Newsletter | October 27, 2021

10.27.21 -- How RWE Is Transforming Clinical Trials

Featured Editorial
Industry Insights
Exploring Clinical Trial Design And Data Collection In A New Environment

New research reveals that COVID-19 has accelerated adoption of decentralized approaches and remote data collection for clinical trials and that this transition has come with both challenges and benefits.

Teamwork: An Evidence-Based Approach For Trial Recruitment

Teamwork is a recurring theme in qualitative studies analyzing the barriers to trial recruitment. Following are some ways to recognizing the root cause of a stalling trial and possible solutions.

Capitalizing On Sensors In Clinical Trials

A decade ago, few people owned wearable technology. Today, fitness trackers and smartwatches are everywhere. As public comfort with wearables has grown, sensors have become more common in clinical trials as well. Some estimates predict that in under five years, up to 70 percent of all protocols will include sensors.

Use Of Rolling Enrollment Designs To Accelerate Clinical Trials

Cohort-based enrollment can slow down dose-finding trials, since the outcomes of the previous cohort must be fully evaluated before the next cohort can be enrolled. This type of cohort-based design can also be inefficient, especially if the trial needs to be frequently suspended. Read how shortening the study duration of Phase 1 trials and reducing the number of accrual suspensions with the use of rolling enrollment designs is recommended, allowing concurrent patient enrollment that is faster than cohort-based enrollment.

Top Six Countries For Rescuing Your Clinical Study

When your study is in trouble, choosing the right country can help get it back on track. While many countries can and should be considered, OCT Clinical discusses the countries they have experience with in regard to clinical trial rescue.

Ethical Issues In The Design And Review Of Decentralized Research

Decentralized clinical trials are gaining popularity and momentum, promoting a more flexible participant experience. However, decentralized trial modalities also present unique challenges. Download the available white paper to find out more.

Placing The Patient First In Clinical Trials

This article discusses ways to adopt patient-centered drug development, changing the corporate culture and trial design, understanding patient needs and incorporating them into trials, and leveraging technology to conduct remote patient-centric clinical trials.

Navigating The Latest ICH E8(R1) Guideline Revisions: Best Practices For Application With Increased Trial Variabilities
This white paper highlights the key principles set forth in E8(R1), which was endorsed in May 2019, and E6(R3), which is scheduled for publication in late 2022, illustrating how sponsors and contract research organizations (CROs) can achieve compliance. Cmed has been operating with the highest clinical research standards for over 20 years.
2020 Completed Trials: A Bumpy Road For Industry-Sponsored Clinical Studies

The COVID-19 pandemic created delays for trials that were planned for completion in 2020 and directly contributed toward trial terminations. Despite this, more diseases, and more indications outside of oncology, achieved at least 25 successful trials. Read the full report.

BYOD: When, Why, And How
This article gathers substantial information on the idea of bring-your-own-device (BYOD), describing the several technical options and showing the numerous advantages of the approach for both patients and clinical trials sponsors.
Actigraphy For Sleep Measurement

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-reported 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.

Delivering Clinical Trial Medications Direct To Patient

In a perfect world, patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately, that is not always the case. In recent years, the direct-to- patient model, which brings medical procedures to a patient’s home, has emerged as a solution for sponsors to increase patient recruitment and retention in clinical trials.

Early-Stage Alzheimer’s

Supporting one of the world's largest pharmaceutical research organizations, MRN has more than doubled patient recruitment rates and quadrupled home visit referrals during the global outbreak of COVID-19.

Strategically Controlling Clinical Trial Costs: 5 Big Takeaways

Ensuring that your trial is delivered with the highest quality, on time, and on budget is essential considering the escalating costs to conduct clinical trials and to avoid unnecessary and often required change orders. This infographic reviews five key takeaways for controlling clinical trial costs while building a focus on quality from the beginning.

Crossing The Trial Master File (TMF) Compliance Gap With Inspection-Ready Access For Closed Studies
Your drug study is closed, and you need inspection-ready access to the trial master file (TMF), but your CRO is ready to get the TMF out of their system and wants to send you a zip folder full of documents. What do you do? In this session, we explore an innovative new way to ensure your TMF stays secure while remaining accessible to audits and inspectors so you can focus on getting your drug to market and not on finding documents.

Building a bridge between academia and industry to advance the use of digital measures

Please join us virtually on November 4, 2021, for the ActiGraph Digital Data Symposium! During this free knowledge-sharing forum, pioneers and innovators in the digital health space will come together to discuss their diverse experiences and perspectives around the collection and use of sensor-enabled digital measures across academic and drug development research. This unique cross-disciplinary event aims to build a bridge between academia and industry to help advance the use of wearable technologies and digital measures in the development of life-changing drugs and therapies.

Topics Include:

  • Past, present, and future of activity monitoring with wearable devices
  • How academia and industry can work together to advance digital measures
  • Biopharma attitudes on the use of wearables in clinical research
  • Enabling new digital endpoints with connected device data

Check back for more details, including the symposium agenda — coming soon!

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