White Papers

1. Actigraphy For Sleep Measurement 10/14/2021

   Wearable devices provide a low-burden and remote approach to objectively quantify people’s sleep in their real life, often revealing meaningful insights that might not be available with polysomnography or self report data. While sleep architecture and sleep staging are difficult to estimate with accelerometry alone, actigraphy is sensitive to treatment effects in previous studies of sleep disorders.

2. China Clinical Trials Landscape: 2016–20 10/12/2021

   Utilizing the gold-standard clinical trials intelligence database Trialtrove, this analysis delves into the sponsors, diseases, and types of trials taking place in China, and considers the drivers shaping the present-day landscape. As the statistics show, the real explosion in clinical activity in China may be just starting.

3. 2020 Clinical Trials Roundup: Disruptions To The Trial Landscape 10/12/2021

   In this year’s analysis, we dissect data from all Phase I–III clinical trials that started in a year dominated by COVID-19. The report reveals trends, discusses the industry’s evolution, highlights shifts in drug development strategies, and examines the emergence of (or declined activity in) key markets.

4. Patient Recruitment: A Critical Component Often Overlooked, Making It The Regrettable Spend 10/12/2021

   One of the biggest and most often overlooked aspects of a study is that of Patient Retention (PR). To better understand the dynamics of PR, the patients’ behavior drivers need to be explored.

5. How To Ensure You Get Optimal Study Power For Your Investment In Time And Cost 10/5/2021

   Cytel’s new position paper takes trial sponsors through a step-by-step process for how to obtain this full set of optimized clinical trial designs.

6. Providing Research Participants With New Information – Is Re-Consent Always Necessary 10/5/2021

   In an ever-changing clinical research landscape, it is critical that we are agile, flexible, and quick to adapt to change. But what if that change impacts currently enrolled study participants? How do we communicate changes to the study effectively and in line with regulatory guidance? This whitepaper provides tips and strategies for how to handle consent documentation with participants when new information becomes available.

7. Improving Subject Selection And Endpoint Management In Alzheimer’s Trials 10/4/2021

   The rapidly growing burden of Alzheimer’s disease worldwide, and the high attrition rate in trials of disease- modifying drugs for AD, call for better-designed clinical research, particularly in terms of selecting the right patients and making sure that endpoints are clear, transparent and well-supported.

8. Tailored, Dedicated Support Expedites COVID-19 Trial 10/1/2021

   As COVID-19 spread around the world, the accompanying lockdowns and travel restrictions brought many challenges for clinical trials. At the same time, there was an urgent effort to develop and test vaccines and therapeutics. These endeavors required enrolling tens of thousands of trial participants as quickly as possible, creating a huge burden on clinical trial sites that were already trying to figure out how to continue work during a global health emergency.

9. The Top 5 Benefits Of Outsourcing Expert Committee Management To An Independent Provider 10/1/2021

   In this article you will see the top 5 benefits of utilizing an Independent Expert Committee.

10. Don't Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise 10/1/2021

    Whether the focus is endpoint adjudication, aggregate data monitoring or safety assessment, the clinical and device development industry clearly understands the value of establishing expert scientific committees to provide oversight on study data. What is less well understood, however, is the importance of independent expertise.