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How inVibe Supports and Enhances the new FDA Guidance on Patient-Focused Drug Development

By Adam Kleger

Fri Mar 18 2022

In February, the FDA issued “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients” as the second in a series of four guidance documents that describe how patients, researchers, medical product developers, and others can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.

The new guidance covers the various approaches to identifying what is most important to patients related to their experience with the burden of disease/condition and treatment. Essentially, the document covers a few core qualitative and quantitative research methodologies, with a focus on their respective strengths and limitations. Particularly compelling is the government’s focus on the importance of infusing drug development with patient voices.

The specific goals of the new guidance are to elicit what is important to patients, which may in turn help inform understanding of disease/condition and clinical trial design. The guidance also hopes to help the generation and use of patient experience data, including clinical outcome assessments and patient preference information, and also inform benefit-risk assessment. Let’s take a look, and discover how inVibe can help fill in some of the blanks.

Limitations of Qualitative Market Research: Cost, Comfort, and Computing

The new guidance breaks down qualitative research modalities into one-on-one interviews and focus groups delivered in-person, through telephone, and online/virtual meetings. In terms of strengths, in-person experiences empower researchers with the greatest flexibility, including the collection of verbal and non-verbal responses. But these sessions tend to be expensive, and inconvenient for patients who may have to commute, or during work hours, etc.

SImilarly, telephone interviews offer the benefits of lower costs and heightened convenience compared to in-person sessions, but are often fraught with technical difficulties and data collection challenges. Virtual meetings have become increasingly common thanks to the pandemic, yet are also compromised by tech and access issues, particularly for disadvantaged patient communities. Patient comfort is also a factor, as clinical settings can prove intimidating.

Limitations of Quantitative Market Research: Anonymity, Applicability, and Analysis

Quantitative research has the distinct advantage of scalability, speed, and cost, and typically comes in the form of surveys that ask closed- and open-ended questions. The former consists of a picklist that patients select from; the latter encourages subjects to submit their own written answers. Response options include yes/no, ratings, rankings, and visual scales. Surveys can be distributed in hardcopy or online, and processed singly or in batches.

Although relatively easy to administer, surveys not only lack the dimensionality and nuance of qual methods, but impose additional limitations on test subjects and market researchers. These include patient challenges with language, interpretation, and the sheer anonymity and depersonalization of the approach. Devoid of feedback or human interaction, results can be incomplete, compromised, or inaccurate – especially for underserved populations.

Supplementing Qual & Quant with inVibe: Voice, Value, and Virtue

The new guidance encourages patient-focused drug development through its broad overview of market research techniques, and implicit encouragement of the industry to infuse every aspect of clinical development with patient insights. By better understanding patient needs throughout, clinical trial design, recruitment, and retention can be heightened, ultimately cascading through the development trajectory to maximize public health benefits.

The inVibe voice-response platform empowers patients from all socio-economic backgrounds to candidly answer questions on their own devices, at their own pace, own their own time, and without the implicit bias of a moderator. Voice responses are collected and analyzed through a combination of machine learning algorithms and human linguistic expertise. Reports are dynamically presented and insights-driven, precipitating actionable recommendations for clinicians to improve processes throughout the development drug development lifecycle. It’s a simple, systematic, and scalable solution for the industry to collect, analyze, and understand the true voice of the patient.

“The new PFDD guidance from the FDA is an expression of the government continuing to encourage our industry to take a more patient-centric approach,” insists inVibe’s co-founder and CEO, Fabio Gratton. “Both quantitative and qualitative market research methods are proven effective, and inVibe was created to apply the latest technology and human expertise to overcome the limitations of each by bringing clinicians the depth and nuance of qual, with the efficiency and scalability of quant.”

All of us at inVibe are thrilled by the ongoing PFDD initiative and are eager to continue partnering with sponsors to ensure their patients are heard and understood throughout the process. Nothing is more natural to people than talking, and no device is more ubiquitous and easy to use than a phone. By encouraging patients from all walks of life and backgrounds to speak, pharma is finally listening at the critical points in the life cycle their voices are needed the most.

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