Clinical Research

Date and Time: Monday, April 29, 2019 - 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

Date and Time: Monday, April 29, 2019 - 11:00am to 12:15pm

Content level: Intermediate

It is scientifically and ethically imperative for researchers to understand it is a key commitment to report the results of clinical trials to research participants, so the advanced knowledge can be utilized collectively to make informed medical decisions. This session will discuss the most recent federal mandates, pertinent requirements of clinical trials disclosure and good practice. The presenters will share the approach that Rutgers, The State University of New Jersey, took to establish a robust, effective program for clinical trials registration and results reporting. Rutgers’ Human Subjects Protection Program (HSPP) has adopted a proactive plan to identify key issues and facilitate investigator to stay compliant within ClinicalTrials.gov records through the HSPP’s guidance, including a website and ongoing, customized trainings.

Learning objectives:

1. Describe why clinical trials disclosure matters and List resources and tools to assist investigators and organizations in maintaining compliance for clinical trials disclosure.
2. Identify key elements to establish a system in your organization to facilitate and monitor clinical trials registration and results reporting.

Prerequisites: None

Speaker(s):

Cheryl Forst, RN, BSN, CCRP, Director, Human Subjects Protection Senior Analysts Rutgers, The State University of New Jersey; Rebecca Niem-Tzu Chen, MS, MEd, CCRP, Human Subjects Protection Senior Analyst, Rutgers, The State University of New Jersey 

Date and Time: Monday, April 29, 2019 - 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

Date and Time: Monday, April 29, 2019 - 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

Date and Time: Tuesday, April 30, 2019 - 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

Date and Time: Tuesday, April 30, 2019 - 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 Use the JavaScript minifier to compress the code before you publish a website.

Date and Time; Wednesday, May 1, 2019 - 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