Clinical Research (CR)

Examines issues relevant to both National Institutes of Health-sponsored and industry-sponsored clinical trials. Much of the material is explored through case studies. Elements of the curriculum include protocol review, recruitment, negotiation of agreements, development and negotiation of budgets, compliance, billing, international studies, and risk management and analysis.

Monday, April 3, 2017

M106: Extreme Makeover: Sponsored Edition
Monday, April 3, 2017 - 9:30am to 10:45am

Content level: Basic

As sponsored administrators, managers and analysts alike, we all face difficult situations that require time and resources to resolve but what happens when resources are limited and the challenges are vast? What happens when turnover and staffing become as much of a challenge as the research management itself? Where does one focus their attention and where does one even begin? In this presentation, two representatives from the Department of Medicine will outline their individual case studies from the same institution. Both speakers will identify their own personal challenges, resolutions and the ultimate fruition of calculated but strategic approaches to seemingly impossible administrative endeavors. Participants are encouraged to speak as a collective forum.

Learning objectives:

  1. Identifying key challenges and resolutions to sponsored award management from an administrative perspective (staffing, training, resources, guidance and support).
  2. Outlining methodologies, tactics and best practice approaches to overcoming these challenges that have proven successful.

Prerequisites: None

Speaker(s):

Chad Restrick, MSM, CRA, Research Service Manager and Tony Brown, Research Service Manager, Johns Hopkins University

M206: Essential Documents - Essential to What and to Whom?
Monday, April 3, 2017 - 11:00am to 12:15pm

Content level: Intermediate

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) provides a list of "Essential Documents" that a clinical trial should have to accurately document information throughout the project.  These documents range from administrative data (e.g., financial agreements, data sharing agreements), regulatory data (e.g., Food and Drug Administration  (FDA) documentation, Institutional Review Board (IRB) documentation), training and qualification records, through actual study data. By keeping these documents on file, research sites are more likely to satisfy research monitors and FDA inspectors.  Reviewing these documents, appropriate documentation, and efficient storage of the documentation will be discussed.

Learning objectives:

  1. Understand essential documents and the reason that they are necessary for each project.
  2. Identify ways to manage documents at research sites to be ready for monitor and inspections.

Prerequisites: None

Speaker(s):

Tonya Edvalson, CCRP, Regulatory Coordinator II, Intermountain Healthcare

M306: Faculty Approaches and Methodologies for Clinical Research
Monday, April 3, 2017 - 2:15pm to 3:30pm

Content level: Advanced

The research environment continues to evolve from the early pioneering days of the individual researcher working away in the lab to the more collaborative and out-reaching world of today.  We are also beginning to take a broader look at how research contributes, not only to the clinical disciplines, but to the patients and the communities we look to serve.  This presentation will offer a researcher’s perspective of the changing landscape of research as it migrates toward greater community engagement research.

Learning objectives:

  1. Enhance understanding of your researchers’ world.
  2. Gain an appreciation of current research trends toward more community-engaged research.
  3. Evaluate current practices in support of research development.

Prerequisites: None

Speaker(s):

Thomas Oates, PhD, Professor and Chair, School of Dentistry, University of Maryland, Baltimore

M406: Capitated Budgets: Post-award Financial Management of Fixed-price Clinical Contracts
Monday, April 3, 2017 - 3:45pm to 5:00pm

Content level: Intermediate

How does managing a fixed-price clinical trial contract differ from a cost reimbursable grant? Even for financial administrators experienced in post-award grant management, capitated budgets may present a challenge. Fixed-price contracts may require a shift in one's perception of and established standards for effort allocation, project periods, budgetary line items, billing procedures, and reconciliation processes. The concepts of flexible budgets, amendable budgets, milestone reimbursements, negotiations with sponsors, flat fees, competitive enrollment, charges vs. costs become a new reality. Recent years show that even National Institutes of Health (NIH) funding is gradually shifting to capitated reimbursement structure for clinical research proposals. In this session participants will utilize sample clinical trial contracts and financial tools to address the differences between fixed-price and cost-reimbursable projects as well as the post-award challenges and the benefits of capitated contracts.

Learning objectives:

  1. Define main differences in post-award management of fixed-price contracts and cost-reimbursable grants.
  2. Utilize practical skills in post-award financial management of capitated clinical trial contracts.

Prerequisites: None

Speaker(s):

Pavel Kruchek, MBA, Director, Business Operations, Clinical Trials Office and Vanessa Bryant, Sr. Budget Analyst, Clinical Trials Office, University of Utah

Tuesday, April 4, 2017

T106: Post-Submission to Award Acceptance
Tuesday, April 4, 2017 - 9:15am to 10:30am

Content level: Basic

The pre-award office is responsible for dealing with a variety of issues that arise after proposal submission and lead to acceptance of the award. The pre-award administrator should be able to deal with publication restrictions, intellectual property, indemnification, facilities and administrative costs questions, and know how to address such special situations as international agreements and JIT requirements. The session will identify troublesome clauses and discuss how to determine what to accept and what to reject, and other difficult contract review topics.

Certificate: PA-R

Certificate: IRAM-R

Learning objectives:

  1. Review different types of award terms and conditions, including Federal Acquisition Regulations and different grants policy manuals.
  2. Negotiate acceptance of awards.

Prerequisites: None

Speaker(s):

Renee Vaughan, MDiv, MA, CRA, Financial Practice Manager, Duke University SoM and Monique Gregory, MRA, Research Administrator, University of Central Florida, College of Health & Public Affairs

T206: Clinical Trial Budget Negotiation Challenges: It's Your Cost of Doing Business
Tuesday, April 4, 2017 - 10:45am to 12:00pm

Content level: Intermediate

Clinical trial budgets are always negotiable. Still, many investigators and clinical teams accept original budgets proposed by industry sponsors. The process of budgetary negotiation may seem intimidating, overwhelming, or ungrateful. In reality, negotiation allows both the sponsor and the site to arrive at a consensus which will benefit both sides. With an acceptable budget the site is more likely to fully commit to subject enrollment and site compliance by allocating proper resources and effort, which will result in producing higher quality data. Trial success can be easily compromised when budgets are negotiated poorly or accepted with no negotiation at all. Who is the right negotiator at the site level? How to muster sufficient negotiation power? When to push back and what to forgo? These and other questions will be addressed in the course of the session. The participants will discuss practical negotiation tips and techniques. Actual budget negotiation examples will be used to reveal most common stumbling blocks between sites and sponsors and the ways to circumvent them.

Learning objectives:

  1. Utilize various budget negotiation tips and techniques.
  2. Define the role of budget negotiation in trial success.

Prerequisites: None

Speaker(s):

Pavel Kruchek,  MBA, Director, Business Operations, Clinical Trials Office and Vanessa Bryant, Sr. Budget Analyst, Clinical Trials Office, University of Utah

T406: Intellectual Property Issues in Clinical Trial Agreements (CTAs)
Tuesday, April 4, 2017 - 3:15pm to 4:30pm

Content level: Intermediate

This session will identify common intellectual property issues that arise when negotiating agreements for clinical research; examine these issues are they appear in typical (and atypical) contract terms; and discuss strategies for negotiating these terms from a University perspective.

Learning objectives:

  1. Identify troublesome intellectual property terms as they appear in CTAs.
  2. Develop strategies to negotiate these terms to reduce overall risk to Universities.

Prerequisites: None

Speaker(s):

Thomas Burns, JD, MBA, Director, Johns Hopkins University School of Medicine

Wednesday, April 5, 2017

W106: Let's Talk Story: Financial/Logistical Lessons Learned from Opening the National Cancer Institute (NCI)'s MATCH Trial
Wednesday, April 5, 2017 - 9:00am to 10:15am

Content level: Intermediate

Offering biopsy-driven precision medicine clinical trials comes with significant administrative complexities, both clinical and non-clinical in nature. The National Cancer Institute (NCI)-MATCH trial, a federally funded precision medicine trial analyzes patients’ tumors for genetic abnormalities for which a targeted drug exists. Patients with an ‘actionable mutation’ are assigned to one of 24 possible treatment arms. This trial is targeted for cancer patients who have advanced solid tumors and lymphomas that are no longer responding (or never responded) to standard therapy. The Queen’s Medical Center (QMC), a private, non-profit, acute care medical facility serving the State of Hawaii, opened the NCI-MATCH trial as part of the statewide Hawaii Cancer Consortium. The opening of this trial at QMC required coordination among the hospital, employed physicians and clinical staff, private practice physicians, multiple clinical partners (e.g., radiologists, pathologists, laboratories) and the University of Hawaii Cancer Center. This case study will present ‘lessons learned’ in the opening of the NCI-MATCH trial, highlighting the importance of educating and coordinating all parties in regards to the trial logistics, protocol requirements, and research billing. In addition, there will be discussion on the overall challenge of trial reimbursement and the dispersing of limited lump sum federal funds among separate entities. 

Learning objectives:

  1. Identify the clinical logistical challenges of opening the NCI-MATCH trial, a biopsy-driven precision medicine trial.
  2. Identify the non-clinical challenges (e.g. research billing, trial funding limitations) involved in opening the  NCI-MATCH trial within a hospital setting that utilizes community clinical partners (e.g. pathology, radiology).

Prerequisites: None

Speaker(s):

Erin Fukaya, Clinical Research Associate, The University of Hawaii Cancer Center; Kate Bryant-Greenwood, JD, Research Coordinator; Rebecca Ohta, Manager Research Regulatory Office and Jennifer Kimbell, PhD, Manager Oncology Support Services, The Queen's Medical Center