The Food and Drug Administration (FDA) released a guidance document in the Fall of 2019, the second in a series aimed at examining how patient and caregiver experience data can be used in product development and clinical and regulatory decision-making. This latest draft explores methods that sponsors can use to identify what is important to patients, which may help inform the selection of clinical trial outcome assessments.
The FDA stresses that trial sponsors need to focus on two critical factors: the methodology used to collect patient experience data, and the partners to help you do so.
Selecting the methods for collecting patient experience data
In this latest guidance document, the FDA encourages sponsors to consider several factors when structuring the collection of patient experience data:
- Inclusion of the appropriate target population characteristics
- The research methodology (qualitative, quantitative, or mixed-methods) most appropriate for the patient population (eg, ability of participants to travel, physical impairments) and study objectives (eg, clinical outcomes, health-related quality of life)
- Approach to questions and prompts
- Health literacy and numeracy, language and translatability, and cultural sensitivities
Selecting patient-centric insight partners
A limited number of vendors are experts at considering these clinical development factors and constructing the most appropriate surveys and studies to collect valuable patient experience data. This latest FDA guidance encourages study sponsors to engage with researchers, methodologists, statisticians, psychometricians, and strategists to ensure patient and caregiver’s perspective on the burden of disease and treatment, and treatment benefits and risks are most appropriately evaluated. It is critical that these partners have experience considering the factors outlined above.
Pulling through FDA guidance
As you evaluate and plan ways to put this FDA guidance into practice, you may find that CROs have built-in biases or that typical market research agencies do not have depth of experience in working in the clinical development arena.
Finding the right partner is critical not only to creating patient-centered clinical trials but to staying up-to-date with the latest FDA recommendations. Reach out to Ross Weaver to discuss how Clinical SCORE can help your insight research align with this guidance.