Table 1.
Factors associated with total length of clinical development time from phase 1 to registration.
| Theme | Factor |
|---|---|
| Regulatory and political factors | Laws and regulations of country/continent where trial(s) are performed |
| Assessment status granted by regulatory body (EMA/FDA) such as accelerated assessment, CMA, PRIME scheme, orphan drug designation | |
| Political declaration of emergency outbreak/outbreak setting | |
| Number of trials performed (or requested) before registration approval by regulatory body | |
| Disease characteristics | Type of disease targeted |
| Disease prevalence or incidence (availability of participants) | |
| Duration of treatment | |
| Compound characteristics | Type of treatment (curative, preventive, suppressive) |
| Combination of medical compounds (combination pill), or rebranding, reusing, repurposing | |
| Large-scale production capabilities | |
| Testing of generic compound | |
| Trial design/methodology | Ethical approval |
| Type of study design (e.g. adaptive trial platform, single-centre) | |
| Combined or overlapping phases | |
| Duration of recruitment | |
| Choice of endpoints (surrogate versus clinical endpoints) | |
| Duration of observation until the primary endpoint for registration | |
| Funding and organisation | Duration of contract negotiations |
| Site organisation (staff turnover, employment conditions, career paths, workload, delegation and management) | |
| Background of sponsor-investigator (pharmaceutical, academic, governmental) | |
| Time between subsequent clinical trial phases | |
| Planning (clear project ideas, realistic deadlines, understanding of trial processes, adaptation to the local context and involvement of site staff in planning) | |
| Funding availability (per phase or per trajectory)/budget feasibility |