Clinical Research

Time: 9:00am to 5:00pm

Content level: Basic

Clinical trials are a rapidly changing field in research administration. Many of the skills needed to administer more traditional investigator initiated, grant funded research projects can be adapted to managing clinical trials. This teaching workshop will examine the basics of clinical trial administration from recruiting projects to archiving records, explore the differences between industry and federally funded studies, highlight special concerns and discuss best practices for managing clinical trials. A CD of useful documents, links and tools will be provided.

Learning objectives:

1. Identify three milestones in the development of clinical research regulations and describe the importance of each.
2. Identify three important regulatory differences between clinical research conducted in the US and in non-US/International regions.

Prerequisites: None

Speaker(s):

Bruce Steinert, PhD, CCRA, Director of Clinical Research, Cancer Treatment Centers of America

Time: 1:30pm to 5:00pm

Content level: Basic

This presentation is designed to explain the fundamental aspects of a contract and the specifics relating to clinical research agreements.

Learning objectives:

1. Understand the fundamental aspects of a contract.
2. Understand the considerations when negotiating an agreement that involves multiple parties (sponsor, collaborators).

Prerequisites: None

Speaker(s):

Carlos Braxton, JD, Associate Director, Johns Hopkins University; Gayle Walters, MS, MAS, Director, Consortia Services, Johns Hopkins University

Time: 9:30am to 10:45am

Content level: Intermediate

This session will cover the important components of a Clinical Trial Agreement, identify areas where research sites and for-profit sponsors spend the most time in negotiation, as well as describe best practice concepts to improve Clinical Trial Agreement throughput while minimizing the risk of subsidizing a for-profit sponsor.

Learning objectives:

1. Identify 3 areas of importance within a Clinical Trial Agreement from a research site perspective.
2. Describe 3 concepts to improve negotiation outcomes.

Prerequisites: None

Speaker(s):

Joe Fugitt, Manager, Research Finance, Spectrum Health

Time:  2:15pm to 3:30pm

Content level: Intermediate

Recently, with the changing of the common rule a topic that garnered much attention was the management of biorepositories in clinical research. This session will address the following topics for research administrators that are involved in clinical trial activity related to biorepositories: - Discussion of various repository models; - Ideas for repository management considerations; - Review of multiple regulatory considerations (HHS, FDA, and HIPAA); - Impact on informed consent; - Implications from the revised Common Rule NPRM discussion -Biospecimen research scenarios for both current and future regulatory considerations.

Learning objectives:

1. Identify different biorepository approaches and models for clinical research.
2. Understand the impact of different regulations on biospecimen clinical research.

Prerequisites: None

Speaker(s):

Philip Cola, PhD, Associate Professor Design & Innovation Organizational Behavior Associate Director, Academic Affairs Doctor of Management Programs Weatherhead School of Management, Case Western Reserve University; Madeleine Williams, MA, Senior Consultant, Huron Consulting Group Use the online HTML editor to maximize your web content composing efficiency.

Time: 3:45pm to 5:00pm

Content level: Basic

Large multi-site trials have unique challenges and the risk increases exponentially when dealing with remote and/or foreign sites. Training is critically important and while initial start-up training for sites sets the stage for ensuring compliance, the ability to assess situations and provide on-demand training when issues arise is essential. How do you deal with access to technology, language barriers, and differences in cultural norms? This session will address effective ways to assess compliance and conformity and proven solutions. Participants are encouraged to be willing to discuss unique challenges and be ready to share creative solutions.

Learning objectives:

1. Identify key areas for assessment in ongoing trials.
2. Understand the key elements of a good quality improvement program for clinical studies.

Prerequisites: None

Speaker(s):

Susan Sedwick, PhD, CRA, Senior Consulting Associate, Attain LLC; Michele Vaughn, Senior Clinical Lead-Oncology, IQVIA

Time: 10:45am to 12:00pm

Content level: Basic

The Clinical Trial Agreement (CTA) is often thought of primarily as a legal document, but it is equally important for the parties to use the CTA terms and conditions to set operational expectations of one another. This presentation will explore the operational implications of various CTA provisions and offer tips and strategies for negotiating contract language that does not conflict with site operations.

Learning objectives:

1. Identify CTA provisions that may negatively impact or conflict with site operations.
2. Negotiate CTA provisions with regard to time frames, notice, and access that harmonize with site operations.

Prerequisites: None

Speaker(s):

Kristine Martens-Ackeret, JD, Associate Director, Office of Sponsored Programs, Ann & Robert H. Lurie Children's Hosptal of Chicago; Allison Teresa Siebold-Guzman, JD, Contracts Officer, Office of Sponsored Research, Northwestern University

Time: 1:45pm to 3:00pm

Content level: Basic

Gene therapy studies are becoming increasingly common as the US FDA (Food and Drug Administration) and other countries have begun issuing approvals for gene therapies, particularly in the field of oncology. Gene therapy studies pose exciting advancements for clinical research but also involve additional risks and regulatory requirements.

This presentation will summarize the current state of gene therapy research and the associated risks as well as the evolving regulatory environment in the U.S. Attendees will learn how to obtain the necessary regulatory approvals and prepare sites to conduct gene therapy research. The presentation will begin by defining gene therapy and summarizing the current state of the field including previous failures, current successes and the emerging regulatory and scientific environment that are resulting in a boom in gene therapy research.

The presentation will provide an introduction, intended for non-scientists, to the science of genetic engineering and gene therapy. This portion of the presentation will utilize graphics, videos and refer to major advances covered in the media to illustrate general concepts. The presentation will then detail the risks and associated regulatory hurdles for gene therapy research as well as outlining strategies for obtaining approval to perform gene therapy research at clinical research sites.

Learning objectives:

1. Understand what is gene therapy research and the associated federal requirements.
2. Understand how to request approval for gene therapy research.

Prerequisites: None

Speaker(s):

Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Director of Biosafety Services, Advarra

Time: 9:15am to 10:30am

Content level: Intermediate

In order to meaningfully evaluate a request to share protected health information with a third party, a reviewer needs information from various sources: the Principal Investigator provides information about data elements to be shared, the human subjects compliance office provides patient authorization information, the data recipient describes how the data will be transmitted, maintained, and used by the recipient, the data security office evaluates the data safety controls, and legal counsel may review the agreement. This presentation explores one academic medical center’s efforts to streamline the process for reviewing requests to share protected health information.

Learning objectives:

1. Evaluate requests to share data including protected health information of research subjects.
2. Leverage technology solutions to gather information quickly and facilitate prompt evaluation.

Prerequisites: None

Speaker(s):

Kristine Martens-Ackeret, JD, Associate Director, Office of Sponsored Programs, Ann & Robert H. Lurie Children's Hosptal of Chicago The Rubik's Cube solver can fix 2x2 cubes and Pyraminx puzzles too. Set the scrambled configuration and let the program find the solution in seconds.