Many trials from yesteryear looked at the benefit of treatment A v treatment B in terms of recurrence and survival data only. With the advent of new research methods available such as whole genome sequencing, digital image analysis, Nanostring technologies, there is a burgeoning trend towards revisiting these older cohorts to collect tissue samples and update the follow-up data. The idea of applying modern research techniques to historic tissue cohorts with 30 years of follow-up data is attractive to commercial investors who are trying to validate new personalised medicine approaches to breast cancer treatments. Applying new methods to patient samples from long ago combined with a wealth of long term follow up is a dream research project. However it is not without several hurdles to overcome.
Patient consent was gathered in a more lax way back in the early 1990’s so although patients consented to enter a trial, the process would not have been as rigorously documented as it is today. This means accessing these patients data records causes issue as we do not have ‘explicit informed consent’ to do so. We could go back to patients and re-consent them but this brings its own issues. How do we locate these patients to get permission to access their patient records without accessing the patient records to find out if they are still alive or are mentally competent to be re-consented?
What data do you require from the patient records? The date of death and /or relapse? Or more specific data such as tumour grade, patient age at diagnosis, surgery or death? Where will the data be stored and who will have access to such data? This is the biggest hurdle we have faced as with overseas funders unable to perform their own analysis on their own sequencing data as the patient derived data must not leave the UK/EU. With the introduction of the Patient Benefit and Privacy Panel in 2016 and the introduction of the new GDPR regulations in May 2018 the access and use of data seems to be getting tighter yet the opportunities to use it keep expanding. Finding the correct balance to satisfy the regulators is key.
A video of this presentation can be viewed at https://media.ed.ac.uk/media/0_z6dtx4z
