Improving patient experience in clinical trials
A group of 18 leading biopharmaceutical companies have come together share ideas, simplify and speed up the research and development of new drugs, and improve patient experience around the globe.
TransCelerate BioPharma was founded as a non-profit organization in 2012 with a mission to improve the health of people around the world by simplifying and accelerating the research and development of innovative new therapies.
TransCelerate is a consortium currently consisting of 18 of the world’s leading biopharmaceutical companies that all share the spirit of innovation and collaboration across its portfolio of 14 active initiatives.
One of the core strategic priorities of TransCelerate is to improve the patient experience, meaning, creating change within the clinical trials landscape in order to create an enabled and better informed patient while improving study participation.
TransCelerate currently has three projects dedicated to improving the patient experience:
The eLabels initiative will help the industry progress on the journey to a digitally supported, patient-centric information channel. Today paper booklet labels are static, have low utility and must be reprinted when changes occur. This initiative will act as a catalyst for clinical supply chain transformation and ultimately a better informed patient. Toolkits and proof of concepts are being developed to facilitate regulatory engagement and uptake of eLabels across the industry.
The eConsent initiative seeks to transform the informed consent process by using an array of patient-focused digital components to better empower patients and their caregivers to make informed decisions and create process efficiencies for sites, Health Authorities, and sponsors. The vision for the initiative is to facilitate broad adoption of eConsent describing a framework/ guidance for eConsent digital components, and a toolkit to aid sponsor implementation. The team is diligently gathering feedback from key stakeholder groups, including: patients, investigator sites, Institutional Review Boards (IRBs), and Health Authorities, which will be used to refine the solutions.
TransCelerate’s third patient focused initiative, Clinical Research Awareness and Access aspires to make clinical trial information, data and participation more transparent, accessible, and patient-friendly. The vision is to give patients and caregivers the tools and options they need in order to make informed choices about volunteering and/or continuing participation in clinical research, based on a robust understanding of the benefits and risks to them and to the healthcare system more broadly. Thus, resulting in faster and more effective recruitment and retention to clinical trials and improved patient and public advocacy for clinical trials.
In addition to the initiatives focused on the improvement of the patient experience, TransCelerate priorities include: enhancing sponsor efficiencies, improving the site investigator experience, enabling harmonization of clinical trial processes and facilitating the sharing of information in appropriate circumstances.