Research in diagnosis, management, and therapy development, as well as development of standardized guidelines for upcoming studies need to be addressed in order to improve the prognosis of DFI patients.
A TrialScope analysis of 16,000+ clinical trials posted on EU CTR revealed many common errors.
See how to implement digital best practices and good design principles to boost transparency and patient engagement efforts.
In order to increase the number of potentially successful clinical development projects in the microbiome space, it will be important to recognize standard drug development principles and global drug or biologic development requirements.
A CRO with deep therapeutic, regulatory and operational expertise facilitates the risk-assessment process by highlighting items within the protocol design that have the potential to impact overall risk levels. Identifying these risks and potential operational challenges early in the process is essential to the success of RBM later in the study.
Revised study now includes the opportunity to demonstrate the cardiac safety of a new drug by utilizing Exposure-QT response study data in dose escalation and other studies.
Obstacles still remain in developing effective and efficient new targeted therapy agents, identifying the biomarker tests that indicate which patients will be responsive to them, and implementing them in clinical practice.
Understand the concept and benefits of adaptive trials and if they should be a consideration for your company.
Understanding the non-invasive methods for assessing fibrosis range from biomarker assays to advanced imaging techniques such as transient elastography.
Applying ‘lessons learned’, innovative thinking, and creative problem solving to overcome unique challenges associated with conducting these studies.
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