Patient-Centered Research

Why is it important?

Incorporating the patient’s voice into the development of pharmaceutical products is no longer a new concept. The patient’s voice now plays a critical role, not only in the development of patient-reported outcomes instruments, but also throughout the entire drug development process.

The patient is now a decision-maker in many areas and the term patient engagement is used to reflect the pharmaceutical industry’s desire to fully include patients, in order to ensure their priorities and needs are being identified and met.

Patient advocacy groups are now commonly consulted by regulators, HTA agencies, and the pharmaceutical industry. In this context of patient engagement, patient preference studies are increasingly used to demonstrate a preference for one treatment vs. another drug or device that is already on the market. These patient preference studies further inform decision-making, both in product development and during pricing and reimbursement negotiations.

Creativ-Ceutical’s Experience

Creativ-Ceutical has a team dedicated to outcomes research, including patient-centered studies and preference studies. We provide specialized support for any patient-related need, from PRO claims strategies and measurement to communication and data generation for HTA authority negotiations. Our team has successfully developed new PRO instruments and validated existing ones.

Our track record

We take pride in our strong track record in robust and creative qualitative research, and in the successful development and implementation of patient-reported outcomes. These range from patient- and caregiver-burden in-depth interviews, to instrument development and content validity studies; We can combine these with our statistical expertise for all aspects of instrument validation. Creativ-Ceutical has long-standing, collaborative relationships with leading experts in the field of PROs and quality of life assessments, as well as our own in-house expertise in developing instruments in several languages, simultaneously.

Patient-Centered study examples
Patient Centered Research
  • Patient-, Clinician- or General population-based studies
  • Discrete Choice Experiment (DCE) or conjoint analysis methods
  • Utility elicitation using time-trade off
  • Patient-, Caregiver- and Healthcare Professional in-depth interviews
  • Cognitive debriefing
  • Exit interviews
  • Conceptual models
  • PROs, Clinical Reported Outcomes (ClinROs), and proxy measures
  • Gold-standard development methodology (following FDA PRO Guidance)
  • Reviewing and selecting appropriate PRO/ClinRO instruments
  • Concept mapping of conceptual models onto instruments
  • Face and content validity evaluations
  • Review and evaluation of psychometric properties of existing questionnaires
  • Support in development of PRO dossiers for FDA and EMA
  • Generating evidence through patient studies to support pricing and reimbursement negotiations