Clinical Study Adherence
"Drugs don’t work in patients who don’t take them” – C. Everett Coop, Former U.S. Surgeon General
“Non-adherence in clinical trials damages more than the patient on the medication. It is also corrosive to the integrity of the trial itself. Issues in adherence can mask important safety signals and greatly complicate the execution of the trial.” – Dr. Freda C. Lewis-Hall
Study participants not adhering to their investigational product regimen results in:
- Increased the number of patients required to complete a study
- Increased costs (higher site and patient recruitment)
- Increased time to complete the study
- Increased investigational products overage and associated costs
We are looking for new, innovative patient-friendly solutions for continuous improvement of investigational product adherence in clinical trials. The solution should also allow for the prediction, assessment, and identification of potential risk factors contributing to clinical trial non-adherence in clinical trial participants.
Find solutions that are patient-focused and engaging, which provide support and motivation to remain adherent with investigational products as well as visit schedules throughout their trial.
- Provide insights and analytics to better predict the adherence curve for clinical trial participants to allow for appropriate intervention to maintain investigational product adherence.
- Capture adherence metrics back to the study teams.
Throughout the Challenge the submissions and developed solutions will be judged and scored by a review panel chosen by Pfizer ('Review Panel') which may include both Pfizer colleagues as well as external experts. The review Panel will rank the entries based on:
- Experience and understanding of the challenges for non-adherence in clinical studies
- Solution must be compliant with all local and globally applicable legal, compliance and regulatory requirements
- Solution fit to the goals of this challenge
- Key stakeholder impact (including but not limited to patients, CRO’s, Hospitals/investigational sites
- Differentiation of solution within the competitive landscape
- Cost-effectiveness (to scale and deploy)
- Capability of participant to launch a pilot for a To-Be-Determined Phase 2 study in 2023.
- Demonstration of total funding requirements for various stages of development
- Accepting applicants through July 15th
- Finalists will be notified by July 31st to pitch at a mid-August event
- Opportunity for Collaboration on a Phase 2 Study
If you are selected as a winner, upon Pfizer’s request, Entrant will first negotiate in good faith with Pfizer for the right of Pfizer to develop and/or license Entrant’s solution, including further changes and/or developments made thereof during the Challenge. Funds of up to $200,000 will be paid based on milestones and scope of work. To avoid any doubt, winning the Challenge does not automatically lead to further legally binding contractual agreements with Pfizer. The detailed terms of possible future agreements between Pfizer and the winner (or any of the Entrants) will be negotiated separately and will not be linked to the Term set herein.
- Mentoring & Guidance
Pfizer experts from various fields will be available for up to 20 hours of mentoring for the winning team. Together with the winner, Pfizer will work out the exact needs and the objectives of the mentoring in order to provide information and connect the winner with the suitable mentors.
In case you have any questions regarding the Challenge please contact the organizing team at Pfizer under [email protected].