fda report title "voice of the patient"

The Voice of the Patient A series of reports from the U.S. Food and Drug Administration’s (FDA’s) Patient-Focused Drug Development Initiative

Full Answer

What is the FDA doing to gather patient input?

FDA recognizes the value of gathering patient input through PFDD meetings and continues to host disease-specific PFDD meetings. More information on FDA-led PFDD meetings. More information on FDA-led PFDD meetings can be found below. Links to meeting materials, including transcripts, webcast recordings, and presentation slides can be found below.

What information is included in the FDA budget and performance reports?

This collection contains budgets, the strategic action plan, user fee reports, performance plans, economic analyses of FDA regulations, and reports on agency policies and initiatives.

Where can I find recent FDA reports and related documents?

Recent reports on the FDA's planning, performance, budgeting, user fee programs, and other agency-wide programs. Reports and related documents issued more than 2 years ago may be found in the FDA.gov Archive . Annual and multi-year budgeting documents in support of the nationwide public health protection programs administered by FDA.

When did FDA conduct a public meeting on patient-focused drug development?

On May 11, 2015, FDA conducted a public meeting on Patient-Focused Drug Development for Functional Gastrointestinal Disorders. FDA was interested in obtaining patient perspectives on the impact of Functional Gastrointestinal Disorders on daily life and patient views on treatment approaches.

How does the FDA collect patient experience data?

The FDA receives patient experience data, which is collected in clinical trials using surveys and completed by trial participants. Many groups, including FDA, would like patient experience data to be available to the public, but the drug label that describes the trial (s) lacks the flexibility (space, color) that an online solution can provide.

What is the purpose of the FDA pilot?

The pilot is currently limited to one drug trial. The purpose of this pilot is to get feedback from the public on the usability of the website. The FDA hopes to expand this to include more cancer drug trials.

What is the drug label?

Information in the drug label is from the doctors’ reports of adverse events that occurred during the clinical trial. Adverse events are unexpected medical problems that occur during a trial. The drug under study may or may not have caused these adverse events. The information on Project Patient Voice is from the same trial but includes symptomatic adverse event data (symptoms) that was reported directly by trial participants. Again, the drug under study may or may not have caused these adverse events. Questions about symptoms were asked to participants. These symptoms were chosen by the drug company to cover known side effects of the drugs under study.

Can you rely on Project Patient Voice alone?

You should not rely on Project Patient Voice alone to make decisions about medical care. You should not use Project Patient Voice to substitute for advice from your healthcare provider. Conclusions about patient symptom experiences may be limited, because not all symptoms may have been collected by the survey.

Does the FDA endorse cancer drugs?

This information was voluntarily provided by the company making the cancer drug and was reviewed by the FDA at the time of drug approval. The FDA does not endorse any drug, company, or specific patient-reported outcome measure (survey or questionnaire).

Can you report adverse events to the FDA?

No, the information included on the website is limited to patient-reported outcomes collected in a clinical trial setting. If you have an adverse event that you would like to report to the FDA, you should use the FDA MedWatch website.

When was the FDA meeting on stimulant use disorder?

On October 6, 2020 , FDA hosted a public meeting on Patient-Focused Drug Development for Stimulant Use Disorder. This meeting provided FDA the opportunity to obtain input from individuals with stimulant use disorder and other stakeholders on the impact of stimulant use disorder and views on treatment goals and approaches. FDA was interested in hearing perspectives from individuals with stimulant use disorder on the health effects and daily impacts of their stimulant use disorder, impact (if any) of opioid and polysubstance use on their stimulant use disorder, treatment goals, and decision factors considered when seeking out or selecting a treatment.

When was the FDA meeting on Chagas disease?

On April 28, 2015, FDA conducted a public meeting on Patient-Focused Drug Development for Chagas Disease. FDA was interested in obtaining patient perspectives on the impact of Chagas Disease on daily life and patient views on treatment approaches.

When was the FDA meeting on hereditary angioedema?

On September 25, 2017 , FDA is conducting a public meeting on Patient-Focused Drug Development for Hereditary Angioedema. FDA is interested in obtaining patient and caregiver perspectives on the on the impact of Hereditary Angioedema on daily life and patient views on treatment approaches.

When is the FDA meeting for vitiligo?

On March 8, 2021, FDA hosted a public meeting on Patient-Focused Drug Development for Vitiligo. FDA was interested in hearing perspectives from individuals with vitiligo on the health effects and daily impacts of their vitiligo, treatment goals, and decision factors considered when seeking out or selecting a treatment.

When was the FDA meeting for systemic sclerosis?

On October 13, 2020 , FDA hosted a public meeting on Patient-Focused Drug Development for Systemic Sclerosis. FDA was interested in hearing perspectives from individuals with systemic sclerosis on the health effects and daily impacts of their systemic sclerosis, treatment goals, and decision factors considered when seeking out or selecting a treatment.

Does FDA have PFDD meetings?

FDA recognizes the value of gathering patient input through PFDD meetings and continues to host disease-specific PFDD meetings. More information on FDA-led PFDD meetings. More information on FDA-led PFDD meetings can be found below.

What is PFDD in FDA?

FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making. This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision making.

What is guidance 1?

Guidance 1 discusses sampling methods that could be used when planning to collect patient input. It also provides a general overview of the relationship between potential research question (s) and method (s) when deciding from whom to get input (including defining the target population and development of the sampling strategy).