<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">tumors</journal-id><journal-title-group><journal-title xml:lang="ru">Malignant tumours</journal-title><trans-title-group xml:lang="en"><trans-title>Malignant tumours</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2224-5057</issn><issn pub-type="epub">2587-6813</issn><publisher><publisher-name>Rosoncoweb</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.18027/2224-5057-2012-2-18-24</article-id><article-id custom-type="elpub" pub-id-type="custom">tumors-106</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОБЗОРЫ И АНАЛИТИКА</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS AND ANALYSIS</subject></subj-group></article-categories><title-group><article-title>РОЛЬ СОВРЕМЕННОЙ СИСТЕМЫ КЛИНИЧЕСКИХ ИССЛЕДОВАНИЙ В РАЗВИТИИ ЛЕКАРСТВЕННОГО ЛЕЧЕНИЯ ЗЛОКАЧЕСТВЕННЫХ ОПУХОЛЕЙ</article-title><trans-title-group xml:lang="en"><trans-title></trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Жуков</surname><given-names>Н. В.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff xml:lang="ru" id="aff-1"><institution>Федеральный научно-клинический центр детской гематологии, онкологии и иммунологии им. Д. Рогачева Минздрава РФ&#13;
&#13;
Российский национальный исследовательский медицинский университет им. Н.И. Пирогова,&#13;
Москва</institution><country>Russian Federation</country></aff><pub-date pub-type="collection"><year>2012</year></pub-date><pub-date pub-type="epub"><day>21</day><month>05</month><year>2015</year></pub-date><volume>2</volume><issue>2</issue><fpage>18</fpage><lpage>24</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Жуков Н.В., 2015</copyright-statement><copyright-year>2015</copyright-year><copyright-holder xml:lang="ru">Жуков Н.В.</copyright-holder><copyright-holder xml:lang="en">Жуков Н.В.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.malignanttumors.org/jour/article/view/106">https://www.malignanttumors.org/jour/article/view/106</self-uri><abstract><p>Появление цитостатиков совершило революцию в лечении злокачественных новообразований, позволив сделать излечимыми ранее фатальные заболевания и продлить жизнь многим больным неизлечимыми опухолями. В настоящее время зарегистрировано уже &gt; 90 противоопухолевых препаратов, многие из которых разработаны с использованием самых современных технологий и знаний в области биологии опухолей. Однако абсолютный выигрыш от применения многих современных противоопухолевых препаратов весьма невелик, а их цена растет темпами, значимо опережающими увеличение эффективности. Возможным объяснением наблюдающейся ситуации является то, что сложившаяся в настоящее время система испытания и внедрения новых противоопухолевых препаратов значительно увеличивает их стоимость, не выполняя при этом исходно возложенных на нее задач по отбору наиболее эффективных и безопасных средств.</p></abstract><kwd-group xml:lang="ru"><kwd>злокачественные опухоли</kwd><kwd>противоопухолевая терапия</kwd><kwd>клинические исследования</kwd><kwd>стандарты лечения</kwd><kwd>фармакоэкономика</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Burris HAR, Moore MJ, Andersen J, et al: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial. J Clin Oncol 1997;15:2403-2413</mixed-citation><mixed-citation xml:lang="en">Burris HAR, Moore MJ, Andersen J, et al: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial. J Clin Oncol 1997;15:2403-2413</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Moore MJ, Goldstein D, Hamm J, et al: Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007;25:1960-1966</mixed-citation><mixed-citation xml:lang="en">Moore MJ, Goldstein D, Hamm J, et al: Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007;25:1960-1966</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Saltz L, Clarke S, Diaz-Rubio E, et al. Bevacizumab (bev) in combination with XELOX or FOLFOX4: updated efficacy results from XELOX-1/NO16966, a randomized phase III trial in first-line metastatic colorectal cancer. Proc Am Soc Clin Oncol 2007;25:170s. Abstr. 4028</mixed-citation><mixed-citation xml:lang="en">Saltz L, Clarke S, Diaz-Rubio E, et al. Bevacizumab (bev) in combination with XELOX or FOLFOX4: updated efficacy results from XELOX-1/NO16966, a randomized phase III trial in first-line metastatic colorectal cancer. Proc Am Soc Clin Oncol 2007;25:170s. Abstr. 4028</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Van Cutsem E, Nowacki M, Lang I, et al. Randomized phase III study of irinotecan and 5-FU/FA with or without cetuximab in the first-line treatment of patients with metastatic colorectal cancer (mCRC): the CRYSTAL trial. Proc Am Soc Clin Oncol 2007;25:164s. Abstr. 4000</mixed-citation><mixed-citation xml:lang="en">Van Cutsem E, Nowacki M, Lang I, et al. Randomized phase III study of irinotecan and 5-FU/FA with or without cetuximab in the first-line treatment of patients with metastatic colorectal cancer (mCRC): the CRYSTAL trial. Proc Am Soc Clin Oncol 2007;25:164s. Abstr. 4000</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Miles, D., Chan, A., Romieu, et al. Final overall survival (OS) results from the randomised, double-blind, placebo-controlled, phase III AVADO study of bevacizumab (BV) plus docetaxel (D) compared with placebo (PL) plus D for the firstline treatment of locally recurrent (LR) or metastatic breast cancer (MBC). Cancer Research Suppl 2009;69(24): Abstr. 41</mixed-citation><mixed-citation xml:lang="en">Miles, D., Chan, A., Romieu, et al. Final overall survival (OS) results from the randomised, double-blind, placebo-controlled, phase III AVADO study of bevacizumab (BV) plus docetaxel (D) compared with placebo (PL) plus D for the firstline treatment of locally recurrent (LR) or metastatic breast cancer (MBC). Cancer Research Suppl 2009;69(24): Abstr. 41</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Cortes J, O’Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet 2011;377:914–923</mixed-citation><mixed-citation xml:lang="en">Cortes J, O’Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet 2011;377:914–923</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Cameron D, Casey M, Oliva C, Newstat B, Imwalle B, Geyer CE. Lapatinib plus capecitabine in women with HER-2-positive advanced breast cancer: final survival analysis of a phase III randomized trial. Oncologist 2010;15:924–934.</mixed-citation><mixed-citation xml:lang="en">Cameron D, Casey M, Oliva C, Newstat B, Imwalle B, Geyer CE. Lapatinib plus capecitabine in women with HER-2-positive advanced breast cancer: final survival analysis of a phase III randomized trial. Oncologist 2010;15:924–934.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Smith I, Procter M, Gelber RD, et al. 2-year followup of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet 2007; 369:29-36</mixed-citation><mixed-citation xml:lang="en">Smith I, Procter M, Gelber RD, et al. 2-year followup of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet 2007; 369:29-36</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Meropol NJ, Schulman KA. Cost of cancer care: Issues and implications. J Clin Oncol 2007;25:180-186 10. Silverman E. Clinical Trial Costs Are Rising Rapidly. PharmaBlog 2011. URL:http://www.pharmalot.com/2011/07/clinical-trial-costs-for-each-patient-roserapidly/</mixed-citation><mixed-citation xml:lang="en">Meropol NJ, Schulman KA. Cost of cancer care: Issues and implications. J Clin Oncol 2007;25:180-186 10. Silverman E. Clinical Trial Costs Are Rising Rapidly. PharmaBlog 2011. URL:http://www.pharmalot.com/2011/07/clinical-trial-costs-for-each-patient-roserapidly/</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Gabriel N. Hortobagyi. «Optimal Therapy for Primary and Metastatic Breast Cancer: Emerging Standards and New Approaches» San Antonio, Texas, December 13, 2001. URL: http://www.medscape.org/viewprogram/1021</mixed-citation><mixed-citation xml:lang="en">Gabriel N. Hortobagyi. «Optimal Therapy for Primary and Metastatic Breast Cancer: Emerging Standards and New Approaches» San Antonio, Texas, December 13, 2001. URL: http://www.medscape.org/viewprogram/1021</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">J. Cuzick, I. Sestak, M. Baum et al. Effect of anastrozole and tamoxifen as adjuvant treatment for earlystage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncology 2010; 11(12):1135–1141</mixed-citation><mixed-citation xml:lang="en">J. Cuzick, I. Sestak, M. Baum et al. Effect of anastrozole and tamoxifen as adjuvant treatment for earlystage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncology 2010; 11(12):1135–1141</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Joerger M, Thürlimann B. Update of the BIG 1-98 Trial: where do we stand? Breast 2009;18,Suppl3:S78-82</mixed-citation><mixed-citation xml:lang="en">Joerger M, Thürlimann B. Update of the BIG 1-98 Trial: where do we stand? Breast 2009;18,Suppl3:S78-82</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Heng DY, Xie W, Regan M, M et al. A multicentered population-based analysis of outcomes of patients with metastatic renal cell carcinoma (mRCC) who do not meet eligibility criteria for clinical trials. GUCS 2012; abstr. 353.</mixed-citation><mixed-citation xml:lang="en">Heng DY, Xie W, Regan M, M et al. A multicentered population-based analysis of outcomes of patients with metastatic renal cell carcinoma (mRCC) who do not meet eligibility criteria for clinical trials. GUCS 2012; abstr. 353.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">David J. Stewart, Razelle Kurzrock. Cancer: The Road to Amiens. J Clin Oncol 2009;27(3):328-333</mixed-citation><mixed-citation xml:lang="en">David J. Stewart, Razelle Kurzrock. Cancer: The Road to Amiens. J Clin Oncol 2009;27(3):328-333</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Koski G. Research ethics and oversight: Revolution, or just going around in circles? The Monitor 2007;21:55-57</mixed-citation><mixed-citation xml:lang="en">Koski G. Research ethics and oversight: Revolution, or just going around in circles? The Monitor 2007;21:55-57</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">URL:http://www.medicines.org.uk/EMC/Default.aspx</mixed-citation><mixed-citation xml:lang="en">URL:http://www.medicines.org.uk/EMC/Default.aspx</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
