The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
COVID-19 has transformed the pharmaceutical industry in a manner that few could have predicted only a year ago. One of the potential effects of these changes is the more strategic use of real world evidence to support evidence generation for regulatory approval of clinical trials.
Dr. Radek Wasiak, Chief Data Officer at Cytel and Sreeram V Ramagopalan, Roche, recently co-authored a publication in the Journal of Comparative Effectiveness Research (JCER) on this likely development. The mix of delayed trials, missing data, and other challenges to traditional statistical design has meant that new tactics need to be deployed to salvage otherwise critical trials.
Outlining the true potential of RWE made Dr. Wasiak’s article one of JCER’s top ten most widely read in 2020.
One of the most difficult challenges facing Research and Development teams involves determining how to make tradeoffs between the speed, savings and success of a clinical trial. While some sponsors have to forego improved power in order to remain within strict resource limits, others sometimes increase their clinical development budget to accommodate unexpected gains in statistical power.
Complicating the picture is the fact that different members of an R&D team might have differing values that they place on speed, savings and success. While all three of these parameters affect the expected revenue from a trial (sometimes called the expected net present value or eNPV), we often find some members of the R&D team more concerned about completion dates, and others about investments in clinical operations, and so forth.
As we enter 2021 with new COVID-19 vaccines and greater optimism about the pipeline of drugs and devices positioned for approval, there remains the question of how this global pandemic has left permanent changes to clinical research and development. We know for example, that more clinical trials have become virtual and that decentralization is going to be a new challenge for clinical data management. Questions about equity and access have also arisen, with new ideas about how the pharmaceutical industry can contribute to greater equality. New quantitative models have also played an important role in expedited data analyses for prediction.
Effective use of the right outsourcing solution can enable sponsors to respond to market needs and change course where necessary, while ensuring a pool of highly qualified personnel are available to work on clinical trial projects. Whether you are a global pharmaceutical company or a virtual biotech, you deserve the dedicated and experienced A-team that can ensure that your projects are executed accurately, on-time and on-budget.
In this blog, we share a Cytel success story to explain how to create a high-quality, globally distributed biometrics team: minimizing recruitment timelines by up to 50% and expanding the team itself by 40% over a two year period
The rapid pace of technology has opened up numerous avenues for advanced innovative clinical trial design, but how can we use this to propel clinical development goals like maximizing revenue, or ensuring a commercially viable product? When operational constraints are limiting, how do we achieve the best possible trial design? What should we do if a competitor is edging us out of the market?
While we know that the statistical design of clinical trials can shorten trials or set realistic enrollment goals, there is still a growing need to tie these features of trial design directly to commercial revenue. Clinical development teams would ideally know how much they are willing to spend for an incremental gain in statistical power, or the marginal financial gains in waiting a week to unblind data.
The good news is the industry is getting there. Here are 5 Questions to help you begin your journey towards the Re-imagined Clinical Trial:
In April 2020, Cytel launched an open-access global COVID-19 Clinical Trial Tracker to help facilitate greater collaboration between researchers, policymakers, clinicians, journalists, philanthropists, and other critical stakeholders. Funded in part by The Bill and Melinda Gates Foundation, a leader in global health solutions, this live dashboard offers an overview of all the clinical trials taking place in the international effort to tackle the pandemic.
We have been posting regular updates on the clinical development of COVID-19 therapy and vaccines, on Cytel’s Blog page. The following details are based on an updated data search accessed on January 11.
At Cytel, we have been diligently working to become an organization deeply committed to uplifting and enriching society. The core purpose of our business is to help our clients in their endeavor to improve human health. Our employees are committed to upholding the highest standards in our interactions with customers, our colleagues and the communities in which we live and work.
Each year, we have several sustainable programs planned around providing education in healthcare and statistics. However, this year with the pandemic disrupting the socio-economic circumstances of the whole world, we were quick to implement new drives to support the fight against COVID-19.
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog saw a lot of activity as we tried to keep our readers abreast with the latest updates on the COVID-19 clinical trials, and covered other trending and important topics such as, the growing adoption of Synthetic Control Arms, master protocols, Head to Head Comparisons and Bayesian methods. We also collaborated with several experts from both within and outside the company to conduct several series of webinars and provided summaries through our blogs.
Continue reading to learn about the top 10 Cytel blogs that resonated most with our community in 2020.
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit executable programs?
Do I need to rename my software programs so that they all have the same extension e.g. “.txt”?
Can I make use of macros in my software programs and if so, should macros be part of the submission package?
What kind of documentations for software programs should I include in the submission package?
Do I need to follow any particular style and conventions when writing software programs that will be part of a submission package?
A single topic generates so many questions! Get the answers in this blog.