Concept Development Scheme
There are many crucial phases before a trial can begin. Typically it takes at least a year to go from idea to finished protocol. Trial success is dependent on developing the appropriate research question from the idea and using the appropriate trial design and methodology to answer the question efficiently. Paediatric trials face particular challenges with heterogeneous populations, often poorly developed outcome measures, interventions that may not be tailored or have adequate dose data for children, and closer ethical scrutiny.
Developing the concept needs a team of experts, critical scrutiny and stakeholder engagement. It is difficult for a single investigator, group or even institution to provide all these. This is where PTNA can help.
The Trial Concept Development Scheme facilitates high quality trial concept development by tapping into the expertise with the PTNA membership. The resulting stakeholder engagement should also result in better translation and greater enthusiasm for site participation.
Similar schemes have been successfully adopted by a number of other networks. Note that this is different to trial endorsement, where a network peer reviews an established protocol and may continue to monitor a trial during recruitment.
How do you submit a concept for review and development by PTNA?
Use the template: Request Concept Development Review. It should be no longer than three pages.
You will receive an email receipt.
Stage 1) Researcher submits a Request form outlining the question, why the question is important and a sketch of trial design clearly indicating the population, planned intervention and outcome of interest. Only ideas that need or want to be multi-centre will be reviewed. The PTNA office will screen the Requests to ensure they meet the above criteria and send back those that don’t. When they meet the criteria the Steering Committee Chair and two or more other members will review it and provide constructive comments. The PTNA office will collate the comments and send them to the researcher.
Stage 2) Researchers can then modify their proposal and respond to the comments. At this stage researchers may request additional assistance such as a PTNA grant for money for services or provision of services (up to $5,000) to assist in developing the idea, indicating exactly where the money will be spent.
Stage 3) Applications will be sent to the full PTNA Steering Committee for assessment prior to being awarded a grant and prior to a recommendation.
Presentation at the annual PTNA meeting, acknowledging PTNA’s support, is a condition of the scheme.
NOTE: PTNA may choose not to award a grant if for example, there is not sufficient justification for the money or the services.
Any unspent money within 12 months or misspent money must be reimbursed to PTNA.
How long does it take?
^iterative process, only if issues are not initially resolved
*expect a slight delay at the time of year when NHMRC review panels meet
Why would you seek review and development of your trial concept?
The Australian Code For The Responsible Conduct Of Research produced by the NHMRC, ARC and Universities Australia describes review by peers as the ‘impartial and independent assessment of research by others working in the same or a related field.’
The Australian Code For The Responsible Conduct Of Research strongly encourages this type of review prior to developing a trial to raise and maintain high standards and accurate reporting.
The Lancet, mong other journals, encourages peer review of protocols as a means to improving confidence in the research process; and improving reliability and credibility of results. This type of review is therefore essential to robust research.
When is review valuable?
Early review, particularly at concept stage, is essential to ensure important health questions are being addressed, resources are focused on areas of need and methods accurately reflect the aims.
Review and concept development is valuable when:
- submitting a grant application
- formulating your question and endpoints
- designing your methodology and data collection
- determining your budget; and
- putting together your research team.
Review is also valuable when writing your protocol and submitting your publications.
What can PTNA offer?
PTNA offers an impartial and independent review of your new trial concept before you embark on writing your protocol and seeking funding. It is a confidential, fair and timely consideration of your idea by paediatric experts. The Committee will provide you with recommendations on developing your trial concept further. Note that PTNA will not have a right to ‘veto’ your trial but it can withhold its recommendations.
A study recommendation letter can be used to bolster your grant application and offer credibility and vigour to your aim and design. It demonstrates your trial is well thought out and consultation has taken place.
PTNA may also be able to offer you:
- a monetary grant for services or provision of services such as trial design, biostatistics or health economics depending on your needs
- additional discounts to WebSpirit (electronic data collection tool)
- connection with trials infrastructure, services and experts (these services may charge you a fee if you choose to use them)
- assistance to identify recruitment sites and/or associate investigators
- a recommendation letter for your grant application
- presentation opportunity to the paediatric research community at the annual PTNA Trials Day.
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