PRA’s Center for Rare Diseases Launches Toolkit to Identify and Mitigate Risks to Rare Disease Clinical Programs
March 22 2021 - 4:01PM
PRA Health Sciences (NASDAQ: PRAH) announced today the launch of
its Patient-Centric Trial Development Toolkit, available now to
clinical development sponsors focusing on rare diseases. Developed
by PRA’s Center for Rare Diseases in collaboration with PRA’s Rare
Disease Advisory Committee (RDAC) and other patient stakeholders,
the toolkit includes four digital resources designed to mitigate
risks that frequently occur in rare disease clinical trials. The
toolkit also introduces and affirms new patient-centric practices
that promote trial participation.
The Patient-Centric Trial Development Toolkit is available at no
cost and can be downloaded at
https://prahs.com/insights/patient-centric-trial-development-toolkit.
“The main purpose of the toolkit is to guide sponsors in taking
a more patient-centric approach in developing clinical trials,”
said Scott Schliebner, MPH, Senior Vice President, Center for Rare
Diseases at PRA Health Sciences. “As an example, the toolkit
includes a risk assessment tool that clinical development teams can
use to identify risk to the efficiency of a clinical program. The
risks that are identified are usually real world burdens for
participants, and the tool provides risk mitigation strategies and
solutions for sponsors to consider.”
PRA’s rare disease experts and RDAC members recognized a gap in
the availability of structured tools for operationalizing
patient-centricity in rare disease clinical development. Patients,
advocates, and industry leaders in rare diseases collaborated and
consulted with PRA to develop four parts of the Patient-Centric
Trial Development Toolkit:
- Patient-Centric Protocol Risk Assessment Tool:
Interactive, spreadsheet-based tool that enables sponsors to
rapidly identify potential risks, track evolution of risk
assessment through stages of the development process and identify
potential mitigation strategies.
- Rapid Participation Burden Survey Tool: An
easy-to-use questionnaire development guide that helps sponsors and
patient advocates develop a rapid survey for patients and
caregivers tailored to their clinical trial’s specific context. The
aim of this tool is to help sponsors quantify risk to the clinical
program through direct patient engagement.
- Patient Involvement Value Dossier: This tool
outlines the evidence of ROI/benefit involvement in the trial
development process from extant literature and provides
illustrative case studies from PRA’s Center for Rare Diseases.
- “What to ask when you’re interested in a clinical
trial: A Guide for Rare Disease Patients and Caregivers”:
Helps prospective participants identify the barriers to
participation they may encounter and request the support they need
to enroll and stay in the trial.
“Rare disease patients and trials face unique challenges
compared to those in more common indications,” said Tracy
Dixon-Salazar, PhD, Director of Research & Strategy at LSG
Foundation, RDAC member. “As a rare disease patient advocate, I
appreciate the genuine care that PRA gives to their patients and
family caregivers. In sharing these resources with sponsors and the
rare disease community, PRA is taking another step in making
clinical research more accessible and ensuring the patient and
their family is top of mind when developing a clinical trial
program.”
“PRA is so sincerely dedicated to putting the patient's
experience first,” said Terry Jo Bichell, Founder & Director of
COMBINEDBrain, RDAC Member. It is easy to give lip service and
small concessions to patients, but PRA is actually digging deep
into what it means for patients and their families to be a part of
clinical trials. Even when a patient wants a new treatment, it is
still stressful, scary, and time-consuming to take part in a trial.
PRA is trying to understand that and make it better.”
While the Patient-Centric Trial Development Toolkit does focus
on lessening the burden on patients to participate in clinical
research, there are also several key benefits for sponsors such as
avoiding significant costs related to inefficiency, high trial
dropout rates, protocol amendments, and not being able to complete
a trial on time.
To learn more about the importance of patient-centricity in
clinical development or to download the toolkit, visit
https://prahs.com/centers/center-for-rare-disease/trial-development-toolkit.
For more information about the Center for Rare Disease, please
visit https://prahs.com/centers/center-for-rare-disease.
About PRA Health Sciences
PRA Health Sciences is one of the world’s leading global
contract research organizations by revenue, providing outsourced
clinical development and data solution services to the
biotechnology and pharmaceutical industries. PRA’s global clinical
development platform includes more than 75 offices across North
America, Europe, Asia, Latin America, Africa, Australia and the
Middle East and approximately 19,000 employees worldwide. Since
2000, PRA has participated in approximately 4,000 clinical trials
worldwide. In addition, PRA has participated in the pivotal or
supportive trials that led to U.S. Food and Drug Administration or
international regulatory approval of more than 95 drugs. To learn
more about PRA, please visit www.prahs.com.
INVESTOR INQUIRIES: InvestorRelations@prahs.com
MEDIA INQUIRIES: Laurie Hurst, Sr. Director, Communications and
Public Relationshurstlaurie@prahs.com | +1 (919) 786-8435
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