The European Medicines Agency (EMA) has announced the launch of the EU Clinical Trials Register. This trial register will allow residents of the 27 EU member states, as well as Iceland, Liechtenstein, and Norway, to more easily find data about clinical trials of therapies for the management of prostate cancer (including new drugs). … READ MORE …
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On December 23, the National Cancer Institute (NCI) issued a media release announcing a first step toward major changes in how big, cooperative clinical trials get managed and funded in the USA. … READ MORE …
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Guidelines suggest that the optimal management of patients with castration-resistant prostate cancer (CRPC) — also known as hormone-refractory prostate cancer or HRPC — is participation in a randomized clinical trial. But encouraging community-based clinicians to enroll their patients in clinical trials has long been problematic. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment, Uncategorized | Tagged: clinical trials, CRPC, eligibility | 1 Comment »
As initially reported in The Gray Sheet, an advisory committee to the US Food and Drug Administration (FDA) has suggested that new forms of device-based treatment for organ-confined prostate cancer should have to demonstrate effectiveness and safety in randomized clinical trials compared to active surveillance. … READ MORE …
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… is that (at least on a national basis) way too few cancer patients participate (for a variety of reasons). … READ MORE …
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A company called Accrual Solutions has built the first phase of a new service that allows patients to search for prostate cancer-specific clinical trials. … READ MORE …
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Intermediate or surrogate endpoints for survival can shorten timelines for drug approval. A paper just published on line in Lancet Oncology aimed to assess the value of circulating tumor cell (CTC) counts as a prognostic factor for survival. … READ MORE …
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Drs Stewart and Kurzrock have just published a provocative article in the Journal of Clinical Oncology arguing that major changes are needed in the philosophic and methodologic approaches to the design and implementation of clinical trials. … READ MORE …
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We say that we need clinical trials, but only a small percentage of patients actually enroll in these trials. We’ve known this for a while, but it has just been confirmed.
A study published in the Journal of Clinical Oncology shows that the overall enrollement in cancer trials hovers in the very low single digits. Men were less likely than women to enroll. Enrollment was lower for African-American and older patients. Lack of enrollment badly hampers the relevance (generalizability) of any trial. This is because it brings an extreme volunteer bias, whose impact on observations is hard to gauge.
To understand prostate cancer tomorrow, we need enrollment today.
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THE "NEW" PROSTATE CANCER INFOLINK 