Clinical Trial Sponsorship
All clinical trials conducted in Australia (including those conducted by international pharmaceutical or biotechnology companies) must be sponsored by an Australian entity which takes responsibility for the creation, management, provision of insurance, indemnity and the financing of clinical trials. The type of sponsor will differ for each study depending on who takes responsibility for the conduct of the trial. Clinical trials can be individually sponsored by Australian researchers (medical professionals) or organisations (hospitals or cooperative research groups). Some of the most common sponsors include Contract Research Organisations (CRO) and pharmaceutical companies. At Novotech CRO, we provide a full range of project management services which include local sponsorship.
All clinical trials need to be approved by the Human Resource Ethics Committee (HRECs) before going ahead and the Australian Therapeutic Goods Administration (TGA) must be informed when they include new medications.
Types of Sponsors
- Commercial sponsor
- Disease or condition specific network of researchers
- Collaborative research sponsors
- Individual institution (university or a hospital)
- Individual researcher (private sector research)
Sponsors Are Responsible for
- Submitting a Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX)
- Setting up the trial design to address key research and medical questions
- Facilitate budget and funding sources
- Determines the viability of the clinical trial
- Select qualified investigators and appropriate clinical trial sites
- Ensure investigators are kept up-to-date on all the data crucial to the clinical study
- Allocate duties to qualified and trained staff
- Ensure medical professionals are on hand for patient care and any medical queries
- Organise the manufacturing, packaging, labelling, coding and distribution of the investigational product to the trial sites
- Overseeing the trial (trial management)
- Ongoing safety evaluation and reporting of any adverse drug events
- Ensuring compliance with monitoring and audit inspection requirements
- Keeping the Human Research Ethics Committee (HRECs) and other regulatory agencies updated about any side effects, safety concerns or benefits of investigational product
- Ensuring Quality Assurance (QA) and Quality Control (QC) systems are in place so that the trials are conducted in compliance with the International Council for Harmonisation’s (ICH) Good Clinical Practice Guidelines (GCP), trial protocols and Therapeutic Goods Administration (TGA) requirements
- Completion of the clinical study report
CROs and Sponsors
Sponsors can choose to use a CRO (Contract Research Organisation) which can act as the ‘middle man’ between the sponsor and the clinical trial site. A CRO company can also assist sponsors with writing the trial protocol, submitting data and monitoring the trial sites.
A trial sponsor ensures that quality management systems are in place and that all the processes are working smoothly enough to fulfill the protocol and regulatory requirements.
Risk Identification and Assessment
When designing a clinical trial, trial sponsors should put procedures in place to ensure that any risks associated with the conduct of the clinical trial are identified as soon as possible. Effective monitoring and management plans can be created to reduce any potential risk that may have an impact on the study or participants’ safety. Keeping clear, accurate records of clinical trials is crucial including primary data and materials.
Sponsors need to ensure that the authors of the clinical trial analysis are those who have made a significant contribution to the clinical trial and that they agree to be listed as an author. They also need to acknowledge the individuals who have contributed to the trial.
All suspected breaches or conflict of interest issues need to be reported to the Human Research Ethics Committee (HREC).
Clinical trial sites which sponsor an investigator-initiated trial might hand off some sponsor duties to the lead investigator. This investigator will then become a sponsor-investigator who fulfills the responsibilities of both the sponsor and investigator as outlined by the TGA: ICH Guideline for Good Clinical Practice. Sponsor-investigators also take over the sponsorship roles usually carried out by the pharmaceutical company.
The roles of the sponsor-investigator include:
- Finalising the funding for the clinical trial
- Creating documentation (informed consent, protocols, as well as any ethics or regulatory documents)
- Ensuring that all the resources are available throughout the trial (experienced staff, clinical supplies and medical equipment)
- Put together written procedures (Standard Operating Procedures (SOP))
- Meeting all the necessary regulatory requirements
- Managing essential documentation using a Trial Master File (TMF)
- Crediting and thanking those who have contributed to the clinical trial
- Participating in peer review while being fair and maintaining the confidentiality of the content.
- Ensure that the conclusions and data drawn from the trial are justified by the results
- Publicise the clinical trial results responsibility and accurately
Other Important Factors
- There is a difference between sponsoring a clinical trial and conducting one (The sponsor initiates a clinical trial, but the investigator conducts it)
- In a commercially-sponsored trial, a pharmaceutical company can assume most of the liability if a participant is harmed
- A sponsor can delegate their duties to CROs or to a Coordinating Principal Investigator (CPI)