Early Phase Complex Clinical Trials
Strategic Considerations for Study Design in Phase I/IIa Trials
- Strategic considerations: how to improve your study design for phase I/IIa?
- The perspective of regulatory authorities
- Officially certified according to ISO 9001 and ISO 21001
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Do you want to strategically plan your early phase clinical trials (phase I/IIa) from the start to accelerate drug development? Then get tips and hands-on experience regarding traditional and complex clinical studies in this online seminar!
Your speakers
What to Expect
- General scope of phase I/IIa trials: development plan, risk assessment, Go/No-Go decision criteria
- Strategic considerations of early clinical trial designs - traditional vs. complex
- Operational implementation of complex early phase protocols
- The PEI perspective on early phase complex trials: "Guard Rail Concept" - study design, stopping rules and the decision making process
Who Should Attend
This seminar will be of benefit to all those working in the pharmaceutical industry who are responsible for the planning and conducting of early phase clinical trials (phase I/IIa) and who want to learn about:
- the possibilities offered by combined study designs
- key considerations in the strategic planning of complex study processes
- regulatory perspectives on the evaluation of such complex study designs.
This course will be conducted in English.
Objective of the Event
A strategically well-planned drug development process offers a significant market advantage for pharmaceutical companies.
In this seminar, you will learn how to strategically align your early-phase studies (phase I/IIa) to maximise insights with minimal time investment.
- What should you consider regarding the translation of preclinical experiences and dose selection?
- How do regulatory authorities evaluate potential ideas and plans for combined study phases?
- And how can the guidelines be practically implemented in terms of study protocol design, risk management, and safety monitoring?
Gain the necessary know-how and valuable hands-on experience in this seminar to efficiently align your drug development in traditional as well as complex early clinical trial phases.
Your Benefit
With the knowledge imparted in the seminar, you will:
- understand the possibilities and limitations of complex and combined study designs.
- be able to assess how regulatory authorities will evaluate your plans.
- know how to strategically approach the planning of your drug development phases.
Programme
09:00-17:00 CET
You may dial in 30 minutes before the session starts.
Dr Mazyar Mahmoudi
- Introduction
- Overview of preclinical and clinical development
- Development plan
- Risk assessments§§§Go/No-Go decision criteria
- Target product profile (TPP)
- Overview of early phase clinical trial objectives
- Preliminary safety
- Pharmacokinetic and pharmacodynamic assessment
Dr. Mazyar Mahmoudi
- Introduction/overview of design principles
- Traditional (rule-based) designs
- Introduction
- Statistical foundation: frequentist framework
- Single ascending dose (rule-based)
- Multiple ascending dose (rule-based)
- Bioequivalence and bioavailibility (cross-over)
- Drug-Interaction
- Proof-of-Concept (rule-based)
Dr Mazyar Mahmoudi
- Complex designs
- Introduction
- Statistical foundation: Bayesian framework
- Single ascending dose (adaptive)
- Multiple ascending dose (adaptive)
- Proof-of-Concept (adaptive)
- Seamless adaptive designs
- Integrated (Combined) early phase protocols
- Evaluation of substudies
- Protocol amendments§§§Feasibility of complex early phase clinical trials
Dr Uta Buckpesch-Heberer
- General aspects of trial approval
- CTIS and the assessment process
- The regulatory perspective
- Lessons learned
- The "Guard Rail Concept": study design, stopping rules and the decision making process
- Criteria for substantial amendments
- Case studies to illustrate the regulatory process (with quiz)
Welcome and introduction
General scope of early phase clinical trials
General scope of early phase clinical trials
Dr Mazyar Mahmoudi
- Introduction
- Overview of preclinical and clinical development
- Development plan
- Risk assessments§§§Go/No-Go decision criteria
- Target product profile (TPP)
- Overview of early phase clinical trial objectives
- Preliminary safety
- Pharmacokinetic and pharmacodynamic assessment
Strategic considerations of early clinical trial designs - traditional vs. complex
Strategic considerations of early clinical trial designs - traditional vs. complex
Dr. Mazyar Mahmoudi
- Introduction/overview of design principles
- Traditional (rule-based) designs
- Introduction
- Statistical foundation: frequentist framework
- Single ascending dose (rule-based)
- Multiple ascending dose (rule-based)
- Bioequivalence and bioavailibility (cross-over)
- Drug-Interaction
- Proof-of-Concept (rule-based)
Strategic considerations of early clinical trial designs - traditional vs. complex (continuing)
Strategic considerations of early clinical trial designs - traditional vs. complex (continuing)
Dr Mazyar Mahmoudi
- Complex designs
- Introduction
- Statistical foundation: Bayesian framework
- Single ascending dose (adaptive)
- Multiple ascending dose (adaptive)
- Proof-of-Concept (adaptive)
- Seamless adaptive designs
- Integrated (Combined) early phase protocols
- Evaluation of substudies
- Protocol amendments§§§Feasibility of complex early phase clinical trials
Regulatory perspectives on early phase complex trials
Regulatory perspectives on early phase complex trials
Dr Uta Buckpesch-Heberer
- General aspects of trial approval
- CTIS and the assessment process
- The regulatory perspective
- Lessons learned
- The "Guard Rail Concept": study design, stopping rules and the decision making process
- Criteria for substantial amendments
- Case studies to illustrate the regulatory process (with quiz)
Closing discussion
Downloads
Request the documents using our form.
Weitere Informationen
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
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Further Information
Your Contact Person
We are happy to advise you personally and individually.
Regine Görner
Dr. Verena Klüver
r.goerner@forum-institut.de
v.kluever@forum-institut.de