Online Extras

Over the past few years, there has been significant growth in the use of more complex point of care laboratory devices.

An amendment to Pediatric Research Equity Act, as part of the 2017 FDA Reauthorization Act, goes into effect soon aiming to change the landscape and promote pediatric cancer drug development.

Understanding how your strategy will be re-shaped post-COVID.

In the third of their survey series, Clinical SCORE uncover the specific hurdles faced by site staff and trial participants during the COVID-19 pandemic and the support needed to overcome them.

To overcome sponsor-related challenges and work to successfully secure more trials, there are tactical steps CROs can take.

While the world focuses on COVID-19, this article provides insight on the current state of the market for antimicrobial resistant (AMR) medicines.

While televisits can address many medical concerns, one frequent reservation expressed by healthcare professionals is that patients during these televisits tend to present too narrow a picture of their clinical condition-resulting in non-comprehensive medical assessments.

Key takeaways from a survey of 250 oncology patients measuring COVID-19’s impact on patient willingness to participate in clinical trials.

Clinical trial stakeholders weigh in on the major shifts unfolding in the era of COVID-19, as efforts move away from the traditional site-based model.

Findings from an OCT Clinical survey of researchers from 61 sites in Russia to gain the perspective of an investigator regarding clinical trials during the COVID-19 pandemic.

IMPs for immunotherapeutics require a different mindset, effective strategies, and meticulous planning, among other things, says KCR Trial Execution and Consulting.

Now that the industry has gotten some experience with CDISC standards, teams are aiming to get more from their standardization efforts.

Outlining the five critical hurdles faced by clinical teams conducting studies in these nations amid quarantine and other restrictions.

The four new methodological Patient-Focused Drug Development guidance documents the FDA is currently developing for the industry that incorporate patient experience data into drug development, summarized.

The development and qualification of biomarkers are keys to the future of drug development and precision medicine, particularly in oncology.

Challenges faced by researchers conducting clinical trials in low- and middle-income countries are examined.

Results from a Clinical SCORE study shows investigators and other site staff are begging sponsors and CROs to match their tenacity to soldier on.

COVID-19 response is leading to new measures being introduced in many countries, including Russia, Europe and CIS countries, especially when it comes to the interaction of research centers with CRAs.

Sponsors need to develop a strategy on how to evaluate the impact of the pandemic on the re-start of halted trials.

Tufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research provide insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.

Following the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.

Leveraging approaches in RBQM to enable effective corrective and preventive action processes.

Implementing centralized risk-based monitoring can help meet strict GCP requirements for study conduct, oversight, and recording.

Regulators are urging the use of data monitoring committees to support clinical trial management and decision-making during pandemic.

Virtual trials tools are usually selected early in the protocol development stage, however, due to the COVID-19 crisis, regulators are encouraging sponsors to consider integrating virtual elements into clinical trials already in progress.

In order to accelerate clinical R&D and bring drugs to the market quicker, it is imperative that science is complemented by new-age technology such as artificial intelligence and data-driven smart analytics.

Many companies during this time of social distancing have paused trial recruitment completely to focus on currently recruited patients, while others rethink their strategy to better accommodate the new digital-only reality.

Policymakers should break with drug and biotech norms and apply risk-based portfolio simulations to understand the global portfolio of COVID-19 vaccines.

In a complex world of global clinical trials where execution is riddled with uncertainty, how should sponsors and providers approach and achieve a balance of risk and reward?

A discussion of how the coronavirus pandemic will have a multitude of impacts on the conduct of trials, as well as on the industry itself.