Gene therapy development is gaining momentum. In 2020 alone, gene therapy attracted $12 billion in global financing through just the first three quarters with more than 370 gene therapy clinical trials underway worldwide.1 The U.S. Food and Drug Administration (FDA) itself predicted it may be approving 10 to 20 gene therapies per year by the...
Dermatology clinical research is evolving rapidly in response to a regulatory landscape that favors clinical trials that are safer, more justifiable, and less burdensome to study participants. Putting the patient at the center of every phase of the research process — from discovery and preclinical testing to clinical trials and post-marketing studies — can help...
Planning a product development program? Learn how to set the stage for success with our on-demand webinar series. The steps you take in the earliest stages can profoundly influence your product’s path through development and marketing approval. When is the right time to engage regulators? Which paths to expedited development make sense for your product?...
The clinical trial industry has been steadily undergoing a data evolution. Data from remote capture devices, such as wearables and other novel sources (e.g., increasingly large health data repositories and electronic healthcare data), have gained importance. Proper management and utilization of such data allows sponsors to untether from a set roster of trial sites, focus...
When developing a long-term follow-up strategy for gene therapy trials, safety is the main concern, closely followed by the patient perspective. Digital technologies and monitoring have proven essential to this, easing the burden on the patient, and providing accurate, time-saving methods of data management. Momentum is increasing in the field of gene therapy, with over...
In the normal course of a clinical trial, delays are often accepted as part of the process. For instance, data entered by the site may not auto-encode correctly and therefore require further review by a medical coder, generally within five days. But in the fight against COVID-19, time is especially critical. A large pharmaceutical company...
The placebo effect can be problematic in analgesia clinical trials with a symptom-based approach, as placebo-related analgesic responses may occur and persist for some time in up to 60 percent of study participants.1 In chronic pain studies, it is generally assumed that the placebo effect accounts for approximately 30 percent of the analgesic response.2 The...
TORONTO (PRWEB) FEBRUARY 08, 2021 Phase 1 clinical trials aim to determine the maximum tolerated dose (MTD) of a new molecule with the goal of identifying a recommended Phase 2 dose (RP2D), often the MTD itself. Ideally, the RP2D would have adequate therapeutic effect to demonstrate preliminary signs of efficacy in Phase 2, but many...
The use of placebo control in clinical trials has long been a topic of spirited debate. Proponents maintain that placebo control is necessary for proving the safety and efficacy of investigational products. Critics argue that use of placebo sacrifices patient welfare and is unethical if a proven therapy is available. In analgesia studies, the question...
Dermatology clinical research is undergoing a rapid transformation in response to new demands for clinical trials that are more justifiable, safer, and less burdensome for patients. In dermatology, a patient-focused approach can be applied to all phases of the research process, from the earliest stages of discovery and pre-clinical testing to clinical trials, regulatory approval,...