Last week Cytel joined forces with Sanofi/Genzyme to devote a full day of workshops and talks related to modern methods in early phase oncology.
Nov 10, 2015 4:00:00 PM
Nov 5, 2015 3:34:15 PM
Oftentimes people perceive a tradeoff between speed and quality. The faster you do something the more likely you are to make mistakes. Then again, checking everything carefully means things take a longer time.
What if you could promise a team that could work 24-7?
Nov 3, 2015 6:14:50 PM
QPP (sometimes called QP2) remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD , statistical modeling and the modeling of go-no-go decision rules.
Oct 29, 2015 4:00:00 PM
A common challenge of working with small sample sizes is determining proper bias correction methods when evaluating a given set of data. Oftentimes, statisticians depend on large sample sizes to naturally correct for any bias. Small sample sizes, by contrast, require innovations like Firth’s famous bias correction method.
Recently, Cytel statisticians Ashwini Joshi and Sumit Singh gave a talk entitled “How to Reduce Bias in the Estimates of Count Data Regression.” Using a number of case studies and simple to use LogXact PROC software, they demonstrate the ease with which bias correction can be implemented for small sample clinical data.
Oct 27, 2015 6:04:00 PM
Here at Cytel we have enjoyed following the debates on the p-value controversy currently taking place on the ASA website, and indeed debating the issue ourselves. While we plan to post our views on the topic in the weeks to come, we would like to invite your thoughts on the issue as well.
Oct 22, 2015 2:28:53 PM
Oct 19, 2015 5:15:40 PM
It is often necessary to pool safety data from late phase studies, in preparation for regulatory submission. Some of our clients have also begun to add Phase 1 safety data to this pool. On some occasions this is required by regulators. In many cases, however, these Phase 1 data simply provide further evidence that a new therapeutic lives up to the promise of safety across patient populations.
Oct 15, 2015 5:31:00 PM
The method for dose-response modeling that is widely called MCPMod allows a sponsor to measure the likelihood that particular dose-response curves are the right mathematical model for a given set of data. Since several different dose-response curves might be able to fit the data, how can you determine which is the best curve for your purposes?
Oct 13, 2015 4:39:00 PM
In honor of World Obesity Day (celebrated on Oct. 11 2015) here is an American Heart Association Statistical Primer on Cardiovascular Research. Cardiovascular outcome trials (sometimes called CVOTs) are clinical trials that are critical for determining the safety of new anti-obesity and diabetes drugs. Early CVOTs like TECOS and SAVOR-TIMI enrolled over 14,000 and 16,000 patients respectively.
Cyrus Mehta, president and co-founder of Cytel, has been on the forefront of developing novel designs to shorten the length of these trials while maintaining high statistical rigor. In this primer he provides an overview of fixed sample, GS and adaptive designs for cardiovascular trials. Other topics include: adaptive sample size re-estimation, and SSR with enrichment for high and low risk subpopulations.
Oct 8, 2015 4:25:00 PM
A recent American Statistical Association conference featured a town hall meeting to discuss the role of the statistician within the pharmaceutical industry, and in particular within the subfield of precision medicine. The panel of distinguished academics, regulators and members of industry confronted the concern that the era of precision medicine heralds an emerging need for statisticians to play a different role than the ones normally associated with technique and craft. Statisticians are now charged with discovering insightful applications to new statistical methodologies, and ensuring that clinical development reflects as many innovative statistical methods as necessary to achieve a successful study. According to the panel, statisticians may even find themselves in a position where they are required to anticipate scientific and technological advances for a study’s benefit.
Oct 5, 2015 4:14:58 PM
One consideration every sponsor of a biomarker-stratified confirmatory trial must take into account, is whether to evaluate the biomarker subpopulation (S) against the rest of the population (S') or against the full population (F).
Mathematically, one would think this makes very little difference as F is partitioned into S and S'. If the null hypothesis is rejected for both S and S' then clearly it is rejected for F too. Similarly, if it is rejected for S and not for S' then the therapy is effective for the biomarker subpopulation, and ineffective for the rest of the population.
As it turns out, whether or not a given biomarker is indeed a predictive biomarker should affect the choice of statistical methodology in time-to-event trials.
Oct 1, 2015 5:22:00 PM
This week marks the sixth annual American Conference on Pharmacometrics, held this year in Crystal City, VA. Situated at the intersection of mathematical modeling, simulation and big data, the field of pharmacometrics is delivering on its promise to revolutionize clinical research and by extension clinical development.
No wonder then that biostatisticians are now fully engaged with the enterprise.
Sep 29, 2015 5:02:00 PM
The Head of the DIA’s Adaptive Design Working Group Asks Us to Consider 5 ‘Soft-Skills’ All Effective Statisticians Should Cultivate
The advent of adaptive designs has meant that statisticians have a new role to play in the drug development process. Not only are they responsible for tackling the precise statistical issues that can arise during the course of a study, but their knowledge and vision can result in innovations that substantially alter study design, strategic decision-making, probability of trial success and level of revenue.
Given this new role played by statisticians, what skills do statisticians now need to cultivate to be as effective as possible in the boardroom and on their project teams?
Sep 24, 2015 3:35:00 PM
Earlier this week, Patti Arsenault, Cytel’s Global Head of Clinical Data Management, sat on an SCDM panel with members of Gilead and Westat. The panel partook in an interactive discussion on both the opportunities and challenges which arise from managing virtual teams.
As teams become more global in nature – optimizing delivery by around the clock work hours –many have weighed in on the best way to manage virtual teams. Unfortunately, there seems to be very little agreement on such best practices. The panel provided insights from industry leaders in clinical data management, and then invited audience members to share their experiences.
Inference on Confidence Intervals for Adaptive Designs: The Latest Breed of Adaptive Clinical Trials
Sep 17, 2015 3:51:00 PM
Most people familiar with adaptive clinical trial designs are familiar with those statistical designs that reject the null hypothesis. These include now familiar designs like the promising zone design and the adaptive switch design.
A newer breed of adaptive designs, however, aims to apply adaptation techniques to confidence intervals.
Sep 15, 2015 3:56:42 PM
Sep 4, 2015 10:30:00 AM
Our Client's Challenge:
Can knowledge of the relationship between biomarkers and clinical endpoints help us to optimize an early development program and improve the probability of selecting the right dose in Phase 3?
Our client approached us hoping to expedite dose-finding with biomarkers in Phase 1b, and to design an optimal Phase 2b clinical endpoint trial to maximize probability of correct Phase 3 dose selection.
Sep 1, 2015 4:01:39 PM
If you’re in the practice of conducting early phase clinical trials, you’ve probably heard that modern trial designs include a number of new methodologies. There’s CRM and BLRM, model-based methods versus rule-based methods, and a number of other developments that might affect your clinical strategy. Each of these methods affects operational, financial and regulatory objectives in unique ways.
As a part of this year’s Joint Statistical Meeting, Cytel statisticians created a primer to go along with a workshop for early phase clinical trial design.
In the primer you will find:
- 1. An overview of 3+3, CRM, BLRM and mTPI methods
- 2. A synopsis of basic concepts like Bayesian and frequentist statistics, models and rules, etc.
- 3. Reflections on regulatory considerations
- 4. Case studies and topical exercises with Cytel’s high-powered simulations
- 5. A solution guide for those with access to Cytel's East software
Click to download the Primer
Aug 13, 2015 9:00:00 AM
Full service or specialized? Full service or specialized?
For many looking to hire a CRO, the answer is obvious.
The decision is difficult in part because it touches upon various crucial points of a clinical trial sponsor's strategy: top-notch knowledge and expertise, timely delivery, simple responses to unforseeable events. Your business and development strategy should ultimately affect your decision-making.
Here are a few things you might consider to avoid making a decision that is wrong for you.
Aug 10, 2015 2:32:34 PM
When approaching a Phase 3 clinical trial, the need to ‘de-risk’ the massive investment often leads sponsors on a quest for the perfect risk mitigating adaptation. While a strategically planned clinical trial design can be an important step in giving a new medicine its best possible chance of success, there are a number of other ways that a trial sponsor can minimize study risk.