advertising rates by buying ad space and time as a group. With the Woodbridge-based firm Mason, Inc., YCCI has created a consistent look and feel for all the materials.

Working with Yale School of Nursing Dean Margaret Grey, DrPH, RN, who leads YCCI's new community engagement group, religious and community leaders have stepped forward as ambassadors and appeared in the posters and other materials. This group, which includes individuals affiliated with the African Methodist Episcopal Zion Church in Connecticut and JUNTA, the Latino advocacy organization, meets monthly to help faculty develop culturally sensitive recruitment efforts, translate research materials, and organize community-based recruitment events.

As a school, we have listened to stakeholders across the board—participants, clinical researchers, and community members—and taken their advice. I invite you to visit yalestudies.org and browse the clinical trials database. Those interested in participating, either as healthy volunteers or as patients advancing the medical science in a particular area, can create a profile in the system and receive alerts when a relevant study is seeking volunteers.

These efforts are all supported by the considerable expertise of YCCI, which was established in 2006 and was among the first 12 centers to receive funding under the federal Clinical and Translational Science Award program. YCCI facilitates the training of clinical and translational scientists and supports investigators in the areas of biostatistics, bioinformatics, study design, core technologies, regulatory review, and community-based research.

A major enhancement to the infrastructure developed by YCCI is the purchase of a new system for managing clinical trials and trials data. The rollout of this new tool, OnCore, began with the Yale Cancer Center in July and will continue over the next 12 to 18 months as other units at the Schools of Medicine, Public Health, and Nursing come online (more information is available at oncore.yale.edu).

A robust clinical trials management system is vitally important to our goal of speeding translation of research into patient care, and OnCore has outstanding capabilities, including electronic data capture and the automated capture of lab values, a biospecimen management system, integrated financial management, and enhanced reporting. It will also interface with Epic, the new electronic medical record system recently implemented by the medical school and hospital.

Now with the implementation of Epic and OnCore well under way, we are beginning the planning process for the enterprise-wide clinical research data repository (CRDR). The CRDR will integrated data from several sources, in diverse formats, into a single repository structure, allowing greater visibility and easier analysis of clinical and research data. YCCI and the IT leadership team are in the process of canvassing other institutions that have had Epic in place for the past few years and have well-developed repositories, in order to learn more about ways of leveraging data to conduct research.

The School of Medicine's central administration has made major investments in support of clinical investigation. Optimal systems for clinical trials management and recruitment are crucial to the school's missions of research, patient care, and education, because clinical research is a critical element in the future of medical science and practice. If your work or study at Yale involves clinical research and you are not already familiar with the resources provided by YCCI, a great deal more information is available at the websites linked above.

Sincerely, 

Robert J. Alpern, MD
Dean and Ensign Professor of Medicine