How Medical Imaging Can Accelerate Drug Development
While imaging is a well-recognized tool in patient care, imaging biomarkers also play an important role in the development of novel therapeutic agents. Generally, imaging-driven measures -- or biomarkers -- are used in research trials to support the rationale of therapeutic intervention and to enable objective decisions in the drug development process.
For specific indications, imaging techniques such as MRI, CT, and PET provide specific biomarkers that are useful in a variety of ways:
Supporting patient stratification
Informing trial protocol and trial design
Providing information for modeling of pharmacokinetics and pharmacodynamics
Predicting early drug response
When a drug combination or an advanced therapy is being applied or tested, medical imaging can reliably and noninvasively monitor short-, mid-, and long-term therapeutic outcomes, giving objective evidence of patient response to treatment.
Which imaging biomarker to use in a trial depends on the stage of clinical development, specific guidance from the U.S. Food and Drug Administration (FDA), and which question needs to be answered.
In early phases of drug development, imaging is needed to answer specific questions about whether the new drug candidate reaches the target and, if so, in sufficient quantity, or whether the expected mechanism of action can be observed.
When a research project is at the preclinical stage, there are a number of tools that can be used to address these questions, assess biological processes, and take greater safety risks, including novel tracers for PET/SPECT, invasive techniques, and others.
Imaging plays a critical role when it comes to translating preclinical biomarkers into clinical procedures.
A number of innovative methodologies, including those based on artificial intelligence (AI) and machine learning, have been used in clinical trials. Finding the right imaging biomarker will allow for much faster assessment of therapeutic efficacy of a new treatment and making early go/no go decisions on whether to proceed with additional development.
On average, it takes 15 years to take a drug from the lab to approval, so more information on the efficacy, safety, and mechanism of action should be sought from early-stage clinical trials to minimize late-stage attrition of drug candidates. The use of imaging biomarkers enables researchers to make objective earlier decisions on new drug safety and efficacy, reducing overall R&D timelines and costs through effective early-phase trials.
The use of imaging biomarkers and surrogate end points can facilitate small group sizes, quick results, and good statistical power when assessing new drug efficacy. Imaging can reveal small, subtle changes indicative of incremental progression or regression that might be missed with traditional approaches.
Imaging can also help to detect early disease and define stratified study groups. Imaging can be used to separate -- as early as possible -- responders from nonresponders in patients undergoing therapeutic intervention. Imaging biomarkers are more objective and faster to measure.
When planning a clinical research trial, one must make critical choices o