Research Flashcards
Why are clinical trials important?
To assess as objectively as possible the effect on patient outcome and QOL of new treatments. i.e. using evidence based medicine to determine more effective treatments for patients via evidence based medicine.
Why is anonymisation important?
To ensure individual patients can have trust that when medical professionals use their data for research (to imporve patient outcomes) that their personal circumstances are not identified to others. If patients cannot trust that their data is being used ethically, this may put them off accessing medical treatment which could lead to very bad outcomes for patients (e.g. late cancer diagnosis).
Additionally, breakdown in trust can lead to reduced recruitment for medical trials, ultimately harming improvement in future patient outcomes.
There is also a requirement under DPA/GDPR that personal data must be processed fairly, transparently, lawfully and only for the purposes of being collected. They should also be stored securely, kept up to date and be relevant and adequate to achieve the clinical goal (in the NHS context).
Data which has been anonymised or pseduo anonymised does not fall under this legislation as it does not contain information that idendifies individuals.
The 7th Calicott principle also acknowledges the need to share data for patient benefit but still requires to be complianct with the law.
How can anonymisation be broken?
If pseudo anonymised, then persons with access to the link table would be able to reidentify the patients.
Details burned into images (e.g. patient name, DOB, etc) that are not removed by the anonymiser would allow identification.
In the DICOM file, UIDs could be linked to patients original data if these are not changed during the anonymisation process. Privacy tags (being vendor specific) could contain patient identification information which has not been removed by the anonymiser.
Do you think clinical trials puts additional pressures on front line staff?
Yes, this is additional work alongside their clinical duties. It would require them to follow additional protocols and for example when identifying patients for recruitment they would need to be extra vigilant when dealing with patients so they remember to consider this.
Potentially there may be several trials running in parallel so this might get confusing. Additionally, possible resistence to additional workload and/or change.
Tell me different groups that would be involved in clinical trials in radiotherapy?
Potentially: Medical Physicists Dosimetrists Oncologists Radiologists Radiographers Nurses Admin staff Urologists Technicians (e.g. mould room) Possibly engineers if equipment modificiation or jiggs required Any specialist related to the study.
What do you think are the future developments in radiotherapy?
Real time adaptive planning (i.e. personalised treatment regimes) in conjunction with IGRT.
Proton Beam treatment
AI auto-contouring OAR and possibly GTV (at least 1st pass for review by oncologist).
Application of radiobiology within TPS.
Hypofractionation.
