Study feasibility

Smooth Drug Development offers an assessment of clinical trial feasibility and site selection in Russia, CIS and Baltic States.

The process of clinical trial documents development always include the assessment of the possibility of future research including obtaining of approvals, recruitment and patient retention and technical and logistical constraints.

These factors influence on the choice of research nosology, geographical coverage, pool of sites, patient population, approaches to the study design, and consequently – the time and cost of a study for the Sponsor.

Data collected during clinical trial feasibility assessment are the basis of the budget and schedule of the study. Accuracy of the forecasts made at this stage determine timings of further development and registration of the product. Overoptimistic approach may lead to extended terms of the trial and delay the product launch.

Study feasibility include:

Scientific, medical and ethical aspects (program / study level)

Scientific value
Relevance of the candidate molecule for practical medicine
The prevalence of the disease
Availability of standard treatments
Availability of alternative treatment options
Risk-benefit ratio for patients

Regulatory aspects (country level)

Requirements of regulatory bodies of the planned countries
Needs of country-specific protocol versions
Possibility and timelines of approvals for:

Clinical trial conduct
Import of the study drug
Export of biological samples

Logistical aspects (study / country level)

The need to use warehouses and their availability
Limitations associated with temperature control, shipment schedule and storage of the investigational product and biological samples
Requirements for:

Import of the study drug
Export of biological samples
Return / destruction of unused investigational product

Operational and clinical aspects (site level)

Ability to conduct research considering treatment standards
Having access to a pool of patients
Equipment avalability at study sites
Competence of Principal investigators
Availability of site staff
Recruitment potential
Requirements of Ethics committees
Influence of competitive trials
Special conditions for conduct of the study

Financial aspects (center level)

Payment grant on similar studies
Adequacy of the proposed payments
Costs of diagnostic procedures
Costs for referral fees and retention of patients

Technical aspects (center level)

Limitations due to technical tools for:

Randomization
Collection of clinical data
Central imaging review
Electronic tools for data collection by site
Electronic tools for patient reported data

As result of the feasibility assessment and preliminary site selection, our specialists prepare a detailed report, which contains the results of the evaluation and a list of potential study sites.