This Initiative thoroughly assessed potential solutions that would lead to faster access to new drugs for pediatric patients. Rather than continue as a standalone initiative, we will transition the focal points of pediatric populations across the broader TransCelerate portfolio, where appropriate.
Sponsors and investigators have historically faced a range of challenges in providing patients with access to pediatric approved medicines in a manner which is both expeditious and minimizes pediatric patient burdens. Those challenges have often been operational in nature and range from the planning and resourcing assumptions not reflecting the true availability of the patient through to sites and site organizations struggling to effectively manage their resources to meet the changing demands of sponsor pipelines.
The Pediatric Trial Efficiencies initiative identified and explored solutions that, if implemented by TransCelerate Member Companies, may lead to faster access to new drugs for pediatric patients, reduced patient burdens, faster and more efficient site contracting, and reduced trial costs.
Clinical Trial Diversification
The Clinical Trial Diversification Initiative has achieved its goal of developing better practice materials for Site and Sponsors to improve engagement and recruitment of minority patient populations.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.
Common Protocol Template
The Common Protocol Template Initiative is working with industry stakeholders and regulators to create a model clinical trial protocol template containing a common structure and model language to improve accuracy in data recordation and speed study start up.