Embedded and Exit Clinical Trial Interviews
The power to enhance clinical research
High-quality patient experience data have become increasingly important for various stakeholders. Maybe you’re seeking to understand the impact of disease on patients’ lives or working to remove participation barriers and optimize future study protocols. Perhaps you want to determine an early safety profile and risk-benefit assessment from your patients’ perspective, or you need to better understand the patient experience with an investigational product not yet on the market. Embedded and exit interviews (EEI) can help provide the guidance you need to enhance your product’s success.
From early Phase II through post-marketing, embedded and exit interviews can bring forth expanded insights that will inform the path forward for your product. The supplemental data gleaned from these interviews have the power to optimize clinical trial design, enhance interpretation of clinical trial findings, improve your product’s value proposition for payers and ensure patients’ unmet needs are being addressed.
Find the answers you are seeking by engaging the largest team of dedicated EEI experts in the industry with a proven track record of success. We enable you to mine those unique patient experience insights at any phase in your trial and make a meaningful difference in advancing your product and improving patients’ lives.
A proven track record of success
When you partner with us, you gain a team of highly skilled strategic planners, scientists and analysts experienced in embedding qualitative interviews with patients, caregivers or trialists into the clinical trial process.
Dedicated EEI scientific experts with experience addressing challenging logistics while conducting EEI in-trial studies.
Years of industry-leading expertise in conducting patient-centered research interviews and illuminating the patient voice throughout the drug development life cycle.
High-quality EEI projects delivered on time and on budget across 25 countries and more than 30 therapeutic areas.
Leverage embedded and exit interviews throughout your product’s life cycle
Understanding the disease
Objectives:
- Understand patients’ experience
- Develop a conceptual model
- Identify concepts/outcomes of importance to patients
- Inform endpoint strategy
- Better understand of treatment side effects
Particularly useful in rare disease
Characterization of treatment benefit and safety profile
Objectives:
- Understand patient experience with new treatment
- Generate a hypothesis on treatment benefit
- Identify what constitutes meaningful effect/change
- Confirm concepts/outcomes of importance
- Cognitively assess new patient-reported outcomes (PROs)
- Maximize signal detection and support internal decision-making
- Build a strong differentiation strategy
- Confirm Phase III measurement strategy
Interpretation of trial outcomes
Objectives:
- Help interpret a clinically meaningful change in clinical outcome score
- Support value messages based on direct input from patients
Support FDA submission, including generating evidence for the ”patient experience” section of the label
Product safety and market surveillance
Objectives:
- Optimize product implementation into clinical practice
- Detect long-term effects of treatment
- Explore the long-term experience of living with new treatment
- Explore adherence and compliance with treatment
Confidently navigate the complexities of EEI with bespoke solutions
There are great benefits that come with high-quality, qualitative data in trial participant interviews, but they can also present added challenges. A customized EEI solution enables you to proactively address unique obstacles associated with trial conduct, interview conduct and quality control. By leveraging proven process and strategies, we ensure the successful implementation of interview studies within the clinical trial program in an ethical and confidential manner, so you get the most out of capturing the patient voice.
We put embedded and exit interviews within reach by:
- Leveraging logistics already in place in the clinical trials (e.g., site contracting, ethics process, patient recruitment and tracking)
- Enacting strategies that remove any extra burden inherent on sites and patients participating in interviews
- Creating a tailored approach that details how patient confidentiality will be maintained
- Defining the appropriate interview window in study design and conducting interviews after the treatment and administration of study measures, not before
- Developing methods to supplement adverse events reporting that are not duplicative of the clinical trial
- Supporting culturally diverse patients with well-trained bilingual and culturally-versed interviewers while assuring consistency across countries
- Conducting bespoke training and standard assessments of interviewer performance
- Managing quality control and providing regular feedback on interviewer performance on an individual basis
- Applying advanced methodologies to enhance clinical trial findings (e.g., mixed methods research, longitudinal qualitative research)