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FDA Patient Voice Project: One step closer to shared decision making…

3 February, 2021

It was with incredible hope that I read the news released by the FDA about their Patient Voice Project1, with this pilot program, the FDA’s Oncology Center for Excellence will make patient reported outcomes data from cancer clinical trials readily available to the public through a website2. This is a serious step that promotes a patient-centric approach to care and will impact the drug development process for the benefit of patients.

As stated in the FDA press announcement, information about patient reported symptoms and side effects has been collected rigorously, as it is part of the evaluation process of drugs. But this patient information was not accessible to the public until now. The Patient Voice Project will soon make information regarding quality of life (QoL) of cancer patients linked to the use of individual treatments publicly available. This will enable patients to know which of two or more efficacious treatments will be more tolerable, so they can improve while also enjoying the best QoL possible. If no alternate treatment option is available, patients will also learn about likely trade-offs in terms of QoL if choosing the novel treatment.

Access to this kind of practical, real-world information will allow patients to explore and evaluate their options with their physician based on information that is not technical but rather empirical. Knowing the impact of treatment on the QoL of other patients who experienced similar medical circumstances is a very relevant way to guide treatment decisions. Patients will be able to avail themselves of this valuable empirical information, enabling more precise tailoring of treatment plans to individual patient characteristics and preferences. In doing so, patients can take a more active role in determining their treatment plan. This type of engagement between the clinician and the patient is, in fact, a step closer to shared decision making3.

In the case of Precision Medicines, the patient-reported outcomes of symptoms and side effects will add a level of richness to the information patients will be able to access; this information will help guide their decisions following results from diagnostic tests linked to specific treatment options. These treatments can then be chosen by QoL data relevant to the patient making the decision. For example, in the case of lung cancer, if a patient is categorized as having adenocarcinoma and further biomarker testing reveals an EGFR mutation, the patient can discuss with his/her doctor the drugs targeting the EGFR biomarker. Roughly speaking, in this case, treatment options may be similar with regards to Overall Survival (OS) or Progression Free Survival (PFS) outcome measures, and instead patients may base decisions on QoL outcome measures linked to the drugs targeting the EGFR biomarker. This informed decision-making capability increases the value of a therapy alone by being part of a more comprehensive pathway with diagnostic and outcome components.         

For now, AstraZeneca is the only company releasing patient-reported symptoms and side effects. However, if other companies follow suit, this program will be elevated exponentially. Then we can finally move from “This is your treatment” to:

  • “This is what patients like you experience when taking this treatment, compared to that treatment"
  • These are the outcomes in terms of life extension
  • This is what it means in terms of side effects and functional outcomes
  • What does that mean to you?
  • Knowing how those treatments could potentially impact your life, how would you like to move forward in your treatment?
  • Considering all this (precious) knowledge of what other patients in your position experience, we can explore which medicine(s) best fits your needs and your life for the best possible decision for you.”

As we start to imagine what that promised land would be, that of a patient centric approach to care, once these data are channeled in a way that patients indeed can learn how their choices will impact their lives, we can already imagine that tools (especially digital tools) that help patients navigate through their conditions will be crucial in a next phase.

Additionally, digital tools that help patient organizations gain insight into what the uptake of these treatment innovations is, will be very helpful. By monitoring how innovations entering the healthcare pathway of patients they represent are implemented, patient representatives can target action in case their communities are missing out on innovations that present important improvement for patients, and even more if the treatment innovation comes with QoL benefits.

This type of overview and insights will be of particular importance for patient advocacy groups which represent patients that benefit from Precision Medicines, where fast paced innovations make it difficult to keep up in the clinical practice. The right tests, the right treatment decisions with quality of life information will be a qualitative leap to better care. Each individual patient will be greatly motivated. After all, it is about his/her life. Understanding the importance of the patient’s voice has been imaginable in Precision Medicine for quite some time, as illustrated by this 2013 blog from a patient advocate: “Bringing Patient Voices to Personalized Medicine”4.


  1. Accessed February 2, 2021.
  2. Project Patient Voice | FDA. Accessed February 2, 2021.
  3. Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23. PMID: 22618581; PMCID: PMC3445676.
  4. Accessed February 2, 2021.

About Diaceutics

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX - the world’s first Network solution for the development and commercialization of precision medicine diagnostics. 

Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries.

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