On August 29th 2018, the FDA announced (1) that it would be establishing a Complex Innovative Trial Design (CID) Pilot Meeting Program. This follows the release earlier in August of a draft guidance (2) to help advance effective and innovative clinical trial designs early in drug development that can expedite new cancer therapies.

Topics: Oncology, FDA, adaptive sample size re-estimation, biostatistics, adaptive trials, Seamless designs

PhUSE 2017 took place in Scotland’s capital city Edinburgh, 8th - 11th October, and brought together a range of experts to tackle the most pressing issues facing statistical programmers today.  We found this year's event informative and well attended. In this blog we share some highlights from the sessions and posters the Cytel team attended.  We will share Cytel's own contributions in a separate article.

Topics: Statistical Programming, FDA, Interim Analyses, biostatistics, CDISC, R programming, clinical trials

In this blog, we share the second part of our interview with Bob Beckman, about a design concept for a confirmatory basket trial. Beckman is Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics at Lombardi Comprehensive Cancer Center and the Innovation Center of Biomedical Informatics, Georgetown University Medical Center. The first part of the interview, which focuses on the context of the design is available to read here.  Otherwise, read on to learn more details about this innovative design which has the potential to drastically increase drug development efficiency. Beckman presented on this topic at Cytel's East User Group Meeting in October.

Topics: Oncology, FDA, Clinical Data, adaptive designs, basket trials

The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association. Each year 800 statistical practitioners come together to absorb new information on statistical practices in all areas regulated by the FDA.

Cytel was honored to be involved in the workshop program, and our subject matter experts added value to the conference by sharing their academic and regulatory experiences.

Don’t worry if you missed the event!

In this blog, we share the full slide set slide from Cytel contributions at the ASA Biopharmaceutical Section Regulatory Industry Statistics Workshop.

Topics: Sample Size, Promising Zone, Clinical Research Services, Regulation, FDA, Clinical Data, Adaptive Clinical Trials, adaptive sample size re-estimation, adaptive designs, Bayesian

 

Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home.  Their story can be an allegory for the concept of traceability in clinical data where we need to  lay a clear path to ensure that the results we have created can be reproduced. This blog looks at some aspects of a presentation Lost in Traceability  by Angelo Tinazzi at the CDISC EU Interchange. 

Topics: Clinical Research Services, Statistical Programming, FDA, Clinical Data, CDISC, SDTM, ADaM, EMA, PMDA, Biometrics

Last week was the CDISC EU Interchange conference in Vienna, a key event on the calendar for Cytel’s statistical programming subject matter experts . Angelo Tinazzi, Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel co-chaired the sessions on Foundational Standards and Standards Governance alongside Astrazeneca’s Daniel Graham, and delivered a presentation on Traceability within the Foundational standards track.

In this blog, Angelo highlights some of the hot topics which emerged from the presentations he attended during the meeting. 

 

Topics: Clinical Research Services, Statistical Programming, FDA, Clinical Data, CDISC, SDTM, ADaM, EMA, PMDA, Biometrics

 

We continue our series of blogs covering the expert presentations from the EAST User Group Meeting. Consultant Claire Watkins of Clarostat provided a different statistical focus, moving the discussion to a later point in the product lifecycle and the area of Health Technology Assessment.  Her presentation, which tackled the topic of Adjusting Overall Survival for Treatment switch, shared the recommendations of a cross-institutional statistical working group ( Sub team of the PSI HTA Special Interest Group). 

Statisticians have crucial role to play in the area of health economics and health technology assessments since payers like regulators require submissions which are robust and evidence based.  However there are key differences in the perspectives of regulators and HTA agencies posing different challenges for statisticians involved in such submissions.

Topics: Oncology, FDA, NICE, HTA, health economics, treatment switch

Imagine that it’s been three years since the completion of a trial, and that suddenly a regulatory body calls into question the findings:

• Was a particular trial site operating properly?
• Can you clarify an aspect of the results? 
• Why did you make a particular decision at an interim look?

Suddenly, your somewhat old data needs to be able to reproduce your initial findings. In such a case, how long would it take you to satisfy the regulatory body?

Topics: Data Management, Trial Quality, Trial Monitoring, FDA, ACES

 

The FDA requires sponsors of new antidiabetic drugs to conduct cardiovascular outcome trials (CVOTs). CVOTs demonstrate that new therapies do not place unacceptable cardiovascular risk on patients suffering from Type 2 diabetes. The average CVOT requires about 5000 patients and takes an average of 5 years to complete. However, a recent white paper by the Cardiac Safety Research Consortium outlines a variety of methods to decrease sample size and study duration, by employing group sequential and adaptive CVOT designs. 

Topics: Cyrus Mehta, Promising Zone, Trial Design, FDA, Interim Analyses, Cardiovascular, Adaptive Clinical Trials

 

The FDA’s Tatiana Prowell (Breast Cancer Scientific Lead in the Office of Hematology  & Oncology Products) recently gave an interview to the Nature Review Drug Discovery, in which she discusses the top three pitfalls faced by drug developers in oncology. Issues which Prowell cite include: selection of appropriate dosage, trial designs without sufficient thought given to interim data, and untimely decisions on the use of biomarkers.

According to the article, “some 90% of drugs that enter phase 1 eventually fail.” The prevalence of these pitfalls is noteworthy for oncology drug development, not least becaues of how easy they are to avoid.When coupled with innovative trial design can achieve significant benefits in efficacy and cost-effectiveness. For example, model-based dose-escalation methods can be used to improve the model dose toxicity profile of the drug in question. Cytel Statistician Charles Liu shows how simple it is to use Cytel’s software to select the optimal dose to carry forward.

Topics: Oncology, East, Regulation, FDA, East PREDICT, Predictive Enrichment, Interim Analyses, Prediction