Looking Ahead: Reducing Risk in Biologics Trials

Despite their complexity, biologics are going mainstream. According to a report by Evaluate Pharma, biologics represent 40% of development pipelines for companies they surveyed. You might even say biologics programs involve lower risks than small-molecule programs – a higher percentage of biologics progress from preclinical to approval. But going mainstream hasn’t made biologics more predictable. Little is known about the immunogenicity of each biologic before trials in humans. That means risks during individual trials of biologics remain high.image 9-17 1

That’s why Health Decisions developed solutions to optimize biologics trials while reducing risk. On Tuesday, September 24, we will share some of these solutions in a new white paper, Reducing Risk in Biologics Trials: Targeted Trials for Targeted Therapeutics.  You’ll find the white paper on the Health Decisions website starting September 24. We will also provide a link here in Trials Without Tribulations.

Safety is a central topic in the white paper.  The possibility of acute adverse events from rapidly developing infusion reactions is ever present in clinical testing of biologics. This is true despite attempts to predict immunogenicity and premedication of test subjects with antifebriles, antihistamines and corticosteroids. For example, premedication with acetaminophen and cetirizine failed to reduce the incidence of acute AEs in infliximab infusions in pediatric patients. (Arthritis Care Res. 2010 Jun; 62(6): 785-90)

Timely tracking of patient response during infusions in biologics trials is essential. We provide near real-time tracking of patient vital signs with the SmartPen™.  (See image.) If the site monitor and sponsor representative can’t be at the infusion station, this is the next best thing.

Site personnel enter information with the SmartPen by writing as though with an ordinary pen. Docking the SmartPen uploads both the data and an image of the CRF, making information immediately available to the study team, sponsor and medical monitor if desired. The site retains a written copy of the CRF for its files. A snip from a SmartPen CRF for infusion reactions appears below.

image 9-17In addition to safety issues, the white paper covers recruitment, monitoring and other issues. It also provides concise case studies of successful trials. We recommend taking a look before your next trial of a therapeutic protein or monoclonal antibody. Safety isn’t usually as big an issue in vaccine trials, but the white paper provides information on rapid reactogenicity reports based on SmartPen input.

Earlier access to actionable information gives you the power to decide the course of your trial. Nowhere is this principle more important than in development of biologics.

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