Clinical evidence generation: clinical trials
Health researchers continually discover new evidence that deepens our understanding of disease processes and progression. This rapidly evolving knowledge must be integrated into ongoing research and development of new therapies in order to deliver the greatest patient benefit in the safest, most cost-effective way. Pharmaceutical and health technology manufacturers are under the obligation to generate strong evidence supporting their products’ safety, efficacy, and impact on disease burden. Without evidence generation, regulators will not grant market approval for new products.
Before a product can be approved for clinical use, a series of clinical trials must be performed, each with specific goals that together serve the overall aim of demonstrating the need for that product on the market. Before such trials can begin, researchers must have a thorough understanding of the disease and of the product’s mechanism of action. Then clinical trials begin, with each subsequent trial involving more volunteers and longer follow-up than the previous one. A product can proceed through the trials only if all safety and efficacy outcomes are met. The process of drug development and the characteristics of each phase are represented in the diagram below.
Health economics and outcomes research evidence
Clinical safety and efficacy are not the only prerequisites for a new therapy to gain market access. Pharmaceutical and health technology companies must also show evidence that their product provides therapeutic benefit at an acceptable cost-efficacy ratio, especially in comparison with therapies already approved for the same disease. Through rigorous systematic reviews and meta-analysis, researchers in health outcomes and economics can help drug and device manufacturers position their products in the treatment landscape through comprehensive synthesis of all relevant evidence. In parallel, they can create models to compare the new product against existing therapies in terms of associated costs throughout the disease cycle, with careful adherence to acceptable cost thresholds stipulated by the relevant regulatory agencies.
Only if a product can satisfy the dual burden of clinical and economic proof will it be granted market access and be able to improve patients’ quality of life.
Post-marketing evidence generation
Evidence generation does not cease once a product has gained market access. “Real-world evidence” — observational data obtained outside of clinical trials — is collected in order to continue monitoring safety and adverse events as the drug becomes established on the market. Patient data are also collected from electronic health records, insurance claims, patient-reported data, and medical electronic devices such as Apple’s Health App. The picture of safety, efficacy and economics that emerges from these myriad data sources helps support decisions about insurer coverage of the product and clinical guidelines for its use.
Evidence generation and Symmetron
You are under constant pressure to develop new therapies to respond to the ever-changing demands on the healthcare system. As you develop new treatments, evidence is used and shared by you and all other healthcare sectors to ensure that patients receive the best possible care. The multi-step process leading to market approval ensures rigorous, comprehensive evaluation of therapy safety and efficacy as well as appropriate distribution to patients.
At Symmetron, we partner with you to guide your products through the entire market access process. Our team of clinical and economic specialists has unparalleled depth of experience in meeting the tough evidentiary standards of health regulatory agencies around the world. To bring your latest product to market, contact us here.