Symfo International and Oxford University Innovation Announce a Unique Turnkey Solution for Patient Reported Outcomes (PRO) Operations
29th June 2011
Isis Outcomes, a part of Oxford University Innovation Ltd, and Symfo are applying their respective areas of expertise to offer Sponsors and CRO1s a unique service that will help Drug Development/Study Managers to assess and choose the right PRO2 measure – validating and deploying PRO instruments, and ensuring that the study will meet Regulatory Authorities requirements.
PROs are increasingly used during the drug and medical device development process to prove effectiveness; most Primary and Secondary endpoints in clinical trials use PRO instruments to measure efficacy. PROs are also used in health policy decision-making processes when comparing treatments. Their accrued importance is such that the US FDA issued Guidance for Industry on the Use of PROs in December 2009.
After a PRO has been designed, tested and validated it must be deployed correctly to collect the required information. Traditionally, PROs have been completed and collected on paper but there is a growing trend to use electronic systems (called ePRO) to collect better and more reliable data.
Now, using ePRO technology, Symfo and Isis Outcomes deliver the whole PRO cycle.
Initially a concept evaluation is performed with the Sponsor. Once the targeted endpoints are identified a suitable PRO will be selected, or, if required, a new PRO will be developed or modified in accordance with international regulatory guidelines. The instruments – and translations, if required – will be validated. The PRO will then be migrated, with appropriate checks to ensure equivalence, to the selected electronic platform. Symfo and Isis Outcomes provide assistance to select the most appropriate e-platform for a trial. The resulting ePRO will be deployed in the selected countries and languages, and data will be collected. Symfo and Isis Outcomes will collate the data, and can perform analysis and assist with submission to Regulatory Authorities.
References:
1CRO: Contract Research Organisation, or sometimes Clinical Research Organisation.
2PRO: ‘a measurement based on a report that comes directly from the patient about the status of a patient’s health condition…’, (source: FDA). PROs are used to measure treatment benefits or risks in medical product clinical trials. Some treatment effects are only known to the patient. The most understandable example is pain, where only the patient can tell us about the intensity of his/her pain.
