Your Easy Guide to Clinical Studies

Here a rough overview regarding the development of Medicinal Products (MPs) and Medical Devices (MDs).

 

Medicinal Products clinical development phases:

• Pre-clinical studies: a new IMP is identified and tested in the laboratory on living cells and animal models
• Phase I: first-in-human studies, with safety being the main concern. Which is the maximum tolerated dose?
• Phase II studies: Established dose in Phase I is tested for safety and efficacy. The aim is to define the lowest required effective dose coupled with a minimum occurrence of Adverse Events (AE)
• Phase III studies: The efficacy and safety of the drug is compared with a current standard treatment, or against a placebo
• Phase IV studies: are done after the IMP has been approved and released on the market. The aim is to study how the now approved MP operates within the general population. Long term or still unknown (rare) safety data are collected. Other aspects such as quality of life, or cost effectiveness are also included

 

By providing scientific evidence from phase III studies that a MP is both effective and safe, allows manufacturers to apply for market authorization from regulatory authorities.

 

Quality needed to develop the drug must also be proven (e.g. GMP).

 

Medical Devices clinical development stages:

• Pilot stage: these studies primarily collect information regarding IMD limitations and advantages. This will help to plan further required steps in IMD development
• Pivotal stage: these are confirmatory studies that evaluate the clinical performance, effectiveness and safety of the IMD
• Post-market stage include:
  • Additional confirmatory studies to establish MD clinical performance or effectiveness in a broader population
  • Observational studies for better understanding of safety

 

The clinical development of Medicinal Products and the potential risks to study participants:

• Phase I: Carries the highest safety risk (especially first-in-human studies). Small test groups with healthy volunteers or patients with the disease under investigation
• Phase II: Test groups enrolling patients with the disease remain small. Many safety risks are still unknown. Consequently, risks to participants remain high
• Phase III: Large test groups based on multi-centre international studies. Safety risks are better defined and the risk for participants is lower
• Phase IV: Safest type of study. Evaluation focuses on long term and rare safety risks

 

The stages of clinical development of Medical Devices and the potential risks to study participants:

• Pilot stage: Includes first in human and feasibility studies. Carries the highest safety risk (especially first-in-human studies)
• Pivotal: Larger numbers of subjects can be recruited, sample size is statistically driven
• Post-market stage: Safest type of study. Evaluation may focus on long term and rare safety risks

 

In order to protect participants from unnecessary risks, the risk-benefit ratio is continuously reassessed. Actions are taken if new information indicates that the therapeutic product (MP or MD) is no longer as safe and effective as previously thought (e.g. implementation of risk reduction measures).

• Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch

• Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch

• Bern, Department of Clinical Research (DCR), dcr.unibe.ch

• Geneva, Clinical Research Center (CRC), crc.hug.ch

• Lausanne, Clinical Research Center (CRC), chuv.ch

• St. Gallen, Clinical Trials Unit (CTU), h-och.ch

• Zürich, Clinical Trials Center (CTC), usz.ch