The Clinical Outcomes (CO) business at OUI has enjoyed another amazing year of growth despite the downturn in licensing due to COVID-19. Clinical trials and other studies employing our outcome measures have been hit hard by the pandemic, with income from licences to our growing portfolio of measures being down by about a half. Fortunately, the Outcomes team have been able to adapt rapidly and returned a record year, achieving 35% growth in income on last year, the third year running we have achieved such growth.

COVID-19 has undoubtedly impacted the way clinical trials and routine clinical care is conducted both in the UK and abroad. Our licensees have had to adapt quickly to support socially distanced clinics which has driven remote digital deployment of our measures, or Electronic COAs (eCOAs). In 2021 we saw a 53% increase for eCOAs on the year before. Also, in response to a demand for greater quality control of eCOAs, CO has now formulated its own new eCOA review service offering, with a pricing and testing structure to suit the client type and resource required. This new service will also ensure the integrity of our managed COA portfolio is retained for the benefit of all stakeholders and patients.

The pandemic has had a knock-on impact on clinical trials and our associated income, but we have reason to believe we are seeing the green shoots of recovery. We have been receiving an average of around 40 new licence requests a month since August 2020. This has shot up to over 60 since March. This year, we have granted over 700 licences (including 149 commercial) of which 126 were in May alone.

Clinical Outcomes translation activity has flourished this year. We have supported the international adoption of our measures with 35 internal translation projects completed and 63 new additions to our existing library of available translations. We now count 545 localised versions among our 36 measures, most of which have been translated and linguistically validated as compliant with sector good practices and in accordance with requirements of the European Medicines Agency and its counterpart in the USA, the Food & Drug Administration. The growth of our library of translations is also supported by groups of non-Oxford academics who, by following specific guidelines, create translated versions of the questionnaires for research purposes. Their contribution supports the global impact of our measures and aids the local adoption of our questionnaires in academic scenarios worldwide.

Alongside the translation project work for our portfolio of questionnaires, we have performed many translations and linguistic validations for third parties’ questionnaires, including for the prestigious European Organisation for Research and Treatment of Cancer (EORTC) and their portfolio of cancer related COAs. We have extended our remit by helping clients delivering rare language projects such as Creole for Haiti, Cebuano and Ilocano for the Philippines, and minor African languages such as Ganda and Swahili, which demonstrates our commitment to make COAs available and accessible as widely as possible.

2021 is the first year CO has been actively supporting non-Oxford parties to manage their Clinical Outcome Assessments (COAs), with the addition of Sheffield University’s Duchenne Muscular Dystrophy Quality of Life questionnaire developed with charity Duchenne UK, or DMD-QoL, to our portfolio. This health outcome measure aims at increasing the chances that patients with DMD could access innovative treatments. CO’s contribution was managing the translation of the DMD-QoL into 26 language versions. It the single largest project CO has tackled to date and greatly enhanced the global impact and engagement of DMD-QoL.

In summary, the pandemic has been a challenge for CO and its users, with clinical trials and associated activity which our questionnaires monitor as healthcare providers worldwide switched track to focus on COVID-19. Yet, through adaptability from CO in redeploying its questionnaires electronically and expanding our reach through translation, we have risen to that challenge and laid firm foundations for the future of CO’s operations.