Code Breaking who, what, when, how and why?

Transcription

1 Cde Breaking wh, what, when, hw and why? June 2015

2 Outline What is blinding? Why are studies blinded? What is cde breaking? When wuld I want t cde break? Cde breaking in the event f a SUSAR Wh can cde break? Ways f cde breaking After treatment has been unblinded Out f hurs arrangements Pitfalls f blinding and cde breaking

3 What is blinding? Randmised Cntrlled Trials (RCT) A study in which participants are randmly assigned t a particular treatment grup t test a specific drug r treatment. One grup (the experimental grup) receives the treatment being tested, the ther (the cmparisn r cntrl grup) receives an alternative treatment, r a dummy treatment (placeb) r n treatment at all. The grups are fllwed up t see hw effective the experimental treatment was. Outcmes are measured at specific times and any difference in respnse between the grups is assessed statistically. This methd is als used t reduce bias. (nice.rg.uk) Usually phase III, sme phase II Variety f chrts

4 Types f blinding and study design Single blind Investigatr Subject/Patient Other medical prfessinal e.g. Radigrapher, physitherapist Duble blind Investigatr and subject Nt always pharmacy Triple blind Until Safety issues Placeb cntrlled Crssver and parallel studies

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6 Why are studies blinded? T prevent bias Different chrts, e.g. accrding t age, disease status, prir treatment Ensure that valid and reliable data are cllected Cnfidence in the findings Placeb effect / N-ceb Prduct licensing

7 Wh is blinded and t what? Investigatr Spnsr Research Team Participant Study Mnitr Pharmacy Other healthcare prfessinals e.g. radigrapher, physitherapist Treatment Participant s respnse t treatment

8 What is cde breaking? Unblinding Breaking the blind Revealing the subject s treatment the cding system fr the IMPs shuld include a mechanism that permits rapid identificatin f the prducts in the case f a medical emergency, but des nt permit undetectable breaks f the blinding. ICH GCP Sectin

9 ICH GCP 4.7 Randmisatin Prcedures and Unblinding The investigatr shuld fllw the trial's randmisatin prcedures, if any, and shuld ensure that the cde is brken nly in accrdance with the prtcl. If the trial is blinded, the investigatr shuld prmptly dcument and explain t the spnsr any premature unblinding (e.g., accidental unblinding, unblinding due t a serius adverse event) f the investigatinal prduct(s).

10 When wuld I want t cde break? In an emergency When knwledge f the subject s treatment will affect hw we treat them E.g. drug interactins, NICE guidance fr treatment ptins

11 Cde Breaking in the event f a SUSAR Suspected unexpected serius adverse reactin Patient safety Reprt t Spnsr Eurpean Cmmissin guidelines (Eudralex Vlume 10): assess, in view f the varius reprted SUSARs, whether an IMP pses an unknwn risk t the subject, and take measures t prtect the safety f subjects, if necessary.

12 Wh can cde break? Accrding t the prtcl D yu have t seek permissin frm the spnsr team first? Chief/Principal Investigatr (CI/PI) Research team members nurses, crdinatrs, sub-investigatrs Pharmacy (CTIMPs)

13 HOW? Permissin btained frm PI & Spnsr? IVRS / IWRS Sealed envelpes Scratch cards Remvable labels Randmisatin list held centrally in Pharmacy

14 After the treatment has been revealed What treatment will the subject receive? Wh shuld be made aware f the treatment? Keep team members blinded, if pssible Keep the subject blinded, if pssible Reprt t spnsr

15 Out f hurs arrangements What plans d yu have in place fr ut f hurs cde breaking? Cnsider individual study requirements Likelihd f having t cde break Wh has the ability t cde break in yur team/ department? On-call services Pharmacy

16 Have yu tested yur cde break prcedures? D the telephne numbers/web addresses wrk? What infrmatin will be required? Any SOPs/guidance in place? Prtcl Departmental arrangements Pharmacy Prcedures Pharmacy Cde break frm (example fund in yur pack) Have yu activated yur IVRS/IWRS accunt? D yu knw yur passwrd? D yu even knw where yur envelpes are?

17 Have I ever had t cde break? Anastrazle/placeb in breast cancer Subjects that had cmpleted the study and required further treatment years later. The current guidance recmmended the use f anastrazle treatment. If the subject had been randmised t anastrazle, an alternative treatment was required. Mnclnal antibdy Death Safety f ther study participants

18 Pitfalls f blinding & cde breaking Investigatr team unfamiliar with prcess r inadequate hliday/sickness cver in event f emergency cde-break Team members & participants may guess the treatment Ptential fr accidental unblinding Hw easy is it t reveal treatment? Unintentinally reveal treatment Wh is lking at yur study infrmatin? Unintentinal exclusin f subjects with mre advanced illness

19 Interesting links Understanding cntrlled trials: Why are randmised cntrlled trials imprtant? Cancer Research UK Eurpean Cmmissin Vlume 10 Clinical trials guidelines MHRA- Adaptive Clinical Trial Design OKane.pdf

20 JREO Wrkshps July Medical Devices 12:30pm 22 nd July Bard Rm H2.6 Training sessins will then restart in the new academic year **Fr full list, please visit ur website** This and previus presentatins will be available n the prtal fr yur reference if yu are interested in any f ur training being prvided specifically fr yur department please get in tuch We are always cntactable t answer queries and help yu thrugh the prcess Check ut ur Guide fr Researchers? Gd Clinical Practice (GCP) GCP Refresher Sessin 8th July am t 4pm 15 th September am-1pm

21 If in dubt please check with yur assigned JREO Research Gvernance Officer