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Personalized medicine is the art and science of “coupling established clinical–pathological indexes with state-of-the-art molecular profiling to create diagnostic, prognostic and therapeutic strategies precisely tailored to each patient’s requirements.”1
The clinical development and regulatory approval of targeted agents that have therapeutic benefit in molecularly defined patient subsets has highlighted the value of personalized medicine, which can be leveraged in clinical trials so that the identification of eligible patients for certain trials is optimized based on the patient’s molecular testing. These targeted patient groups are often rare and expensive to identify, particularly in the field of oncology, making clinical trials targeting these populations difficult to enroll.
Patient pre-profiling, determining a patient’s tumor-specific molecular profile, could have great value for physicians and patients as they consider potential clinical trial options. To the extent that a molecular profile is broad, encompassing many potential target alterations, one can easily imagine benefits such as more efficient enrollment, increased participation by physicians and patients and more informed treatment decisions. Pre-profiling before a trial is set up at a particular site offers a more efficient approach to enrollment while also providing greater molecular testing to support patient care.
Our current understanding of cancer biology indicates that cancer is a large number of niche diseases that may be targeted with therapies against specific molecular alterations. Drug development under this model creates new challenges for both the development program itself and for patient care. Patient preprofiling promises to leverage high throughput genomic profiling, bioinformatics and, where possible, new trial designs to drive better trial matching and faster enrollment to clinical trials.
Preprofiling may require new relationships and business models, most notably, among patients, clinical sites, biopharmaceutical sponsors and CROs to enable data sharing, site start-up and funding of the genomic testing. The adoption of a new model of patient genomic profiling linked to novel clinical trial designs testing targeted therapies in development is becoming a key response to the challenge to develop many compounds in niche populations in a cost and time sensitive manner.
Via nrip
La gestión de ensayos clínicos es complicada. En este caso, se añade la dificultad de dividir a los pacientes según sus mutaciones. A medida que la medicina personalizada avanza, se hace más necesaria una colaboración internacional entre centros u hospitales para abarcar a todos los pacientes posibles en los ensayos clínicos. Esto también hace necesario tener en cuenta las diferencias que puedan existir entre las leyes regulatorias de los ensayos clínicos de los distintos países.