Shared Agenda for Clinical Research on Smell and Taste (SACR-ST)

Background: More than 3 million Americans will have sustained or long-term smell and/or taste loss from COVID-19. Addressing these unprecedented numbers of new patients with chemosensory loss will require a coordinated effort among researchers, patients, and clinicians. 

Proposed Solution to the Problem: To solve the problem, the Monell Center seeks to partner with clinicians at Thomas Jefferson University and with patients through the Smell and Taste Association of North America (STANA) to develop a shared agreement about how to propel patient-centered outcomes research/comparative clinical effectiveness research (PCOR/CER) on taste and smell disorders. 

Objectives: The primary objective of this project is to develop a shared PCOR/CER agenda and learning community surrounding smell and taste loss. 

Activities:
a) Convene a working group that represents the stakeholder group: researchers, clinicians, and patients. 
b) Hold regular meetings of the working group to move through the project objectives.
c) Establish contract with a patient engagement specialist and outside chemosensory specialist to assist with patient surveying and communications to update a current whitepaper, develop a shared research agenda, and develop a relationship map. 

Projected Outcomes and Outputs: 
Outputs:
(a) Updating a 2018 whitepaper on smell and taste disorders research to make it more representative of patients in today’s context – particularly the growing population of patients with chemosensory loss due to COVID-19 (Goal #1).
(b) Establishing a shared research agenda involving actions, outcomes, and milestones, to create collaborative processes and systems that incorporate patient voices in PCOR/CER on taste and smell disorders (Goal #2). 
(c) Developing a relationship map that identifies structural, cultural, administrative, and communications stakeholders and barriers that hinder PCOR/CER, and strategies to overcome these barriers (Goal #3).

Outcomes: Even before the COVID-19 pandemic, there were inadequate data on prevalence and risk factors for chemosensory loss, scant treatment options, and a need for better tools for rapid clinical diagnosis. Because of COVID-19, we have a critical mass of smell and/or taste loss patients who can both advocate for themselves and present similar symptoms and challenges, which provides a significant new population for CER on existing interventions.  While many in the biopharmaceutical or bench science space are focused on identifying new diagnostic methods and new therapies and others are working to best quantify and describe the problem, the project team is dedicated to the outcome of identifying the best options available today for preventing, diagnosing, and treating anosmia. The project team’s partnership is founded to ensure that future research is embedded with the learned patient experience, that the team articulates this outcome widely to key stakeholders, and that the project stimulates new collaborations and draws attention to the gaps in existing knowledge about taste and smell disorders and disruptions. 

Patient and Stakeholder Engagement Plan: The project’s three major stakeholder groups are: 
(1) Patients and caregivers affected by COVID-related smell and taste dysfunction, pre-pandemic smell or taste dysfunction, or congenital anosmia (a rare condition).
(2) Clinicians such as ENTs, ENT nurses, GPs, dentists, psychiatrists, and nutritionists.
 (3) Chemosensory researchers. 

STANA will spearhead patient engagement by crowdsourcing patient and caregiver experiences with smell and taste loss to better understand their research priorities and needs, Jefferson clinicians will bring learnings to their colleagues in allied fields, and Monell researchers will partner with consultants and patients in gathering patient insights and experiences. 

Project Collaborators: The three major collaborators are:
1. The Smell and Taste Association of North America
2. Thomas Jefferson University Department of Otolaryngology
3. The Monell Chemical Senses Center