Inspired Health Outcomes
Improving Patient Voice with Impeccable COAs

Clinical Outcome Assessments (COAs) are crucial for capturing patient perspectives and measuring various aspects of their health status, care or quality of life. To use the FDA definition, a COA is a measure that describes or reflects how a patient feels, functions, or survives. Initially considered a complementary element from a regulatory standpoint, COAs have become a must-have for validating evidence of intervention efficacy. In the U.S., with the FDA and in Europe, with the EMA, COAs have transitioned from a desirable randomized controlled trial (RCT) component to an essential one.

InSpired Health Outcomes is dedicated to the development of new COAs and their proper application. That activity falls into two core responsibilities, the first around the design, development, testing, and validation of new COAs. Secondly, InSpired Health Outcomes manages, promotes, and supports COAs in all aspects of their use. This involves providing appropriate guidance in their proper use including licensing, translation and linguistic validation services, and reviews of digitally migrated instruments, or eCOA – facilitating the seamless (and faithful) transition of COAs to digital formats. Beyond managing its own portfolio of COAs InSpired Health Outcomes also offers advice and guidance on the appropriate utilization of third party COAs.

"Our vision is to give a voice to everybody in healthcare. We aim to achieve this by providing and supporting the use of COAs in capturing the patient's outlook in all aspects of measuring healthcare," says Dr. David Churchman, founder of InSpired Health Outcomes.

The firm achieves this by supporting suppliers (academic institutions and industry that develop COAs) and users of COAs like pharmaceutical companies, contract research organizations, healthcare providers, and medical device companies with intuitive services and the ability to be flexible, not constrained by legacy business structure, processes, or systems.

Dr. Churchman notes that COA management is a niche activity, particularly for technology transfer offices embedded within universities. While these offices are well-versed in protecting intellectual property (IP) and the subsequent knowledge exchange through licensing, or the creation of spin-out companies, they often need more familiarity with the intricacies of COAs. Such niche expertise relies on managing copyright ownership and licensing, which may involve high-volume express licensing to an industry that requires expertise in the topic of COAs along with being responsive to potentially challenging timelines.

Recognizing this, InSpired Health Outcomes collaborates with academic colleagues to provide clients comprehensive assistance in establishing a firm foundation for copyright ownership in COAs. Its focus is to ensure all interested parties have confidence in the ownership of the copyright associated with the questionnaire. However, navigating the complexities of this specific IP type is far from straightforward due to the involvement of multiple stakeholders, who drive added intricacies. InSpired Health Outcomes' role is to assist them in conducting due diligence to ascertain and safeguard their rights and maintain consistent copyright ownership of COAs.

The team at InSpired Health Outcomes offer a rich blend of academic origins and extensive industry experience, which sets them apart. While the company may be relatively young, it comprises former leading health outcomes researchers from the University of Oxford, who were the lead authors in developing well-known and highly regarded COAs that are relied upon throughout the pharmaceutical sector.

With over 15 years’ experience working with academic colleagues at the University of Oxford acquiring, promoting, and supporting the use of the portfolio of clinical outcomes assessments, Dr. Churchman possesses unique insights into their needs and aspirations. His colleague, Prof. Crispin Jenkinson, is known worldwide for his expertise in COAs, in particular Patient Reported Outcomes (PRO) Measures (or PROMS).

Having fostered a culture of continuous improvement unburdened by legacy systems, InSpired Health Outcomes continues to be flexible and agile in meeting evolving client demands.