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BENEFIT ASSESSMENT OF MEDICINES

HETEROGENEITY OF TREATMENT EFFECT IN CLINICAL TRIALS

Considering the average results of a clinical trial, they often do not apply to all, or even most, individuals in the study. Important differences may exist in relative as well as absolute responses among patients.

This course intends to propose you several approaches for being able to identify clusters of patients with a similar benefit-risk profile, from naive subgroup analyses to more sophisticated procedures.

120 minutes
English
FUNDAMENTALS OF THE ADAPTIVE CLINICAL TRIALS

Adaptive design is based on allowing modifications in the design or in the statistical procedures of an ongoing clinical trial. Use of the adaptive design methods in clinical trials has experienced an important increase in the last years. This strategy, based on accrued data, has become popular because it has shown to be flexible and efficient.

This course intends to bring you knowledge and understanding of the currently raising concerns about feasibility, validity, and integrity, with the consequence of a rise in errors in efficacy assessment.

120 minutes
English
STRATEGIES FOR HANDLING MISSING DATA IN CLINICAL TRIALS

Losing data is one of the main sources of bias in clinical trials. This may have serious consequences to establish true causal links.

This course aims to give you knowledge and expertise on how to minimise the impact of missing data by taking some precautions and strategies especially during design and analysis of a clinical trial.

120 minutes
English
EARLY STOPPING RULES IN CLINICAL TRIALS

This course intends to question when to stop a clinical trial considering clinical, economic and also ethical concerns.

  • On one hand, to continue a clinical trial aiming to obtain full information on the main clinical variables can be desirable from a clinical point of view, but can be economic and time consuming or even unethical for patients not treated with the experimental intervention.
  • On the other hand, early stopping of a trial at interim analysis can raise concerns about the possibility of missing information on some benefit and harm variables and to overestimate treatment effects.
120 minutes
English
RECRUITMENT STRATEGIES IN CLINICAL TRIALS

Patient recruitment and retention is crucial in order to accomplish clinical trial deadlines and not to delay their finalization. Several strategies have been described to recruit and retain patients in clinical trials.

This course gives you the overview and expertise of the most important strategies.

120 minutes
English
SELECTING OUTCOMES: SURROGATE ENDPOINTS

Surrogate endpoints are increasingly used in clinical trials as the principal variable to assess medicine efficacy.

This course intends to make you qualified on the advantages and limitations of use, clinical meaningful and usefulness of surrogate endpoints in order to assess new drug efficacy in some clinical areas with increasing drug innovation (such as diabetes or multiple sclerosis).

120 minutes
English
FUNDAMENTALS OF THE NETWORK META-ANALYSIS

This approach of meta-analysis offers a set of methods to visualize, compare and interpret the evidence about multiple interventions proposed for a same disease. With network meta-analysis is possible to estimate indirect comparisons that have not investigated, head to head, in single clinical trials. For this reason this approach has gained popularity quickly.

This course aims to give you knowledge on some inconveniences that may affect the goodness of the results and conclusions of this approach.

120 minutes
English
COMPOSITE OUTCOMES IN CLINICAL TRIALS

Using composite endpoints permits to decrease sample size needs, to better assess the net effect of an intervention and to minimize bias in presence of competing risks.

This course intends to give you knowledge and expertise on the risk of misinterpretation related to the magnitude of treatment effect.

120 minutes
English
NON INFERIORITY APPROACH IN CLINICAL TRIALS

Non inferiority approach design is increasingly used in clinical trials, but often it is incorrectly applied and misinterpreted. Compared to superiority trials, these trials have challenges in design and analysis that can influence proper inference. Also, regulatory guidelines sometimes disagree on recommendations.

This course intends to increase your understanding of the essential statistical and methodological issues of this design.

  • An appropriate understanding of such issues is crucial to correctly use and interpret in clinical practice.
120 minutes
English
MINIMAL CLINICALLY IMPORTANT DIFFERENCES IN CLINICAL TRIALS

There is an increasing interest in evaluating and defining minimal clinically important thresholds instead of statistically significant differences in studies.

This course intends to let you know when clinical significant differences instead of statistically significant outcomes can be a better way to assess clinically meaningful improvement of patients.

120 minutes
English

COMPANIES OFFER

Short courses can be included in a training package for your team!


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