Predicting the course of a clinical trial is something which people will always want to do-whether for statistical reasons, planning reasons or business reasons. In this blog we look at examples of where prediction goes off course, and how we can resolve these issues. We also share valuable video and slidedeck resources from our VP Consulting and Software, Yannis Jemiai.
Jun 16, 2016 10:23:00 AM
Jun 14, 2016 8:00:00 AM
At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees) in a variety of capacities. Our statistical experts are recognized for their work in many of the areas related to DMCs including-group sequential and adaptive designs, multiplicity, missing data, and decision sciences. One key operational management issue when producing analysis for DMCs is that rules must be defined so that trial unblinding is not compromised and bias remains controlled. In this blog, we will explore an innovative approach developed by members of our statistical programming team to improve the efficiency of this process, while maintaining the highest levels of data security.
Jun 7, 2016 8:00:00 AM
At the recent CMO Summit East James ( Jim) Bolognese, Cytel’s Senior Director of Strategic Consulting, and Lou Vaickus,MD, FACP, Founder and President of aktaPD jointly explored how the critical connection between a CMO and a biostatistician can help enhance communication with internal and external stakeholders, ensure patient safety and ultimately improve clinical development efficiency. Below you can catch up with some of the key topics they covered and watch the video of the presentation.
May 31, 2016 7:30:00 AM
Last week, we were delighted to announce the release of East 6.4 bringing further cutting –edge approaches to the East user community. East is the industry standard platform for clinical trial design, simulation, and monitoring, improving scientific productivity during the critical planning stages of clinical development. In this blog we catch up with Yannis Jemiai, VP of Cytel to gain some behind-the-scenes insights into the development and new features of this important release.
May 26, 2016 11:37:20 AM
A number of the Cytel team were in Berlin 22nd- 25th May for the PSI Annual conference. The PSI Conference is an important forum for statisticians and we found this year's event to be energetic, technically interesting and well attended. In this blog, we’ll summarise some of the particular highlights from the sessions that our team members attended.
May 19, 2016 6:00:00 AM
The explosion in healthcare information and “big data “has been one of the most written about topics in the last few years. These big data in the form of electronic health records, diagnostic tests, genomics, proteomics, not to mention data from wearable devices and apps have the potential to transform healthcare. That potential can only be realized though through the application of advanced analytics to recognize patterns from the vast information available. As such, disciplines such as pattern recognition play a pivotal role in the future of healthcare.
May 17, 2016 8:30:00 AM
Cytel participated at PharmaSUG 2016 in Denver recently. A key event on the statistical programming global calendar, the topics included Submission Standards, Application Development and Data Visualizaton. Sharmeen Reza, Associate Director Statistical Programming at Cytel was selected to present a paper presentation in the Statistics and Pharmacokinetics stream on the topic of Scrambled Data- A Population PK/ PD Programming Solution. The presentation was very popular and well attended, so we've included an abstract of the presentation below, and made her slides available for download.
May 12, 2016 10:18:00 AM
Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home. Their story can be an allegory for the concept of traceability in clinical data where we need to lay a clear path to ensure that the results we have created can be reproduced. This blog looks at some aspects of a presentation Lost in Traceability by Angelo Tinazzi at the CDISC EU Interchange.
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.
Apr 28, 2016 12:30:00 PM
Adaptive Designs in Practice: Interview with NIHR Research Fellow Munya Dimairo
NIHR and University of Sheffield researchers recently published a paper, ‘Adaptive designs undertaken in clinical research: a review of registered clinical trials’(Hatfield et al) which explores the current state of adaptive designs in practice. In this blog we catch up with Munya Dimairo, NIHR Research fellow and one of the paper’s co-authors to find out more.
Apr 26, 2016 11:30:00 AM
In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when working on early phase Oncology trials. We’ll also discuss approaches which can be employed to mitigate these issues.
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 other complex diseases. This increased understanding has provided further impetus for new therapeutic approaches using combinations of drugs directed at multiple therapeutic targets to improve treatment response or minimize development of resistance.” In this setting, it’s important to be able to design dose escalation studies which can identify the synergistic activity of compounds, and less toxic combinations.
Apr 20, 2016 8:00:00 AM
During the course of any clinical trial, there are often data which, while collected electronically, are outside of the scope of the eCRF . These data include central lab results like ECGs, PK/PD data and others. In this blog we’ll take a look at some key considerations in handling electronic data transfers and any subsequent integration with the core EDC database.
Apr 15, 2016 9:00:00 AM
It's critical for biostatistics and data management to be closely aligned and working effectively together. The consequences when these biometrics teams aren't integrated can be significant- impacting on both efficiency and data quality. If data is collected and cleaned without the input of statistics, the assumptions which have been made may not be adequate, resulting in additional work and compromised timelines. So, let's take a closer look at 5 important interactions between the two functions during the course of a clinical trial.
Apr 13, 2016 11:00:00 AM
We continue our series of blogs covering the expert presentations from the EAST User Group Meeting. Consultant Claire Watkins of Clarostat provided a different statistical focus, moving the discussion to a later point in the product lifecycle and the area of Health Technology Assessment. Her presentation, which tackled the topic of Adjusting Overall Survival for Treatment switch, shared the recommendations of a cross-institutional statistical working group ( Sub team of the PSI HTA Special Interest Group).
Statisticians have crucial role to play in the area of health economics and health technology assessments since payers like regulators require submissions which are robust and evidence based. However there are key differences in the perspectives of regulators and HTA agencies posing different challenges for statisticians involved in such submissions.
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.
Apr 5, 2016 4:00:00 PM
Cost of pharmaceutical development and R&D productivity is an ongoing industry concern, consistently discussed in the mainstream and specialist press. The issue is held in delicate balance against the increasing pressure on pharmaceutical pricing and cost containment measures.
A study by Tufts Center for the Study of Drug Development published earlier this year in the Journal of Health Economics (1) provides new estimates of R&D costs, building on previous work in the area.
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 Early Phase Clinical Development. This talk was very well received by the delegates and prompted plenty of discussion afterwards.
Mar 23, 2016 9:30:00 AM
“How many statisticians does it take to ensure at least a 50% chance of a disagreement about p-values?”
So questions George Cobb of Mt. Holyoke College in his commentary on the ASA’s 7th March ‘Statement on P Values: context, process and purpose’
The association took the unprecedented step of publishing the statement following a long litany of criticism of misuse of the P value. This included the decision last year by Journal of Basic and Applied Social Pyschology to restrict the publication of papers where hypothesis testing is used for analysis.
Mar 11, 2016 12:30:00 PM
There has been increasing interest in multi-arm multi-stage trials with treatment selection and sample size re-estimation at interim analysis. The East 6.4 release incorporates new Multi-Arm Multi-Stage (MAMS) module to support statisticians designing these studies. In this blog, we take a high level look at some of the features and advantages of this approach.