Link to BCM home page
 

 

In for a Checkup? Check out the Research Too

by Ron Gilmore

Simple solutions to something as basic as how long must research participants be kept waiting to volunteer their time are part of the "new thinking" occurring as BCM research leaders aim to incorporate scientific study into the new Baylor Clinic, set to open its doors in early summer 2005.

Such new thinking is critical because clinical studies, as with clinical treatment, are increasingly outpatient focused. No longer are the majority of patient studies occurring in hospitals, but rather in clinic settings that are more than likely not set up for both treatment and research.

Helen Shepherd, director of research infrastructure programs at Baylor College of Medicine, enthusiastically refers to a principle of "connectivity of thought" that not only makes the clinical study process easier for participants, but also encourages more cross-collaboration between investigators while providing them the support they need to carry out their studies.

"The idea is to incorporate clinical research into the new Baylor Clinic in layers. A starting point would be to bring together a group of clinical researchers as an advisory group to discuss strategy on where to emphasize clinical research, and to analyze its strengths and weaknesses," said Shepherd.

Two key goals for the Office of Research in regard to Baylor Clinic include developing resources and systems to assist faculty in the conduct of clinical research, as well as recruiting an experienced physician investigator to fill the role of associate dean of clinical research.

According to Dr. James Patrick, senior vice president and dean for research, Baylor Clinic will provide opportunities to integrate research into the overall patient care and educational aspects targeted for the new ambulatory facility.

"The goal is to eventually have one research program that helps investigators with Institutional Review Board issues, educational components, software and grant assistance, quality assurances, and other vital aspects of conducting clinical research in today's environment," said Patrick. "We will be starting in the 6620 Main phase of Baylor Clinic by providing a research team who will be there to help clinical investigators. As we move into the next phase at 6600 Main, we will grow this program and offer more support for our clinical researchers."

Phase II of Baylor Clinic will be an academic model of care that will strive to fully integrate research, patient care and education, said Patrick. Such "connectivity of thought" will begin with the placement of seven research staff members located on the 11th floor of 6620 Main in a 1,100 square foot office dedicated to serving clinical investigators.

"The Office of Research has two clients," said Shepherd. "It serves both the study investigators and the study participants. The new clinic will provide an ideal location to do both."

Based on a series of interviews with clinical chairs in September-October 2004, the Office of Research began formulating plans for a Baylor clinical research office. "We asked them ‘what do you need?' and based on their responses, we began developing a working plan for both 6620 and 6600," said Shepherd.

The 6620 phase of Baylor Clinic plans to offer support in the following areas:

  • Grants and contracts, material transfer agreements and other budget issues associated with clinical studies
  • Office of Technology Administration, Institutional Review Board (IRB) and Biomedical Research Assurance and Information Network (BRAIN)
  • Recruitment, including development of a registry and database that can be used by investigators
  • Assistance in working with the U.S. Food and Drug Administration on investigational drug applications, regulatory affairs support, and working to attract more complex clinical trials
  • Creation of new models for different types of grants such as non-R01 training grants
  • Data management support such as implementation of a clinical trials management system
  • Adverse events handling, including data safety monitoring and use of shared databases
  • Grant searches and a central pool of coordinators available for investigators with limited resources

The 6600 phase will "grow" the level of support, boost collaboration, and encourage new directions for research, according to Patrick. Some services may include the following:

  • Develop cores, such as genetics and biostatistics, for research investigation
  • Offer educational programs for principal investigators and study coordinators
  • Identify an industry liaison to attract clinical trials and market BCM as a center of research excellence
  • Support for outcomes and quality
    assurance for studies
  • Addition of a research pharmacist on site
  • Trials setup services including budgetary
    issues
  • Storefront services for patients who don't
    require a clinic visit
  • Trial design and development support
  • Project management for studies
  • Data Safety Monitoring Board support

Yet another timesaver for researchers would be the creation of a research data repository that would allow them to "mine" a shared database for information that is currently localized by investigator and/or department. Such shared services will mean ready access to data pertinent to studies in different disciplines.

We intend to develop an enterprise-wide solution for clinical trial management... this includes robust support around recruitment strategies for study participants.

The result?
Ready access to data pertinent to studies in different disciplines.

"We intend to develop an enterprise-wide solution for clinical trial management," said Patrick. "This includes robust support around recruitment strategies for study participants. This new ambulatory setting will provide an ideal ‘shared' environment for fostering collaborative and ultimately successful clinical studies."

 

Patient Care

Two Halves to a Puzzle

Baylor Clinic from the Inside Out

Getting from There to There

Oil and Medicine: Profile on Dan Duncan

EMR as Easy as ABC

Research

Epilepsy: Seeking the Cause of a Lonely Disease

Epilepsy: A history of stigma and superstition

Dancing with a Deadly Disease

In for a Checkup? Check Out the Research Too

Wanted: More Space!

Education

All About the Education Evolution Revolution

Longing for the Short Coat

Community Service

Introducing the Problem Solvers

College News

Rededication of a Monument to Medicine

New BCM Logo Takes Center Stage

The Perfect Fit: Putting the Pieces Together

 

Our Mission, Values, and Imperatives

A Message from Dr. Traber

Conventional Thinking

A patient reads about a new drug study and decides to sign up. He sets up an appointment with the investigator, drives to the doctor's office, and sits with patients waiting to be seen. An hour later, he is handed a form and told to come back next time to begin study participation.

Result

The patient and potential study participant is frustrated, and the research process is slowed down.

New Thinking

Clinical research is integrated into an ambulatory care center. The patient goes to a storefront service area to drop off a form or have his blood pressure checked without ever visiting a waiting room. Or vice versa, a patient in for a check up learns of a study and she is allowed to enroll during the clinic visit.

Result

Happier participant; study sped up.

     
 

Volume 1, Issue 1, Spring 2005

   
 

BCM Home | BCM Intranet | Privacy Notices | Contact BCM | BCM Site Map

© 2005-8 Baylor College of Medicine®
Office of Public Affairs
One Baylor Plaza, Houston, Texas 77030
Mail: One Baylor Plaza, Mail Stop 106, Houston, Texas 77030
Phone: 713-798-4710 | Fax: 713-798-3692
E-mail: solutions@bcm.edu

   
  Last modified: October 10, 2008