The problem for the patient or the public/in care/in practice, and thus the relevance for the mission goals, is leading in the study goals. Reaching implementation requires optimal alignment between the current research project and the envisioned end product and its users.
The Development track is defined as the stages that are necessary to implement the research findings in practice. This development track must be set out in the project proposal in a development plan that details the relevant stages, stakeholders, feasibility, and risks.
The Development track has 3 research phases:
- Phase 3: Creation of modality
- Phase 4: Pre-clinical research
- Phase 5: Clinical research
Creation of modality (phase 3)
The goal of this research phase is the extensive validation and further development of new inventions/modalities until there is sufficient (in vitro and in vivo) evidence in model systems or retrospective data and sample sets to start preparing for human evaluation. The development of psychosocial interventions is included in this research phase. Human participation in the development of inventions/modalities is possible in this phase, but only if it is not aimed at validation in human setting. Starting from this research phase, concrete solutions for specific problems/(unmet medical) needs are developed and validated.
Pre-clinical research (phase 4)
The goal of this research phase is the realisation of all aspects required to start the clinical/human evaluation of a new invention/modality. For example: GMP/clinical grade production, toxicity testing, pilot/technical tests, IND-/IMPD-/CE-marking, and regulatory/ethical aspects. Furthermore, this research phase includes prospective analyses of the clinical feasibility of an invention/modality without performing the actual intervention (e.g. prospective biomarker studies without changing the actual treatment).
Clinical research (phase 5)
The goal of this research phase is to perform prospective clinical research: a first prospective clinical /human evaluation of a new invention/modality in a small target population, but also research aimed at establishing the effectiveness of a new invention/new dosage/off-label usage/new combinations/new psychosocial treatment/changes to treatment regimes of existing methodologies, including population checks, in a (patient) population.
NB: Clinical diagnostic research concerns the validation of new techniques, whereby the potential clinical value from a diagnostic or prognostic prospective is determined in a patient-based or population-based study. The research has to involve evaluation and monitoring using techniques that have already been validated. Clinical diagnostics are only included in the clinical research phase if the study also includes a treatment decision. If not, this type of research belongs in a different phase. Observational studies are categorized as credentialing.
If a prospective clinical study is carried out during the course of the project, the project proposal has to be submitted in the clinical research phase, even if it involves other activities in previous research phases. Side studies of the clinical study can be submitted in the same project proposal. In such cases, the side studies do not have to be further defined into research phases, but should be described as separate work packages in the project proposal. The dividing line between clinical research and implementation (within the Implementation track) is the point at which the human evaluation is completed and the findings are actually evaluated.