From a resource perspective, there are limitations in terms of having the research staff and the funding to open a trial at a specific hospital. There are also challenges around having the consents in different languages so that [patients] from all backgrounds can join the trial. From the prov...
How the Trial Complexity Score is constructed, and how it correlates with trial duration. (a) Overview of the process by which clinical trial data was accessed and analyzed, and how the Trial Complexity Scores are calculated. (b) Correlation between Trial Complexity Score and phase 1 trial time...
Although, R has been used in exploratory analysis in Pharma/Biotech industry for a long time, it has not been used for creating and analyzing clinical trial datasets (SDTM/ADaM). Traditionally, SAS(R) has been used to generate clinical trial datasets. In this paper we will explore the ...
Clinical Data Management Leaders Reveal Underlying Challenges Impacting Trial Timelines
Clinical Trial Regulations in India: Progress and Challenges Arising from Recent Amendments to Schedule Y of the Drugs and Cosmetics (D&C) Act 1940 (D&C... The Central Drugs Standard Control Organization, which is the drug regulatory authority in India, has recently amended the regulatory framework...
The Digital Medicine Society (DiMe) CEO Jennifer Goldsack and Takeda’s Head of Digital Health Sciences, Data Sciences Institute Shoibal Datta describe the current landscape of digitized clinical trials and discuss the business imperatives and strategic decisions needed to realize the full promise of ...
Clinical Trial Compression FDA Data Standard Compliance Clinical Data Standardization & Analytics Platform 8 Months 100 % Current Practice :Manual data standardization at end of Phase III study to partialCDISC standards. Limitations & Challenges:
However, implementing wearables and sensors brings new challenges to clinical trial conduct, data management and interpretation. BYOD promises greater patient-centricity by enabling patients to conduct assessments using the convenience and familiarity of their own hardware devices. Harnessing blockchain ...
Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group Author links open overlay panelEU-Response investigators group, Alpha Diallo 1 2, Marius Trøseid 3, Victoria ...
How to solve clinical trial challenges We have to be realistic about any change, especially when it occurs in such a heavily regulated domain as clinical research. Yes, we can achieve uniformity by scrapping the whole passel of tools and replacing them with a single, integrated system, but we...