Trial Development Process
Clinical Trial Development Process
Advantages of developing a clinical trial through the ALTG include access to a national network of sites and access to peer- and consumer-review processes that critique clinical trial design, assess feasibility, equipoise and scientific merit of the proposal and determine support for the trial by the wider membership. Endorsement of the clinical trial by ALTG gives confidence to sites involved in the recruitment of participants to the clinical trial and can assist in providing a track record of successful clinical trial design and completion for new investigators when applying for funding.
Submit trial concepts or trial ideas to email@example.com
The ALTG convenes working groups of consumers and health professionals reflecting the multidisciplinary membership to assist with review and development of clinical trial concepts. These were previously referred to as SAC subgroups and have recently undergone a restructure to be renamed as concept development working groups.
The working groups’ role is to:
- Develop and/or review new research concepts and grant applications
- Identify gaps in research activities and the clinical trial portfolio and actively encourage the submission of concepts to fill this gap
The ALTG concept development working groups are:
- Early NSCLC
- Advanced NSCLC
- SCLC, mesothelioma and other thymic cancers
In addition, the ALTG convenes a supportive care panel and a consumer advisory panel (CAP) that provide input into developing concepts.
Approval to progress the study as an ALTG study is provided by the ALTG SAC.
Downloads to assist with clinical trial concept development
- Download Guide Concept Outline here.
- Download Concept Outline Template here.
- Download the SPIRIT checklist of recommended items to address in a clinical trial protocol here.
- Download the items adapted from the SPIRIT clinical trial protocol checklist regarding patient-reported outcomes (PROs) in a protocol here.