Concept↦Quality and Risk↦Study Feasibility↦Aim
What is it? Why is it important?
The aim of study feasibly is to evaluate, based on a set of criteria, the likelihood that a study can be conducted, such as:
- Is target population defined and available?
- Does the study provide valuable information (e.g. to target group participants, the therapeutic area)?
- Are selected sites able to conduct the study (e.g. resources, expertise, infrastructure)?
- Based on study risk category (A, B or C), what are the organisational implications (e.g. safety documentation and assessment, additional EC submission, regulatory (e.g. Swissmedic) submission, FOPH submission?
- What is the expected budget and financial means?
Assessment of study feasibility is based on information gathered at:
- Potential scientific significance
- Applicable expertise and staff (e.g. project-, data-manager, monitors, statistician)
- Availability of partners (e.g. study site(s), service providers)
- Management of study risks
- Feasibility of study procedures (e.g. randomisation, design)
- Available funds
Site-INV level – as applicable
- Required infrastructure (e.g. storage facilities with access control, work space, computers, patient rooms, laboratory facilities, handling of biological material)
- Resources (e.g. expert physician(s), study nurse or coordinator)
- Availability of target participants (e.g. sufficient number of patients willing to participate)
- Sufficient time available required to conduct the study
What do I need to do?
- Find out how to obtain information on target population at your institution (e.g. number of patients with breast cancer)
- Be up-to-date on scientific questions pertaining to your study (e.g. scientific publications, expert conferences)
- Establish and maintain an important network of experts and colleagues
- Train yourself on setting up a study budget
- Familiarise yourself with risks as defined by the Swiss law
When planning a study, many potential risks must be taken into consideration.
In the Swiss law risks are defined based on type of study and its intervention:
- Studies under ClinO
- Medicinal products: Risk category A, B and C with category C having the highest risk
- Other clinical trials: Risk category A and B, with category B having the highest risk
- Studies under ClinO-MD
- Medical Device: Risk category A and C, with category C having the highest risk
- Decisions regarding target population
- Adults, children, adolescents
- Participant with or without capacity
- Participants in an emergency situation
- Type of intervention
- With or without expected direct benefit
- With or without minimal risks and burdens
Depending on risk category the required risk management of the study can vary greatly.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 5.0 Quality management
ISO 14155 – see in particular section
- Medical Device (access liable to costs)
HRA – see in particular articles
- Art.16/24 Adults
- 22 Children
- 30/31 Emergency
ClinO – see in particular articles
- Art. 19–22 Risk categorisation of studies with therapeutic and transplant products
- Art. 61 Risk categorisation other clinical studies
ClinO-MD - see in particular article
- Art. 6 Categorisation of clinical investigations