INSIGHTS ON CLINICAL TRIAL TECHNOLOGIES

• Operating System Upgrades Do Not Adversely Affect eCOA Completion Behavior

  To understand the effect of operating system upgrades managed by subjects when using their own device (Bring-your-own-device – BYOD) to collect eCOA data on ongoing eCOA data completion rates, based on device usage data collected in a large ongoing clinical trial.

• Survey Reveals Industrywide Need To Improve Information Exchange And Accelerate Study Start-Up

  With a record-setting number of 59 drug approvals last year and the number of registered clinical trials having increased five-fold in the last 10 years there is a tremendous opportunity to make clinical research more effective as life sciences companies are taking action to speed study execution. However, fragmented processes and siloed systems are still slowing trials. Explore two areas that are key to driving greater efficiency and speeding trials.

• Disclosure & Transparency Trends Webinar

  Hear results from TrialScope’s 2019 Global Clinical Trial Disclosure & Transparency Benchmark Survey, highlights from our Plain Language Summaries Survey, and predictions for 2020.

• 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.

• Partnering For Quality, Innovation And Expertise – Conversations With Industry Pharma Leaders

  Jennifer Aquino, Chief Operating Officer at Cenduit recently had the opportunity to visit with several clients and opinion leaders on a year-end “listening tour,” to discuss their issues and goals for 2019 and beyond. Read what they had to say regarding the industry’s challenges and opportunities.

• 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.

• Artificial Intelligence And Machine Learning/Translation In Pharma Language Translation

  AI is being used to model, extrapolate, and automate tasks throughout the lifecycle of a drug (as it should be). The potential benefits are substantial, both in terms of clinical efficacy and financial savings. With all of the supposed power and promise of this advanced technology, what are the real, practical implications for clinical outcome assessments?

• Putting CDISC Standards To Work

  Read how integrating CDISC standards at the very beginning of a clinical trial, research organizations can leverage powerful analysis tools to cut through much of the tedious, time consuming, and expensive manual work typically associated with collecting, cleaning, analyzing, quality controlling, and reporting clinical study data.

• Finding Trial Summaries Online A Plus For Patients

  Regulatory agencies such as the European Medicines Agency (EMA) mandate that plain-language summaries (PLS) be objective and nonpromotional. That’s why, even if posted on a sponsor’s site, PLS should also be posted on a portal open to all sponsors.