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A global survey of clinical trials sites, conducted by insights company Clinical SCORE, revealed how deep the effect of the COVID-19 pandemic is and how sponsors can help sites stay the course.

Diversity in clinical trials is an important part of developing new medications that are safe and effective for all potential patients, understanding the demographic disparities within them will provide several benefits to the field.

Industry experts weigh in on how much traditional approaches in clinical operations need to change to meet new expectations for clinical delivery.

Lockstep with regulatory guidance on conducting trials amid crisis, here are four key actions sponsors can take to minimize disruptions.

Findings from a survey of 363 clinical trial sites showing the profound effect of the coronavirus pandemic.

The latest FDA and EMA guidelines permit sites, sponsors, and CROs to adjust their operations to meet changing conditions for ongoing trials, including some concerning the safety of participants, that must be met in order for new solutions to be considered.

Biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.

Outlining the three concerns communicated the most when it comes to implementing an FSP outsourcing strategy.

Clinical research sites feel growing pressure to perform work in a compliant manner while keeping pace with stakeholder information exchange workstreams, but lack the consistent processes to do so.

ICH E6-R2 has taken another leap forward as quality-focused personnel have shifted focus to vendor oversight plans, essential document management, and evaluating quality tolerance limits in more depth.

The Clinical Study Data Request consortium is actively pursuing platform interoperability to allow data to be merged and analyzed as an important step for advancing human healthcare.

The need for biopharma companies to equip data managers with the training and resources necessary to capitalize on new digital health tools.

Breaking down the evolving role of today’s clinical data manager-and its importance as a key cog in the clinical research ecosystem of tomorrow.

With radio, billboard, TV, and digital advertisements being left in the dust, additional engagement from influencer communities are more likely to be reach patients.

A case study of the risk-based quality management learning curve.

The elderly population is still underrepresented in clinical trials, with nearly a third of newly registered drugs included an insufficient number of elderly participants, leading to uncertainties regarding safety and effectiveness for prescribers.

With the final approval and release of ICH E9 (R1), clinical trial sponsors should prepare to include estimands in their protocols as well as their statistical design documents and study reports.

How modeling and simulation technology can predict and better manage immunogenicity, a key challenge for biologics drug development.

The perfect storm of industry growth, opportunity, and demand is translating to solid salary and satisfaction levels among clinical trial professionals, according to new survey.

New recommendations offer guidance on overcoming legal, regulatory, and practical hurdles.

During clinical trials of pharmaceutical treatments, sponsors and CROs need to detect possible suicidal ideation and behavior related to their drug during baseline assessments, and throughout treatment as well as during the follow up phases.

For years, Duchenne muscular dystrophy drug trials included a specific endpoint requiring that they enroll only patients who were still able to walk. That changed when a DMD-focused advocacy organization took the matter up with the FDA and helped develop new trial guidelines.

Yoong Kai Shen and Joanne Yeoh, both of Clinical Research Malaysia, analyze the pre- and post- workshop assessment score for GCP workshops conducted since 16 March 2017.

Pharmaceutical companies should consider implementing a structured, semi-automated process for intake of compassionate use requests. says ViiV Healthcare executives.

Insights from a roundtable at Halloran’s Clinical Operations Retreat for Executives covering major topics in both clinical design and execution.

Exploring the three most common concerns with the FSP model: resource forecasting, quality and training of staff, and innovation.

Explore the growing interest in better understanding the potential for cardiovascular complications associated with cancer therapies.

Given the wide use of digital technologies in society today, apprehension about implementing eCOA and creating an eCOA back-up plan is unwarranted.

Darren Davis, Senior Vice President at Precision for Medicine, explores the need for specialty labs in cancer treatment plans.

AJA Ooi and KF Khalid, of Clinical Research Malaysia, describe the opportunities for growth of early phase studies in Malaysia and the initiatives taken to attract these trials into the country.