 |
A successful pre-marketing clinical development depends essentially on choosing sensibly the study protocol and each link of a long logical chain that should lead to obtaining a marketing authorisation. |
ICTA provides study design service that benefits from the joint expertise of all its R&D departments potentiated by the design know-how of a specific « Design » department.
which basics have to be mastered in design?
Designing a clinical, epidemiological or econometrics research protocol or even a development plan calls for two qualities:
Mastering the critical reading of articles and study reports related to the clinical issue at stake, i.e. the hypothesis laid out. The awareness of the latest knowledge should lead to the relevance of the project and be a guideline for reflexion.
Mastering methodology so as to be able to address the study protocol. This step involves a cross-disciplinary reflexion where all the specificities of classical R&D should intervene including clinicians and biostatisticians well trained to statistical methodology.
STUDIES MANAGED BY ICTA...
Studies of superiority, non-inferiority, equivalence and translational studies,
Cross-sectional epidemiological studies, cohort and case control studies,
Medical devices studies including evaluation of diagnostic methods.
...which encompass all modern R&D
"New chemical entities” whether classical or stemming from biotechnology,
Cellular and gene therapies,
Immunotherapies and oncology in general,
Vaccinology.
...WITH A COMPREHENSIVE METHODOLOGICAL RANGE
Traditional Frequentist methodologies
- Traditional «Dose escalation » «3 + 3» (Phase I),
- Classical «Dose Range» (Phase II),
- Traditional comparative studies (Phases II, III).
Adaptive frequentist methodologies
- «Group Sequential» studies
- «Drop Loser» studies
Bayesian studies
- Comparative Bayesian studies (Phases II, III),
- «Seamless» studies (Phases I, II, III)
- «Continued Reassessment Methods» CRM (Phase I).
FREQUENTIST OR BAYESIAN DESIGN ?
The emergence of Bayesian adaptive studies has changed the scene in clinical R&D. Today, they have been made available thanks to the powerful progress of IT tools these last few years which allowed to have access to MCMC methodologies[1].
Recently still, the systematic use of traditional frequentist technologies, systematic because no other way was possible, forced the decision makers to costly returns in terms of time and investments in phases I and II.
It is undeniable that the Bayesian approach is the best approach to acquire structured information in a “natural” way.
ICTA's EXPERTISE IN PRE-MARKETING
ICTA guides its clients for choosing their methodological approach whether it is traditional, frequentist adaptive or Bayesian. It also helps them with the design of their study protocol and the preparation of specifications best suited to the approach chosen so as to ensure the success of the ongoing study or project.
and post-MARKETING
Whether integrated or not in a Risk Management Plan, our design department, in order to use the data effectively, makes available for its clients an analysis plan that includes Frequentist and Bayesian methodologies as well as data mining and neural networks in descriptive analysis.
[1] Markov Chain Monte Carlo