Call for advancement of biomarkers to daily practice 2024

Problem

Biomarkers, as measured by imaging, in blood, urine, stool or breath, are key to identify patients at risk of developing cancer, to monitor treatment response and to early detect disease progression.

Despite decades of discovery-driven biomarker studies, only a small number of biomarkers has been successfully validated and implemented in daily care. A reason is that in order to advance validation and implementation of the biomarkers, multidisciplinary research and clinical teams are required that might differ from the team making the initial discovery. Moreover, the use of a single biomarker is often not sufficient for clinical decision-making and it takes expertise from different research fields to integrate several biomarkers and to make them applicable in daily practice. Finally, it takes a lot of work and a variety of both laboratory and applied clinical studies to determine the best way to increase the acceptance of new biomarkers and to make them broadly available.

Ambition

To validate (combinations of) already discovered, promising biomarkers that correlate with patient relevant outcomes or treatment responses and that can be used in daily clinical practice in the near future. Therefore, efforts are needed to set up collaborative, multidisciplinary studies with special attention to (combinations of) biomarkers that are potential candidates for clinical implementation. The focus of this call is to bring together the necessary expertise in the field of biomarker research and clinical care to reach the next developmental phase of the biomarker candidate(s) on their way to daily practice and to provide the appropriate framework and funding. 

Definition

Biomarkers: (Bio)characteristics that are objectively measured and evaluated as an indicator for cancer risk, the presence of a specific cancer or recurrent cancer, the stage or aggressiveness of a specific cancer, and how well the patient responds to therapeutic intervention(s).

Note: biomarkers to identify/predict side effects of cancer treatment are not included.

Requirements:

• Research type: (multidisciplinary) consortium addressing the required variety of disciplines with a minimum of 4 participating parties (which may include private partners)
• Research phase: creation of modality/preclinical/clinical. 
• Cancer type: all cancer types.  
• Promising biomarkers that are not yet validated on their (added) role to the intended clinical context. 
• Sustainable data sharing plan (according to FAIR principles).  
• Multidisciplinary team supported by a project manager. 
• Detailed developmental plan.
• The project addresses patient needs.
• Participating parties: all required expertise, including e.g., biostatistician, HTA-expert (in-house service/not-for-profit organization). Public/Private collaborations are encouraged if co-funding is in place. KWF holds the right to request additional information about the for-profit partner if this is deemed necessary.  

Recommendations and considerations for applicants and reviewers

The Dutch Cancer Society includes a pre-proposal round for this call to be able provide recommendations for the researchers and input and/or guidance for the reviewing committee. Those additional considerations for proposals, which allow prioritization if necessary are:  

• The perspective of patients is incorporated. Patients/patient associations are closely involved during the set-up of the proposal, the conduction of the research, and the sharing of the (lay)results with the target group. 
• A proven regulatory/market-access strategy and/or regulatory support
• An early Health Technology Assessment (HTA) (if applicable)
• Make use of or participate in existing central facilities and (data) infrastructures (databases, biobanks, imaging data, etc.)
• If not yet participating, an advisory board with parties that are familiar with the implementation of a biomarker in daily practice is a pre. 

Evaluation

KWF uses three review criteria: relevance for KWF’s main goals, scientific quality and feasibility. In addition, the emphasis of this thematic call will be on moving the findings forward and the final patient’s health gain and not so much on novelty of the findings, which is in line with the advancement to daily practice. A special review committee will be selected for this call, consisting of experts in relevant areas. Additionally, the full proposal will also be reviewed by the patient advocacy committee (PACO).

After evaluation of the full proposals the (multidisciplinary) consortia will be invited for an interview.

Indicative budget and duration

The total budget for this call is 4 - 5 million euro (budget indication per proposal: €800k- €2M) 

Project duration: 2-5 years 

Timeline

Pre-proposal template

An example of our pre-proposal template is available for download below, but please do not use it to submit. As of the 5th of March you need to register and download the most recent version of the pre-proposal template in our Grant Management System (GMS).

Additional conditions

Specific guidelines on the process, characteristics and eligibility terms for the Thematic Call 2024 will be based on the current KWF Guidelines. Guidelines will include specific information on application requirements, preferences and recommendations, review procedure and timelines, and estimated total budget. Granted KWF projects will be funded under the current Funding Terms and Conditions.

Additional conditions (in addition to the standard KWF funding conditions)

• If the for-profit private partner, larger >250 FTE, has an active role within the project, this party is considered a participating party and to this end must make a financial contribution: this is 10% co-financing of the KWF requested budget (in kind and/or in cash).
• There is a maximum hourly rate for payroll costs:
  • Supportive (MBO) € 85,00
  • Project Management (HBO) € 100,00
  • Expert (WO) € 125,00

    This is the maximum hourly rate excluding VAT and including all other costs (travel costs, parking costs, travel hours, etc.) as they should be applied. If institutes would like to apply a higher hourly rate for motivational reasons, this must always be agreed and approved in advance by KWF.

Additional project specific conditions may be applied.