Submission

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introduction
title
Identify, train and inspire emerging PIs
short description
A program to identify, train and inspire emerging principal investigators for breast cancer trials, with a support package to maximise succe
Eligibility
Barriers
New Zealand has few breast cancer clinical trials for the 3000 women diagnosed each year. Currently, there are <10 treatment trials recruiting or pending. We lack eager, experienced PIs, and existing investigators are busy and reluctant to admit patients from beyond their immediate geographic area. This means important drug trials have failed to recruit, short-changing patients and damaging NZ’s reputation for future trials. Other issues are low adherence to protocols. Our patient group – women with metastatic breast cancer – is highly motivated to participate in trials. We want more trials in NZ, led by trained, passionate investigators committed to wider recruitment.

1. Outline of the NZ government Health Select Committee’s review of clinical trials, which identified need for national recruitment and observed that district health boards do not incentivise or require clinicians to be involved in trials (this page contains further links to the full report and media release).
2. A January 2015 report by the Tufts Center for the Study of Drug Development (Boston) shows that global clinical trial performance and efficiency are hampered by high turnover and noncompliance among principal investigators.
3. There are increasing calls for mandatory training / accreditation for Principal Investigators, with institutions like Stanford University already requiring such training, currently not available in a formal offering in New Zealand.
Provide link to a source describing the barrier
http://bit.ly/1FuRwbP
Provide link to a source describing the barrier
http://csdd.tufts.edu/news/complete_story/pr_ir_jan_feb_2015
Provide link to a source describing the barrier
https://doresearch.stanford.edu/training/principal-investigator-pi-training
What is your proposed solution to addressing the barriers?
Identify, train and inspire emerging PIs.docx
What are potential obstacles to your solution? How will you work around these roadblocks?
Potential obstacle could be a lack of willingness by health board to release staff for training time. However, Government directives suggest that clinical trials will be more important and all staff have CME requirements. We will consult extensively with employers and clinicians as we develop the course to ensure it is fit for purpose.
What % increase in accrual rates do you anticipate?
500% in the next 3 years over the past 2 years.
Last year, no New Zealand women were admitted to new drug trials for breast cancer, as far we know, and in 2013 fewer than 5 women were. If we can secure 5 new breast cancer trials over three years, each admitting 10 patients as a result of strong national recruitment, we will have achieved a 500% increase. This is easily monitored by checking in with principal investigators.
How do you anticipate maintaining the % increase in accrual rates over time?
A pool of qualified PIs will be able to continue running trials. The training program is easily replicated for future emerging PIs.
How will you overcome legal/regulatory hurdles, if any?
We don't believe there will be any. We have experience in developing CME accredited training, so are confident we can achieve this.
Why hasn’t your proposed solution been tried before? If it has, what prevented it from succeeding?
No, this has not been tried in New Zealand. We will improve the success rate by not stopping with the training, but by going on to support the investigator's first trial.

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