- Posted By: Vicki Barber
This week in OCTRU there has been a bumper week of training with there having been 135 training instances recorded. For those that were not able to make some or all of the training, a summary follows:
The week started with Bethan Copsey, one of the OCTRU Medical Statisticians giving a presentation on systematic reviews – including the pitfalls and joys of undertaking one. Some useful directed reading to accompany this talk was the PRISMA statement and its associated website. Read more about this statement at http://www.prisma-statement.org/
Dr Gareth Bicknell then gave a very entertaining and informative seminar on Biobanking with reference to the Human Tissue Act where relevant. Some useful reading that was highlighted on this topic was the BRISQ Statement for reporting biospecimens that is a crucial tool for depositing correctly labelled samples into a biobank. To read more about this, go to http://www.equator-network.org/reporting-guidelines/biospecimen-reportin... . Further information on the HTA can also be found on the Human Tissue Authority website, http://www.hta.gov.uk/licensingandinspections/sectorspecificinformation/... .
There was then a session highlighting the value of audits and feedback following the first audit by OCTRU senior staff on the statistical part of a Trial Master File. The session involved overview of audits from a QA and Regulatory perspective, audits specific to statistics led by OCTRU Lead Statistician and feedback from the auditee. All those working on trials should be mindful of being adherent to Standard Operating Procedures and note that every OCTRU Registered Trial will be audited at least once in its lifetime. Highlights from an Auditee perspective were that the: “Most important SOP is GEN-002 Document Control. If you are following the SOPS correctly then audits shouldn’t scare you. Get it right the first time, it takes much longer to correct things than you expect, even when they are only minor findings”.
Finally, some of the oncology early phase statisticians presented a session for non-statisticians on the continual reassessment method and they hope to be using this in the near future on some early phase oncology trials in Oxford. You can read more about this method at these links: http://www.ncbi.nlm.nih.gov/pubmed/21610004 and http://www.ncbi.nlm.nih.gov/pubmed/24982451 .
To find out what training is on the calendar for the rest of the year, visit the OCTRU website for details of all the training sessions and seminars that are coming up are coming up. http://www.octru.ox.ac.uk/events