Part I: Essential Pre-Launch Market Research
Clinical Diagnostics Product Launches Require Primary Market Research
Pre-Launch Primary Research: Perceptions of Utility and Efficacy are Key
Whether the launch involves a completely new test or approach to determining clinical values or an update to a current test, clinical diagnostics product managers require clear feedback concerning their prescribing audiences’ perceptions of the clinical utility and efficacy of existing tests in comparison to what is proposed. In cases where the test and approach are well known, quantitative research is generally sufficient, however, there are a few situations where performing initial qualitative research will prove exceedingly valuable:
- Novel diagnostics where there are no existing tests or established clinical values
- Innovations which have the potential to change test algorithms for diagnoses
- Test updates which are based on different markers or antibodies than those currently in use
Here the core approach is to establish a dialog with target audience clinicians concerning their current goals for clinical values and opportunities available for improved patient care, reductions in total cost of care or improvements in clinician quality of life. From these broad categories, perceptions regarding the current market state and a hypothetical post launch market state can be established.
At this point, the important question of reimbursement should be addressed. If a new test does not have established codes, a critical step in understanding perceptions of the new test is understanding the role reimbursement will play in prescribing behavior. This is dependent upon the cost of the test or the proposed cost of an instrument which performs the test (expressed as a breakeven period in months) and cannot be left out of any initial utility and efficacy perception research.
For many readers working with larger CD companies with ample primary market research budgets, these are not new efforts. However, even mid-sized start-up companies can realize significant benefit from research of this type.
Clinical Utility Studies and the Patient Vignette
One of the most powerful forms of evidence for the effective promotion of your test or instrument lies in performing clinical utility or clinical value marketing research. Utilizing a clinical research organization (CRO) to perform these studies, however, can be prohibitively expensive due to patient enrollment and administrative costs, in addition to clinician compensation.
Using patient vignettes is one way to reduce the cost of these efforts. Patient vignettes are hypothetical patients who are evaluated virtually by clinicians in a study. Clinical diagnostics (in particular, novel diagnostics that establish risk or verify the occurrence of an event through the presence of specific biomarkers) are especially well-suited for studies utilizing patient vignettes, since there is no physical interaction required with the “patient” and they do not require any action on the patient’s part. In these situations, patient vignettes present relevant clinical values along with Hx data that represent a patient seen by a clinician. Clinicians suggest treatment plans and/or further tests to be performed.
Once the clinician has made their recommendations concerning next steps, a description of the diagnostic or prognostic test under study can be presented along with its range of clinical values and their meaning. The clinician then receives the values associated with a particular patient and decides how to modify their treatment plan or lifestyle recommendations accordingly.
Utilizing a well-defined set of questions which will expose significant changes in behavior for pre-defined success criteria, the resulting analysis provides validation of the initial study goals. If the study protocol is approved by an IRB, the results can be submitted for publication.
Stay tuned for Part II, focused post-launch primary research activities.
