Featured Articles

81. The Regulatory Grade External Control Arm To Power Your Clinical Trials 12/9/2022

    Examine the growing role of external control arms in clinical trials, including the distinctions between control groups that use real-world data and those that use historical clinical trial data.

82. Connecting Patient-Level Clinical Data To RWD 12/8/2022

    Discover data linkage: a cutting-edge innovation that unlocks a new frontier of enhanced evidence generation by linking clinical trial data and real world data at the patient level.

83. Imunon Phase IB Ovarian Cancer Study Shows Strong Progression-Free Survival Treatment Effect Using A Synthetic Control Arm 12/8/2022

    Explore how Imunon used a control arm among stage III/IV ovarian cancer patients in their clinical trial.

84. A Mid-Sized Sponsor Increased Site Count By 50% In A Rare Disease Clinical Trial 12/8/2022

    In this case study, explore how a mid-sized sponsor chose high-performing sites based on reliable data to set their trial up for success.

85. Clinical Trials Are Better, Faster, Cheaper With Big Data 12/8/2022

    The path from study design to approval is long, winding, and expensive. Explore how researchers are using artificial intelligence and advanced analytics to speed up the process, reduce costs, and get effective treatments swiftly to those who need them while tapping into data on patients from past trials.

86. Medicenna Gains Precedent-Setting FDA Approval 12/8/2022

    Learn how Medicenna was able to leverage Synthetic Control Arm (SCA) to bolster Phase 2 findings and gain FDA approval to design a hybrid external control arm for their Phase 3 registrational trial.

87. Synthetic Control Arm In Clinical Trials 12/8/2022

    Get an overview of the SCA, an external control generated with the goal of improving the interpretation of uncontrolled trials, which can enable better product development decisions.

88. Site Perspectives On Decentralized Clinical Trials 11/15/2022

    Discover why understanding clinical research sites’ experiences and perspectives on DCTs will help industry stakeholders  refine trial design, operational procedures, and regulatory policy to better serve patients and sites.

89. Predictors Of Severe CRS In Longitudinal CAR T-Cell Clinical Trial Data 9/15/2022

    Find out how laboratory tests were analyzed with repeated measurements to identify differences in trends that persist across a variety of study designs, sponsors, and indications.

90. Adopting Decentralized Clinical Trial Approaches Is More Than Implementing Technology: 5 Potential Pitfalls 9/12/2022

    When looking at adopting decentralized clinical trials, much of the focus is on technology design and implementation. While this is critical, there are several other key considerations to be aware of for successful DCT execution and improved site and patient experiences and adoption.