US-based contract research company PRA Health Sciences has launched its Patient-Centric Trial Development Toolkit to identify and mitigate risks to rare disease clinical programmes.
The new toolkit is developed by PRA’s Center for Rare Diseases in partnership with its Rare Disease Advisory Committee (RDAC) and other patient stakeholders.
It supports clinical development sponsors focusing on rare diseases, patient communities and other stakeholders to operationalise the true patient-centricity in clinical development.
This patient-focused toolkit is designed to reduce risks that often occur in rare disease clinical trials and helps to promote trial participation.
It comprises four digital resources, including a patient-centric protocol risk assessment tool, rapid participation burden survey tool, patient involvement value dossier and a guide for rare disease patients and caregivers.
PRA Health Sciences Center for Rare Diseases senior vice-president Scott Schliebner said: “The main purpose of the toolkit is to guide sponsors in taking a more patient-centric approach in developing clinical trials.
“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.”
The toolkit also focuses on reducing the burden on patients to participate in clinical research and avoids significant costs related to inefficiency, high trial dropout rates, protocol amendments, and not being able to complete a trial on time.
PRA Health Sciences’ new Patient-Centric Trial Development Toolkit is available for download for free.