The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

The 24 Hour Work Day

November 5, 2015

People Together-4

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.

Right?  

What if you could promise a team that could work 24-7?

Read More

Quantitative Pharmacology & Pharmacometrics for Biomarker Driven Clinical Strategy

November 3, 2015

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.

Read More

P-Values & Pharma Development: We Want to Hear from You

October 27, 2015

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. 

Read More

3 Statistical Challenges for Pooling Phase 1 Data

October 19, 2015

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.

Read More

It’s Time to Bridge the Gap Between Pharmacometrics and Biostats

October 1, 2015

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.  

Read More

Virtual Teams and Clinical Data Management

September 24, 2015

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.

Read More

Inference on Confidence Intervals for Adaptive Designs: The Latest Breed of Adaptive Clinical Trials

September 17, 2015

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.

Read More

Do you really need a full service CRO? An exploration of strategic options

August 13, 2015

Full service or specialized? Full service or specialized?

For many looking to hire a CRO, the answer is obvious.

Obvious Answer #1: A full service CRO simplifies your life by ensuring you need only one point of contact in stressful situations or when things appear to be going wrong. Clearly you want a full service CRO because clearly you want to keep things simple.  
*
Obvious Answer #2: A specialized CRO is exactly that, specialized. It sustains itself by being extremely good at doing the thing you hired it to do, and doing it better than everyone else. Clearly you want a specialized CRO because clearly you want the best.
*

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. 

Read More

Mitigate Phase 3 Clinical Trial Risk by Optimizing Phase 2 Data

August 10, 2015

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.

Read More