Trial Design

While little research on open-cohort designs currently exists, could this design be a solution to challenges currently seen in closed-cohort designs?

A framework to understand the different approaches of trial matching solutions and the major operational and workflow challenges that all matching solutions share.

The FDA has taken a clear position with Project Optimus in shifting toward more progressive tailored approaches while rejecting antiquated study designs to evolve clinical trial strategies to better align with newer drug classes.

Webinar Date/Time: Tue, Mar 26, 2024 11:00 AM EDT

It is crucial throughout the clinical trials space to understand the challenges and triumphs of DEI.

Webinar Date/Time: Tuesday, March 12th, 2024 at 12pm EDT | 9am PDT | 4pm GMT | 5pm CET

The DCT-driven evolution requires new levels of understanding and expertise.

Despite repeated calls from the FDA, patient advocates, and scholars for the need to address demographic disparities in clinical research, White participants still remain overrepresented while racial minority participants remain underrepresented in clinical trials.

Webinar Date/Time: Wed, Mar 27, 2024 11:00 AM EDT

For effective rollout on a global scale, sponsors must address and develop a plan around known challenges including recruitment, sit adoption, and technology integration.

Webinar Date/Time: Wednesday, February 14th, 2024 at 11am EST | 8am PST | 4pm GMT | 5pm CET

Expanding clinical trial access to include historically underrepresented ethnic and racial minorities means addressing root-cause barriers, including taxation.

DCTs, data, and analytics are all areas that could be impacted in the near future.

Parents of children with cancer and limited health literacy were associated with lower comprehension of informed consent.

Webinar Date/Time: Tuesday, February 6th, 2024 at 11am EST | 8am PST | 4pm GMT | 5pm CET

Women within underserved populations with an endometrial, ovarian, or cervical cancer diagnosis were found to be underrepresented in trials.

V940 (mRNA-4157) to be evaluated in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.

Recent study proposes consensus-based extension to the Consolidated Standards of Reporting Trials 2010 Statement for factorial trials.

How novel clinical trial designs can help minimize patient burden.

While still in its infancy, generative AI will continue to be integrated into clinical operations.

Despite regulatory guidance, disability status is frequently unreported or overlooked in trial design.

Results from decade-long analysis suggest great improvement is needed in the quality of control groups.

The careful selection of sensor technology prioritized in clinical trials, considering regulatory compliance, data security, device characteristics, and the specific needs of the trials for successful and confident implementation.

There is a growing need to refocus efforts on how diversity is achieved in clinical trials, because some are doing it wrong despite their best intentions.