Jun 28, 2018 6:53:00 AM
By Esha Senchaudhuri
With thanks also to Jitendarreddy Seelam and Ramanatha Saralaya for their input.
The fact of the matter is that I now want to recall everything, every trifle, every little detail. I still want to collect my thoughts and - I can't, and now there are these little details, these little details...” ― Fyodor Dostoyevsky, The Meek One
Old Fyodor was hardly talking about...
Topics: clinical trials, Clinical Development Strategy, Early Phase Trials, pharmacology
Apr 19, 2017 5:19:08 AM
The ASCPT is the largest scientific and professional organization serving the disciplines of Clinical Pharmacology and Translational Medicine, and its annual conference is one of the most important events on the calendar for those involved in Quantitative Pharmacology and Pharmacometrics (QPP). Cecilia Fosser, Nand Kishore Rawat and Tina Checchio represented Cytel’s expanding QPP team at this...
Topics: biostatistics, pharmacology, Early Phase Trials, pharmacometrics, Phase 3
Feb 9, 2017 7:34:58 AM
In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shares some of the most important knowledge he uses in his day to day work as a biostatistician working extensively in oncology research. Adam has broad experience with statistical analysis and methodology over all phases (I-IV) of development, in particular working in the oncology arena.
As a Director of Biostatistics at...
Topics: Oncology, Dose-Escalation, Dose-Finding, biostatistics, adaptive trials, Interim Analyses, Phase 1, phase 2, Phase 3, Early Phase Trials
Sep 2, 2016 10:30:00 AM
Topics: biostatistics, adaptive trials, Dose-Escalation, EAST 6.4, East ESCALATE, BLRM, CRM, Oncology, Early Phase Trials, Eearly Development
May 10, 2016 8:00:00 AM
We were fortunate to welcome Björn Bornkamp of Novartis to the EUGM 2016 presenting work he has developed jointly with Marius Thomas (1) on methods of adjusting treatment effect estimates in subgroup analyses with a focus on early phase trials.
Topics: Early Phase Trials, clinical development, biostatistics, subgroup analysis
Apr 22, 2016 9:30:00 AM
FDA draft guidance on “Co development of two or more unmarketed investigational drugs for use in combination” notes that:
“Combination therapy is an important treatment modality in many disease settings, including cancer, cardio-vascular disease, and infectious diseases. Recent scientific advances have increased our understanding of the pathophysiological processes that underlie these and...
Topics: Oncology, Phase 1, Early Phase Trials, Adaptive Clinical Trials, BLRM, Bayesian, PIPE
Apr 7, 2016 10:30:00 AM
Francois Beckers, Global Head of Biostatistics & Epidemiology at Merck KGaA joined us at the East User Group Meeting in March and presented case studies of Merck KGaA’s experiences with Blinded Sample Size Re-estimation in early phase studies, more specifically in the context of biosimilar studies.
Topics: sample size re-estimation, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials
Mar 29, 2016 11:00:00 AM
On March 16th and 17th the 5th East User Group Meeting took place in London. This very successful 2 days saw a variety of talks on aspects of clinical trial design innovation. Over the next couple of weeks, we will be reviewing some of the key topics which were addressed during the meeting.
In this post, we'll take a look at Paul Frewer of Astrazeneca's presentation on Decision Making in...
Topics: Bayesian Methods, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials, phase 2
Nov 12, 2015 4:00:00 PM
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. Patrick Mitchell, an Associate Director of Statistical Sciences at Astra Zeneca, gave this talk on Bayesian go/no-go decision-making in an early phase oncology event study.
Astra Zeneca recently invited Cytel to take part in a collaborative initiative...
Topics: Bayesian Methods, Early Phase Trials, Clinical Development Strategy, go-no-go
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.
Topics: Data Management, Safety, Early Phase Trials, Small Sample Sparse Data
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...
Topics: Cytel Consulting, Early Phase Trials, Clinical Development Strategy, Proof-of-Concept, Case Study, Biomarkers, Simulations
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...
Topics: Bayesian Methods, CRM, Early Phase Trials, Clinical Development Strategy, BLRM
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.
Topics: Dose-Finding, Early Phase Trials, Proof-of-Concept, Clinical Data, MCP-Mod
May 20, 2015 5:56:47 PM
Seamless adaptive clinical trials have gained popularity for reducing the projected time it takes to complete the process of drug development. However, a study by Cuffe et al., shows that despite a tremendous amount of statistical knowledge about seamless trials, sponsors remain unsure about how to calculate the financial and operational costs of a seamless clinical development program [1]....
Topics: Phase 1, Early Phase Trials, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, phase 2
Apr 23, 2015 3:53:00 PM
Last week the Cytel Blog discussed the benefits of using the Adaptive Maximizing Design [AM Design] for dose-finding trials involving clinical utility limiting therapies. However, there are other ways that a dose-finding trial can make use of frequent-adaptation maximizing designs. Here we look at what happens to early phase clinical development when an AM Design combines with another adaptive...
Topics: Cytel Consulting, Early Phase Trials, Clinical Development Strategy, Adaptive Clinical Trials, psychiatry and neuroscience
Jan 22, 2015 9:00:00 AM
The Journal of the American Medical Association recently published an article entitled ‘The Anatomy of Medical Research: US and International Comparisons.’ The stated objective of the study was to “quantify total public and private investment and personnel (economic inputs) and to evaluate resulting patents, publications, drug and device approvals, and value created (economic outputs)“ [1]
...
Topics: Dose-Finding, Early Phase Trials, Proof-of-Concept, Case Study
Jan 20, 2015 10:30:03 AM
According to a recent Cytel Whitepaper on Adaptive Clinical Trials, 50% of Phase 3 trials eventually fail. This new Cytel Infographicoffers a breakdown of why so many drugs fail in Phase 3.
Topics: Early Phase Trials, Clinical Development Strategy, Phase 3
Dec 18, 2014 3:40:00 PM
Earlier this week, we at Cytel enjoyed a riveting in-house discussion on the uses of Bayesian decision rules for Go/No-Go (GNG) decision-making. GNG rules establish the trajectory of a particular clinical program’s development by assessing whether or not a trial has met particular objects (e.g. target regions for PK, PD and safety endpoints.)
Traditionally, statisticians have used p-values and...
Topics: Early Phase Trials, Clinical Development Strategy, Adaptive Clinical Trials
Nov 18, 2014 4:32:00 PM
Statisticians and scientists at Novartis have been at the forefront of developing a new method in early phase oncology trials called the BLRM. Many believe that the BLRM, (short for the Bayesian Logistic Regression Method,) allows for the construction of clinical trials that have the dual benefit of improving treatment for patients participating in the trials, and allowing the trial to complete...
Topics: Dose-Escalation, Bayesian Methods, Phase 1, Early Phase Trials