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About the June 2012 Issue
The “business of clinical research” encompasses the institutional operations, administrative functions, and fiscal processes related to the management of clinical research activities. However, as the cover for this issue suggests, for these activities to be of maximum benefit to institutions and society as a whole, it is not enough to simply have all the pieces in place—one must put them in motion at the right time and in the right order. This issue’s contributing authors illustrate varied perspectives on the business of clinical research and highlight strategies for process improvement.
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FREE Article - Centralized Clinical Trial Support Infrastructure: An Academic Medical Center’s Experience
Tina G. Noonan, MBA, CHRC
The regulatory and compliance framework for clinical research has become increasingly complex and difficult to navigate, especially in terms of industry-funded research studies. This has greatly increased the administrative burden on clinical researchers and their teams. At the same time, the risk to the institution at which research is performed has grown, leading many academic medical centers to re-think the administrative infrastructure supporting these endeavors. This paper discusses the experience of one academic medical center that chose to adopt a centralized institutional clinical research support office. While the concept of such an office is not new, this office is unique in that it is a formal, joint operation of the academic and healthcare institutions that make up the medical center. The considerations for establishing this unique structure, as well as the lessons learned, are presented.
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Table of Contents
CHAIR’S MESSAGE
Principle Three: Humans Seek Predictability and Betterment
Clara H. Heering, MSc
Chair, Association Board of Trustees
GUEST EDITOR’S MESSAGE
Return on Investment and the Business of Clinical Research
Erika J. Stevens, MA
PEER REVIEWED ARTICLES
The Business of Clinical Research
Centralized Clinical Trial Support Infrastructure: An Academic Medical Center’s Experience 
Tina G. Noonan, MBA, CHRC
The regulatory and compliance framework for clinical research has become increasingly complex and difficult to navigate, especially in terms of industry-funded research studies. This has greatly increased the administrative burden on clinical researchers and their teams. At the same time, the risk to the institution at which research is performed has grown, leading many academic medical centers to re-think the administrative infrastructure supporting these endeavors. This paper discusses the experience of one academic medical center that chose to adopt a centralized institutional clinical research support office. While the concept of such an office is not new, this office is unique in that it is a formal, joint operation of the academic and healthcare institutions that make up the medical center. The considerations for establishing this unique structure, as well as the lessons learned, are presented.
The Business of Clinical Research
Jean M. Gatewood, RN OCN, BS, MBA
As research funding sources tighten their belts, clinical experts need to master familiarity with standard business principles in order to operate a successful research program while simultaneously attending to the bottom line. A common belief held by many in the healthcare sector is that clinical research programs often operate at a financial loss to the institution tasked with gathering the subject data. By applying sound business techniques that are widely used in other industries, a clinical research program can be conducted while avoiding a deficit situation. Implementation of important assessment measures, background fact gathering, and motivation to address break-even analysis need to occur in advance of setting up a clinical research study. The objective is not to profit, rather to be mindful of key considerations that affect the margin. This article will investigate and explore what works as researchers learn to apply strategic thinking to avoid potential gaps.
Protecting, Prioritizing, and Funding Research Personnel: Development of a Centralized Support Core
Philip A. Cola, MA | Sonya Mihalus, RN, BSN, CCRC | Carol Fedor, ND, RN, CCRC
There are many challenges that affect clinical research infrastructure in academic medical centers (AMCs), including regulatory burden on the investigators; protected time for investigators to conduct research; recruitment and retention of research participants; and retention of qualified clinical research personnel who serve as the critical factor in ensuring the responsible conduct of research. Historically, clinical research coordinators were hired by a principal investigator under the auspices of an institution, based on the availability of grant funding. There have been calls for centralized clinical research support to ensure that essential infrastructure exists in AMCs to conduct clinical and translational research. This paper reviews this basic research personnel dilemma through a case study outlining a suggested model for the sustainability of study staff during an era of reduction in federal funding for research and an extremely competitive market for industry sponsored clinical research.
Developing and Evaluating a Scoring Rubric for Determining the Acuity of a Clinical Research Protocol: The Protocol Acuity Scoring Tool (PAST)
Patricia Robinson, RN, BSN, MBA, MS | Tracy Robbins, RN, BSN, MS, CCRP | Jane Conner Kane, RN, BSN, CCRC | Angela Gibbs, RN, MSN, OCN | Kahsi A. Threlkeld, PhD
In the absence of a standardized tool to determine feasibility of participating in a clinical trial, this article reports on the development and evaluation of a protocol acuity scoring tool used to provide structure to the initial review of a research protocol by scoring elements such as feasibility, recruitment, study process, and follow-up. Subcategories within these elements were identified and a simple numerical scoring rubric was developed. The consistency in scoring among raters was evaluated and inter-rater reliability was determined by intra-class correlation coefficients. This paper provides insight into the development and validity testing of the acuity tool, and will serve as groundwork for further investigations of the tool and its ability to predict the budgetary requirements and workload of a particular protocol.
Developing Centralized Monitoring Support Services for Sponsor-Investigators in Academic Medicine
Cynthia Hahn | Emmelyn Kim, MA, MPH, CPH
Advancements in biomedicine have led to increased pressure for clinicians to conduct research and an increase in investigator-initiated research, where the investigator holds the Investigational New Drug or Investigational Device Exemption application and acts as the sponsor. Sponsor-investigator trials require regulatory monitoring services that cost money, and most universities, academic medical centers (AMCs), and hospitals are operating at low profit margins, if any at all. This tension between compliance and how to pay for it may not be reason for concern when all involved understand the risk, responsibility, and business of clinical research. Institutional research compliance programs should consider enhancing regulatory supports by providing clinical trial monitoring services for sponsor-investigators in addition to comprehensive regulatory guidance, tools, and education to facilitate the responsible conduct of research. This article will present how these objectives may be met for sponsor-investigators at AMCs by providing central monitoring and regulatory support services.
Research Pharmacy Services: A Review of Licensure Requirements, Regulations, and Standard Operating Procedures
Robert MacArthur, MS, PharmD
Research pharmacies are found at most major academic medical centers and large research clinics. Their primary function is to ensure that investigational medications are managed locally in a manner that minimizes the possibility of medication errors, promotes high-quality research, and optimizes patient compliance. Many regulatory bodies enforce regulations that affect the process of investigational drug handling with these objectives in mind, including local/state medical and pharmacy boards, the Food and Drug Administration, the Drug Enforcement Agency, the European Medicines Agency, the United States Pharmacopeial Convention, and others. To place research pharmacy practice into the appropriate regulatory context, this review describes the licensure requirements and major regulations that affect the investigational drug handling process. A minimum set of standard operating procedures that should be in place where investigational drugs for human use are stored and managed also are described.
Data Service Providers: A Primer for Successful Global Partnerships
Laurin Mancour, CCRA, CCRP, RAC | Yvonne Rollinger, PhD | Bev Hudson, MBA
A well-run partnership between a clinical research organization and technology service provider contributes to quality and efficiency in data management. Electronic data capture applications are generally considered to be cost-effective resources for promoting transparent access to study data and faster timelines, but poor communication of expectations and inconsistencies in shared processes will likely create challenges and unanticipated outcomes. In order to navigate this relationship effectively, clinical research organizations need to consider protocol and regulatory implications, case report form design, quality assurance processes, and vendor support capabilities. This article suggests points to consider so that organizations can anticipate and articulate operational concerns and increase the opportunities for successful partnerships with their data service providers.
Pathways for Translating Research to Communities: NIH’s Partners in Research Program
Patricia A. Grady, PhD, RN, FAAN | Yvonne T. Maddox, PhD
For decades, the National Institutes of Health (NIH) has been taking on some of the most pressing U.S. public health issues by supporting a wide array of biomedical and behavioral research. For this effort to successfully translate into improvements in the nation's health, the public needs to be aware of, and to trust in, this research enterprise. In 2004, the NIH initiated the NIH Partners in Research program to support feasibility studies to improve the public's understanding of biomedical and behavioral science, and to support strategies for the promotion of collaborations between scientists and community leaders. Ultimately, 37 partnerships received awards, the first time the NIH has made co-awards to academic/community partners. These pilot studies provide guidance for future collaborative efforts supported by the NIH through scientific publications, conference presentations, and other dissemination materials.
Other Issues in Clinical Research
Meeting the Challenges in Outsourcing Clinical Research to Contract Research Organizations
Patricia Kasper, MS
Biotechnology and pharmaceutical industries continue to increase the number of services outsourced to contract research organizations (CROs). Some experts estimate that roughly 40% of drug development will be outsourced by 2012, resulting in challenges, advantages, and controversies. To further explore and define these challenges faced by the industry, 10 senior directors from top biotechnology and CRO companies gathered for a roundtable discussion on "Meeting the Challenges in Outsourcing Clinical Research to CROs." This article explores how sponsors can partner with CROs to ensure CRO staff have the same motivation and dedication as the sponsor; how small biotech companies find and manage CROs when their resources are limited; how small CROs compete and get repeat business when bidding against large CROs; and the benefits and inherent problems of anticipated regulations that increase the rules governing sponsor-CRO relationships.
OPINION
Fair Play with Freelancers? A Case for a Voluntary Ethical Code of Practice for Recruiting Agencies
Jorge Garcia, PhD
It used to be quite common for employees to stay continuously employed in one pharmaceutical company for a long time, even 30 years or more, but this will soon be a thing of the past. The globalization and reorganization of the pharmaceutical environment is leading to a demand for flexible working structures and highly qualified, specialist research professionals. A growing number of clinical research professionals are discovering the alternative of working as a freelancer. This path offers many opportunities, but also involves some risks. This article provides a perspective on such issues, based on the author’s experiences in Germany.
COLUMNS
AMC ROUNDTABLE
Surviving in the Corporate World: An AMC Clinical Trials Office Perspective
Melinda Muenich, RN, MBA
DATA-TECH CONNECT
Supporting Remote Workers
Kirk Mousley, MSEE, PhD
OFF THE WIRE
Taking Care of Business (in the News)
Gary W. Cramer
OPERATING ASSUMPTIONS
The Best We Can
Ronald S. Waife
RESEARCH COMPLIANCE
Energizing a Radioactive Drug Research Committee
Brent Ibata, PhD, JD, MPH, RAC, CCRC
ASSOCIATION NEWS
ACRP 2012 GLOBAL CONFERENCE & EXHIBITION WRAPUP
Houston, the Conference Has Landed
The 2012 ACRP Annual Awards
The 2012 APCR Awards
Long-Term Achievements Lauded at Certification Milestone Recognition Ceremony
PROFESSIONAL DEVELOPMENT
Soft Skills in Clinical Research
Thomas Coffey, CPLP
CHAPTERS
ACRP Chapter Listing
Chapter Notes
APCR NEWS AND COLUMNS
APCR Board of Trustees & Organizational Listing
APCR PRESIDENT’S MESSAGE
Clinical Research—Low Barrier to Entry, High Barrier to Success
Michael J. Koren, MD, FACC, CPI
PI CORNER
The Business of Clinical Research as an Owner/CEO/PI: Know Before You Go!
Joel S. Ross, MD, FACP, AGSF, CMD, CPI, LLC
DEPARTMENTS
Home Study: The Business of Clinical Research
ACRP Board of Trustees, Committees, and Staff
ACRP/APCR Uniform Code of Ethics and Professional Conduct
Monitor Article Submission Guidelines
Index of Advertisers
Calendar of Events