1. Clinical Trial 'Metrics': Benchmarking Australia’s Performance
Dr Martin Cross
Chairman, Medicines Australia
Clinical Trials Advisory Committee Meeting
20 February 2014

2. Overview
Essential KPIs
Local Experience
Case Study (Company Data)

3. Essential KPIs Process KPI Definition Target Start Up Start up time
Document submission to initiation (HREC approval, RGO approval, CTN complete, contact signed)
12 Weeks (84 Calendar Days)
Recruitment
Recruitment target
Studies meeting overall recruitment target
Non- / Under-recruiting sites: < 10%
Quality
Site quality
For any internal or external site audits during current year, no critical audit findings and any other audit findings would be proactively address and a Corrective and Preventive Action (CAPA) plan put in place
0 critical audit findings; CAPA in place for all other audit findings within 3 months of adverse finding
Cost
Cost containment
Full cost of running a clinical trial (start up, HREC, per patient and pharmacy fees, etc.)
Cost of running clinical trials in Australia is equal to or lower than the median compared to other countries of similar economic profile (Canada, France, Germany, UK)
There are four essential KPIs (or “metrics”) which many companies use to track their performance domestically, and compare performance against their counterparts in other countries. These KPIs include:
- start up time,
- recruitment target,
- site quality, and
- cost containment
Each company may have a different method of collecting data and measuring performance (including through numerous sub-KPIs to track performance of individual components of a given “process”).
What we need in Australia is system to be able to collect performance data in a consistent manner and on an ongoing basis.

4. Study Start Up – Local Experience
HREC Approval (HREC Approval Letter) to
SSA Completion (Last Contract Signature) – Calendar Days
Source: Medicines Australia Survey
Average Study Start Up Times: Australia v. Global
Source: Medicines Australia Survey
Medicines Australia has conducted numerous sponsor surveys in recent years to collect information on key clinical trial “metrics”, including start up times, recruitment efficiency and costs.
In 2013, for example, we conducted a survey to collect data on the efficiency of research governance processes in Australia. The results of the survey were published in the ARCS Source Document. Among other things, they revealed that, on average, research governance reviews alone add 49 calendar days to study start up (excluding the time taken to complete ethics reviews and other start up activities).
Key:
S1: Victoria S4: South Australia
S2: New South Wales S5: Western Australia
S3: Queensland

5. Average Recruitment Rate: Australia v. Global
Recruitment – Local Experience
Average Recruitment Rate: Australia v. Global
Source: Medicines Australia Survey
Recent Medicines Australia surveys also reveal that clinical trial sponsors have serious problems in meeting patient recruitment targets, especially when it comes to Phase III trials.
It is important to develop and implement strategies to boost recruitment across all phases of clinical trials in Australia. Phase III in particular is largest source of investment in clinical trials for Australia. It is also where the most number of patients have the opportunity to potentially benefit from new therapies.

6. Cost – Local Experience
Per Patient Cost – Median (Standardised;
excl. tax concessions; AUS$1 = US$0.82)
Phase I
Source: Medicines Australia Analysis
Per Patient Cost – Median (Standardised;
excl. tax concessions; AUS$1 = US$0.82)
Phase III
Source: Medicines Australia Analysis
Despite the recent fall in the value of the Australian dollar, the cost of conducting clinical trials in Australia remains very high by international standards.
The Independent Hospital Pricing Authority’s work on developing a standard list of costs associated with conducting clinical trials in Australia is extremely important. Standard costs, based on the principles of cost recovery and efficient delivery of service, would not only help sponsors to reliably predict the cost of conducting clinical trials in Australia but also significantly reduce the time it takes them to negotiate contract with individual research sites.

7. Case Study (Company Data) – Start Up
Study Start Up Times (Individual Trials, Australia), 2014
Calendar Days
Source: Company Data
Study Start Up Times, 2014 – Calendar Days
Source: Company Data
This, along with the next two slides, present data on key performance metrics from a single company as a case study. The pharmaceutical company in question is one of the three largest private investors in clinical research in Australia.
Note here that median start up times for this company in Australia are 64% higher than the company’s global average and 58% higher than the company’s global target.

8. Case Study (Company Data) – Recruitment
New Patients – All Regions
Clinical Trials (All Phases), 2014
Source: Company Data
New Patients – Asia-Pac
Clinical Trials (All Phases), 2014
Source: Company Data
Australia accounted for 1% of new patient enrolments in clinical trials conducted by this company in 2014.
Regional competitors such as South Korea, Taiwan and China contributed significantly more patients, but tellingly, Singapore, a country with a quarter of Australia’s population, contributed nearly twice as many patients to global clinical trials as Australia.

9. Case Study (Company Data) – Recruitment
(Average) Patients Per Site, Clinical Trials (All Phases), 2014
Source: Company Data
There is obviously scope to improve patient recruitment rates in Australia. There are numerous ways to do this, for example, by raising awareness among healthcare providers and patients of the potential benefits of participating in clinical trials, by creating a clinical trials web portal that allow patients and volunteers to register their interest in participating in clinical trials and by developing innovative tools such as “apps” to simplify access to relevant information.

10. Questions