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Patient preference studies

What is the level and type of risk patients will tolerate, in return for improvements in treatment effects? Would patients prefer a highly effective treatment, which has potentially, severe side-effects, or would they choose a less effective option with has less associated side-effects? Does mode of administration impact willingness to accept new treatments?

​We are able to quantify, scientifically, patient preferences regarding treatments. We have unique expertise and specialize in qualitative and quantitative techniques, including key methods such as discrete choice experiments (DCE), best-worst scaling (BWS), thresholding, and swing weighting. These methods can be successfully applied to elicit not only patient, but also caregiver, physician or other stakeholder treatment preferences for informing development of any type of therapeutics, including pharmacological treatments and medical devices.

By using innovative methodological advances, we can further leverage data to provide the necessary evidence for successful regulatory submissions. We tailor our consulting services to provide guidance on how potential new therapies are evaluated by regulatory agencies, or how current ones are being used.

We believe marketing of innovative therapies is most effective when backed by science and when data is generated in a holistic manner, and this is the approach we take in producing any materials needed for promotional purposes.

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Real-world patient insights

Demonstrating value of novel therapies often requires deep insights into how patients are affected by their disease.

Interview and focus group studies can be used to uncover unmet need, disease burden, and other critical aspects influencing market authorization and access decisions.

We have expertise in developing and conducting qualitative studies both for standalone purposes and for supporting the design and interpretation of quantitative patient preference studies. Our researchers have conducted qualitative studies that were included in regulatory and Health Technology Assessment (HTA) submissions.

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Patient-centered clinical trial design

What is the appropriate strategy in endpoint selection when there are various options, or if your asset is expected to perform well on novel endpoints?

We can ensure that your trial measures endpoints that matter to patients, which often are patient-reported outcomes. We can also help you measure and understand how patients value improvements in such endpoints and how these map against clinically-relevant outcomes (i.e., survival, hospitalization, etc.).

Contact us to learn more about adding patient-centricity to your clinical trials. We can leverage both qualitative and quantitative techniques to optimize trial design, to ensure that the resultant evidence can support positive evaluation from the patient perspective.

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Benefit-risk assessment

Structured benefit-risk assessments are formal analyses of key treatment risks and benefits, using clinical trial or observational data. These may also incorporate explicit outcome weighting using patient preferences into a Multi-Criteria Decision Analysis (MCDA).

A key technique developed by our scientists is Stochastic Multicriteria Acceptability Analysis (SMAA). It is established as a central method, endorsed as fit-for-purpose in benefit-risk assessment by US Food and Drug Administration (FDA). We therefore have the unique experience developing relevant methodology, and applying it to develop benefit-risk assessments that were included in submissions to the European Medicines Agency (EMA) and FDA.

Our thought leadership in the field is furthered by our chief scientist, Dr Tommi Tervonen who co-chaired the ISPOR Task Force on Quantitative Benefit-Risk Assessment. In this role, Dr. Tervonen set methodological standards for benefit-risk assessments for regulatory and reimbursement purposes, and value communication.

Our services regarding benefit-risk assessment include full structured benefit-risk assessment, on-demand support, development of patient preference studies to be included in regulatory filings, and strategic support to ensure positive benefit-risk profile throughout development activities.

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Training

Informed by our extensive expertise in the field, we provide customized, in-house trainings on technical and non-technical aspects of patient-centered research, patient preference research, MCDA, and benefit-risk assessment. These can vary from single half-day training sessions to multi-day training programs. We personalize the content and learning goals to tailor to specific audiences and we partner with our clients to ensure the right level of complexity is used depending on needs their needs.

Our training offering is provided by experienced and accredited educators. Past clients include top-20 pharmaceutical companies.

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