News Briefs
Eli Lilly and Company announced it will begin
sharing its clinical trial data with scientific researchers through www.clinicalstudydatarequest.com. This website, which
houses data from several clinical trial sponsors, was created in support
of ongoing efforts by the Pharmaceutical Research and Manufacturers of
America (PhRMA) and the European Federation of Pharmaceutical Industries and
Associations (EFPIA) to increase access to and transparency of clinical trial
results with researchers around the world. The portal differs from previous
Lilly data-sharing sites in that an independent scientific review panel, in which
Lilly will not be involved, will be responsible for granting access to clinical
trial data after reviewing research proposals from applicants. Press
release
Natera, Inc. and the International 22q11.2 Foundation
entered a partnership to raise awareness about 22q11.2 deletion syndrome and
the importance of early diagnosis. The partnership aims to encourage scientific
research, influence current medical practice and raise awareness among the
medical community and general population. One of the most common human genetic
disorders, 22q11.2 deletion syndrome (“22q”) occurs when a small piece of the
22nd chromosome is missing, and it can lead to severe clinical
outcomes. Natera’s Panorama test is currently the only non-invasive prenatal
test on the market that uses a SNP-based approach to screen for chromosomal
abnormalities, including microdeletions like 22q. Press release
For
more detailed coverage of recent developments in prenatal diagnostics, see “A
European Look at the Changing Landscape of Prenatal Testing.”
The American Society
of Human Genetics and the Jackson
Laboratory will team up to produce educational programs to integrate
genetic and genomic advances into healthcare. ASHG members and Jackson
Laboratory faculty have jointly organized and taught an annual, two-week “Short
Course on Medical and Experimental Mammalian Genetics” for more than 50 years.
Through the new collaboration, the Jackson Laboratory and ASHG will further
coordinate their educational activities by developing complementary programs.
The first joint educational program will aim to educate primary care physicians
on cancer genetic testing, and is slated for launch in November 2014 at the new
Jackson Laboratory for Genomic Medicine in Farmington, Conn. Press
release
Comprehend
Systems’ Comprehend
Clinical platform was selected to manage site data in Versartis’ clinical trial
of a treatment for growth hormone deficiency. Versartis selected Comprehend
Clinical, a cloud-based platform, for its ability to provide the clinical
operations team with real-time access to data from multiple sources, for trial
management and safety review. Press release
Celmatix
began a clinical trial for Polaris, a platform that aims to help doctors at
fertility clinics design personalized treatment plans based on a couple's
specific clinical metrics. The predictive models that power Polaris are the
first to show side-by-side comparisons of a patient's cumulative chances for success with in vitro fertilization (IVF) now
and in the future, timed intercourse, and non-IVF treatments. The clinical
study will enroll 1,000 patients. Celmatix’s preclinical analyses, using
retroactive data, found Polaris to be more accurate than published predictive
models on fertility treatment outcomes, but this trial will be the first test
of Polaris in an active clinical setting. Press release
New Products
Aptiv Solutions, a subsidiary of ICON that designs and implements adaptive trials, released ADDPLAN
DF 3.0, which uses statistical methodologies to prevent under and
over-estimation of a drug’s maximum target dose (MTD) during Phase I dose
escalation trials. Accurate estimation of MTD minimises safety and efficacy
issues leading to late phase clinical trial failures and is of particular importance
in oncology. ADDPLAN DF 3.0, which benefited from beta testing feedback from ADDPLAN
DF Consortium members at Eli Lilly, Janssen, and Novartis, simulates and allows
comparison of the 3+3, mTPI, CRM, and Bayesian logistic regression models for
estimating MTD. Press release
For more on Aptiv
Solutions and the development of ADDPLAN DF, see “Taking on an Adaptive Dose Response
Model.”
MolecularHealth announced
the official launch of TreatmentMAP, its cancer treatment decision support
offering, which was first made commercially available this April. TreatmentMAP
uses the results of next generation sequencing genetic tests to identify
treatment options for each individual patient. The company has two available
versions of its offering: TreatmentMAP Targeted Panel,
the largest gene panel commercially available today, covering several thousand
variants across 500 genes that have been associated with cancer outcomes; and TreatmentMAP Whole Exome,
the first commercially available whole exome analysis for cancer, which
examines the genes of both the tumor and germline. Both testing options
incorporate SafetyMAP, a proprietary identification of drug target safety or
resistance effects that uses the FDA’s Adverse Event Reporting Systems as an
input for analysis. Both tests results in simple-to-understand reports
delivered to the patient’s medical team. Press
release
For more detailed coverage of MolecularHealth’s service, see “MolecularHealth
Enters the American Cancer Genomics Market.”
CluePoints, a provider
of Centralized Statistical Monitoring (CSM) solutions for clinical trials,
released a web-based version of its risk-based monitoring platform that helps
sponsors to determine the quality and integrity of their clinical trial data.
The web-based CSM software as a service offering will enable customers to
upload clinical data for assessment, visualize the findings and interact with
analyses. CluePoints' products are driven by the company's SMART engine,
which provides customers with the ability to check data quality across all
clinical subjects, sites, regions and countries involved in a trial, while
documenting where and why any anomalies have occurred. Product page
For more information on CluePoints’ SMART engine, see “CluePoints’
Statistical Strategies Enhance Risk-Based Monitoring.”
Infosys produced a cloud-based version
of its Clinical Trial Supply Management (CTSM) solution, a collaboration
platform for pharmaceutical companies and contract research organizations
(CROs). The new cloud-based version of the CTSM solution offers a set of tools
to manage complex clinical trials, covering demand and supply planning as well
as distribution across clinical sites. The on-premise version of the solution
has been used to manage clinical trial processes at a number of large global
pharmaceutical companies across the U.S. and Europe. Press release