Trial Design

Despite agreement on recommendations between European regulators, DCT unclarity remains.

Webinar Date/Time: Tuesday, January 24th, 2023 at 11am EST|8am PST|4pm GMT|5pm CET

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 the decisions needed to fully utilize their potential.

Webinar Date/Time: Wed, Nov 30, 2022 10:00 AM EST

Anticipating the need for both virtual and traditional sites during the planning process can provide high ROI for sponsors.

Webinar Date/Time: Wednesday, December 7th, 2022 at 11am EST | 8am PST | 4pm GMT | 5pm CET

What is next for DCTs after acceleration from COVID-19?

Sites not expected to fade away even as DCTs continue to grow past COVID-19.

Identifying and providing clarity on the GCP quality and risk concerns associated with DCT modalities.

Tufts CSDD study in collaboration with ten biopharmaceutical organizations and CROs examines sponsor/CRO relationships.

Ken Getz, executive director and research professor at the Tufts Center for the Study of Drug Development, discusses the value of breakthrough findings with ROI and eNPV models.

Richard Young previously explained on ACT why sponsors need a strong data foundation for successful digital clinical trials. Now he focuses on how to address some of the associated data management challenges.

DCTs can be a great tool for small-to-midsize pharma and biotech companies despite misconceptions of them being advantageous for only Big Pharma.

Patients reap benefits of strong collaboration in executing DCTs.

How DCTs can impact pharmaceutical companies exploring DTx combination products and standalone DTx studies.

As market factors drive the rapid growth of decentralized clinical trials, organizations should embrace risk-based quality management to evaluate the new dimensions of risk and ensure effective oversight of disparate data sources, writes John Hall.

Industry provides endless methods in crafting solutions for patients.

DCTs proving to solve numerous pain points for patients in clinical research.

COVID-19 forces sponsors to take new approach for assessing trial support models.

Portable imaging technology presents yet another opportunity for decentralized trials.

Without a strategy for managing clinical data centrally, sponsors lack the visibility needed to optimize trial outcomes.

New era of technology brings unique obstacles.

The need for specific capabilities to suit DCT business models is creating new challenges in team building, training, and development.

A look at the positive impact shifting to a patient-centric, data-led approach can have on clinical development through the lens of medical monitoring.

Dave Hanaman, Co-founder of Curavit, discusses his perspectives on decentralized clinical trials.

Five therapeutic areas that are apt for an all-virtual approach, and that can serve as an entry point for sponsors who are hesitant yet interested in exploring the growing DCT model.

This article sets out a vision of adopting convenient alternative blood sampling approaches that places the needs of the patient at the center and enables active monitoring, before the onset of clinical events, leading to improved healthcare.

Guidance on the unique challenges presented by electronic outcomes.

Using the promising-zone approach can salvage an underpowered trial.