We have used the term EDC (Electronic Data Capture) for around 14 years. Prior to that, we had RDE – Remote Data Entry. The terms switched largely because the old ‘RDE’ systems were offline, non internet based whereas the new solutions were online, or hybrid internet applications.
This paradigm shift occurred as the technology and internet came together to offer a new type of solution that solved the scalability issues of earlier systems.
2012 – and I think we are seeing the next revolution wave. All of a sudden, it is viable to offer up a single centralized solution that can be used by many different stakeholders, including – most importantly – the patients, and for the interface to this to exist on a number of different devices – Desktops, Laptops, Tablets and PDA’s.
Is it time for a new term - Patient Data Capture?… in this, I mean the technology, processes and regulatory support for capturing clinical trial data directly from Patients. I believe this to being a cross over between electronic Patient Recorded Outcome solutions and traditional site based Electronic Data Capture
The concepts are not new. All of the elements have already existed in different forms. Patient Recorded Outcome studies (PRO) or electronic Patient Recorded Outcome studies (ePRO) have been around for many years. What we have not seen is the ability to combine ePRO with EDC effectively. Yes – interfaces exist… but they are seperate datasets with seperate metadata.
Will the existing ePRO and EDC firms step into the other world – will Medidata or Oracle release an ePRO and/or PDC solutions – possibly. Will ePRO firms such as PHT or CRF Health release EDC solutions – less likely. They have tried this before, and failed. Instead it seems likely that the ePRO firms will move to be more ‘web’ focused with their offerings. They will provide WebPRO solutions that provide the option to ‘also’ capture patient data through a browser. However, we may find a number of the ePRO vendors reluctant to move quickly risking damaging their cash cow legacy solutions – dedicated device eDiary solutions. The competition is going to heat up, and purely web based PRO solutions emerge as the issues around Instrument validation are solved.
Will we see pure PDC? – patient data capture studies – I doubt it. There are many reasons why pure Patient Data Capture studies will not work for many types of studies (Centerwatch Article, ClinPage – No Site? No PI? No Problem) . In my humble opinion, it is not a case of EDC or PDC. It is a case of EDC + PDC.
One barrier to effective innovation in this space is the scourge of industry specific ‘obvious’ patents. We have seen 4 patents in the last few years that have effectively limited the freedom that software developers have in utilizing standard off the shelf technologies. Lets hope we don’t see many more of these. Ultimately, it will be the patients that will suffer as the cost of going to market with innovative solutions becomes too high.
I will be blogging more on this topic, as well as speaking at the Annual DIA Meeting in June in Philadelphia as Session Chair – The Cross-over Between Direct-to-patient Studies, Social Media, and EDC together with Ben Heywood – Co-Founder of PatientsLikeMe and Valdo Arnera – General Manager, PHT Corp, Europe.