A Phase I study is the first time a new drug or treatment procedure is tested in-humans. The purpose of this phase is to determine the metabolism and pharmacologic actions of the drug in-humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
Phase I studies in-human participants are closely monitored and conducted in healthy male patients or healthy male volunteers (trialling on women may affect their reproductive organs). These type of trials are conducted in Phase I units that are specifically set up for this purpose. However, later Phase I-Ib trials are conducted in patients with the affected disease the compound is intended to treat. In this case, more parties are involved, including the Phase I units, clinical research organizations (CRO) and the sites (hospitals).
The role of the CRO
As in-patient Phase I-Ib trials require patient referrals from hospitals or clinics to the Phase I unit, CROs play an important role to the study conduct. The CRO collaborates with multiple sites, informing them of the trial along with the subject requirements that meet the protocol specifications. Once the sites have been informed of the trial, the patients are screened by the sites and referred to the participating Phase I unit. The CRO then monitors the patients and manage the activities at the Phase I unit, much like a clinical site. Similarly, the Phase I unit’s responsibility is to treat patients according to the protocol and manage the on-site responsibilities such as entering study data into EDC. For an in-depth look into the division of responsibilities between a CRO and a Phase I unit, the table below illustrates the task ownership matrix between George Clinical and a Phase I unit for a recent in-patient Phase I study in Australia.
Phase I Unit
|Protocol/ Documentation Development||Responsible|
|CRF and Database Development|
|Pre-study activities (excluding HREC submission)|
|Ethics Submission and approval Monitor||Monitor|
|Investigational Product – Supply||Monitor|
|Investigational Product – Import|
|Investigational Product – On site management||Monitor|
|Investigational Product – Final reconciliation||Responsible|
|Conduct Patient visits per protocol Monitor||Monitor|
|Patient data entry into eDC||Monitor||Responsible|
|Clinical Study Monitoring||Responsible|
|Ongoing Data Management||Responsible|
|Interim/ Final Data Analysis||Responsible|
|Clinical Statistical Reports||Responsible|
*Either GC or Phase 1 Unit can be responsible
Australia is recognised for its highly trained clinical work force and high quality data produced by some of the world’s top researchers and health professionals. The Phase I units established in Australia are well equipped with advanced medical technology and nationally, Australia has access to over two million young males. Australia also has good access to populations of various ethnic backgrounds.
In order to promote research in Australia, the Australian Government has implemented a research and development (R&D) tax incentive – providing businesses a 43.5% refundable R&D tax offset for companies with aggregated annual turnover of less than $A20 million and a 38.5% non-refundable R&D tax offset for all other eligible companies. This is a lucrative option for small biotech and pharma companies to reduce their R&D cost, whilst obtaining access to excellent research infrastructure and services.
Phase I studies are essential for the identification of safety risks and for the correct dosing regimen to be used for further development. To successfully conduct these studies in-patient, close collaboration is required between CROs, Phase I units and clinical sites that see these patient populations. Australia is an appealing destination to conduct these trials with an abundance of scientific expertise and world class infrastructure. Furthermore, the introduction the R&D tax incentives greatly reduces the cost of conducting these trials in Australia.
About George Clinical
George Clinical is a leading clinical research organisation in the Asia-Pacific region with 200 staff operating in 11 countries. George Clinical provides a full range of trial management services to pharmaceutical and biotech customers, for both registration and post marketing trials. George Clinical’s unique scientifically based operational model allows us to leverage well established relationships with physicians across Australia, removing the difficulty out of referring site identification and management. As clinical trial costs and complexity continue to escalate, we provide our customers with new ways to access patient populations, and ensuring that clinical trials has an impact for clinicians and patients.