Currently, there is no recognized framework to understand and measure patient burden in clinical trials. This results in difficulty knowing which “patient centric” initiatives actually benefit patients. In addition, sponsors seek innovative technologies that can enhance their trials. However, these technologies often are novel and have no track record of being used successfully in trials, which can present challenges for sponsors, patients, sites, and those tech companies looking to expand their technologies into the clinical setting.
The Patient Experience & Technology (PE&T) Initiative seeks to facilitate and accelerate the industry’s progression towards a future where patients have access to innovative technologies that enhance the patient experience and reduce patient burden in clinical trials.
The Initiative team is building tools and frameworks that facilitate:
- Better understanding and measurement of patient burden in clinical trials towards the enhancement of patients’ participation, engagement and retention in clinical trials.
- An enhanced and more efficient innovative process for creating products that are “fit-for-patient” and take into account the many regulatory, safety, and technical considerations of modern trials.
- Improved patient experiences throughout the patient journey across acute, chronic, and terminal indications.
- Increased access to high quality, fit-for-patient technologies that are ready for clinical trial use.
- Higher volume of novel innovations that meet clinical trial regulatory requirements.
- Enhanced patient and site engagement to understand and address needs and perspectives.
The following assets will be delivered by this Initiative:
- Patient POV Papers that highlights patients’ unmet needs in clinical trials and highlights opportunities to improve the patient experience.
- Patient Journey Maps that identify major patient pain points across the clinical trial process for acute, chronic, and terminal trials.
- Patient Measurement Framework that measures patient burden and engagement levels across different times within clinical trials.
- Clinical Trial Technology Starter Kits that identifies key considerations for technology innovators in developing patient-facing tech solutions for clinical trial use.
Please check back for more information.
The eConsent Initiative will create a common approach for the electronic consenting of patients using an array of digital elements and process efficiencies to increase insight patients’ understanding, increase regulatory compliance, and reduce quality risks.
The TransCelerate eLabels initiative will help the industry progress on the journey to digitally supported, patient-centric clinical supply chains.
Clinical Research Awareness & Access
Clinical Research Awareness and Access seeks to increase awareness of and education about clinical research and its impact, improve potential participants’ access to clinical study opportunities and information on available studies, and enable more meaningful sharing of information with study participants.