Request for Application
HIGH IMPACT CLINICAL TRIALS IN PANCREATIC AND BILIARY TRACT CANCER
For this call for clinical trials, the Anticancer Fund has joined forces with the
Rising Tide Foundation for Clinical Cancer Research.
Scope of this call
We are seeking to support clinical trials testing novel and unique strategies in the treatment of patients diagnosed with pancreatic ductal adenocarcinomas (PDAC) and/or biliary tract cancer (BTC)*. The proposal needs to have the potential to have a high impact (e.g. improve cure rate or survival) on the treatment of these cancers.
We are looking for innovative approaches extrapolated from laboratory work in relevant cancer models or extrapolated from other cancer types but deemed applicable in PDAC and/or BTC. Both early phase trials as later phase trials with an out-of-the-box concept are permitted. In principal, generating proof-of concept data or exploring novel promising interventions not investigated yet or building on preliminary pilot data are welcomed. Proposals might not be deemed innovative if the intervention is being or has been investigated by other groups or if there is only a small incremental gain in knowledge and/or outcome.
We acknowledge that innovation might have inherent risks, the proposal must be realistic and deemed feasible to execute. We welcome applications from all research groups with a track record in PDAC and/or BTC.
As ACF and RTFCCR seek proposals in line with their vision and mission, the proposed intervention must be commercially neglected (as defined in detail in the eligibility criteria).
*Biliary tract cancers (BTCs) constitute epithelial malignancies of the biliary tree and include the following: gallbladder cancer, ampulla of Vater cancer, cancer of the extra-hepatic and intra-hepatic bile ducts.
Clinical trials are eligible if they meet all of the following criteria.
- Clinical trials in patients with pancreatic ductal adenocarcinoma, gallbladder cancer, ampulla of Vater cancer, cancer of the extra-hepatic and/or intra-hepatic bile ducts.
- Clinical trials need to be an interventional trial with commercially neglected interventions, such as drug repurposing, surgery, radiotherapy.
- Open to innovative clinical trials with “out of the box” thinking such as new design, innovative technology, and must have a high impact for patients.
- Open for early to late-stage clinical trials (e.g., pilot study, Phase I, Phase II or Phase III).
- The ultimate goal is to improve cure rate or survival with the intervention. Clinical trials should serve patients interests with primary endpoints that seek to provide clinical benefit. Trials should not have biological or translational primary endpoints, but applicants may include secondary non-clinical endpoints.
- Trials should be patient centric. Applicants must include a patient engagement plan from research question through to dissemination.
- All interventions are allowed, except:
- Compounds (chemical/biological) that are still in drug development.
- Drug products without marketing authorisation or approval from competent authorities (i.e., FDA, EMA, national) for any indication (cancer or not cancer related indication).
- Cell-based therapy.
- For on-patent drugs or non-drug products (e.g., machines, devices…) with commercial owner: a written statement should be provided that the commercial owner is not willing to give funding for the conduction of the trial. On-patent drugs or non-drug products (e.g., machines, devices…) intervention should be provided for the trial by the commercial owner (a written statement should be provided).
- The leading clinical trial team has a track record of high-quality trials – preferentially investigator-driven trials – in the field of PDAC and/or BTC. Applicants without expertise in this field should seek collaboration with investigators who have demonstrated expertise in PDAC and/or BTC. A formal proof (letter) of collaboration should be provided.
We encourage applicants to contact email@example.com for any questions related to the RFA or to check eligibility of their proposal in case of doubt.
- The budget must be realistic and limited to the core activity of conducting the clinical trial.
- Investigator fees and institutional overhead costs will not be funded.
- Co-funding is welcome. All applicants must disclose the funding already secured and all past and ongoing funding applications.
We foresee a total budget of 3 million US dollars and we anticipate supporting up to 1-3 trials with this budget.
Submission and selection process
This is a 2-step RFA
- Step 1: applicants are requested to submit a Letter of Intent (LOI).
- Step 2: after a pre-feasibility call with ACF and RTFCCR, successful applicants are requested to submit a full application, i.e., a trial protocol (ready or almost ready to be submitted to authorities and IRB/ethics committee), a detailed budget, a rebuttal letter on feedback about the LOI and a detailed patient engagement plan.
Step 1: Letter of Intent (LOI)
We ask all applicants to complete the LOI form which includes 2 main sections:
- The eligibility section where applicants demonstrate that their proposal meets all the above-mentioned criteria as well as demonstrating Patient Engagement in the trial design from research question through to dissemination.
- The trial information section where applicants provide details on their proposal.
-- Deadline for submission of the LOI is Wednesday 30 June 2021, 23:59 CET --
Evaluation of the LOIs will be done by ACF and RTFCCR review team and will include
- Checking the eligibility criteria
- Evaluating the scientific rationale and the possible existence of counterevidence
- Performing horizon scanning to assess competition
- Reviewing alignment with mission, focus areas and core belief of RTFCCR and ACF
- Assessing patient engagement in the trial design from research question through to dissemination.
From all applications, we expect to select 5-10 applications to go forward to step 2. Applicants will be notified whether their LOI has been selected by 16 August 2021.
Step 2: Full Application
Step 2 starts with a teleconference between the ACF review team, Valerie Behan from RTFCCR and the applicant. The goal of this teleconference is to explain the process, perform a preliminary evaluation of the feasibility for running the trial, and assess whether any circumstances have changed since receipt of the LOI.
After the teleconference, the applicants will be asked to submit a full application containing:
- Protocol: we ask the applicants to submit a protocol ready (or almost ready) to be submitted to the competent authorities and to the IRB/EC.
- Budget: we ask the applicants to provide detailed breakdown of the budget.
- Rebuttal: we might ask further elaboration on specific questions and/or concerns that arose during the evaluation of the LOI.
- Patient engagement plan: we ask the applicants to further describe the strategy, modalities, and budgets for patient engagement based on the plan submitted during the LOI.
-- Deadline for full application is Sunday 17 October 2021, 23:59 CET --
The evaluation of the full applications will be done by a grant review committee (GRC), consisting of patient expert, biostatistician, and subject matter experts, in addition to ACF and RTFCCR review team and RTFCCR scientific advisory board members. The GRC members will select the best applications for submission to the ACF and RTFCCR Board for approval.
The final selection is expected to be communicated on 20 December 2021. Selected applications will receive a conditional go and will be contacted by both organisations individually regarding the next steps.
Letter of Intent form
Submit your LOI to firstname.lastname@example.org. Deadline is Wednesday 30 June 2021, 23:59 CET.
Please read all instructions above carefully. If you prefer a printable document, download it below.
- Deadline Letter of Intent: 30 June 2021
- Selection step 2: 16 August 2021
- Deadline Full Application: 17 October 2021
- Final decision: 20 December 2021
Please send us an e-mail at email@example.com or give us a call on +32 2 268 48 16.
We encourage applicants to contact us for any questions related to the RFA or to check eligibility of their proposal, in case of doubt.