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 26, 2016 11:30:00 AM
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FDA draft guidance on “Co development of two or more unmarketed investigational drugs for use in combination” notes that: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.
Mar 8, 2016 9:30:00 AM
Data standardization is critical to ensure successful regulatory submissions. While many sponsors now choose to create CDISC compliant outputs as part of their in-line study analysis and reporting, inevitably legacy conversion of older studies is required.
A legacy conversion project is one which requires a significant transformation effort, where neither CDASH nor SDTM has been used. Migrating to SDTM is of course a complex activity, requiring a precise and intelligent approach- it’s not just a matter of renaming variables. A gap analysis which assesses the current state of the data can ensure the project is commenced on the right footing. In the below example, we conducted a gap analysis as part of a project for a client who engaged Cytel for support with their ISS/ISE.
Mar 3, 2016 3:00:00 PM
'The aim of a discussion should not be victory but progress.'
This principle, expressed by the French essayist Joseph Joubert, applies effectively to the spirit of scientific debate. More specifically, within the clinical development space, the field of adaptive designs has seen its fair share of both discussion and progress. In this blog we’ll take a look at one debated area- the efficiency of Adaptive SSR designs.
Feb 26, 2016 9:00:00 AM
Remember the early days of Electronic Data Capture? Those first systems, which were revolutionary for their time featured basic data entry screens, simple edit checks and a handful of reports.
Technology has come a long way since then, and the EDC landscape has matured dramatically along with it. Current EDC must-haves include easy user and site management, secure automated password retrieval, robust reporting, query and SAE management, as well as Source Data Verification, and Risk based monitoring. Many sites need to be active at the same time; labs need to enter or upload data directly into the system; medical coding should be performed inside of the tool; images need to be uploaded and stored; email and text alerts sent to investigators and sponsors, and patient reported outcomes and diaries need to be available.
Counter intuitively, while EDC system functionality is becoming ever more sophisticated, the interface to build the systems is becoming easier to use and understand.
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 leading events on the conference calendar for clinical operations executives, with 1100 delegates from over 300 companies expected to attend this February.
Dec 3, 2015 2:30:17 PM
On Dec. 12, 2015 Sangeetha Gandepalli, a Technical Lead in Clinical Data Management at Cytel, will speak before SCDM India. Here is a preview of her talk entitled "Data Standards and My Experience."
Data standards play a key role in improving the efficeincy and quality of health care delivery. Without data standards organizations cannot readily share clinical information and medical care becomes geographically isolated.
Data standards are an agreed upon set of rules that allow information to be shared and processed in a uniform and consistent manner.
Dec 1, 2015 3:00:00 PM
Risk based monitoring is a strategic monitoring practice which aims to shine the spotlight on problematic study areas, to maximize oversight of the most vulnerable data. The efficiency promised by RBM arises from the ability to detect the sources of data require the most attention, and distribute finite resources for oversight to the most problematic areas. This distribution aims to optimize attention on data sources which are in the most need of oversight, while decreasing attention on sources of data that have historically proven to be reliable.
Nov 19, 2015 4:00:00 PM
Nov 16, 2015 4:30:00 PM
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 to develop software for go/no-go decision-making. Pat demonstrates the uses of this proprietary software in early phase oncology.
Nov 10, 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.