Australian clinical trials website external website eligibility requirements

The eligibility requirements for inclusion of external organisations’ websites on the Australian Clinical Trials (ACT) website reflect policy decisions on the part of the NHMRC and the Department of Industry, Innovation, Science, Research and Tertiary Education.  These decisions are indicative of the fact that the website is a government website designed for the benefit of potential research participants, researchers, clinicians, advocacy groups, the local and international pharmaceutical and biotechnology industries and the general public.  As such, the website cannot promote the economic (or other) interests of any of these groups over any other.

Accordingly, the following organisations involved in providing access to or conducting clinical trials are not eligible for inclusion on the website:

1. Commercial companies or entities operating under the branding of a commercial company, including, but not limited to those involved in the development, manufacture or distribution of therapeutic goods or devices, contract research organisations (CROs) and commercial industry lobbying groups.
2. Research departments or units within larger organisations.
3. Government hospital networks and health districts (although organisations within those networks or districts may be independently eligible).

For the purposes of the articulation of inclusion and exclusion criteria, organisations that meet website eligibility requirements are categorised on the website as a

1. Registry – defined as an organisation or website that either (a) lists clinical trials being conducted (or that have recently been conducted) in Australia (or internationally, including Australia), (b) provides a mechanism for patients or others to register their interest in participating in an Australian clinical trial or (c) provides a link between potential participants and Australian clinical trials.
2. Clinical trial site – defined as a non-commercial entity (e.g. a hospital or research institute) that conducts clinical trial research or under whose auspices a clinical trial is conducted.
3. Clinical trial network – defined as a formalised consortium, collective, cooperative or collaborative research group established for the purpose of facilitating the conduct of clinical trial research.
4. Clinical trial resource organisation – defined as an organisation that provides information, guidance, resources or other services to the public related to understanding or participating in clinical trial research.
5. Disease/Condition-specific support group – defined as an organisation that supports participation in clinical trial research associated with a specific disease, condition or set of diseases or conditions via advocacy, promotion or networking.

Inclusion and exclusion criteria

Registries
Clinical Trial sites
Clinical Trial Networks
Clinical Trial Resource Organisations
Disease/Condition - specific support groups

Inclusion criteria
 
 
 
 

Any registry, Australian or international, that (a) includes listings of ethically-approved Australian clinical trials, (b) provides a mechanism for patients or others to register their interest in participating in an Australian clinical trial or (c) provides a link between potential participants and ethically approved Australian clinical trials.

Any Australian organisation that conducts clinical trials and
(a) has the capacity to receive enquiries from potential trial participants, and
(b) is able to provide contact information for listing on the ACT website that includes:

• phone number
• email address
• valid and active URL
   

Any team of researchers or institutions engaged in clinical trial research as a consortium, cooperative or collaborative group,
either independently or, formally, under the auspices of a public or private health organisation or public-private partnership
Any organisation that provides information, guidance, resources or other services to the public related to understanding or participating in clinical trial research
Any organisation supporting participation in clinical trial research associated with a specific disease, condition or set of diseases or conditions via advocacy, promotion or networking.

Exclusion criteria
 
 
 
 

• Any registry that only lists clinical trials conducted by one or more selected commercial companies
• Any registry that lists trials that have not been ethically approved
• Any registry that only lists trials being planned for, conducted in or completed outside of Australia
   

Research departments or units that operate within larger organisations and are not independent from that organisation
Government hospital networks or health districts (i.e. structures developed for administrative purposes)
Any organisation that only provides information or resources related to clinical trials conducted by one or more selected commercial companies
Any organisation that only promotes the interests of one or more selected commercial companies

Note:

1. As used in the eligibility criteria, the term ‘Australian’ shall be defined as an organisation that:
   1. Provides its services in Australia; and
   2. Provides an Australian postal address or an Australian domain name (URL).