Patient Reported Outcomes (PRO),
Observer Reported Outcomes (ObsRO) and Clinician Reported Outcomes
(ClinRO) are today summarized under Clinical
Outcomes Assessments (COA).
In December 2009 the FDA released a Guidance for the Industry to clarify their requirements for Patient Reported Outcomes supporting labeling claims. The agency put special emphasis on Reliability, Validity and Ability to Detect Change and expects to see sufficient documentation included in the submission package. They also point out the importance of Recall Bias: "If a patient diary or some other form of unsupervised
data entry is used, we plan to review the clinical trial protocol to determine what steps are taken
to ensure that patients make entries according to the clinical trial design and not, for example,
just before a clinic visit when their reports will be collected" .
While this is easy to document in the controlled environment of a clinic visit it strongly favors the use of electronic systems for any form of take home diaries ("unsupervised data entry"). There are different ways to electronically collect patient data. Electronic Pens, Interactive Voice Response systems (IVRS) and it's Web based version usually called IWRS, pre-configured and validated Hand Held Devices, Web applications and Smart Phone Apps (currently often summarize as BYOD - Bring Your Own Device). There is no one-size-fits-all-solution. Each Modality has it's strength and challenges with regards to cost, patient population, geographic distribution of patients and sites. Since many of the currently existing standard COA instruments have been originally developed and validated on paper it is important to consider validation efforts as part of the Paper-to-Electronic (P-to-E) migration. We can help you to
- select the right instruments for your endpoint model
- choose the right modality for your specific protocol
- acquire a license for copyrighted instruments and discuss
validation requirements with the authors
- define steps necessary for Paper to Electronic (P to E) migration
- select technology vendors and define a data integration plan
- support your clinical team with management of technology components of their trial
We know all the major systems in the market but are not affiliated with any technology vendor and provide objective advise. If you are planning to use Clinical Outcomes Assessments in your next trial, please contact us, we would be happy to discuss how we can help.