Clinical Outcome
Assessments Strategy

COS can provide strategic advice on the best COA measurement strategy based on the requirements of your target product profile or, more broadly, your value messages for differing audiences – patient, physician, and/or payer. COS start with a comprehensive literature review and intelligence gathering exercise to make robust recommendations to maximize likelihood of success for achieving your objectives.

You may have need to train your internal clients on the requirements for a robust and rigorous COA strategy, highlight what it will take to gain labelling with any given measure or discuss increased scrutiny from a payer perspective, or discuss ways position your PRO data with innovative statistical approaches. COS has a strong team that can deliver bespoke training to meet your needs.

COS has authored numerous evidence dossiers to defend a COA’s inclusion in the label and defended them at the FDA and EMA.

To obtain labelling with a COA is a challenging task and has become increasingly so over time. The FDA PRO Guidance and EMA HRQOL Reflection paper provide some advice on best approach to take for ensuring a smooth journey to labelling. However, there regulatory environment has and continues to change and requires constant monitoring. COS has much experience in negotiating with the FDA and EMA regarding COA strategy, and across numerous therapeutic areas. COS leadership is able to assist in the development of regulatory documentation as well as attend key meetings.

Successful use of COA data with regulators and payers is more than just choosing the correct measure; correct implementation of these measures into a clinical trial including planning for the statistical evaluation is critical. Many the COS leadership previously worked in industry and so has much experience in the successful implementation of COAs into clinical trials. Service that COS can provide are: writing relevant sections of clinical trial protocols, SAPs, and CSRs, advise on translation process, use of electronic data capture systems etc.

Determining if a measure is fit for purpose from a regulatory and/or payer perspective is critical to ascertain prior to use in your pivotal trials. COS can provide strategic advice about filling any identified gaps in a measures validation history, whether that be content validation, psychometrics, or derivation of a meaningful change threshold.