Electronic Patient Reported Outcomes (ePRO), i.e. patient-reported outcomes collected by electronic methods, provide an accessible social e-modality whereby clinical research professionals can interact with trial participants to capture critical trial data and reduce attrition by providing a more responsive experience. Of course one potential caveat that exists is the potential for the integrity of a clinical trial to be compromised by patients sharing information about their trial experience via the various social media platforms. Participants swapping personal outcomes and trial data could lead to breaches of confidentiality and possibly (partial) unblinding of the trial if the information exchanged allows participants and possibly clinical research professionals involved in the trial to realise who has been assigned to the varous treatment options. This could have result in a call for the trial to be terminated prematurely.
A degree of concealment is vital for unbiased reporting of trial data and outcomes, but to date there has been little exploration of the means of formulating protocols to reduce the risk of social sharing leading to trial bias and invalidation of study results. As with the questions and issues raised by medical innovations surrounding pharmacogenomics and the recording of patient specific DNA sequencing there is currently no consistent protective legislation in place.
The ePRO Consortium was established by the Critical Path Institute (an independent non-profit organisation based in Tucson, Arizona) in cooperation with firms that provide electronic data collection technologies/services to the medical products industry for capturing patient-reported outcome (PRO) endpoints in clinical trials. Their mission is to advance the quality, practicality, and acceptability of electronic data capture (EDC) methods used in clinical trials for PRO endpoint assessment. The ePRO Consortium provides a pre-competitive space where a critical mass of experts can collaborate to generate measurement equivalence data, develop specification documents and data standards, and produce methodological guidance on measurement issues related to ePRO applications.
The ePRO Consortium recommends the following measures when implementing the use of ePRO in clinical trials:
1) At the outset be as specific as possible about the requirements for the effective use of ePRO
2) Training of staff is absolutely essential
3) Feasibility is important and ideally usability
4) Contingency planning for problems with the device in the field
There is likely to be increasing use of ePRO methods in the future to support clinical trials and patients in regular care. An example of this is the collection of symptom data from patients undergoing chemotherapy, using handheld diaries. This allows clinic staff to monitor outpatients, and to identify the occurrence of adverse reactions that may require intervention. Similarly ePRO could be deployed for the phase iv process in clinical trials; pharmacovigilence.
Watch this space...