Clinical Trials Advisory Board (CTAB)

‘Developing and delivering research to improve the care and treatment for people with cancer cachexia’

‘Connecting people, researchers, pharma, and organisations to catapult cachexia research from bench to bedside’


The Cancer Cachexia Society Clinical Trials Advisory Board (CCS-CTAB) aims to provide a route for clinical trials and therapies to reach people with cachexia as quickly as possible. Recent years have seen a number of developments in cancer cachexia from scientists and researchers, and a similar surge in interest from pharma. In addition, our increased understanding of the genesis of cancer cachexia has led to promising preclinical results which may lead to new therapies in the near future. Yet translational research towards cachexia therapy development has faced a number of barriers:

For people with cachexia, promising research has not translated to clinical treatments, and despite published guidelines, integrated cachexia care remains the exception in routine oncology treatment.

For clinicians and researchers, there have been multiple barriers, including: limited research funding; lack of consensus in clinical trial methodology and endpoints; differing cachexia definitions; and various guideline recommendations. Together, these have impaired investigator-led research and trials.

For the pharmaceutical industry, additional challenges include identification of investigators and sites with the relevant expertise and access to the appropriate patient cohorts for clinical trials in cancer cachexia. Applying oncology or palliative medicine research models to cachexia has failed to yield success, and specific expertise and research design are needed. 

The CCS-CTAB addresses these issues, uniting stakeholders in the community and provide an infrastructure to accelerate research and therapy development, increase collaboration and improve patient care on an international scale.

Our Aim

We aim to provide clear, transparent and up-to-date guidance in cancer cachexia research from a drug discovery and development context with the aim of improving clinical research on cancer cachexia. This guidance comes from a multidisciplinary group of cachexia and nutrition experts, including patient advocates. 

What we do

CCS-CTAB will provide a confidential and comprehensive review process with recommendations and is independent of any funding stream. Review by, and endorsement of, the CCS-CTAB may be used by applicants to support applications or inform discussions.

Specifically, we will:

  • Provide a once-off multi-disciplinary review.
  • Assess applications under a confidential non-disclosure agreement (NDA).
  • Convene a bespoke panel of experts from the extensive committee for each review based on the needs of an application, recruiting new key opinion leaders from the membership or the extensive collaborative network of the CCS as needed.
  • Undertake a conflict-of-interest assessment with all reviewers for all applications, and communicate the details of the panel members with applicants in advance of sharing the full application.
  • Provide applicants with a comprehensive written review, including recommendations no later than 6 weeks following our appraisal meeting.

 The CCS-CTAB will not undertake the following:

  • Provide on-going feedback to applicants who have a development programme.
  • Engage with funding organisations on behalf of applicants.
  • Provide funding; CCS-CTAB is not a funding organization but provides evaluation and recommendations which might facilitate development of a review into an application to a funding organization. Members of the CCS-CTAB may collaborate with applicants if mutually agreed.

What we assess

  • The CCS-CTAB will cover the following areas:
  • Phase 1 clinical trials including proof of concept and safety
  • Phase 2 clinical trials including dose-finding and feasibility
  • Phase 3 clinical trials
  • Phase 4 clinical trials including long term safety and tolerability
  • Observational studies and biorepository development
  • PhD proposals specifically aimed at clinical studies and trials
  • Biomedical trial development (including all stages above)
  • Qualitative cachexia studies

We will review therapeutics at any stage of development, so long as a lead compound has been identified, and that studies have a long-term goal of an intended clinical trial and potential registration.

We will consider re-assessing previously reviewed applications if they have substantially progressed or changed and if the committee felt that re-review could add further value.

Where possible address possible regulatory requirements. 

Who can apply

Applicants need to be a member of the CCS to submit a full proposal to the CTAB, but pre-applications will be considered from all. Applicants may include principal investigators planning a study, preclinical investigators who wish to move to the clinical arena, industry sponsors, or funding bodies seeking input on the feasibility of a given program considered for funding. All costs are waived for non-profit and academic institutions. 

Who we are

The CCS-CTAB is run under the aegis of the Cancer Cachexia Society. The CCS-CTAB has two chairs, one of whom is a CCS Board member.  All committee members sign a confidential NDA and complete a declaration of all potential conflicts of interest.


  • Co-Chairs – Barry J A Laird and Richard J E Skipworth
  • Executive – Jose Garcia, Denis Guttridge, Tora Solheim, Teresa Zimmers
  • Committee – Matthew Maddocks, Trude Balstad

The co-chairs lead the CCS-CTAB with the support of the executive committee members and ad hoc committee members, together whom cover the following areas of expertise:

  • Preclinical research
  • Biostatistics and clinical trials methodology
  • Cachexia regulatory expertise in both the US and the EU
  • Clinical research/clinical development/clinical trials expertise
  • Oncology – specifically lung and gastrointestinal oncology
  • Nutrition
  • Physiotherapy
  • Patient advocacy

Where needed, ad hoc reviewers may be invited to review specific applications where expertise is not available on the committee.

How do I apply?

All applicants are expected to complete a standard application and provide supporting data. The completion of this focused application form is in itself an educational tool. CTAB may proactively call for nomination of drugs and approaches from potential principal investigators to inform them of the role of CTAB.   


Potential applicants should contact the committee by email ([email protected]) with a short synopsis of the proposed study. Following review by the chair(s), applicants will be informed as to whether they should complete a full application.

Full application

Full applications are completed electronically approximately 6 weeks prior to the review meeting. Completing the application focuses the applicant on a number of important considerations including: scientific rationale, the appropriateness and interpretation of the preclinical studies performed, safety and toxicology issues, drug distribution and kinetics, drug manufacturing and supply, context of the project in the clinical development plan and regulatory consideration critical to advancing a compound into the clinic.

Materials submitted to CTAB should include the items listed on the application form (which includes study rationale, pilot data, outcomes, statistical considerations – Download the Form here: CTAB_ApplicationFormV1.docx).

It is understood that not every project will be fully developed in all of these areas.  However, this list of considerations will allow a meaningful set of recommendations from CTAB.

Each application will have assigned a lead appraiser and a co-appraiser who will review the application and feedback to the executive committee. If it is a clinical trial, patient representatives will be invited (optional) to complete reviews. These reviews are distributed to the committee prior to the meeting.

How will I receive feedback?

Reports are sent to the applicant within 6 weeks of the meeting. The report includes an objective assessment of the project plan and recommendations for the program. Typically, the applicant poses important questions in writing to CTAB along with the application form, and these are addressed in the written review. The applicant receives this full report therefore if other parties are interested in the report, they should request this from the applicant directly. Applicants will be required to share the report in full rather than any abbreviated version or specific sections. 

When are the deadline for submissions?

We have no specific deadlines and will accept applications at any point.