Adaptive Dose Finding Using Toxicity Probability Intervals

Posted by Esha Senchaudhuri

Oct 28, 2014 9:30:00 AM

Phase 1 oncology trials typically use either rule-based methods or model-based methods to determine the most acceptable level of dose toxicity with which to move forward in Phase 2. This level of toxicity, called the maximum tolerated dose (or the MTD), is the dose which best balances the medical benefits of a higher dose with the risk of toxicity which comes from subjecting a patient to that...

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Topics: Oncology, East 6.3, Access to Slides PDF, East ESCALATE, Adaptive Clinical Trials


5 Scenarios When ‘Keep it Simple’ May Be Bad Advice for Clinical Trial Designers

Posted by Esha Senchaudhuri

Sep 18, 2014 10:44:00 AM

When designing clinical trials, many trial designers are advised to keep the trial simple. Prima facie, the keep it simple principle seems like sound advice. There are various logistical uncertainties that arise when implementing a clinical trial, and the more simple a trial – so conventional wisdom says – the easier it is to respond to these uncertainties.

According to Zoran Antonijevic, a...

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Topics: Oncology, Promising Zone, sample size re-estimation, Enrichment, Cytel Consulting, Efficacy, Interim Analyses, forecasting, optimization, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials


FDA Industry Session Features Panel on "Seamless Adaptive Designs"

Posted by Cytel

Sep 16, 2014 3:30:00 PM

An FDA Industry Statistics Workshop on September 23 will feature a panel on seamless adaptive designs. Seamless adaptive designs are studies which are able to combine two stages of a clinical trial into one adaptive study, thereby cuting trial costs and reducing study length. The panel will feature Cytel Statistician Lingyun Liu,Lisa Kammerman of AstraZeneca, and Joshua Chen of Merck. The FDA's...

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Topics: Cytel Consulting, Adaptive Clinical Trials


Empirical Study Confirms Positive Impact of Adaptive Designs

Posted by Esha Senchaudhuri

Sep 11, 2014 11:56:00 AM

According to a recent Impact Report from the Tufts Center for the Study of Drug Development, 21% of active clinical trials improve trial success rates and cut operating costs by designing trials with simple adaptive elements like sample size re-estimation and opportunities for early stopping. 

Cytel Senior Biostatistician Zoran Antonjevic, who also chairs the DIA’s Adaptive Design Scientific...

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Topics: White Paper, Adaptive Clinical Trials


FDA-Industry Session on Cardiovascular Outcome Trials: Mehta on EXAMINE Trial’s Promising Zone Design

Posted by Esha Senchaudhuri

Sep 9, 2014 10:41:00 AM

 

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...

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


Adaptive Designs for Evidence Based Oncology: Insights from the Experts

Posted by Esha Senchaudhuri

Sep 4, 2014 1:10:00 PM

Imagine if we were to count the number of possible reasons that investigators might have for monitoring a biomarker during a clinical trial, and multiply that number by the number of possible adaptive designs available for such investigation. We would naturally assume that whatever the number, it would be rather large. This poses an interesting question for a sponsor of an adaptive clinical...

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Topics: Access to Paper PDF, Dose-Escalation, Cytel Strategic Consulting, Adaptive Clinical Trials


Impact of Study Design and Development Strategy on Pharmaceutical Programs and Portfolios

Posted by Esha Senchaudhuri

Sep 2, 2014 11:19:00 AM

As more clinical trials make use of adaptive designs, investors have come to realize that high quality trial designs can result in significant improvements to a trial’s financial risk profile. Regardless of a trial’s eventual success or failure, a well-constructed design provides a drug with the highest possible probability of success while mitigating financial risk.

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Topics: Nitin Patel, Cyrus Mehta, Promising Zone, Trial Quality, Cytel Strategic Consulting, Trial Design, Entrepreneurship, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials


Why adaptive sample size re-estimation designs preserve type 1 error

Posted by Esha Senchaudhuri

Aug 28, 2014 8:00:00 AM

 

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Topics: Promising Zone, type 1 error, Adaptive Clinical Trials


New ISCB Course on Adaptive Design

Posted by Esha Senchaudhuri

Aug 19, 2014 8:48:00 AM

Biostatisticians from Cytel will be delivering a course on adaptive designs at this year’s International Society for Clinical Biostatistics. The course will help attendees develop strategies for interim decision-making, by providing an overview of recent advances in statistical methodology and applying them to case studies in oncology and cardiology

Members of Cytel Consulting are not only...

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Topics: Adaptive Clinical Trials


Backward Image Confidence Intervals for Adaptive Group Sequential Designs (Full Article Attached)

Posted by Esha Senchaudhuri

Aug 14, 2014 8:00:00 AM

Cytel statisticians are looking foward to attending the Conference of the International Society for Clinical Biostatistics, which will be held in Vienna during the week of August 24th. Members of Cytel will be contributing to four sessions at this conference, including an invited talk on innovation entitled 'Beyond Wild Horses: Developing Innovation at Cytel.' They will also be contributing to a...

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Topics: Cyrus Mehta, Access to Paper PDF, Adaptive Clinical Trials


Why Using Adaptive Designs Can Attract Investors to Your Trial

Posted by Esha Senchaudhuri

Jul 29, 2014 6:30:00 AM

Adaptive designs are the unsurprising hot topic of this year’s Joint Statistical Meeting, which features over one hundred and thirty sessions on the subject. Statisticians at Cytel look forward to contributing to the dialogue with two papers on adaptive designs, and a workshop for using simulations to benefit from interim data (i.e. for prediction and trial forecasting.) In addition, Cytel...

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Topics: optimization, Adaptive Clinical Trials


Mehta Publishes Article on Adaptive Designs for Biomarker Driven Population Enrichment in Oncology

Posted by Esha Senchaudhuri

Jul 10, 2014 1:53:00 PM

Complexities with identifying suitable test populations in oncology studies contribute significantly to the 60% attrition rate in Phase III trials. Cyrus Mehta, (President of Cytel) has recently authored a paper on ‘Biomarker Driven Population Enrichment for Adaptive Oncology Trials,’ (forthcoming in Statistics in Medicine) which provides an innovative method for using two-stage adaptive...

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Topics: Oncology, Access to Paper PDF, Enrichment, Adaptive Clinical Trials


5 Reasons to Invest in Adaptive Designs for Population Enrichment

Posted by Esha Senchaudhuri

Jul 8, 2014 6:00:00 AM

The above graphic is from Cyrus Mehta's slides on 'Adaptive Population Enrichment for Oncology Trials with Time to Event Endpoints.'

 

Recent advances in precision medicine have meant that therapeutic treatments can now target subsets of a population that are most likely to respond well to treatment. Identification of such subsets largely relies on the presence or absence of particular...

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Topics: Oncology, Predictive Enrichment, Precision Medicine, Adaptive Clinical Trials


'Multivariate Approaches for Risk-Based Monitoring' An Adaptive Design (Slides Attached)

Posted by Esha Senchaudhuri

Jul 1, 2014 9:47:00 AM

A recent Cytel Seminar on Adaptive Statistical Designs featured a talk by Michael Elashoff (Patient Profiles) on Multivariate Approaches for Risk-Based Monitoring. Elashoff, a former statistical reviewer at the Food and Drug Administration, recommended combining cluster and rules based methods for statistical monitoring. Such adaptive monitoring approaches can substantially reduce the time and...

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Topics: Access to Slides PDF, Trial Quality, Trial Monitoring, Adaptive Clinical Trials


Adaptive Designs for Precision Medicine: A Look at Pfizer's Xalkori Trial (Slides Attached)

Posted by Esha Senchaudhuri

Jun 26, 2014 8:44:00 AM

The rise of biomarker based treatments in oncology has meant a reconceptualization of what constitutes a particular disease. According to the American Society for Clinical Oncology, “We can no longer think of cancer as one disease. Even something like lung cancer could be hundreds of different cancers, each defined by specific molecular characteristics requiring different treatment...

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Topics: Oncology, Access to Slides PDF, Precision Medicine, Adaptive Clinical Trials


Powering Oncology Trials for Success: Adaptive Designs in East

Posted by Charles Liu

Jun 5, 2014 9:37:00 AM

Charles Liu, PhD, Cytel Statistician and Product Manager

In the US, cancer is the most common cause of death after heart disease, accounting for nearly 1 of every 4 deaths [1]. Tackling the immense burden of this disease, researchers are currently investigating an estimated 900 novel cancer agents in over 6,000 clinical trials [2]. Unfortunately, the clinical success rate remains low, and failed...

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Topics: Oncology, Education, Adaptive Clinical Trials


Cytel Joins DIA Discussion on Predictive Enrichment Strategies

Posted by Cytel Consulting

May 16, 2014 2:48:00 PM

Cytel Consulting's Zoran Antonijevic

The key focus of precision medicine is identification of patients who would most benefit from a treatment. Proper enrichment of patient population greatly improves the probability of regulatory approval as well as product differentiation through improved efficacy and safety. Greater product differentiation leads to greater market access, as reimbursement is...

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Topics: Enrichment, Cytel Consulting, Adaptive Clinical Trials


De-Risking Drug Development using Adaptive Design

Posted by Cytel

May 13, 2014 8:31:00 AM

The VALOR trial recently applied a promising zone design to a Phase 3 evaluation of Vosaroxin, a candidate for the treatment of relapsed/refractory acute myeloid leukemia. CMO Dr. Adam Craig reports that there were intial anxieties about financing a trial that required 800 patients. However, a promising interim look raised investors' confidence in the treatment's success, leading to a...

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Topics: Oncology, Promising Zone, sample size re-estimation, Movers & Shapers, Adaptive Clinical Trials


The Perils of Poor Recruitment

Posted by Esha Senchaudhuri

May 5, 2014 10:21:00 PM

A new JAMA study on discontinued randomized trials in Switzerland, Germany and Canada, reports that poor recruitment accounts for 101 out of 253 trials that were eventually discontinued (or about 10% of the 1017 trials which participated in the study). When restricted to industry-sponsored trials with non-healthy volunteers, poor recruitment accounted for the discontinuation of 40 trials out...

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Topics: Nitin Patel, East, East 6.3, Access to Slides PDF, Recruitment, East Recruit, Sample Size, Promising Zone, sample size re-estimation, Adaptive Clinical Trials


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