Podcast: Enhancing Patient Enrollment Forecasting with EnForeSys 2.0

Posted by Cytel

Sep 5, 2018 8:50:00 AM

 

EnForeSys is Cytel’s tool for patient recruitment planning. We have discussed on the blog recently with Tufts University's Center for the Study of Drug Development, Ken Getz, the problem the industry continues to face with patient recruitment, and the fact that most trials significantly exceed their original planned duration. In the face of this problem there's a pressing need to create more...

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Topics: patient enrollment, enforesys, clinical trials


Interview with Ken Getz: Exploring Challenges of Clinical Trial Operations Part 2

Posted by Cytel

Apr 13, 2018 7:21:00 AM

We return to our discussion with Ken Getz of the Tufts CSDD for part 2 of our blog post on  key challenges in clinical trial operations. You can find Part 1 of the interview here, or read on to gain his insights on the fundamental problem at the heart of clinical trial operations challenges, and his views on the initiatives and programs that he believes show the most promise for the future. 

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Topics: enforesys, forecasting, patient enrollment, clinical trials


Interview with Ken Getz: Exploring Challenges of Clinical Trial Operations Part 1

Posted by Cytel

Apr 5, 2018 8:30:00 AM

Photo by J. Kelly Brito on Unsplash

Research on clinical trial enrollment makes for sobering reading, characterized by the oft-cited statistic that 11% of active sites fail to enroll a single patient. In this first part of a two part interview, we sit down for a discussion with Ken Getz of the Tufts CSDD. Here, Mr. Getz expands on some of the Center’s more recent research on challenges in...

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Topics: enforesys, forecasting, patient enrollment, clinical trials


When Biostatisticians Disagree About Ethics

Posted by Cytel

Jul 6, 2017 9:09:00 AM

 By Esha Senchaudhuri

The ethical benefits of adaptive clinical trials have been widely acclaimed: higher prospects for patients to be enrolled into the correct trial arm [1]; shorter trials for the most effective new therapies (see the early stopping outcome of the MUSEC trial) [2]; and enrollments commensurate with the needs of research, i.e. the last patient enrolled is not superfluous to a...

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Topics: biostatistics, Regulation, patient enrollment, Adaptive Clinical Trials, medical ethics


Innovative Phase 3 Adaptive Enrichment Design in Oncology

Posted by Cytel

Dec 2, 2016 9:19:10 AM

At a recent Pfizer/ Cytel seminar on rare disease and oncology development, Cytel’s Lingyun Liu presented innovative work on a patient enrichment design. In this blog, we share some design and operational considerations. This approach can help mitigate against underpowering of a clinical trial where there is uncertainty and heterogeneity of treatment effect among subpopulations.

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Topics: biostatistics, Cytel Strategic Consulting, Enrichment, patient enrollment, adaptive trials, Oncology, Phase 3, personalized medicine


Overcoming challenges of 'Less Well Understood' Adaptive Designs

Posted by Cytel

Sep 7, 2016 8:00:00 AM

In the 2010 draft FDA ‘Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics',  the agency makes an important distinction between ‘well understood’ and ‘less well understood’ adaptive designs.

‘Well understood” adaptive designs may include such approaches as adaptation of eligibility criteria, adaptation for stopping early and adaptations to maintain study power...

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Topics: Clinical Research Services, adaptive trials, adaptive designs, type 1 error, Software Simulations, DMC, sample size re-estimation, patient enrollment


EnForeSys® enrollment forecasting showcases at SCOPE

Posted by Cytel

Feb 17, 2016 12:32:45 PM

Charles Liu, Statistician and Product Manager at Cytel will be part of the expert speaker panel at the 7th Annual SCOPE Summit on 23-26th February. This year’s meeting is taking place in Miami, and offers a packed program with tracks covering such varied topics as risk based monitoring, clinical data technology and integration, and managing outsourced clinical trials. SCOPE has become one of the...

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Topics: feasibility studies, patient enrollment, enforesys, Scope conference


3 Questions to Ask About Your Trial's Enrollment

Posted by Charles Liu

Jul 2, 2015 1:33:01 PM

 

Clyde Haberman, a columnist for the New York Times, once commented on the remarkable consistency of train arrival times on the Tokyo subway: "Every station lists the scheduled arrival times: 9:01, 9:04, 9:08 and so on. I lived in that city for five years...I never saw a train arrive so much as a minute late, not once. A posting of 9:01 meant 9:01." [1]. Such predictability is rarely observed in...

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Topics: feasibility studies, patient enrollment, enforesys


Patient Recruitment Feasibility: Would you bet $12 million dollars on it?

Posted by Charles Liu

Jun 4, 2015 3:11:26 PM

Two insightful papers from Applied Clinical Trials should be of interest to many clinical trial planners. The first by Kenneth Getz describes the problem of enrollment performance, while the second by Matthew Kibby proposes a potential solution. The Facts

Getz reports a study providing recent estimates of industry-wide rates of enrollment delays [1]. In 2012, the Tufts Center for the Study...

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Topics: feasibility studies, patient enrollment, enforesys


New Cytel Whitepaper: Monte Carlo Simulations for Patient Recruitment

Posted by Cytel

Apr 13, 2015 11:23:00 AM

Cytel has published a new whitepaper on Monte Carlo Simulations for Patient Recruitment, which illustrates how a technique already popular within industrial and business environments is now changing the game of data-driven patient enrollment forecasting. 

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Topics: White Paper, Software Simulations, patient enrollment, Monte Carlo


Monte Carlo Simulations II: Reassessing Strategic Options During an Interim Look

Posted by Esha Senchaudhuri

Apr 2, 2015 1:32:00 PM

 

Midway through a trial is a terrible time to realize that you need a new strategy to complete the study. Sadly, it is typically midway through a trial when drug supply, patient recruitment and budget all tend to deviate from the planned development path. Sometimes this is because the initial plan utilized idealized assumptions, (i.e. non-random patient enrollment), which failed to give the...

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Topics: Clinical Development Strategy, patient enrollment, enforesys


Monte Carlo Simulations for Patient Enrollment: A Presentation by the Director of Pfizer's Feasibility Center for Excellence

Posted by Esha Senchaudhuri

Mar 12, 2015 5:08:00 PM

Enforesys: Learn More Recently, we published an interview with Chris Conklin, the Director of the Center for Feasibility Excellence at Pfizer. During the interview, Chris spoke about how his team navigates the complex terrain of trial planning and patient recruitment, and achieves those high flying enrollment milestones for each and every trial. His key...

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Topics: Software Simulations, patient enrollment, Monte Carlo, What are...


Data-Driven Trial Planning: An Interview with Pfizer's Chris Conklin

Posted by Cytel

Feb 12, 2015 2:59:00 PM

Data driven decision-making can ensure that every feasibility team achieves its enrollment milestones. By transforming how pharmaceutical companies and CROs conduct feasibility studies, new techniques in recruitment planning are affecting every aspect of trial planning and clinical development strategy.

We sat down with Chris Conklin, the Director of the Feasibility Center for Excellence at...

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Topics: Clinical Development Strategy, feasibility studies, patient enrollment


3 Key Trends in Clinical Trial Enrollment Forecasting

Posted by Esha Senchaudhuri

Feb 5, 2015 4:50:00 PM

Every clinical trial requires some manner of trial forecasting, normally for feasibility and patient enrollment. However, studies reveal that more than 50% of clinical trials fail to meet enrollment targets, and that enrollment is the most commonly cited reason for Phase 3 trial discontinuation [1].

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Topics: feasibility studies, patient enrollment


How to Take Control of Your Enrollment Woes

Posted by Esha Senchaudhuri

Jan 27, 2015 4:01:00 PM

Last week we released an infographic on why Phase 3 trials fail. The numbers, while eye-opening, did not capture a related and equally important issue: Why are so many late stage clinical trials discontinued?

Nearly 50% of all Phase 3 trials that are submitted to the FDA fail upon first submission [1]. However, 25% of all trials that begin are never even submitted for review [2].  According to a...

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Topics: feasibility studies, patient enrollment, trial planning


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