July 24th 2020
While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.
A first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.
Over the past few years, there has been significant growth in the use of more complex point of care laboratory devices.
July 22nd 2020
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.
July 17th 2020
Understanding how your strategy will be re-shaped post-COVID.
A compilation of recent notable news developments that pertain to the clinical trials industry.
Initial Design Considerations for Immuno-Oncology Trials
Perspectives and insights regarding regulatory considerations when planning and conducting immunotherapy studies.
Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs
The increasing need for treatments to slow the global spread of COVID-19 has prompted greater cooperation between drug regulatory authorities around the world.
Following the FDA: Sites Want Flexibility From Sponsors
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.
How Clinical Trial Research Sites Can Gain Access to a More Level Playing Field
To overcome sponsor-related challenges and work to successfully secure more trials, there are tactical steps CROs can take.
A Market Failure for Antimicrobial Resistant Medicines
While the world focuses on COVID-19, this article provides insight on the current state of the market for antimicrobial resistant (AMR) medicines.
Use of Televisits in Studies and Related PV Concerns
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.
What Patients Expect from Clinical Trials in the COVID-19 Era
Key takeaways from a survey of 250 oncology patients measuring COVID-19’s impact on patient willingness to participate in clinical trials.
COVID-Sparked Practices Driving New Patient-Centric Behaviors
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.
Trials During the Pandemic: A CRO's Perspective
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.
Initial Design Considerations of Trials of Immuno-Oncology: Domains and Elements
IMPs for immunotherapeutics require a different mindset, effective strategies, and meticulous planning, among other things, says KCR Trial Execution and Consulting.
Emerging Practices Employing CDISC Standards in Clinical Trials
Now that the industry has gotten some experience with CDISC standards, teams are aiming to get more from their standardization efforts.
COVID Challenges for Trials in Low-to-Middle-Income Countries
Outlining the five critical hurdles faced by clinical teams conducting studies in these nations amid quarantine and other restrictions.
FDA Patient-Focused Drug Development Guidance Update: Incorporating Patient Experience Data in Clinical Trials
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.
Integration of Biomarker Validation in Clinical Development in Oncology
The development and qualification of biomarkers are keys to the future of drug development and precision medicine, particularly in oncology.
Five COVID-19 Related Challenges for Trials in Low-to-Middle Income Countries
Challenges faced by researchers conducting clinical trials in low- and middle-income countries are examined.
Listen, Learn, Respond: Pandemic Presents a Critical Time for Sponsors and CROs
Results from a Clinical SCORE study shows investigators and other site staff are begging sponsors and CROs to match their tenacity to soldier on.
How European Countries are Approaching Pandemic-Era Clinical Trials and Monitoring
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.
The Only Thing Certain is the Uncertainty: How to Re-Plan Future Clinical Trial Enrollment in Covid-19 Times
Sponsors need to develop a strategy on how to evaluate the impact of the pandemic on the re-start of halted trials.
Understanding the Complexities of Diversifying Clinical 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.
The Regulatory Requirements and Key Points of Drug Clinical Trials Registration in China
Following the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.
Bridging the Gaps in CAPA Planning in Clinical Trials
Leveraging approaches in RBQM to enable effective corrective and preventive action processes.
Central RBM Supports Reduced Cost, Higher Data Quality
Implementing centralized risk-based monitoring can help meet strict GCP requirements for study conduct, oversight, and recording.
DMCs: Maintaining Data Integrity in COVID-19 Climate
Regulators are urging the use of data monitoring committees to support clinical trial management and decision-making during pandemic.
Virtual Trials Save the Day
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.
Agile Drug Development’s New Reality
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.
Navigating Clinical Trial Recruitment in the Midst of COVID-19
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.
COVID-19 Vaccines: Tool to Predict and Manage Global Portfolio Productivity and Risk
Policymakers should break with drug and biotech norms and apply risk-based portfolio simulations to understand the global portfolio of COVID-19 vaccines.
A New Approach to Risk Balanced Contracting
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?
COVID-19 Will Have a Heterogeneous Impact on Clinical Trials, Biopharmas
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.
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