Call for advancement of biomarkers to daily practice

biomarker buisje bloed dna

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. 

Requirements:

  • Research type: (multidisciplinair) consortium addressing the required variety of disciplines with a minimum of 4 participating parties (which may include private partners)

  • Research phase: creation of modality/pre-clinical/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  

  • 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. 

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:  

  • 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. 

Indicative budget and duration

The total budget for this call is 5 – 7 million euro (budget indication per proposal: €800k- €2M) 

Project duration: 2 – 5 years 

Timelines

Call opens: 4th of October 
Closing pre-proposal: 13th of December 2022 (12.00 noon) 
Closing full proposals: 11th of April 2023 (12.00 noon) 
Funding decision: summer 2023 

Pre-proposal template

An example of our pre-proposal template is available, but please do not use it to submit. As of the 4th of October you need to register and download the most recent version of the pre-proposal template in our Grant Management System (GMS).

More information

Specific guidelines on the process, characteristics and eligibility terms for the Thematic Call 2023 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.

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.