Patient Perspective Studies

The perspective of patients’ experiences with a disease or condition and its management

The future has arrived and it is giving an active voice to patients. If in the past, we had a traditional medicine with the provider leading the treatment decision-making, today the Internet empowers patients through information, giving them a central role in the treatment decision-making.

Five new dimensions are starting to be measured through qualitative and quantitative assessments:

Regulatory Authorities and the Pharmaceutical Industry are adjusting themselves to this new patient centricity reality and a new relationship is being established:

In the context of benefit-risk assessments, Patient Preferred Information (PPI) is being studied at two different levels:

  • Qualitative Patient Preferred Information (PPI): can be useful to identify which outcomes, endpoints or other attributes patients value the most and which factors affect their perspective on risk and benefit. This qualitative perspective is applied during the development and the clinical trial design.
  • Quantitative Patient Preferred Information (PPI): can be useful to estimate how much different outcomes, endpoints or other attributes are valued by patients as well as the tradeoffs they are willing to make among them. This quantitative perspective is applied during the pre and post-market environment.

If well-designed and conducted, these studies can provide accurate scientific evidence regarding patients’ perspective on benefit and risk tolerance. The HTA might be changing as patient preferences are useful in regulatory decision making and they reflect decisions among individual patients when faced with treatment choices. Talking about patient centricity is also talking about:

  • Patient right perspective
  • Need for value determination
  • Evidentiary contributions

We will work with you during the product life cycle to generate the appropriate evidence of patient’s perspective.