Key considerations for combination therapy in Alzheimer's clinical trials: Perspectives from an expert advisory board convened by the Alzheimer's drug discovery foundation.

There is growing consensus in the Alzheimer's community that combination therapy will be needed to maximize therapeutic benefits through the course of the disease. However, combination therapy raises complex questions and decisions for study sponsors, from preclinical research through clinical trial design to regulatory, statistical, and operational considerations. In January 2024, the Alzheimer's Drug Discovery Foundation convened an expert advisory board to discuss the key considerations in each of these areas.

Seven Former FDA Commissioners: The FDA Should Be An Independent Federal Agency.

Seven former commissioners of the Food and Drug Administration (FDA) from both sides of the political aisle recommend that the FDA be moved out of the Department of Health and Human Services and reconfigured as an independent federal agency. We believe that such a reengineering would promote reliance on consistent science-based regulation and ensure that the American public has access to the best that science and industry can offer.

Roundtable--the changing oncology landscape: evolution or revolution?

Complex challenges face all players in the oncology landscape, from health care policy leaders and third-party payers, to practicing physicians and nurses, to patients and their families. In these unsteady economic times, possible answers proposed by some may represent part of the problem to others. A distinguished panel assembled at the NCCN 18th Annual Conference: Advancing the Standard of Cancer Care to explore the changing oncology landscape.

Eliminating error-prone notations in medical communications.

Three decades advocating the elimination of ambiguous medical notations, one of the most common, but preventable causes of medication errors, came into sharp focus in 2006 when the FDA and the Institute for Safe Medication Practices launched a comprehensive educational campaign against medical mistakes rooted in unclear abbreviations, symbols and dose designations. Acting out of a joint effort to promote safe healthcare practices, FDA and the Institute for Safe Medication Practices determined that eliminating the use of potentially confusing notations in all forms of medical communication is one way to increase awareness about this important issue, and is one area in which education could help save lives. Still, the frequency of preventable medication-related injuries represents and remains a very serious cause for concern.

A vision for the National Cancer Program in the United States.

The intersection of two noble endeavors - the scientists' quest to understand life itself and the physicians' dedication to relieve suffering and prolong life - came into sharp focus in 1971 with the United States National Cancer Act. This focus has led to an exponential expansion of our understanding of cancer at the genetic, molecular and cellular levels, and concomitant advances in our ability to disrupt the disease process through prevention, early detection and successful treatment. At the National Cancer Institute we are committed to capitalize on these achievements.

Molecular markers of outcome after radiotherapy in patients with prostate carcinoma: Ki-67, bcl-2, bax, and bcl-x.

Background: Abnormal expression of key proteins of the apoptotic pathway has been associated with poor prognosis, although there have been few studies of these correlations in patients with prostate carcinoma who are treated with radiotherapy. The current study examined the association between expression levels of Ki-67, bcl-2, bax, and bcl-x in pretreatment biopsy specimens and patient outcome after definitive radiotherapy alone.

Methods: Archival pretreatment prostate biopsy tumor tissue was retrieved from 106 patients with Stage T1-T3 prostate carcinoma who were treated at the University of Texas M.

Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial.

Purpose: A randomized radiotherapy dose escalation trial was undertaken between 1993 and 1998 to compare the efficacy of 70 vs. 78 Gy in controlling prostate cancer.

Methods And Materials: A total of 305 Stage T1-T3 patients were entered into the trial and, of these, 301 with a median follow-up of 60 months, were assessable.

Salvage cryotherapy for recurrent prostate cancer after radiotherapy: variables affecting patient outcome.

Purpose: To determine the long-term disease-specific survival (DSS) and disease-free survival (DFS) rates after salvage cryotherapy for locally recurrent adenocarcinoma of the prostate and to identify pretreatment factors that have an impact on DSS and DFS.

Patients And Methods: Between July 1992 and January 1995, 131 patients who had received definitive radiation therapy (XRT) underwent salvage cryotherapy for locally recurrent adenocarcinoma of the prostate. Cryotherapy failure was defined as an increasing postcryotherapy prostate-specific antigen (PSA) level of > or = 2 ng/mL above the postcryotherapy nadir, a positive prostate biopsy, or radiographic evidence of metastatic disease.

Ki-67 staining is an independent correlate of biochemical failure in prostate cancer treated with radiotherapy.

Purpose: To determine the significance of Ki-67/MIB1 staining as a marker of patient outcome for prostate cancer patients treated with radiotherapy.

Experimental Design: Pretreatment archival prostate biopsy tumor tissue was available from 106 stage T1-T4 prostate cancer patients treated with external beam radiotherapy between 1987 and 1993 at M. D.