Meeting UK IRB/EC Expectations for Patient review of Research Participant Information

From December 1st 2023, applications to conduct clinical research in the United Kingdom must meet the Health Research Authority’s (HRA) Quality Standards and Design and Review Principles to receive a favorable opinion. Research Ethics Committees (RECs) will check whether the standards have been achieved, including implementation of a sufficient patient review process to ensure that participant information is relevant and understandable for the intended audience.

This webinar reviews key elements of these expectations and provides logistical and practical considerations for meeting them. Speakers include experts in patient engagement and involvement of patient communities in the development of clinical trial related documentation and participant communications, as well as perspectives from stakeholders who have experience in the roles that must fulfil the new requirement.

Featured Speakers

Behtash Bahador

Behtash Bahador

Director, Health Literacy, CISCR

Thomas Rhode Jørgensen

Chief Operating Officer (COO), James Lind Care

 

Results from CISCRP’s 2023 Perception & Insights Study

CISCRP’s Perceptions & Insights Study routinely assesses global trends in attitudes, perceptions, and experiences associated with clinical research among patients and the public. The results from our latest 2023 study are in, with over 12,000 responses from around the world! We discuss the latest findings from this study during the webinar.

Featured Speakers

Annick de Bruin

Chief Research and Insights Officer, Research Services, CISCRP

Rebecca Nordland

Senior Project Manager, Research Services, CISCRP

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Emily Clifford

Senior Project Manager, Research Services, CISCRP

Jackie Zimmermann MS Advocate

Jackie Zimmerman

MS & IBD Patient Leader

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Twyla Bode RN BSN MN

Clinical Research Nurse Coordinator

Highlights From the 2023 Study Include:

  • Public understanding of clinical research and perceptions of safety increased post-pandemic
  • Top mentions for increasing trust in pharma companies conducting trials:
    • By the company sharing information about the health risks and benefits of their medicines
    • Knowing that the company actively works with patients, caregivers, and patient communities to make clinical research studies easier to participate in
    • By the company sharing information in patient-friendly language that they can easily understand
  • About half were ‘very willing’ to go to a pharmacy for study visits, however those who were not willing were most concerned:
    • About the facilities (i.e., too public, lack of a private room/area)
    • That their privacy/confidentiality would not be protected, and
    • About the quality of care they would receive

Insights on Developing an Impactful DEI Video

Hear from our panelists who share insights gained while developing CISCRP’s video, The Importance of Diversity in Clinical Trials. The discussion will focus on how to embed key DEI principles and concepts, not only in the product but also in the process, ensuring a balance is struck between nonpromotional education and advocating for participation, logistical tips for planning and executing a successful live-action video project.

Featured Speakers

Lucas Goren

Senior Project Manager, CISCRP

Behtash Bahador

Director, Health Literacy, CISCRP

Tammy Wilkins

Tammy Wilkins

Senior Manager, Applied Innovation and Process Improvement, Otsuka

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Matt Low

Chief Creative Officer, Praxis Communications

Mel Hardman

Dr. Melissa Hardman, MPH, MS

Faces of Research

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Ashley Nealy

COVID-19 Clinical Trial Participant

Melvin

Melvin Mann

Video Participant

Working Towards a More Inclusive Environment: Transgender & Non-Binary Participants in Clinical Research

Trans and non-binary people face significant barriers to participation in clinical trials. To transform lives and collect the best evidence, we need to fully understand and work together to solve these challenges, by creating more diverse and inclusive clinical trials. This talk features two speakers from these communities who will provide insights, both for attendees that are new to this topic and for those who already have started learning. This webinar was organized and hosted by CISCRP for Clario.

Featured Speakers

Jae Bailey
(They/Them/Their(s))

Liam Paschall
(He/Him/His)

Voices Yet to Be Heard: Including People with Disabilities in Clinical Research

By its very nature, clinical research must align with diversity, equity, and inclusion for it to be fair and representative. But the inclusion of people living with visible and invisible disabilities in clinical trials is often not the focus of the DEI discussion. Voices Yet to Be Heard: Including People with Disabilities in Clinical Research is a conversational webinar featuring a powerful panel of experts and advocates. Our panelists share their experiences participating in clinical research, accessibility challenges they have faced, and suggestions for systemic improvements.

Meet the Panelists

Pam Cusick | Moderator
Senior Vice President, Rare Patient Voice
Pam Cusick is an experienced research professional with more than 30 years of expertise in study design, implementation, and analysis. Her background in public health communications and research, coupled with her passion for patient advocacy, dovetail with Rare Patient Voice’s mission and vision. Pam hopes to expand Rare Patient Voice’s panels to include all patients and caregivers worldwide who want to share their opinions and impact their disease category. Pam earned a BA in Psychology from Sweet Briar College, and a MA in Psychology from the New School for Social Research. She is Past-President of the Board of Directors and Scientific Advisory Council Lead for the Horses and Humans Research Foundation. As Senior Vice President, Pam’s focus is on the continued growth and success of RPV, with an eye on client services, business development, and oversight of patient outreach, panel management, and marketing.

Richie Kahn | Panelist
Co-Founder & Principal at Canary Advisors
Richie is a health policy professional by training, clinical researcher by trade, and patient advocate by necessity. A rare disease patient and clinical trial participant himself, Richie is intensely passionate about better incorporating the patient perspective into the clinical development process. Through his work at Canary Advisors, he assists organizations set on patient-focused drug and device development by serving as an early-stage patient advocacy function; supporting regulatory patient advocacy; crafting patient-facing market access and reimbursement strategies; and providing clinical trial support services.

Sabina Kineen | Panelist
Rare Disease Patient, Caregiver, and Advocate

Sabina Kineen is a rare disease patient, caregiver, and advocate with a deep passion for health equity, mental health, and patient engagement. Diagnosed with Fabry Disease in her teens, Sabina has spent numerous years advocating for the rare disease community. She is a vocal advocate for mental health, recognizing the critical importance of addressing the psychological impact of living with a rare disease. Sabina is also a strong proponent of health equity and strives to ensure that every patient has access to the care, including clinical trials, they need and deserve.

Sabina’s twelve years of experience as a clinical trial participant gives her a unique perspective and she believes in the power of patient engagement. She recognizes that patients are experts in their own experiences and should have a seat at the table in decisions that affect their care and drug development. 

Sabina has spoken at numerous conferences, served on Patient Advisory boards, serves as a Fabry Champion and Community Ambassador, sharing her story as a patient and caregiver and advocating for the needs of the rare disease community. Through her advocacy work, Sabina aims to raise awareness, promote understanding, and create meaningful change for rare disease patients and their families.

Ash Rishi | Panelist
Founder and Chair of the Board of Trustees, Demand Diversity 

Ash Rishi is a health equity advocate and a leader in patient and community engagement and has been working to improve strategies globally while founding and running the creative health engagement agency, COUCH Health.

Building on his personal ambitions, Ash founded Demand Diversity, initially as a campaign for change, to raise awareness around representation of patients in clinical research. The work Demand Diversity has done over the past few years has led to Ash setting up Demand Diversity as a non-profit initiative to educate and raise awareness of clinical research within under-served populations – with particular focus on improving trust.

Ash’s overall ambition is to make research more equitable, so all communities benefit from the advancement from medicine.

The Clinical Trial Challenge: Boosting Clinical Trial Appeal in Patient Communities – Part 2

Part 2 of 2 Part Series

Clinical research is critical to progress towards new treatments and cures for all diseases. But engaging patients in clinical trial participation is often an uphill battle. Rare Patient Voice President Wes Michael and patient advocate Amy Gietzen discuss the results of a new RPV survey exploring factors that could make participation of greater interest to patients and family caregivers. This webinar is part two of a two-part flash webinar series, The Patient Journey in Clinical Research.

View the webinar below.

Panelists:

Wes Michael | Panelist
President, Rare Patient Voice

Amy Gietzen | Panelist
Patient Advocate, Columnist, and Public Speaker

The Clinical Trial Challenge: Boosting Clinical Trial Appeal in Patient Communities – Part 1

Part 1 of 2 Part Series

Clinical research is critical to progress towards new treatments and cures for all diseases. But engaging patients in clinical trial participation is often an uphill battle. Hear from Rare Patient Voice Senior Vice President Pam Cusick and patient advocate Grace Charrier about the results of a new RPV survey exploring factors that could make participation of greater interest to patients and family caregivers.

View the webinar below.

Pam Cusick | Panelist
Senior Vice President, Rare Patient Voice

Grace Charrier | Panelist
Host, Cancer Convos with Grace B., and Cancer Advocate

To view the second part in this webinar series, click here.

Voices from Within: Humanizing Clinical Research Data: Episode 2- Conversations on DCTs: Data Privacy

3 PART FLASH WEBINAR SERIES

Join in on the growing topic of patient data protection and policies. In a time when healthcare has adopted technology and data collection software at an exponential rate, it is important to educate patients and stakeholders on what that standard for patient data collection should be. 

Join Curebase’s Vice President of Clinical Trial Innovation, Jane Myles, Vice President of Clinical Operations, Sean Lynch, and Type 1 Diabetes Clinical Trial Participant, Phyllis Kaplan for Episode Two of our Voices from Within: Humanizing Clinical Research Data series.

View the webinar below.

Watch Webinar Episodes 1 & 3

Voices From Within: Humanizing Clinical Research Data:
Episode 1 – Patient Data Collection 101 Flash Webinar
Watch Here

Voices from Within: Humanizing Clinical Research Data:
Episode 3 – Conversations on Clinical Trials
Watch Here

Panelists:

Jane Myles
VP, Clinical Trial Innovation, Curebase

Phyllis Kaplan
Type 1 Diabetes Clinical Trial Participant

Sean Lynch
VP of Clinical Operations, Curebase

Voices from Within: Humanizing Clinical Research Data: Episode 3- Conversations on Clinical Trials

Jane Myles, Curebase’s VP of Clinical Trial Innovation, Sean Lynch, VP of Clinical Operations, and patient Qiana Alexander discuss the difference between clinical data and experiential data, focusing on the patient point of view. In their engaging conversation, they shared the importance of collecting patient experience data, how patient input/insights can be used to assist in trial design for decentralized clinical trials, and the difference in how DCTs enable gathering patient feedback.

View the webinar below.

Watch Webinar Episodes 1 & 2

Voices from Within: Humanizing Clinical Research Data:
Episode 1- Patient Data Collection 101
Watch Here

Voices from Within: Humanizing Clinical Research Data:
Episode 2 – Conversations on DCTs: Data Privacy
Watch Here

Panelists:

Jane Myles
VP, Clinical Trial Innovation, Curebase

Sean Lynch
VP of Clinical Operations, Curebase

Qiana Alexander
Lupus Clinical Trial Participant

Voices From Within: Humanizing Clinical Research Data: Episode 1 – Patient Data Collection 101 Flash Webinar

3 Part Flash Webinar Series

There are a variety of ways in which patient data can be collected in clinical research. As such, it’s critical to keep patients informed on these methods as they progress through trials. Jane Myles, Curebase’s VP of Clinical Trial Innovation and Director of Data Management, Kim Andreasen, discuss how patient data is collected in clinical trials.

View the webinar below. View article brief here.

Watch Webinar Episodes 2 & 3

Voices from Within: Humanizing Clinical Research Data:
Episode 2 – Conversations on DCTs: Data Privacy
Watch Here

Voices from Within: Humanizing Clinical Research Data:
Episode 3 – Conversations on Clinical Trials
Watch Here

Panelists:

Jane Myles

VP, Clinical Trial Innovation at Curebase

Kim Andreasen

Director, Data Management at Curebase