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Principles for the translation of ‘omics’-based tests from discovery to health care submission

ID: 
10
This submission reflects the views of
Organisation Name: 
Queensland Department of Health
Please identify the best term to describe the Organisation: 
Government department – State / Territory
Questions
Q1. Is the draft document presented and written in a manner that is appropriate for the target audience (ie medical researchers, health professionals, health administrators and policy makers with responsibility for oversight of research or clinical care)?: 

Generally yes.

Principles 2.9 and 2.10 appear to be exact duplications of Principle 2.7 and 2.8. It is not clear if these were intended to be additional Principles or if this is a typographical error.

Consider using the term massive parallel sequencing rather than next-generation sequencing (NGS) because the technology is constantly advancing.

It isnt clear why monogenic assays will be the preferred method of gene analysis in many clinical circumstances if it is just as cost effective to use NGS.  The last paragraph in the introduction appears to also contradict this.

Q2. The draft document includes governing principles that apply across all domains and specific principles that apply to each of the four domains. Is this structure useful?: 

Generally yes.

Q3. The draft document includes five case studies. Are the case studies appropriate and do they sufficiently cover the range of situations that might be encountered in practice?: 

 

Yes. While a few case studies cannot be expected to cover all possible situations, they are very useful in illustrating how some of the principles may apply in practice.

Note that the reference to the principles in some of the case studies appears to be inaccurate. For example, Case Study 3 refers to Principle 3.1 as ‘There is a need for rapidly evolving guidance to inform the clinical use of omics tests’ which is different to the Principle 3.1 outlined on Page 16 (ie correct title is “Clinical use of omics tests needs to be informed by the best available evidence”).

Q4. Would you be able to use the document as the basis for drafting specific principles, policy or actions in your local context?: 

 

Yes (noting the comments above in response to Question 1).

Q5. Is the draft document comprehensive and does it cover the key issues in terms of principles? Is there further advice that should be included in the draft document?: 

Recommended that the following is added to Appendix B:

Thus, before granting approval to conduct a clinical trial, all parties must be satisfied that the conduct of the proposed trial is in accordance with:

           the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007);

           the current World Medical Association Declaration of Helsinki;

           the CPMP/ICH Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) or the ISO 14155 Clinical Investigation of Medical Devices, whichever is applicable;

           the requirements of the Therapeutic Goods Administration as outlined in this document; and

           any requirements of relevant Commonwealth and/or State/Territory laws.

Page reviewed: 15 April, 2015