Many confirmatory clinical trials turn out to be negative and do not lead to the registration of a new drug or the introduction of a new treatment. Consequently, there is growing interest amongst clinical researchers in the use of efficient methods for conducting early and late phase trials to identify the most promising compounds, and in using interim analyses to allow trials to be stopped as soon as there is sufficient evidence to reach a convincing conclusion.

Adaptive designs allow mid-trial modifications to be made to the trial so that the accumulating data guides investigators to the most appropriate form of evaluation. While offering great flexibility during the trial, they require specialised approaches to be designed and analysed.

Dates
Tuesday 17th of September – Thursday 19th of September 2024 (3 full days)

University of Cambridge Students and Staff, whose department will be covering the participation cost, please contact Admin Team at [email protected] to arrange an internal crosscharge and obtain an access passcode to use this booking system. PO number and Access Passcode is required during the booking process.

Early phase trials are recognised to have a major impact on later phase confirmatory trials. This course presents state of the art methodology for Phase I dose-escalation studies that are delivered via a mixture of lectures, practical sessions, and discussions.

The topics will include:
•    Model-based and model-free Phase I dose-escalation single-agent designs;
•    Phase I designs for dual-agent and dose-schedules trials
•    Phase I/II designs for molecularly targeted agents;
•    Randomised dose-escalations trials;
•    Inclusion of covariates into Phase I dose-escalation;

Among other methods we will learn about model-based dose-escalation in-patients studies (such as Continual Reassessment Method [CRM], Bayesian logistic regression model [BLRM], Escalation with Overdose Control [EWOC]), model-free and model-assisted designs, their extensions for dual-agent and dose-schedule trials, and implementation of these designs in a software (specifically, R).

Dates
Monday 24th of June – Wednesday 26th of June (three full day)

University of Cambridge Students and Staff, whose department will be covering the participation cost, please contact Admin Team at [email protected] to arrange an internal crosscharge and obtain an access passcode to use this booking system. PO number and Access Passcode is required during the booking process.

Recent high-profile clinical trials have used a response-adaptive procedure as the way to implement an “adaptive” experiment. Such response-adaptive designs allow a variety of mid-trial modifications to be made to the trial so that the accumulating data guides investigators to the most appropriate form of evaluation (e.g. they can be used for arm selection, arm dropping, or simply to assign more patients on average to a superior treatment where possible). While offering great flexibility during the trial, they require specialised approaches for both the trial design and analysis.

Consequently, there is growing interest amongst clinical researchers and the clinical trials community in the use of these methods for conducting either early or late phase trials that more efficiently or more accurately balance competing goals, while gathering sufficient evidence to reach a convincing conclusion.

University of Cambridge Students and Staff, whose department will be covering the participation cost, please contact Admin Team at [email protected] to arrange an internal crosscharge and obtain an access passcode to use this booking system. PO number and Access Passcode is required during the booking process.

The course comprises four half-days’ worth of content plus the final hackathon, and will take place over 3 weeks (plus a preliminary week 0). It consists of some on-demand pre-recorded content and some timetabled (live) content. The first day of Week 1 will be Monday 4th November 2024. All the core content of the course is pre-recorded - live sessions are not compulsory to attend, but are supplementary to the core content. They represent a chance to engage with the course tutors. Several of the live sessions will be recorded.

Each half-day can be done whenever is convenient. A half-day of content includes three pre-recorded talks (around 20-30 minutes each) and one practical session (around 1-1.5 hour). Each of the three computer practicals should be performed individually, but there is an associated live drop-in session to come and ask questions. There is also a recorded debrief session that runs through the practical content. In terms of live content, in addition to the practical drop-in sessions, paper discussion, and hackathon, there is also a question and answer session each week to ask your questions. Questions can be asked during the week on a dedicated Slack channel, or you can ask questions live (Q+A sessions will be recorded).

University of Cambridge Students and Staff, whose department will be covering the participation cost, please contact Admin Team at [email protected] to arrange an internal crosscharge and obtain an access passcode to use this booking system. PO number and Access Passcode is required during the booking process.

The majority of biologic and small molecule drugs perturb protein targets to exert their effects. With the recent explosion in the availability of large-scale genetic association data, it is increasingly feasible to identify genetic variants that proxy the effect of perturbing a protein drug target. Leveraging such genetic data thus offers an efficient and cost-effective approach for identifying drug targets and studying their effects.

This short course “Genetics in drug development” will provide theoretical and practical advice on using genetic data to:
1.    Identify drug targets
2.    Investigate the effects of drug target perturbation for different indications
3.    Explore potential adverse effects and repurposing potential for drug targets
4.    Identify biomarkers to explore drug efficacy in early stage clinical trials
5.    Identify population subgroups for which drug effects may vary
6.    Explore interactions between different drugs and exposures

University of Cambridge Students and Staff, whose department will be covering the participation cost, please contact Admin Team at [email protected] to arrange an internal crosscharge and obtain an access passcode to use this booking system. PO number and Access Passcode is required during the booking process.