Meeting the EU Regulation: Plain Language Summaries & Protocol Synopses

On January 21, 2022, the European Medicines Agency (EMA) launched a new clinical trials website, Clinical Trials Information System (CTIS). The new website was launched with the application of the new clinical trials regulation, Regulation (EU) No 536/2014.

The regulation requests a plain language version of the protocol synopsis to be submitted as part of the initial application for a clinical trial.

Hear from CISCRP colleagues and industry experts who discuss creating a plain language protocol synopsis that can be used for non-expert audiences, preparing plain language summaries of trial results to meet the new regulation, and best practices for developing and implementing a plain language summary program.

Panelists:

Julie Faries-Mitchell, MS

Associate Director

Health Communication Services

CISCRP

Christopher Pfitzer

Associate Director

Transparency Operations Lead

UCB Biosciences, Inc.

Kim Edwards, PhD

Associate Director

Medical Writing

CISCRP

To access more educational content about clinical trials and clinical research participation click here. 

Tools of the Trade for Patient-Centric Clinical Development

ICON’s Center for Rare Diseases industry experts and clinical research panelists discuss how the Patient-Centric Trial Development Toolkit for rare diseases can incorporate and elevate the patient voice in a company’s drug development program.

About the Panelists

Click on each photo to read biography.

Amy Raymond
PhD, PMP
ICON

Laura Iliescu
ICON

Kelli Wright
Patient Advocacy Professional

Kendall Davis
Spark Therapeutics

Straight Talk on Clinical Trials: Patient Perspectives on Clinical Trial Participation

Mike Wenger of Informa Pharma Intelligence and Wes Michael of Rare Patient Voice and panelists discuss insights from a recent survey of patients on their perspectives of clinical trials, reasons for non-participation in clinical research and ways that sponsors, advocacy organization and recruitment companies can refine the clinical trial enrollment process. Sponsored by Informa Pharma Intelligence and Rare Patient Voice.

View companion material: Q&A | Article Brief | Infographic

About the Panelists

Click on each photo to read biography.

Mike Wenger
Informa Pharma
Intelligence

 

Wes Michael
Rare Patient
Voice

 

Steve Jones
EU-IPFF

 

Ashley
Smock

Sarah Nechama Frisch

 

AWARE for All- Atlanta Webinars

Taking good care of your health is one of the most important things you can do for yourself.

Watch the AWARE for All – Atlanta Webinar Series to learn about the clinical trial process and how trial work. You can also view a panel discussion to hear personal stories from patients who participated in clinical trials and why they chose to participate and listen to healthcare professionals on how they help patients participating in clinical trials.

November 16th Webinar: Clinical Trial Overview Presentation

Watch to Hear From:

rabih

Rabih Dahdouh
Overview Presenter

November 17th Webinar: Panel Discussion

Watch to Hear From:

tina berry

Tina Berry
Oncology Trial Participant and Project Manager at Northside Hospital Cancer Institute

Terp_Vairin

Terp Vairin
Mental Health/Depression Trial Participant

ashley

Ashley Nealy
COVID-19 Trial Participant

Melissa Hardman

Melissa Hardman
Trial Participant, Founder & CEO of Faces of Research, LLC

glenn

Glenn Bachmann
Lymphoma Trial Participant

November 18th Webinar: Panel Discussion

Watch to Hear From:

phyllis

Phyllis Kaplan
Diabetes Trial Participant, Sr. Manager of Events & Community Engagement, CISCRP

meg

Meghan McKenzie
Principal Inclusion, Internal Partnering in Chief Diversity Office at Genentech

Untitled design (11)

Leah Szumita
 Director of the Clinical Trial Support Center for the Leukemia & Lymphoma Society

Zach-Mitchell

Zach Mitchell
Director of Business Operations & Recruitment at iResearch Atlanta

tamara

Tamara Wakhisi
Medical-Surgical Research Supervisor, Oncology at Northside Hospital – Central Research Department

Yolanda in Savannah

Yolanda Little
Diverse Patient Recruitment and Retention, Novartis

mary

Mary Slomkowski
Director, Clinical Management CNS, Otsuka

Findings from the CISCRP 2021 Perceptions & Insights Study

Learn about the latest trends in clinical research awareness and perceptions, including shifts from past studies, patient engagement preferences, overall receptivity to decentralized trials and the evolving role of technology. Panelists also review perceptions among diverse communities and the impact of COVID-19 on clinical research.

About the Panelists

ken 300

Ken Getz
Founder & Board Chair

Annick Anderson

Annick de Bruin
Senior Director
Research Services

Jessica Cronin

Jessica Cronin
Project Manager
Research Services

Gina-Pryciak resized

Gina Pryciak
Research Associate
Research Services

Kim Harper

Kim Harper
Site Director

Benchmark Research

Krystal Doucet
Associate Site Director

Benchmark Research

stephanie aleite

Stephanie Aleite
Patient Advocate
The Young Face of Arthritis

Supporting Caregivers in Clinical Research: Navigating the Pandemic

The Trifecta lived daily by Rare Disease families is now experienced by the whole world: 1) Isolation, 2) Medical Uncertainty, 3) Disruptions in Home/Work Life. Scott Schliebner of ICON & Cristol Barrett O’Loughlin of Angel Aid Cares discuss how caregivers are navigating the impact of these three forces for the whole family.

You can access the article brief based on the webinar here.

About the Panelists

Moderator
Scott Schliebner
SVP, Scientific Affairs
Therapeutic Expertise Head
Center for Rare Diseases, ICON

 Click on image for biography.

Panelist
Cristol Barrett O’Loughlin
Founder & CEO
Angel Aid Cares

Click on image for biography.

Rare Disease Clinical Trials

Gain a better understanding of rare disease clinical trials by listening to patient advocates and health care providers, learn how to be prepared for when the trial ends, and hear from those who chose to be advocates in this 3 part webinar series.

Video Playlist
1/3 videos
1
Rare Disease Clinical Trials - Being Informed
Rare Disease Clinical Trials - Being Informed
2
Rare Disease Clinical Trials - How to Prepare for When the Clinical Trial Ends
Rare Disease Clinical Trials - How to Prepare for When the Clinical Trial Ends
3
Rare Disease Clinical Trials: After Participation, Paying it Forward
Rare Disease Clinical Trials: After Participation, Paying it Forward

Part 1 Panelists

Christian Rubio WOW1

Moderator
Christian Rubio
VP of Strategic Advancement,
Global Genes

dr. dastgir wow1

Panelist
Dr. Jahannaz Dastgir DO

Director, Pediatric Neuromuscular Program,
Goryeb Children’s Hospital

Melanie Havert WOW1

Panelist
Melanie Havert

Project Manager,
Rare Patient Voice, LLC

Jennifer McNary wow1

Panelist
Jenn McNary

Founder & Patient Advocate,
One Rare

Stephanie Loomer Headshot wow1

Presenter
Stephanie Loomer

Project Manager,
CISCRP

Part 2 Panelists

marsha-lanes-200px

Marsha Lanes,
Genetic Counselor/
Medical Editor,
NORD

tracy dixon salazar 200px

Dr. Tracy Dixon-Salazar,
Executive Director,
Lennox-Gastaut
Syndrome Foundation

Richie Kahn, MPH
Senior Director,
Patient Engagement,
Medable Inc.

dana holinka 200px

Dana Holinka,
Operating Board Member,
TSC Alliance

Part 3 Panelists

Britta Dornan headshot2

Britta Dornan
EveryLife Foundation for Rare Diseases

Ryan Colburn

Ryan Colburn
Patient Advocate
(Pompe disease)

Dr. Kim Stephens.PNG

Dr. Kim Stephens
Project Alive

Marc Yale Headshot

Marc Yale
International Pemphigus & Pemphigoid Foundation 

Companion Content

Part 1:

Part 2:

Part 3:

Advocating for Yourself or Your Child in a Clinical Trial

Dr. Mark Sorrentino, MD, MS, Vice President, Center for Pediatric Development, ICON, and Dr. Joanna L. Perkins, MD, MS, Director of Medical Affairs, Hematology-Oncology, Americas, ICON, discuss how to advocate for yourself or your child in a clinical trial. Dr. Sorrentino brings his perspective as a clinical study participant and Dr. Perkins  expands on her experience from an investigator’s lens.

You can read an article brief based on the webinar here.

About the Panelists

Dr. Mark Sorrentino, MD, MS, Vice President
Center for Pediatric Development, ICON

 Click on image for biography.

Dr. Joanna L. Perkins, MD, MS, Director of Medical Affairs, Hematology-Oncology, Americas, ICON

Click on image for biography.

AWARE for All- Southwest Webinar

Taking good care of your health is one of the most important things you can do for yourself.

Watch the AWARE for All – Southwest Webinar to learn about the clinical trial process and how trial work. You can also view a panel discussion to hear personal stories from patients who participated in clinical trials and why they chose to participate and listen to healthcare professionals on how they help patients participating in clinical trials.

Watch to Hear From:

Untitled design (8)

Charlene Upshaw
Breast Cancer Trial Participant

Untitled design (7)

Angie Volk
Multiple Sclerosis Trial Participant

Lisa Trevino

Lisa Treviño
Vice President, DHR Health Institute for Research and Development

Untitled design (9)

Al- Malik Edwards
Recruitment Specialist, Excell Research

Becky Johnson

Becky Johnson
Director, Global Diversity & Inclusion in Clinical Trials, IQVIA

Carmen White

Carmen White
Director, Multi-Cultural Participant Experience Lead, Pfizer

Improving Access to & Experiences of Transgender & Non-Binary Patients in Clinical Research

Rosamund Round, Vice President, Patient Innovation Center & Decentralized Trials, Parexel International, Liam Paschall, Global Training Business Partner, Parexel International and Dr. Sebastian Barr, PhD, Licensed Psychologist & Consultant, discuss the barriers that transgender and non-binary individuals face to medical care and ways to scale access to clinical research participation.

Related Articles:
Working Towards A More Inclusive Environment: Transgender & Non-Binary Participants in Clinical Research
Improving Access to & Experiences of Transgender & Non-Binary Patients in Clinical Research

About the Panelists

Rosamund Round, Vice President, Patient Innovation Center & Decentralized Trials, Parexel International

Click Photo to Read Bio

Liam Paschall, Global Training Business Partner, Parexel International

Click Photo to Read Bio

Dr. Sebastian Barr, PhD, Licensed Psychologist & Consultant

Click Photo to Read Bio