This webinar discusses communicating clinical trial results to study participants. It features presentations from industry and academic perspectives on establishing standards for returning trial results. The panel will review regulatory guidance and recent initiatives to develop programs for research sponsors. Speakers include representatives from Halozyme Therapeutics, the Center for Information and Study on Clinical Research Participation, and Patient Advocates In Research. They will present data on the value of communicating results and discuss developing guidance for sponsor companies. The webinar aims to provide information for those in clinical research operations, medical writing, and patient advocacy.

1. Building Bridges: New Rules and
Guidance for Communicating
Clinical Trial Results to Study
Participants
March 4, 2015

2. Presenters
Moderator: Steve Shuey, Director, Oncology Clinical
Operations
Halozyme Therapeutics, Inc.
Communicating Trial Results to Study Volunteers:
Establishing a Standard Practice
Program Speaker: Zachary Hallinan, The Center for
Information and Study on Clinical Research Participation
Putting Patients First with Research Results
Program Speaker: Deborah Collyar, Patient Advocates In
Research

3. Program Summary
In this era of transparency, patient communication is becoming an
increasingly important consideration in science industry. This panel will
discuss considerations for communication of trial results to patients both
from academic and industry perspectives.
This webinar is relevant for individuals in clinical research operations and
management, medical writers, regulatory affairs, IRBs, and patient advocates.
Speakers will:
• Present data on the need and value of “returning” trial results to study
participants
• Review regulatory rules and guidance related to communicating trial results to
study participants
• Discuss recent initiatives (CISCRP, MRCT) to develop guidance for research sponsor
companies that wish to set up programs to communicate clinical trial results

4. Housekeeping
• Please mute your phones &
do NOT put us on hold!
• Please type your questions into the Chat area
on your GoToMeeting Control Panel.
• We will take a few questions between
presentations, and get to as many as possible
after both speakers are done.

5. Thank You
We wish to thank Rebecca Li & Dimitrios Dogas of the
Harvard MultiRegional Clinical Trial (MRCT) Center for
allowing us to use their webinar platform.
The following organizations are hosting this webinar:
American Medical Writers Association Pacific Southwest
chapter, an organization of ~350 medical writers in Southern
California, Arizona and Nevada
San Diego Clinical Research Network serves as a network for
individuals in clinical research and related areas and a forum
for clinical research in Southern California. Founded in 2012,
the group has over 800 members

6. Speaker Bios
Moderator
Steve Shuey is Director, Oncology Clinical Operations at Halozyme Therapeutics, Inc. Steve has
worked in the San Diego biotech industry for 27 years, first at IDEC Pharmaceuticals, then Biogen-
Idec, and now at Halozyme.
Zachary Hallinan is the Director of Patient Communication and Engagement Programs at the non-
profit Center for Information and Study on Clinical Research Participation (CISCRP), where he
oversees CISCRP's programs for better understanding and meeting the needs of clinical research
volunteers globally. Recognized by CenterWatch as one of twenty innovators changing the face of
the clinical trials industry, he leads CISCRP’s work to assist the research enterprise in
communicating clinical trial results to study volunteers.
Deborah Collyar is President of the Patient Advocates In Research (PAIR) international network,
and has utilized her successful business, leadership and communication skills to bridge gaps
between science, research, medicine and patients. As Vice Chair of the Alliance for Clinical Trials
in Oncology Publications Committee, Deborah has led the participant summary initiative for many
years, and also serves as Co-Chair of the Harvard Multiregional Clinical Trial (MRCT) Return of
Results Working Group.

7. Q & A
• Please type your questions into the Chat area
on your GoToMeeting Control Panel

8. Thank You
We wish to thank Rebecca Li & Dimitrios Dogas of the
Harvard MultiRegional Clinical Trial (MRCT) Center for
allowing us to use their webinar platform.
The following organizations are hosting this webinar:
American Medical Writers Association Pacific Southwest
chapter, an organization of ~350 medical writers in Southern
California, Arizona and Nevada
San Diego Clinical Research Network serves as a network for
individuals in clinical research and related areas and a forum
for clinical research in Southern California. Founded in 2012,
the group has over 800 members