Klinične raziskave v onkologiji Clinical trials in oncology

Abstract

Klinične raziskave ali klinična preskušanja so raziskave, ki vključujejo ljudi. Na njihovih izsledkih temelji vsakodnevna obravnava bolnikov, zdravljenje, ki temelji na dokazih. Klinična preskušanja razvrščamo v več faz. V fazi I ugotavljamo predvsem toksičnost, v fazi II aktivnost zdravila pri določeni bolezni in v fazi III primerjamo učinkovitost nove oblike zdravljenja s trenutno priporočenim zdravljenjem določene bolezni. V želji po hitrejši informaciji o učinkovitosti številnih novih, predvsem tarčnih zdravil, se je razvil novi tip kliničnih raziskav, klinične raziskave tipa %košara%, %dežnik% in %prilagoditev%. Vse klinične raziskave morajo izpolnjevati stroga merila, ki zagotavljajo, da so bolniki v raziskavah zaščiteni in so rezultati pravilno ovrednoteni. Dostopnost do raziskav je pomembna za razvoj stroke, pa tudi za bolnike, saj v okviru teh lahko dobijo dodatne možnosti zdravljenja. Zato je pomembno, da zdravniki bolnike spodbujamo k sodelovanju v kliničnih raziskavah.

Abstract (Eng)

Clinical trials or clinical studies refer to research that is done in people. Their results are the backbone of daily clinical practice, namely evidence- based medicine. Clinical trials involve several phases. The main purpose of a phase I trial is to determine the safety of treatment, a phase II trial aims to determine if the new treatment is effective in treating a certain cancer, and a phase III trial compares the new treatment to the current standard treatment for a certain type of cancer. Aimed at providing prompt information on the effectiveness of many new agents, especially targeted drugs, new types of clinical study designs have been developed, namely basket trials, umbrella trials, and adaptive trials. All clinical trials have to meet strict criteria to ensure that patient rights are protected and that the results are properly evaluated. Accessibility to clinical trials is important for the development of oncology and for patients as well, as clinical trials may provide them with additional treatment. It is, therefore, important that doctors encourage patients to participate in clinical trials.