Clinical Value of Biomarkers

Using biomarkers in a clinical setting

Implementing biomarkers on all levels of drug development has been proven to facilitate better and faster drug development, and improve the outcomes of clinical trials. Biomarkers are important for all stakeholders involved in drug development; patients, payers, regulators, and drug developers all alike, as the right biomarkers can lead to cost-effective trial design.

This is achieved by reducing trial duration before reaching significant endpoints, by preventing unnecessary treatment, or by reducing testing and evaluation of patients. Improving these factors could also lead to improved patient-reported outcomes through an overall improvement in quality of life.

The clinical utility of a biomarker is first and foremost confounded in its ability to accurately diagnose the presence of disease and provide information on the course of disease and subsequent risk of outcome. Once such relationships are established, the biomarker can be used for several different clinical applications, such as pharmacodynamic studies, trial enrichment and monitoring of disease development and treatment response. In direct association with these uses there is also the potential of assisting treatment decisions.

Table 1. Clinical utility value of biomarker implementation.

Clinical utility of biomarkers

Applied and interpreted correctly, biomarkers may help inform and guide decisions across the spectrum of drug development (table 1). Biomarkers can be used for answering multiple relevant questions regarding the biological effects of therapeutic intervention, which can lead to better decisions and chances of success, such as which individual pathways are affected or how patients should be treated.

One of their most important ability to improve diagnosis of patients (with improved insight in disease activity, or as an aid in the diagnosis to save on cost- and time-consuming diagnostic procedures), to reflect pharmacodynamic effects and efficacy, to select patients in most risk of disease progression to allow an optimal clinical trial design to allow an efficacious treatment to be identified.

Reducing trial costs and helping decision makers

Biomarkers help cut costs during clinical trial development through patient trial enrichment and by providing a way of evaluating positive effects of therapeutic intervention, prior to standard outcomes or imaging technologies. Applied in a medical context, biomarkers can aid in triaging, by supporting and informing on decisions regarding which patients should receive treatment first or who should receive specific treatment according to their disease activity and endotype. Thus, the utility of biomarkers listed in table 1 is not extensive, and they could significantly improve clinical practice as well.

In this context, biomarkers can provide even more additional value, in relation to how much time each patient is admitted to hospital. These decisions come with great economical and health consequences, as hospital stays are costly and could expose patients to additional harm. Using biomarkers to help increase the accuracy in medical decisions related to hospital admission therefore poses a great benefit, which further adds to the importance of regulatory approval of biomarkers.

More effective stakeholder communication

Having thoroughly validated biomarkers is not just beneficial for drug development; it also provides a basis for better understanding and communication to patients. They can help in disease understanding and communication, by objectively portraying changes in disease status and activity, whether a given treatment has a beneficial effect and how fast the patient can expect to see such effects, whether a patient should be given different or additional treatments, and, ultimately, how the biomarker levels translate to clinical risk profile.

Some biochemical biomarkers are the results of disease activity, and treatment affecting disease activity will change these biomarkers prior to disease status. This is an important communication opportunity, as patients often need to be motivated to continue treatment to obtain the full clinical benefit and be ensured that they have a clinical benefit well in advance of a statistical possibility of a devastating outcome.

This approach has been successful in the bone/osteoporosis field, as bone resorption or formation change years before fractures appear, and treatments affecting these activities haven been demonstrated to be efficacious. While implementing and validating biomarkers can be challenging, their importance in expediting drug development cannot be overstated, benefitting the 3 key stakeholders: patients, payers, and drug developers.

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