How/Where Can we Convey the Notion that Clinical Trials are Relevant for Everyone and Thereby Enhance Delivery of Patient Care?

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1 How/Where Can we Convey the Notion that Clinical Trials are Relevant for Everyone and Thereby Enhance Delivery of Patient Care? Dr. Mei Krishnasamy Executive Director of Cancer Nursing and Allied Health Peter MacCallum Cancer Centre Professor of Cancer Nursing, Translational Research University of Melbourne

2 Clinical Trials

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4 In Australia

5 But what we do know. Approximately 30-35% of people in UK are on a trial in This compares with 2-5% in Australia and new Zealand

6 In Victoria we aim to have 40% of all patients with a cancer diagnosis on a trial within 3 years.

7 Trials : Enhancing Delivery of Patient Care Enhancing outcomes:

8 Enhancing outcomes but what about safety? What nurses need to know and patients need to be assured of Declaration of Helsinki A set of 13 Ethical Principles for Medical Research involving Human Subjects All staff involved in clinical trial patient care must be able to demonstrate knowledge and awareness of GCP It is the duty of the physician in medical research to protect the life, health, privacy and dignity of the human subject.

9 What did we decide to do at PeterMac? Good Clinical Practice training mandated for all nursing staff Training program adapted from NIHR and delivered by NIHR trained trials manager Dr Sophie Mepham

10 Good Clinical Practice (GCP) GCP : an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that: the rights, safety and well-being of trial subjects are protected (Declaration of Helsinki) that clinical trial data are credible.

11 Why is GCP training so important? Recent paper citing collated results of FDA audit findings : Failure to follow investigational plan (34%) Inadequate informed consent (28%) Inadequate/inaccurate records (27%) Only 31% of audits resulted in no action indicated We wanted to address this.. 1 Clin Can Res 2014;20:

12 How did we set out to convey the notion that clinical trials are relevant for everyone? Local training every month, minimum1 day all staff Flexible and accommodating: Consultants flexible bookings by session and by tumour stream Registrars early mornings NUMs/ANUMs nurse leadership days All nurses scheduled in-service times Dieticians weekly 1 hour sessions 5 weeks Pharmacy/radiology/pathology GCP

13 GCP training does not need to be complex! What is GCP actually about? Safeguard and protect research subjects Reduce risk Ensure quality data Ensure excellent research and good science.

14 The Peter Mac/NIHR GCP program 5 hours maximum 5 key topics: GCP: The Standards Study Set Up Informed Consent Case Report Form and Data Entry Safety Reporting Full GCP done once by all staff and then a refresher every 3 years (max 2 hours) Programs are accredited by TransCelerate

15 TransCelerate GCP Accreditation with TransCelerate means training is now recognised by all Pharma Standardised processes, forms and templates enhance pharma relations

16 What will our GCP training mean in practice? Inadequate/inaccurate records (27%): Clinical trial patient visit recorded in medical record template Doctors now prompted to record all Adverse Events and concurrent medications in required clinical trial format Leads to improved compliance, reduced monitoring letter issues, improved audit findings

17 Inadequate informed consent (28%): Mr/Mrs has agreed to participate in the HREC # (& Name of trial) clinical study. PICF Version dated was given to the patient on and it was signed on by the patient in presence of. Mr/Mrs has had full opportunity to read and be informed of the trial and the following questions were discussed: An interpreter was/was not present during the consenting process (Name of Interpreter & relationship to participant, if applicable) Copy of the signed PICF(s) has been given to participant. Screening procedures were commenced once the PICF was signed. Nursing Research : SPIF

18 Failure to follow investigational plan (34%): Central clinical trials site on intranet, provides all hospital staff with: Protocol IB Fast Facts CTCAE SAE reporting guidelines Radiology manual

19 International collaborations : UK Clinical Research Network New collaboration proposed to share best practice with UK CRN and Peter Mac research nurses: to realise the potential to develop collaborative working across clinical, educational and research communities in the UK and Australia.

20 Summary Embedding clinical trials into routine care is possible Giving all staff access to this information in combination with an accessible and appropriate GCP training program Manageable, feasible and effective Reduction in non-compliance Making trials the business of every nurse

21 Further information