Klinische Studien: Fundament einer Evidenz-basierten Onkologie – Bestandsaufnahme und Zukunft im Zeitalter des Internet

Abstract

Clinical Trials: Prerequisite of Evidence-Based Oncology. Reality, Perspectives and a New Tool Recruited – the Internet Leider besteht für diesen Artikel keine Zusammenfassung. Als Einstieg stellen wir den Textanfang zur Verfügung. Scientifically sound clinical research is an undispensable prerequisite to establish innovative therapeutic principles, to support applications for marketing authorization of proprietary new drugs, to advance therapeutic results in cancer therapy, and the only route towards an evidence-based clinical oncology at the advent of the 21st century. Treatment of cancer patients based on scientific evidence derived from clinical studies outperforms compassionate individual therapeutic decisions with a lack of evidence, whenever such evidence is available or whenever a clinical trial is addressing the clinical situation that must be addressed for an individual patient. A stable trend towards improved survival of cancer patients was first observed in 1999. The advent of new technologies of drug design, the integration of pharmacology, genomics and DNA microarray chip technologies will produce a myriad of new anticancer drugs with promising potential for cancer therapy that need to be tested in the clinical setting without delay. To match that challenge, clinical oncology must streamline the laborious process of conducting clinical trials. The process of planning, multicenter coordinating, recruiting, treatment, analyzing, and reporting of clinical trial results must be further optimized. The best possible quality control of all steps of that process is a prerequisite to motivate patients to participate in clinical trials of cancer therapy – always one of the most promising treatment options for patients seeking the best possible cancer care. At the same time as the internet goes mainstream and cancer care information is ubiquitously laymanized and dispersed via cancer cybermedicine, clinical researchers may employ the internet to exchange information, facilitate conduction of clinical trials, and facilitate recruitment to clinical studies via web-based trial registries. This will be more than an incremental step forward to deliver the best possible clinical care towards the ultimate goal: to deliver evidence-based medicine en route to a cure for more cancer patients than ever.

How can current oncological datasets be adjusted to support the automated patient recruitment in clinical trials?

“…Clinical research has played a pivotal role in driving this progress. 1 Participating in oncological studies offers patients the opportunity to receive early treatment using new and innovative methods. However, the current approach of relying on doctors, tumor boards, or interdisciplinary oncological councils to recruit patients for study participation poses numerous challenges.…”

O uso de drogas ainda experimentais em assistência: extensão de pesquisa, uso compassivo e acesso expandido

“…A utilização de uma nova droga em seres humanos como parte de um projeto de pesquisa deve ser aprovada previamente por um comitê de ética em pesquisa. Quanto à liberação para uso assistencial, são exigidos inúmeros estudos, que geram as informações necessárias para comprovar a sua segurança e eficácia (1)(2)(3).…”