Recently there has been an increase and awareness of the long-standing problems with diversity and the inclusion of under-represented populations in clinical research.
2021 survey highlights challenges and opportunities for investigators, coordinators, and patients.
Following a discussion around summarization in Part 1, Part 2 discusses the method of pure abstraction in light of recent advances in deep learning and AI.
Differentiating FSO and FSP approaches can better align definitions of models for CROs and sponsors.
Best practices for assessing publications.
With an AI-enabled virtual assistant as part of your clinical research toolkit, deriving insights from clinical data is as simple as asking a question.
Considerations to help tailor new tools as part of a custom clinical trial strategy.
Poll taken by leading biotech executives in clinical development addresses state of data quality and management.
Esther Howard, Oncology Advisor at THREAD, will be shedding light on how DCT design brings clinical research as a care option to cancer patients. In 2021, over 608,000 Americans alone passed away from cancer- equating to 1,600 deaths a day. Because clinical trials become the only treatment option for cancer patients after they have exhausted all standard of care options, we desperately need solutions to bring real access to clinical trials as a care option to more cancer patients. Esther will focus on some of the challenges that patients face, and how elements of a DCT design can not only save the lives of more patients but can also be a key driver in improving diversity in enrollment.
Beyond technology, awareness, and access—cultural competence is key.
Study designs, coupled with difficulties finding, enrolling and retaining trial participants, further intensify operational challenges and prevent new treatments from getting to market.
In an earlier article, we reviewed the randomization risks that could arise if an interactive response technology (IRT) system isn’t designed and/or implemented correctly. Here we address the consequences that trial sponsors could face if their IRT system isn’t adequately designed to handle the many and often complex drug allocation and trial supply aspects of their clinical trials.
Accelerating trends in clinical data are forcing changes in strategy.
Sites not expected to fade away even as DCTs continue to grow past COVID-19.
Overall rate of significant KRI results for sites located in Ukraine has consistently risen since 2021.
With poor retention of women in the biomedical workforce amid the pandemic, industry leaders in clinical research must step up to provide solutions.
Following the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.
Aggressive focus by DOJ has put increased burden on stakeholders to understand their obligations and exposure.
COVID has accelerated to the scene upstart digital efforts to transform patient engagement and data management/integration—but progress remains measured.
While Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.
Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation.
Operational and patient burden considerations for self-collection of blood specimens in clinical trials
Successful oncolytic virus immunotherapy clinical development requires unique features that focus on viral biology and host immune response.
Pilot study seeks to validate new and more granular outsourcing model classifications in differentiating performance across custom contract-service approaches.
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.
Successful collaborations between Pharma/Biotech/Device industries and CROs will play a key role in an effective fight against the global COVID-19 pandemic.