GET IN TOUCHWHY VITRORAREDIS - The rare disease patient registry & beyond?
A patient registry or rare disease database should be designed to operate for 20-30 years. It is never a static standalone software tool. It must be developed with a long term integration plan to add features as it becomes increasingly valuable.
VitroRareDis is a full Rare Disease Management System providing all the clinical data required for clinical trials and Health Technology Assessments and includes a rare disease specific branching registry.
Registries ERNs and clinical trials
European Reference Networks (ERNs) represent a paradigm shift in the treatment and care of rare diseases. This gives Pharma’s an opportunity to take advantage of this shift, to redesign how data will be collected for rare disease research and clinical trials.
- Extend the registry to support Phase IV Clinical Trials standards. VitroRareDis has been extended to include all the extra checks and balances required to run a legally enforceable clinical trial including a robust security model that supports auditing, discrepancy notes and digital signature requirements for Nurses, Monitors and Principal Investigators. Our software and company procedures are compliant with Good Clinical Practice Guidelines (CGP).
- Pharmas can now use ERNs linked to VitroRareDis as their main vehicle for clinical trials.
- Many registries get bogged down with local hospital ethics and consent issues. ERNs however will provide a unified consent model. All members of an ERN have agreed to share clinical data. We suggest that when a patient is presented with the ERN consent form, he/she can agree to make their data available for research using the ERN registries.
Optimising data entry for clinical trials & registries
A clinical trials compatible Rare Disease Management System supports a rigorously defined protocol. It should be able to detect which clinical trials patients are on and if none provide the default simple data entry system for annual summaries. The registry should therefore support two data entry modes: general registry data entry and clinical trial data entry.
Pharma companies require access to patient clinical data as mandated by the EMA and national HTA.
Clinicians and patient organisations are reluctant to deal with companies seen to be motivated by profit, there is perceived clinical bias (the Sunshine Act legislation).
In our experience the best way to avoid Pharma-Patient Organisation conflicts is for Pharma’s to deal with commercial companies such as Vitro.
George Reynolds is an expert in Rare Disease ICT. He has spoken at many industry conferences and chaired Round Table events. George's last role was being in charge of the commercial registry and European Reference Network (ERN) business in OpenApp, who together with Vitro were awarded the CPMS diagnostics registry solution by the European Commission. The wider Vitro team include clinical and operational members and come with many years experience in healthcare ITC.
Vitro's experience includes work with Operation Smile, the cleft lip and pallet charity who work in over 60 countries. Vitro provides a international cleft pallet registry and clinical patient management system to collect clinical data and help manage surgery for thousands of cleft pallet patients. Vitro have also developed a dedicated Cystic Fibrosis registry and clinical management system.
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