Are you and your trial eligible?
If you are employed at one of the PTNA member organisations (a paediatric research entity) you are automatically considered a part of the PTNA community and are eligible to request a review of your trial concept with the intention of developing your concept. A trial may still be submitted for review if non-PTNA members will participate in the trial as long at the lead site is a PTNA member.
If there is an industry partner involved please contact PTNA prior to submitting your request. Eligibility will depend on the circumstances and will be determined on a case by case basis.
The trial must:
- align with the PTNA vision and objectives
- be multi-site, preferably multi-jurisdictional
- have a potential impact on child health (0-18years of age)
- be presented at the annual PTNA trials day (after the review).
Researchers developing studies in adolescents and non-novel drugs (such as post clinical effectiveness or drug repurposing) are encouraged to participate in the Scheme.
PTNA strongly recommends that you are validly trained in Good Clinical Practice and that you understand your obligations as an investigator.
There is currently no cost for the concept development scheme. The scheme is provided in-kind to enhance the quality and quantity of paediatric research in Australia. However, there is an expectation that you will respond to the Committee within timelines and complete the process; as well as present the concept at the annual PTNA Trials Day.
Publication acknowledgement and attribution requirements:
Acknowledgement of ‘Paediatric Trials Network Australia’ in presentations and publications is expected if a grant of money or services is provided.
In the case of a review-only (no grant), PTNA should be acknowledged if appropriate.
How do you find out when callouts are made?
PTNA provides the Concept Development Scheme throughout the year. There are no specific callouts however reminders about the Scheme will appear in the PTNA newsletter and on the PTNA website.
Keep in mind that once PTNA reviews your concept you will be asked to present it at the annual PTNA Trials Day, usually held in the second half of the year. In addition, there may be slight delays if the review of your study clashes with grant application periods or other grant reviews as the Concept Development Scheme reviewers may be otherwise occupied.
Leave plenty of time for the development of your concept if you are planning to apply for a grant. Your institute may also have internal deadlines prior to you submitting an application for a grant.
What tools are available?
PTNA recommends that you keep the PICOT format in mind when developing your research concept. PICOT refers to: Population, Intervention, Comparison, Outcome and Time. See reference.
The CONSORT statement including a checklist and flow diagram) provides a good guide as to how to design your study to ensure that you can report it. This is particularly important for publishing your results.
In addition, the International Harmonised Tripartite Guidelines, Clinical Investigation of Medicinal Products in the Pediatric Population (E11) provides helpful information for developing your paediatric trial.
Note: Assent is not legally recognised in Australia.
Depending on the type of trial you are developing you may consider the following guidelines:
Source: presentation by Tibor Schuster, MCRI. 2015 PTNA Trials Day
Protocol templates are also available on the PTNA website (courtesy of MCRI) and you may also consider the SPIRIT content (which includes a checklist).
Importantly, please consult your research ethics and governance office for assistance. They are there to help you. The Australian Peadiatric Research Ethics and Governance network is a sub-committee of PTNA and contact details can be found on the PTNA website.
Reviewer attributes and obligations
- Expert and Informed
- Conflicts declared
- Reviewers will not take advantage of knowledge gained
- Criteria driven (relevant, unbiased)
- Proper, robust consideration (especially, to any challenges posed).
Researcher’s attributes and obligations
- concise and truthful
- able to comply with timelines
- does not endeavour to influence any of the reviewers
- declares conflicts of interest
- agrees to acknowledge PTNA.
What are conflicts of interest and how are they managed?:
According to the Research Code of Conduct a conflict of interest is when a person’s personal interests diverge from their professional interests. Conflicts of interest can be actual or perceived. Conflicts are assessed independently of Committee members and best endeavours are made to avoid conflict situations. In most circumstances the Committee member with the actual or perceived conflict will be withdraw from the process.
There is an inherent risk of conflict whenever a network such as PTNA undertakes a process such as a review due to the nature of the collaborative work it undertakes as well as the people, services and infrastructure that are involved. PTNA manage these situations through declarations of conflicts and transparency to ensure an impartial review process.
An example is an affiliation with a pharmaceutical company involved in a particular trial. Another is a Committee reviewer from the same employing organisation as the principle or chief investigator of a trial that is under review.
The researcher will be requested to complete a conflict of interest declaration form and each Committee reviewer will also be required to declare known conflicts.
Declarations of potential conflicts are maintained confidentially by PTNA Executive. A register of conflict situations is also kept by PTNA Executive.
Who are the reviewers and could you be a reviewer?
The review Committee is made up the PTNA Steering Committee with the addition of invited non-Committee reviewers dependent on the focus of the research. These additional reviewers are invited to provide the appropriate level of expertise.
All Committee members provide their time in-kind and are committed to raising and maintaining high-standards in paediatric research.
 Australian Government, National Health and Medical Research Council, Australian Research Council and Universities Australia 2007, Australian Code For The Responsible Conduct Of Research, Canberra. Section 6.
 Lancet, T., 2010. Strengthening the credibility of clinical research. The Lancet, 375(9722), p.1225.
 Riva, J.J., Malik, K.M., Burnie, S.J., Endicott, A.R. and Busse, J.W., 2012. What is your research question? An introduction to the PICOT format for clinicians. J Can Chiropr Assoc, 56(3), pp.167-71.
 David Moher, Sally Hopewell, Kenneth F Schulz, Victor Montori, Peter C Gøtzsche, P J Devereaux, Diana Elbourne, Matthias Egger, Douglas G Altman, 2010. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. British Medical Journal, 340:c869 <http://www.consort-statement.org/>.
 Tetzlaff, J.M., Moher, D. and Chan, A.W., 2012. Developing a guideline for clinical trial protocol content: Delphi consensus survey. Trials, 13(1), p.176.
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