Supporting our userbase during the COVID-19 (coronavirus) pandemic

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21st April 2020

As the COVID-19 pandemic continues to affect the way in which healthcare and research are being administered and conducted on a global scale, we are rapidly adapting to support our userbase to help safeguard patients and minimise the disruption to scientific research. As providers of some of the most widely adopted Clinical Outcomes Assessments, the Clinical Outcomes Team at OUI continue to help our Licensees around the world adapt to the challenges posed.

With social distancing and self-isolation being recommended or imposed in many countries, there is growing demand for alternative methods of administering our instruments to study subjects and patients.

Industry thought leaders and regulatory bodies such as the FDA, have always provided guidance that any change in mode of delivery of a PRO instrument needs to provide evidence that captured data is ‘comparable’ to the original, normally pen and paper completion PRO. Although a pragmatic approach to changing delivery mode as a response to the COVID 19 crisis, seems to be acceptable by some regulators, it is our responsibility as owners / managers of our COAs to ensure our measures continue to return reliable data.

 

Human Lead Telephone Interviews

The completion of COAs as part of a clinic visit during a clinical trial is a common method for collecting such instruments. With lockdown and social distancing, telephone interviewing (delivered by a person), seems to be the preferred alternative of deployment for some licensees. However, the routine adoption of this methodology as an alternative to pen and paper completion needs to be approached with caution. We have therefore, with the support of our instrument developers, devised a set of tailored instructions that accompany our Clinical Outcome Assessments, to be used by the interviewer/clinician. To enhance confidence that this approach is delivering comparable results, we are advising that the patient is also provided a copy of the standalone measure in paper form or electronically, so that they can view the questions in parallel to the interview and so have a visual reference (or prompt) as part of the telephone interview. If you are a user of one of our COAs and wish to use our telephone interview scripts, please do contact us.

Electronic Clinical Outcome Assessments (eCOA)

This mode of delivery brings about many advantages to a study and as such, developer/owner approval of content and function is key part of ensuring a faithful reproduction of the original paper and pen mode of completion. We have therefore allocated new specialist resource to meet increased user demand and ensure that licensees eCOA platforms are reviewed in a timely manner with the same high-quality approach we always provide. In this way all stakeholders can, with confidence, rely on the faithful reproduction of our COAs. We are on hand to advise and discuss your study requirements for electronic deployment of our own and other COA instruments.

Translation Activities

We are very pleased to announce that Beatrice Tedeschi joined us in early March to help coordinate our rapidly expanding translation activities. The first major project being managed by Beatrice, in response to COVID-19, has been the delivery of translations around the telephone interview instructions for our measures to support our global userbase.

 

If you are faced with COA administration challenges please contact us to discuss your specific requirements. You can also directly contact us to discuss specific topics as below. We will endeavour to provide our best advice and solutions as promptly as we can.

Licensing: Martina Zagaria

Translations: Beatrice Tedeschi

eCOA: Justin Raymer

 

The Clinical Outcomes Team

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