Its integration is opening up more opportunities for sustainable study practices.
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.
A data-fueled framework for sponsors and CROs in navigating this shifting terrain.
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.
Despite industry-wide excitement over the involvement of retail pharmacies in clinical research, there is little information currently available on how retail pharmacies are perceived by investigative sites and patients.
Differentiating FSO and FSP approaches can better align definitions of models for CROs and sponsors.
Life sciences leaders are overcoming challenges to speed the development, launch, and education of novel medicines for rare diseases.
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.
GenAI is on the precipice of making regulatory strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.
Considerations to help tailor new tools as part of a custom clinical trial strategy.
Insights on leveraging outsourcing partners to gain expert, streamlined, and personalized support.
Despite limitations to its widespread use within healthcare, there is great potential for ChatGPT’s application in drug development.
Industry leaders discuss how technology can help companies adapt to the regulatory changes and accomplish their DE&I goals.
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.
Compliance with diverse clinical trial payment and data standards requires specialized skills.
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.
How the inclusion of measures centered on net treatment benefit can drive an effective multifaceted approach.
Accelerating trends in clinical data are forcing changes in strategy.
A data-fueled framework for sponsors and CROs in navigating this shifting terrain.
In a rare disease space that faces challenges in measurement quality, these technologies can enable the use of real-world data and improve study timelines.
Sites not expected to fade away even as DCTs continue to grow past COVID-19.
Recent analysis showed 81% of clinical trial sites using RBQM statistical data monitoring experienced an improvement in quality.