<?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">clinvest</journal-id><journal-title-group><journal-title xml:lang="ru">Качественная клиническая практика</journal-title><trans-title-group xml:lang="en"><trans-title>Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2588-0519</issn><issn pub-type="epub">2618-8473</issn><publisher><publisher-name>ООО «Издательство ОКИ</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">clinvest-178</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>КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CLINICAL TRIALS</subject></subj-group></article-categories><title-group><article-title>Оценка физибильности как краеугольный камень успешного клинического исследования</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>Саватеев</surname><given-names>А. В.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белоцерковский</surname><given-names>М. В.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мосчицка</surname><given-names>К.</given-names></name></name-alternatives></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Палумбо</surname><given-names>Доменико</given-names></name></name-alternatives></contrib></contrib-group><aff xml:lang="ru" id="aff-1"><institution>Международная контрактная исследовательская организация PSI CRO AG</institution><country>Russian Federation</country></aff><aff xml:lang="ru" id="aff-2"><institution>Контрактная исследовательская организация PSI CRO AG</institution><country>Germany</country></aff><pub-date pub-type="collection"><year>2013</year></pub-date><pub-date pub-type="epub"><day>07</day><month>06</month><year>2018</year></pub-date><volume>0</volume><issue>2</issue><fpage>37</fpage><lpage>46</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Саватеев А.В., Белоцерковский М.В., Мосчицка К., Палумбо Д., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Саватеев А.В., Белоцерковский М.В., Мосчицка К., Палумбо Д.</copyright-holder><copyright-holder xml:lang="en">Саватеев А.В., Белоцерковский М.В., Мосчицка К., Палумбо Д.</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.clinvest.ru/jour/article/view/178">https://www.clinvest.ru/jour/article/view/178</self-uri><abstract><p>Традиционно задача по выполнению оценки возможности проведения клинического исследования (КИ) в определённых клиниках, странах и регионов (то есть то, что на профессиональном сленге называется оценка физибильности) возлагалась (а во многих компаниях до сих пор возлагается) на опытных клинических проектных менеджеров (clinical project manager). Однако постепенно увеличивающийся спектр и объём задач по оценке физибильности, связанный как с ростом количества новых исследований и расширением их географии, так и с возрастанием сложности проектов, актуализировал необходимость разработки методологии оценки физибильности и концентрации опыта в рамках специального структурного подразделения — отдела физибильности, сотрудники которого занимаются исключительно оценкой физибильности. Профессиональный подход к оценке физибильности позволил нашей компании разрабатывать оптимальные и надёжные сценарии выполнения КИ и, как результат, брать на себя более жёсткие контрактные обязательства. Эта статья обобщает опыт работы отдела физибильности компании PSI в период с 2002 по 2013 годы. За этот период отдел физибильности произвёл оценку возможности проведения более чем 1 500 клинических исследований в странах Северной и Южной Америки, Азии, Европы, Африки и Австралии.</p></abstract><kwd-group xml:lang="ru"><kwd>физибильность</kwd><kwd>клинический проектный менеджер</kwd><kwd>клинические исследования</kwd><kwd>отбор клинических центров</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">AAN Practice Guidelines and Tools. American Academy of Neurology. Published electronically on http://www.aan.com/go/practice/guidelines.</mixed-citation><mixed-citation xml:lang="en">AAN Practice Guidelines and Tools. American Academy of Neurology. Published electronically on http://www.aan.com/go/practice/guidelines.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Aplin A.E., Kaplan F.M., Shao Y. Mechanisms of resistance to RAF inhibitors in melanoma. //J Invest Dermatol, 2011, vol. 131(9), pp. 1817-1820.</mixed-citation><mixed-citation xml:lang="en">Aplin A.E., Kaplan F.M., Shao Y. Mechanisms of resistance to RAF inhibitors in melanoma. //J Invest Dermatol, 2011, vol. 131(9), pp. 1817-1820.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Bensinger W., Schubert M., Ang KK, Brizel D., Brown E., Eilers J.G., Elting L., Mittal B.B., Schattner M.A., Spielberger R., Treister N.S., Trotti A.M. NCCN Task Force Report. Prevention and management of mucositis in cancer care. //J Natl Compr Canc Netw, 2008, Suppl.1 (S1-21).</mixed-citation><mixed-citation xml:lang="en">Bensinger W., Schubert M., Ang KK, Brizel D., Brown E., Eilers J.G., Elting L., Mittal B.B., Schattner M.A., Spielberger R., Treister N.S., Trotti A.M. NCCN Task Force Report. Prevention and management of mucositis in cancer care. //J Natl Compr Canc Netw, 2008, Suppl.1 (S1-21).</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Dyk J., Barnett R., Battista J. Computerized Radiation Treatment Planning System. In: Th e Modern Technology of Radiation Oncology: A Compendium for Medical Physicist and Radiation Oncologists. Medical Physics Pub Corp; 1st edition, October 1999, pp. 232-286.</mixed-citation><mixed-citation xml:lang="en">Dyk J., Barnett R., Battista J. Computerized Radiation Treatment Planning System. In: Th e Modern Technology of Radiation Oncology: A Compendium for Medical Physicist and Radiation Oncologists. Medical Physics Pub Corp; 1st edition, October 1999, pp. 232-286.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). National Comprehensive Cancer Network. Published electronically on http://www.nccn. org/professionals/physician_gls/f_guidelines.asp.</mixed-citation><mixed-citation xml:lang="en">NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). National Comprehensive Cancer Network. Published electronically on http://www.nccn. org/professionals/physician_gls/f_guidelines.asp.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Practice guidelines of the American College of Rheumatology. Th e American College of Rheumatology. Published electronically on http://www.rheumatology.org/ practice/clinical/guidelines/index.asp#available.</mixed-citation><mixed-citation xml:lang="en">Practice guidelines of the American College of Rheumatology. Th e American College of Rheumatology. Published electronically on http://www.rheumatology.org/ practice/clinical/guidelines/index.asp#available.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Rodriguez-Caballero A., Torres-Lagares D., Robles-Garcia M., Panchon-Ibanez J., Gonzalez-Padilla D., Gutierrez-Perez J.L. Cancer treatment-induced oral mucositis: a critical review. //Int J Oral Maxillofac Surg., 2012, vol. 41(2), pp. 225-238.</mixed-citation><mixed-citation xml:lang="en">Rodriguez-Caballero A., Torres-Lagares D., Robles-Garcia M., Panchon-Ibanez J., Gonzalez-Padilla D., Gutierrez-Perez J.L. Cancer treatment-induced oral mucositis: a critical review. //Int J Oral Maxillofac Surg., 2012, vol. 41(2), pp. 225-238.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Rustin G.J., Vergote I., Eisenhauer E., Pujade-Lauraine E., Quinn M., Th igpen T., du Bois A., Kristensen G., Jakobsen A., Sagae S., Greven K., Parmar M., Friedlander M., Cervantes A., Vermorken J. Deﬁ nitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and CA 125 agreed by the Gynecological Cancer Intergroup (GCIG). //Int J Gynecol Cancer, 2011, vol. 21(2), pp. 419-423.</mixed-citation><mixed-citation xml:lang="en">Rustin G.J., Vergote I., Eisenhauer E., Pujade-Lauraine E., Quinn M., Th igpen T., du Bois A., Kristensen G., Jakobsen A., Sagae S., Greven K., Parmar M., Friedlander M., Cervantes A., Vermorken J. Deﬁ nitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and CA 125 agreed by the Gynecological Cancer Intergroup (GCIG). //Int J Gynecol Cancer, 2011, vol. 21(2), pp. 419-423.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Surati M., Patel P., Peterson A., Salgia R. Role of MetMAb (OA-5D5) in c-MET active lung malignancies. //Expert Opin Biol Th er., 2011, vol. 11(12), pp. 1655-1662.</mixed-citation><mixed-citation xml:lang="en">Surati M., Patel P., Peterson A., Salgia R. Role of MetMAb (OA-5D5) in c-MET active lung malignancies. //Expert Opin Biol Th er., 2011, vol. 11(12), pp. 1655-1662.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Th e CDC Prevention Guidelines Database. Th e US Center for Disease Control and Prevention. Published electronically on http://wonder.cdc.gov/wonder/ prevguid/prevguid.html.</mixed-citation><mixed-citation xml:lang="en">Th e CDC Prevention Guidelines Database. Th e US Center for Disease Control and Prevention. Published electronically on http://wonder.cdc.gov/wonder/ prevguid/prevguid.html.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Th e Rules Governing Medicinal Products in the European Union. Volume 1. “Pharmaceutical Legislation Medicinal Products for Human Use”. European Medicines Agency. Published electronically on http://ec.europa.eu/health/documents/eudralex/index_en.htm.</mixed-citation><mixed-citation xml:lang="en">Th e Rules Governing Medicinal Products in the European Union. Volume 1. “Pharmaceutical Legislation Medicinal Products for Human Use”. European Medicines Agency. Published electronically on http://ec.europa.eu/health/documents/eudralex/index_en.htm.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Th e Rules Governing Medicinal Products in the European Union. Volume 2. “Pharmaceutical Legislation Notice to Applicants and Regulatory Guidelines Medicinal Products for Human Use”. European Medicines Agency. Published electronically on http://ec.europa.eu/health/documents/eudralex/index_en.htm.</mixed-citation><mixed-citation xml:lang="en">Th e Rules Governing Medicinal Products in the European Union. Volume 2. “Pharmaceutical Legislation Notice to Applicants and Regulatory Guidelines Medicinal Products for Human Use”. European Medicines Agency. Published electronically on http://ec.europa.eu/health/documents/eudralex/index_en.htm.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Th e Rules Governing Medicinal Products in the European Union. Volume 3. “Scientiﬁ c Guidelines for Medicinal Products for Human Use”. European Medicines Agency. Published electronically on http://ec.europa.eu/health/documents/eudralex/index_en.htm.</mixed-citation><mixed-citation xml:lang="en">Th e Rules Governing Medicinal Products in the European Union. Volume 3. “Scientiﬁ c Guidelines for Medicinal Products for Human Use”. European Medicines Agency. Published electronically on http://ec.europa.eu/health/documents/eudralex/index_en.htm.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Th e Rules Governing Medicinal Products in the European Union. Volume 10. “Clinical Trials Guidelines”. European Medicines Agency. Published electronically on http://ec.europa.eu/health/documents/eudralex/index_en.htm.</mixed-citation><mixed-citation xml:lang="en">Th e Rules Governing Medicinal Products in the European Union. Volume 10. “Clinical Trials Guidelines”. European Medicines Agency. Published electronically on http://ec.europa.eu/health/documents/eudralex/index_en.htm.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">U.S. Food and Drug Administration. Guidance, Compliance and Regulatory Information. Division of Drug Information. Published electronically on www.fda.gov.</mixed-citation><mixed-citation xml:lang="en">U.S. Food and Drug Administration. Guidance, Compliance and Regulatory Information. Division of Drug Information. Published electronically on www.fda.gov.</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>
