EXTERNALLY SPONSORED RESEARCH
EUSA Pharma Clinical Research and Development seeks to extend and enhance the use of its products to maximise their clinical benefit to patients suffering from cancer or rare diseases with high unmet medical need. The devastating impact of these diseases drives our sense of urgency to develop solutions that have a meaningful impact on patients’ lives.
As part of our commitment to extend and enhance the knowledge and usage of our products, our Medical Affairs group supports meaningful Externally Sponsored Research (ESR), sometimes also known as Investigator-Initiated Research or Studies (IIR or IIS).
ESR studies can play a key role in answering important medical and scientific questions regarding EUSA’s products and their related therapeutic areas. Such clinical studies can contribute to extending the understanding of EUSA’s products and their appropriate application, thus improving patient care, and sparking new ideas for further disease-related research aimed at creating improved treatment for patients.
ESR studies are initiated and managed by non-pharmaceutical company researchers, like individual investigators, institutions, collaborative study groups or cooperative groups. The sponsor is responsible for the legal and regulatory obligations of the trial and for the conduct and management of the study as defined by all applicable laws and regulations.
EUSA Pharma may support ESRs with drug supply, funding, material and/or information, as allowed under local laws and regulations, provided that they align with the company-defined areas of strategic interest.
EUSA Pharma welcomes applications from scientists and healthcare professionals wishing to apply for grants to conduct research as part of an ESR program.
EUSA Pharma has a strict policy for assessing all applications for ESR grants. No application will be judged on the basis of past, present, or future intention or willingness to prescribe, use, or recommend EUSA Pharma products, and all applications will be assessed according to the merits of the study in terms of the quality of the proposed nonclinical and clinical research.
- Clinical studies of approved and investigational uses, involving marketed EUSA drugs or those still in development (interventional study Phases 1-4)
- Clinical observational studies, real world evidence
- Requests for compassionate use should be submitted to the EUSA affiliate in your country or where appropriate, to EUSA HQ at email@example.com
- No research grant funding will be provided without ethics committee or similar approval of the research proposal.
- All studies will be expected to be original research that will not replicate previous or ongoing studies, and to have a documented statistical plan that demonstrates that the proposed research has adequate power to assess the defined primary objective.
The sponsor/investigator has to fulfil (or agree to) the following requirements
- Have the scientific, technical, and operational capabilities to conduct a study as a sponsor, including adequately trained staff to execute a study (GCP, GMP, etc.)
- Have expert statistical support
- Agree to safety reporting to Health Authorities and to EUSA Pharmacovigilance
- Agree to provide study updates to EUSA
- Submit a scientifically well-designed and well-written study proposal
- Be able to fulfil all regulatory requirements (including submitting an IND/CTA)
- Deliver to agreed upon timelines
- Deliver a written report of the final study results to EUSA
- Publish the study in a peer-reviewed scientific journal
Researchers are invited to submit their concept proposal via the ESR form. Concept submission will be reviewed collectively by EUSA’s ESR Review Committee based on scientific merit and alignment with corporate research and development plans.
The requester will be informed about the outcome, and if the concept submission passes ESR screening, then the investigator will be invited to submit further details and a final ESR protocol in order to be considered for full approval.
EUSA requires that the following documents are in place before ESR support may be provided:
- A fully executed ESR agreement between the sponsor and EUSA
- A fully executed ESR safety data exchange agreement between the sponsor and EUSA
- An EC/IRB and/or Health Authority approval
ESR support may include investigational drug supply and/or financial support to fund the research project. Any financial support must not exceed local fair market value.
Combination (Siltuximab + Spartalizumab) in Metastatic Pancreatic Cancer (mPC)
Recently initiated (Q2, 2020) phase 2 study (Emory University, Atlanta, US)
Allogeneic Stem Cell Transplant (ASCT) symptom burden reduction in Multiple Myeloma (MM)
Study initiation anticipated in 2021
Phase 1 (supported by Solving Kids’ Cancer (UK), Solving Kids’ Cancer (US), J-A-C-K (UK), Band of Parents (US))
A Study of mIBG, Nivolumab and Dinutuximab Beta for Neuroblastoma (‘MiNivAN’)Further Information
Open-label, multi-centre, phase II randomised study: temozolomide/irinotecan +/- dinutuximab beta (‘BEACON-Immuno')Further Information
Single-Arm, Open-Label Study of Dinutuximab Beta Monotherapy in Patients with Relapsed or Refractory (R/R) Neuroblastoma
Active, not recruiting
Phase 1b/2 (sponsored by AVEO, co-sponsor EUSA & BMS)
Advanced Renal Cell Carcinoma (RCC)
TiNivo (Tivozanib + Nivolumab in RCC) under data analysis
Phase 1b/2 (sponsored by AVEO & AstraZeneca)
Advanced or Metastatic Hepatocellular Carcinoma (HCC)
DEDUCTIVE (Tivozanib + Durvalumab in HCC) active & recruiting
Phase 3 (sponsored by AVEO)
Relapsed / Refractory (R/R) Renal Cell Carcinoma (RCC)
TIVO-3 completed & published
EUSA Pharma Clinical Research and Development seeks to extend and enhance the use of its products to maximise their clinical benefit to patients suffering from cancer or rare diseases with high unmet medical need.
Dinutuximab beta plus induction chemotherapy regimens in patients with newly diagnosed high-risk neuroblastoma (HRNB)