News

This article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).

Real-world evidence (RWE) is needed in addition to clinical trial data to understand drug effectiveness in a real-life setting and to profile patient populations in terms of their clinical characteristics and drug utilization.

In the following Q&A, Guillaume Marquis-Gravel, MD, and Kevin Monroe discuss the advancements and related challenges of incorporating new technological tools in drug development, including eClinical approaches currently undertaken in the foundation’s own studies.

To further streamline product development and facilitate post market safety surveillance, the agency has developed a new Framework for Real-World Evidence that spells out opportunities and concerns in advancing these approaches.

This eBook will focus on advancing research, drug development, and trial management in rare diseases. Articles cover considerations from virtual trials and eCOA to the case for highly-skilled CRAs.

As the use of PRO expands in clinical trials, ePRO vendors themselveshave expanded beyond this constrained definition. Increasingly, the use of eCOA is being used to encompass all data collected related to the patient, which includes PRO, clinician reported (ClinRO) and observer or caregiver reported outcomes (ObsRO). Further, with mobile health technology use growing in general healthcare, that use is changing outcomes data collection in clinical trials. This e-Book tackles the changing world of PRO collection in clinical trials.

Applied Clinical Trials presents the latest issues that have risen to prominence since RBM adoption grows. This edition presents a well-rounded look at RBM including articles that describe current RBM trends; a survey of European CRAs, which shows the difficulties among sites and monitors with RBM; a comprehensive look at how sponsors and CROs can support their employees in the RBM transition, and closes with a case study on Novartis' use of adaptive monitoring.

Oncology remains the therapeutic area with the most drug failures, the lowest numbers of patients enrolled and the highest with the number of drugs in clinical trials. Many trends in oncology clinical trials seek to address these challenges and include the use of biomarkers, immunotherapies, and adaptive designs.

It is important to devote quality time to challenge yourself and your teams on whether there is a need to strategize and rethink the way you are conducting teleconferences for your clinical trials.

Translational medicine; bench-to-bedside; agile development. All these terms use updated processes, new technologies and data to inform decisions earlier in clinical development. Supported by expedited regulatory pathways, which require extensive safety monitoring to accompany these earlier approvals, has made the gaps between preclinical and clinical a looming reality.

Have the roles of the monitor advanced? How are CRAs accepting the change? How is pharma implementing RBM-is it more remote, centralized or a combination? How important is eSource to RBM? This eBook will highlight articles that answer these question.

This eBook will focus on the specific needs and concerns of the smaller to mid-size biopharmaceutical company. Articles cover considerations from Phase II to commercial pathways.

What used to be segregated approaches in clinical trials-ePRO, telemedicine, mobile health, devices and wearables-now gather under the umbrella of technologies that touch the patient. And those technologies can have positive implications for costs efficiencies in clinical trials, streamlined data collection, as well as on patient compliance and retention.

Cancer's R&D Convergence will highlight the changing landscape for clinical trials in this therapeutic area based on the promise of the Cancer MoonShot initiative, along with new oncology immunotherapies.

This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT-a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments-offers expert view on this regulatory change.

Clinical trials have increased in number and complexity for numerous reasons-global trials, outsourcing, protocol requirements, and multiple regulatory issues. Factor this with the increased need to bring efficiencies and lower prices to the clinical trial process, and the need to stay on top of trials only becomes more crucial. This eBook will include articles on logistics of clinical trials supplies, negotiating with investigative sites, use of e-signatures and more.