FEATURED ARTICLES

• New Opportunities & Implications For The Future Of Drug Development In Emerging Economies

  Ed Mills, Cytel’s Vice President of Real World Evidence hosts a panel on how COVID-19 is affecting access to drug development and equitable medical care in emerging economies.

• Podcast: COVID-19 Trial Tracker

  The Cytel COVID-19 Trial Tracker is an interactive tool to help you get answers to specific questions about the state of COVID-19 studies. Organized by country, therapeutic area, and trial status, this COVID-19 Trial Tracker helps visualize the state of clinical development. Whether you want to know how long recruitment for a vaccine trial is projected to take, or the number of hydroxychloroquine and remdesivir trials globally, this Trial Tracker is designed to answer transparently. Listen to a podcast with its creator Louis Dron.

• COVID-19 Pandemic: Response To Regulatory Guidance

  A number of non-COVID related trials are facing disruptions due to the coronavirus pandemic. Cancelled patient visits, new comorbidities, and more resource constraints have resulted in missing data, questions about recalibrated SAPs, and concerns about maintaining statistical power. Cytel co-hosted a panel to talk through some of these challenges.

• COVID-19: Trials, Designs And Tools For Promising Results

  How can we harness the power of data science and trial design to achieve expedited clinical development for a new coronavirus vaccine? Experts from around the world weigh in on this panel.

• Cytel's Response: EMA Guidance On The Management Of Clinical Trials During The COVID-19 (Coronavirus) Pandemic

  On March 20th the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the COVID-19 pandemic. Here is a review of selected elements of the guidance, interpretations and recommendations.

• Cytel's Response: FDA Guidance On Conduct Of Clinical Trials During The COVID-19 Pandemic

  The FDA recently issued a guidance on how the COVID-19 Pandemic may affect the conduct of clinical trials. Here are some key messages from the guidance along with some interpretations and recommendations.

• Clinical Development Challenge - Use Of RWA To Understand Natural History

  A biotechnology company without an in-house real-world evidence team did not have the adequate resources, connections, or expertise available to conduct a natural history study of the rare, oncology indication for which they were developing a new therapy. Their solution was found in a virtual real-world evidence department.

• Bayesian Methods For Contending With Homogeneity And Heterogeneity In Real World Data

  Over the past decade, single arm trials have increasingly become an accepted way of assessing a new treatment intervention. These trials make use of synthetic control arms (SCAs) and real-world data or historical clinical trial data. Learn what situations are best suited for SCAs and how homogenous and heterogenous patient populations can impact the trial.

• Ensuring An Unbiased Comparator Arm In Clinical Development

  Regulators in the U.S. and Europe have issued a positive response to the use of synthetic control arms (SCAs) in clinical development. The desire for faster and less expensive clinical trials, coupled with the availability of real-world data, were prominent factors. Learn how to avoid sampling bias when using real-world data in conjunction with SCAs.

• Are You Harnessing The Power Of Your Clinical Data?

  In clinical development, we all strive to deliver therapies that improve patients’ lives. However, the clinical data we generate can profoundly impact our success in achieving this goal. However, generating high-quality clinical data is far from straightforward, especially if you don’t have the appropriate in-house expertise. In this eBook, we discuss what is involved in planning a clinical data strategy for the entire duration of a development program, as well as for Phase 1 and Phase 2 trials specifically. We also outline some best practices for planning your data strategy, including tips from Cytel experts working in our Strategic Consulting, Clinical Research Services and Data Management teams.

• The Good Data Submission Doctor: Should I Stay Or Should I Go?

  A recurring question we get from clients is whether it is worth adopting data standards such as CDISC in the early phase of their drug development, and if it is worth spending more to produce SDTM and ADaM packages at an early stage. Learn more about why this could be a good decision for your company and steps you can take towards adopting them.

• Adaptive Design And Health Economic Analysis: Interview With Laura Flight

  In this Q&A with Laura Flight, National Institute for Health Research (NIHR) Doctoral Fellow we take a deep dive into the objectives of her recent paper "A Review of Clinical Trials With an Adaptive Design and Health Economic Analysis" Learn more about the next steps for promoting better understanding in this area.

• Advancing Oncology Development With A Synthetic Control Arm Trial

  A specialized biopharmaceutical company had a breakthrough therapy that had the potential to be first-in-class for a rare and aggressive hematological cancer and had shown great potential in earlier clinical trial. In many breakthrough treatment areas, where the patient population is small, or there is overwhelming evidence of efficacy at Phase 2, it has become common for drugs to be approved based on a pivotal single arm trial – however, this is not always optimal. Read how synthetic control offers a practical, effective way to leverage real-world evidence and has been applied in regulatory approvals.

• Handling The Specialized Data Requirements In Oncology Clinical Trials

  The right design and the right data ultimately leads to the right decisions, so obtaining fit-for-purpose data, collected based on what your protocol is looking for is vital. However, there are several data pressure points facing oncology drug developers that need specialized expertise and processes to handle. In this blog, we run through some key aspects to consider to smooth your data collection and analysis.

• Predictive Biomarker Signature Characterization

  A client was developing a new drug for complex neurodegenerative disease in pre-clinical development. The drug may be only effective for a particular subgroup of patients. They needed to generate a hypothesis on the molecular pathway and the targeted drug activity and identify a biomarker signature defining potential response to the new drug. Read how Cytel’s analysis produced a biomarker signature that was provided to the client for in-vivo validation.

• Innovative Data Science And Real-World Analytics Approaches In Practice

  With the rise in digital technologies, there has been an explosion in volume and type of data sources we can obtain. However, new data sources bring inherent challenges to be overcome including lack of standardization, missing data, and variation in quality. Read how Cytel's data science and real-world evidence groups have helped clients apply advanced analytical techniques to large, complex historical or real-world data sets to improve their decision-making, accelerate development pathways, and enhance their probability of success.

• 2018 vs. 2010 FDA Draft Guidance For Industry On Adaptive Designs For Clinical Trials Of Drugs and Biologics

  In September 2018, FDA issued a new draft Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance. Here, we summarize the differences between the two documents and highlight any significant new elements introduced in the most recent material. Of note, the 2018 guidance is more compact and streamlined than its 2010 predecessor, also evident by a fewer number of total pages (36 vs. 50 in the 2010 version).

• Cytel And Axio Join Forces To Create An Industry Leader In Analytical Solutions For Drug Development

  Cytel Inc., the leading global provider of innovative analytical software and services to the life sciences industry, and Axio Research, a premier provider of biostatistics to pharmaceutical, biotechnology and medical device companies, today announced that they have joined forces to create the largest global biometrics organization focused on delivering advanced analytical solutions for the life sciences industry.

• Opening The Black Box: Moving To Explainable AI

  For the biopharma industries specifically, AI represents an opportunity to avert the R&D productivity crisis with paradigm-shifting applications such as in-silico drug design, prediction of trial risks and big data analytics. However, with every opportunity, there are risks and challenges, and this blog discusses how pharma needs to address the opacity of AI to ensure trust and credibility with all stakeholders.

• Assuring Outsourcing Obligations With Specialist Data Management Oversight

  This blog discusses how specialist CROs can add value and streamline processes by providing oversight of data management services delivered by another CRO. This model helps to fulfill essential regulatory obligations for biopharma companies who may lack their own internal oversight resources.