How HSMD supports cancer drug clinical development and post-market research
Identify clinical function of somatic mutations – HSMD enables researchers to easily search and explore mutational characteristics across genes, synthesize key findings from drug labels, clinical trials, and professional guidelines, and receive detailed annotations for each observed variant.
Conduct research use only (RUO) studies – Researchers can leverage HSMD to deepen their understanding of disease mechanisms at the molecular level. RUO studies can explore how specific genetic alterations contribute to disease initiation, progression, and resistance, providing insights into potential therapeutic interventions.
Clinical trial optimization – HSMD contribute significantly to clinical trial optimization by facilitating patient recruitment, informing trial design, and providing valuable insights throughout the trial lifecycle.
Patient stratification – The real-world, de-identified patient data in HSMD enables the identification of eligible patients based on specific criteria for clinical trials. Improved patient identification streamlines recruitment efforts, accelerates trial enrollment, and reduces the time and costs associated with the initiation phase.
Clinical trial feasibility assessment – With clinical trial data that can be segmented by geographic location, HSMD can used to assess the feasibility of conducting a clinical trial at specific sites or within particular patient populations. Understanding patient demographics, disease prevalence, and historical treatment patterns aids in identifying suitable trial locations and estimating recruitment potential.
Regulatory submission and approval – HSMD data can complement traditional clinical trial data in regulatory submissions, providing additional evidence of a treatment’s effectiveness and safety. Regulatory agencies increasingly recognize the value of real-world evidence in supporting decision-making during drug approval processes.
Companion diagnostic design – Users can search HSMD by disease and receive a ranked list of associated genes to help design custom assays that enable better prediction of response and resistance to specific therapies.
Drug repurposing – HSMD enables the analysis of the frequency and distribution of somatic mutations across various cancer types. The database also provides a catalog of drugs employed in the treatment of patients with specific mutations, along with available response data. Using this information, researchers can explore potential new indications for existing cancer drugs.
Want to learn more?
Read an expert article on how biopharma researchers can use genomic knowledge bases to bring better drugs to more patients in less time.
