KUALA LUMPUR: PRA Health Sciences has announced 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.
According to a statement, the toolkit also introduces and affirms new patient-centric practices that promote trial participation.
“The main purpose of the toolkit is to guide sponsors in taking a more patient-centric approach in developing clinical trials,” said PRA Health Sciences Senior Vice-President, Center for Rare Diseases, Scott Schliebner, MPH.
“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 programme. 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 recognised a gap in the availability of structured tools for operationalising patient-centricity in rare disease clinical development.
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, including avoiding significant costs related to inefficiency, high trial dropout rates and protocol amendments.
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. — Bernama
