{"id":16621,"date":"2024-11-18T13:34:55","date_gmt":"2024-11-18T11:34:55","guid":{"rendered":"https:\/\/jurmed.ro\/medici\/?p=16621"},"modified":"2024-11-18T13:34:55","modified_gmt":"2024-11-18T11:34:55","slug":"simpozionul-anual-de-studii-clinice-2024","status":"publish","type":"post","link":"https:\/\/jurmed.ro\/medici\/simpozionul-anual-de-studii-clinice-2024\/","title":{"rendered":"Simpozionul Anual de Studii Clinice 2024"},"content":{"rendered":"<p style=\"text-align: justify;\">Simpozionul Anual de Studii Clinice, edi\u021bia a XVI-a, cu tema <strong>\u201cFii cu un pas \u00eenainte: Transformarea studiilor clinice \u00een era Inteligen\u021bei Artificiale,\u201d <\/strong>organizat de AVANTYO Institute of Clinical Research, sub patronajul Federa\u021biei Europene CRO (EUCROF), Asocia\u021biei Companiilor Produc\u0103toare de Studii Clinice din Rom\u00e2nia (ACCSCR) \u0219i Asocia\u021biei Rom\u00e2ne a Societ\u0103\u021bilor de Cercetare Clinic\u0103 (ACCSCR) a avut loc pe 8 noiembrie 2024, \u00een sala de conferin\u021be a hotelului Novotel din capital\u0103.<\/p>\n<p><em>\u201cPeisajul studiilor clinice trece printr-o transformare profund\u0103, determinat\u0103 de nevoia de inovare, cre\u0219terea eficien\u021bei \u0219i capacitatea de a naviga \u00eentr-un mediu de reglementare din ce \u00een ce mai complex. Acest lucru se \u00eent\u00e2mpl\u0103 \u00een contextul volatilit\u0103\u021bii economice, instabilit\u0103\u021bii geopolitice \u0219i ale progreselor rapide \u00een domeniul inteligen\u021bei artificiale.<\/em><\/p>\n<p style=\"text-align: justify;\"><em>Simpozionul Studiilor Clinice ofer\u0103 o platform\u0103 multidisciplinar\u0103 pentru comunitatea studiilor clinice, inclusiv mediul academic, industria farmaceutic\u0103, agen\u021biile de reglementare, centrele de cercetare \u0219i entit\u0103\u021bile de cercetare clinic\u0103, pentru a discuta despre progrese vizionare \u00een cercetarea clinic\u0103. Aceast\u0103 conferin\u021b\u0103 va oferi oportunit\u0103\u021bi de networking fa\u021b\u0103 \u00een fa\u021b\u0103 cu factorii de decizie \u0219i va pune accent pe studii de caz din via\u021ba real\u0103 \u0219i prezent\u0103ri valoroase.\u201d,<\/em> a spus \u00een deschiderea evenimentului <em>dr. Cristina Florescu Moraid &#8211;<\/em> Pre\u0219edintele Simpozionului Anual de Studii Clinice \u0219i CEO AVANTYO Institute of Clinical Research.<\/p>\n<p style=\"text-align: justify;\"><strong>Mesajul de deschidere<\/strong> a venit \u0219i din partea <em>dr. Martine Dehlinger Kremer<\/em>&#8211; Pre\u0219edintele Federa\u021biei\u00a0 \u00a0Europene CRO cu sediul \u00een Germania.<\/p>\n<p style=\"text-align: justify;\"><em>\u201eEcosistemul studiilor clinice europene este esen\u021bial pacien\u021bilor, dar \u0219i sistemului de s\u0103n\u0103tate \u0219i societ\u0103\u021bii, \u00een general. Pentru pacien\u021bi studiile clinice ofer\u0103 posibilitatea de a testa medicamente inovatoare \u0219i uneori este singura lor \u0219ans\u0103 \u00een a le ob\u021bine. Pentru sistemul de s\u0103n\u0103tate studiile clinice \u00eenseamn\u0103 economii \u0219i cre\u0219terea satisfac\u021biei \u00een r\u00e2ndul personalului medical, iar pentru societate \u00eenseamn\u0103 investi\u021bii economice. \u00cen ultimii ani interesul, atractivitatea \u0219i capacitatea de a\u00a0 desf\u0103\u0219ura studii clinice \u00een \u021b\u0103rile din Europa a crescut.<\/em> <em>Europa continu\u0103 s\u0103 fie un juc\u0103tor cheie \u00een peisajul global, cu numeroase puncte forte de care s\u0103 se foloseasc\u0103 pentru cre\u0219terea sa viitoare.\u201d<\/em><\/p>\n<p style=\"text-align: justify;\">Prima tem\u0103 principal\u0103 de discu\u021bie \u00een cadrul conferin\u021bei a fost despre <strong>rolul strategic al Europei \u0219i al Rom\u00e2niei \u00een modelarea studiilor clinice globale:<\/strong> <strong>gestionarea reglement\u0103rilor \u0219i oportunit\u0103\u021bilor<\/strong>. <em>PhD Claudia Hesselmann, <\/em>fondator \u0219i CEO ARENSIA Exploratory Medicine GmbH din Germania a vorbit despre studiile clinice aprobate \u00een Europa \u0219i respectiv, \u00een Rom\u00e2nia, \u00een contextul actual global, f\u0103c\u00e2nd o compara\u021bie cu principalii juc\u0103tori, Statele Unite \u0219i China. Printre provoc\u0103rile globale se num\u0103r\u0103 turbulen\u021bele politice, volatilitatea economic\u0103, deficitul de personal \u0219i impactul inteligen\u021be artificiale. \u00cen ciuda faptului c\u0103 studiile clinice globale au crescut cu 38% \u00een ultimul deceniu, ponderea global\u0103 a studiilor din spa\u021biul economic european s-a redus la jum\u0103tate \u00een aceea\u0219i perioad\u0103 (ceea ce \u00eenseamn\u0103 undeva cu 60 000 de locuri de studii clinice mai pu\u021bine \u00een Europa). Astfel, asist\u0103m ast\u0103zi la sc\u0103derea cotei europene \u0219i la cre\u0219terea influen\u021bei asiatice \u00een ceea ce prive\u0219te noile studii clinice.<\/p>\n<p style=\"text-align: justify;\">\u00cen cadrul primului panel a fost dezb\u0103tut\u0103 tema privind<strong> strategia na\u021bional\u0103 pentru dezvoltarea studiilor clinice \u00een Rom\u00e2nia. <\/strong>Dac\u0103 Europa cunoa\u0219te o sc\u0103dere a studiilor clinice, \u021bara noastr\u0103 a \u00eenregistrat o cre\u0219tere \u00een ultimii ani.Principalele arii de interven\u021bie strategic\u0103 \u00een Rom\u00e2nia sunt: educarea pacien\u021bilor \u0219i a p\u0103r\u021bilor interesate, recrutarea pacien\u021bilor \u00een procesul de selec\u021bie, dezvoltarea resurselor umane implicate \u00een studiile clinice, promovarea interna\u021bional\u0103 a poten\u021bialului Rom\u00e2niei \u0219i m\u0103surile economice \u0219i fiscale aprobate. Aceste arii de interven\u021bie strategic\u0103 au fost dezvoltate \u0219i detaliate \u00een cadrul conferin\u021bei de c\u0103tre exper\u021bi locali.<\/p>\n<p style=\"text-align: justify;\">Moderatorul dezbaterii a fost <em>Dr. George Regio T\u0103n\u0103seanu<\/em> &#8211; Pre\u0219edinte ACCSCR \u0219i CEO PSI CRO AG Rom\u00e2nia, iar invita\u021bii \u00een cadrul panelului au fost: <em>Dr. Farm. R\u0103zvan Mihai Prisada <\/em>&#8211; Pre\u0219edinte al Agen\u021biei Na\u021bionale a Medicamentului \u0219i a Dispozitivelor Medicale din Rom\u00e2nia (NAMMDR), <a href=\"https:\/\/www.clinicaltrialsymposium.com\/speaker\/108\"><em>Prof. Dr. Doina Draganescu<\/em><\/a>&#8211; Pre\u0219edinte al Comisiei de Etic\u0103, Comisia Na\u021bional\u0103 de Bioetic\u0103 a Medicamentului \u0219i Dispozitivelor Medicale \u0219i totodat\u0103 Decan la Facultatea de Farmacie din cadrul Universit\u0103\u021bii de Medicin\u0103 \u0219i Farmacie \u201eCarol Davila\u201d din Bucure\u0219ti,<em> Conf. Dr. Michael Schenker &#8211;<\/em> Pre\u0219edintele Comisiei de Oncologie din cadrul Ministerului S\u0103n\u0103t\u0103\u021bii, Fondator \u0219i Manager al Centrului Oncologic \u201eSf\u00e2ntul Nectarie\u201d, <em>Dr. Frank Loeffler<\/em> \u2013 Membru al Consiliului Strategic pentru Health Innovation Hub \u0219i Vicepre\u0219edinte Local al Grupului de Lucru American (LAWG), Country Manager Roche Rom\u00e2nia, <em>Asist. Univ. Dr. Teodor Cristian Blidaru<\/em> &#8211; Manager de Proiect la Health Innovation Hub \u0219i <em>Constantin Volovat<\/em> &#8211; <em>Prof. Dr.<\/em> la Universitatea de Medicin\u0103 \u0219i Farmacie \u201eGrigore T. Popa\u201d din Ia\u0219i.<\/p>\n<p style=\"text-align: justify;\">La finalul panelului s-au tras concluzii despre importan\u021ba dezvolt\u0103rii \u00een Rom\u00e2nia a infrastructurii de studii clinice (prin crearea unor noi centre clinice), despre instruirea profesioni\u0219tilor (educarea \u0219i informarea s\u0103 fie o prioritate \u00een centrele medicale, al\u0103turi de cre\u0219terea interesului studen\u021bilor din facult\u0103\u021bile de medicin\u0103), despre c\u00e2t de important este s\u0103 se fac\u0103 lobby pentru ca anumite studii clinice s\u0103 ajung\u0103 \u0219i \u00een \u021bara noastr\u0103 (mai ales cele \u00een zona de oncologie), la care se adaug\u0103 provoc\u0103rile aduse de inteligen\u021ba artificial\u0103 (rolul transformator pe care-l va juca \u00een urm\u0103torii ani).<\/p>\n<p style=\"text-align: justify;\">Urm\u0103toarea tem\u0103 discutat\u0103 a vizat<strong> viitorului tratamentului cancerului \u0219i mai exact studiile clinice privind terapia celular\u0103 de tip CAR-T \u00een oncologie.<\/strong>\u00cen acest context, <em>Prof. Dr. Ciprian Tomuleasa \u2013 <\/em>doctor \u00een cadrul Centrului de Cercet\u0103ri pentru Medicina Avansat\u0103, MedFuture, din Cluj-Napoca a vorbit despre inova\u021biile \u0219i perspectivele \u00een studiile clinice din oncologie care includ terapia cu celule CAR-T. Aceasta este o terapie imunologic\u0103 de ultim\u0103 genera\u021bie care utilizeaz\u0103 celulele imune ale pacientului, modificate genetic pentru a viza \u0219i distruge \u00een mod specific celulele canceroase. Terapia s-a dovedit a fi extrem de eficient\u0103 \u00een anumite tipuri de cancer de s\u00e2nge, cum ar fi leucemia \u0219i limfomul, ob\u021bin\u00e2nd rate mari de remisie, \u00een special pentru pacien\u021bii care nu au r\u0103spuns la alte tratamente. \u00cen 2012, Emily Whitehead a fost primul pacient pediatric care a primit terapie cu celule CAR-T \u0219i a fost vindecat\u0103 de leucemia limfoblastic\u0103 acut\u0103 la v\u00e2rsta de \u0219apte ani.<\/p>\n<p style=\"text-align: justify;\"><em>Alina Georgiana Axinte<\/em> &#8211; Senior Manager Opera\u021biuni Clinice, Divizia Opera\u021biuni Clinice Regionale (RCO) Bristol Myers Squibb a continuat discu\u021bia \u0219i a vorbit despre <strong>dep\u0103\u0219irea provoc\u0103rilor \u0219i valorificarea oportunit\u0103\u021bilor de cre\u0219tere a centrelor care se ocup\u0103 cu terapia <\/strong><strong>CAR-T<\/strong>. La ora actual\u0103, \u00een Rom\u00e2nia, din cele \u0219apte centre de studii clinice existente dou\u0103 au experien\u021b\u0103 \u00een terapia CAR-T, iar \u00een derulare sunt trei studii.<\/p>\n<p style=\"text-align: justify;\">Urm\u0103torul invitat, <em>Pierre Frederic Omnes &#8211;<\/em> Director executiv la TransPerfect Life Sciences din Fran\u021ba a intrat \u00een direct la conferin\u021b\u0103 \u0219i a vorbit despre <strong>Regulamentul UE CTR 536\/2014 \u0219i despre provoc\u0103rile \u00eent\u00e2mpinate la sf\u00e2r\u0219itul perioadei de tranzi\u021bie (30 ianuarie 2025).<\/strong><\/p>\n<p style=\"text-align: justify;\">Regulamentul Uniunii Europene privind Studiile Clinice 536\/2014 a intrat \u00een vigoare la 31 ianuarie 2022 \u0219i are ca scop s\u0103 se asigure c\u0103 Uniunea European\u0103 dispune de un cadru favorabil pentru desf\u0103\u0219urarea studiilor clinice prin existen\u021ba unor standarde \u00eenalte de siguran\u021b\u0103, transparen\u021b\u0103 sporit\u0103, \u00eembun\u0103t\u0103\u021birea siguran\u021bei pacien\u021bilor \u0219i o colaborare bine consolidat\u0103 cu \u0219i \u00eentre statele membre.<\/p>\n<p style=\"text-align: justify;\">\u00a0\u00cen a doua parte a conferin\u021bei prima tem\u0103 de dezbatere sus\u021binut\u0103 de <em>Prof. Dr. Anca Streinu Cercel<\/em> &#8211; Prof. Dr. Matei Bal\u0219 \u201dInstitutul Na\u021bional de Boli Infec\u021bioase\u201d, de la Universitatea de Medicin\u0103 \u0219i Farmacie \u201cCarol Davila\u201d din Bucure\u0219ti, a fost despre <strong>construirea unor pun\u021bi comune \u00eentre principalii stakeholderi<\/strong>: <strong>sponsori, companiile conduc\u0103toare de studii clinice (CRO), <\/strong><strong>mediul spitalicesc, autorit\u0103\u021bile de reglementare \u0219i pacien\u021bii.<\/strong>\u00a0Conferin\u021ba a continuat cu prezentarea sus\u021binut\u0103 de <em>Dr.Cristina Florescu Moraid &#8211; <\/em>CEO Camina Medical Experts, intitulat\u0103 <strong>Studii clinice descentralizate: dep\u0103\u0219irea provoc\u0103rilor \u0219i valorificarea oportunit\u0103\u021bilor \u00een <\/strong><strong>suportul investigatorilor \u0219i pacien\u021bilor<\/strong>, care a \u00a0vorbit despre actualul context al cercet\u0103rilor clinice cu focus asupra studiilor clinice descentralizate, pun\u00e2ndu-le \u00een compara\u021bie cu studiile clinice clasice.Astfel, pandemia COVID-19, cu un impact major asupra vie\u021bilor pacien\u021bilor, a demonstrat mai mult ca niciodat\u0103 nevoia de cercetare clinic\u0103. Comunitatea de cercetare medical\u0103 a adoptat studiile clinice descentralizate (DCT) ca o modalitate de a continua cercetarea atunci c\u00e2nd metodele tradi\u021bionale fa\u021b\u0103 \u00een fa\u021b\u0103 deveniser\u0103 imposibile.<\/p>\n<p style=\"text-align: justify;\">Multe studii clinice includ deja elemente descentralizate. De exemplu, testele de laborator sunt adesea efectuate \u00een unit\u0103\u021bi de laborator situate \u00een loca\u021bii \u00eendep\u0103rtate de site-urile tradi\u021bionale ale studiilor clinice.Studiile clinice descentralizate (DCT) ofer\u0103 o abordare mai centrat\u0103 pe pacient, reflect\u00e2nd o filozofie transforma\u021bional\u0103 pentru desf\u0103\u0219urarea studiilor clinice, \u00een care sunt necesare mai pu\u021bine vizite la clinic\u0103, iar efortul asupra pacientului \u0219i a \u00eengrijitorilor este redus\u0103.\u00a0<em>Asistent Prof. Bart Lagerwaard \u00a0<\/em>de la Centrul Medical Universitar Utrecht din Olanda a continuat <strong>subiectul studiilor descentralizate<\/strong> \u0219i a vorbit despre centrarea pe pacient, mai exact pe nevoile, preferin\u021bele \u0219i experien\u021bele acestuia pe parcursul unui studiu clinic. Pentru exemplificare a folosit <strong>studiul de caz RADIAL, <\/strong>un studiu DCT pan-european desf\u0103\u0219urat \u00een \u0219ase \u021b\u0103ri europene.<\/p>\n<p style=\"text-align: justify;\">Urm\u0103toarea tem\u0103 de dezbatere, cea care a dat \u0219i titlul conferin\u021bei, se refer\u0103 la <strong>rolul AI (inteligen\u021bei artificiale) \u00een studiile clinice. <\/strong><\/p>\n<p style=\"text-align: justify;\"><em>Asistentul universitar<\/em> <em>Octav Andronic<\/em> &#8211; Chirurgie general\u0103, Coordonator Departament Analiza BigData \u2013 Universitatea de Medicin\u0103 \u0219i Farmacie CieH Carol Davila din Bucure\u0219ti a vorbit despre <strong>AI \u00een scrierea medical\u0103<\/strong> \u0219i a oferit inclusiv instrumentele adecvate pentru fiecare activitate \u00een parte, de la colectarea \u0219i analiza datelor p\u00e2n\u0103 la redactarea \u0219i definitivarea articolului. Totodat\u0103 a discutat despre beneficiile, dar \u0219i limit\u0103rile inteligen\u021bei artificiale \u0219i considera\u021biile etice.<\/p>\n<p style=\"text-align: justify;\"><em>Alexandre Malouvier, PhD<\/em> &#8211; Director Senior Afaceri \u0218tiin\u021bifice \u0219i Inovare Digital\u0103, Dezvoltare Clinic\u0103 \u0219i Solu\u021bii Comerciale, Servicii de Comercializare \u0219i Rezultate ICON din Fran\u021ba a continuat subiectul despre AI \u0219i a vorbit despre <strong>Revolu\u021bionarea dezvolt\u0103rii medicamentelor: Inteligen\u021ba Artificial\u0103 &#8211; un factor transformator \u00een cercetarea clinic\u0103 pentru Organiza\u021biile de Cercetare Contractual\u0103<\/strong>. Mai exact, despre contribu\u021bia acestui nou instrument \u00een dezvoltarea cercet\u0103rii clinice \u0219i despre modul de integrare al inteligen\u021bei artificiale \u00een studiile clinice, oferind ca studiu de caz organiza\u021bia ICON.<\/p>\n<p style=\"text-align: justify;\">Tot despre aceast\u0103 tem\u0103 a vorbit \u0219i <em>Florin Petru\u021biu, <\/em>CIO\/CISOCIO\/CISO, CNS Healthcare, USA, o companie de cercetare clinice american\u0103 care sus\u021bine p\u00e2n\u0103 la 200 de noi studii clinice \u00een fiecare an. Abord\u00e2nd subiectul <strong>Cum sunt integrate tehnologiile digitale \u00een platformele de studii clinice? <\/strong>a pus accentul pe provoc\u0103rile aduse de tehnologie, d\u00e2nd totodat\u0103 exemple de instrumente de inteligen\u021b\u0103 artificial\u0103 utlizate ast\u0103zi \u00een studiile clinice. Utilizarea dispozitivelor avansate, cum ar fi dispozitivele purtabile, este esen\u021bial\u0103, dar doar dac\u0103 este asigurat accesul at\u00e2t al pacien\u021bilor, c\u00e2t \u0219i al profesioni\u0219tilor la ele.<\/p>\n<p style=\"text-align: justify;\">Ultima dezbatere din cadrul conferin\u021bei a avut \u00een vedere <strong>Abordarea centrat\u0103 pe pacient: \u00eembun\u0103t\u0103\u021birea implic\u0103rii \u0219i reten\u021biei lui.<\/strong> Moderatorul panelului a fost <em>Rozalina Lapadatu<\/em> &#8211; Pre\u0219edinte al Asocia\u021biei Pacien\u021bilor cu Boli Autoimune, iar la dezbatere au luat parte <em>Alina Comanescu<\/em> &#8211; Pre\u0219edintele Asocia\u021biei S\u0103n\u0103tate pentru Comunitate, <em>Radu G\u0103nescu<\/em> &#8211; Pre\u0219edinte al Coali\u021biei Organiza\u021biilor Pacien\u021bilor cu Boli Cronice (COPAC) \u0219i <em>Marinela Debu<\/em>\u00a0 &#8211; Pre\u0219edinte al Asocia\u021biei Pacien\u021bilor cu Afec\u021biuni Hepatice. S-a discutat despre provoc\u0103rile \u00een recrutarea pacien\u021bilor \u00een studiile clinice. Printre acestea se num\u0103r\u0103 lipsa inform\u0103rii, a \u00eencrederii \u00een studiile clinice \u0219i a educa\u021biei (de multe ori pacien\u021bii nu \u00een\u021beleg ce implic\u0103 procesul, iar personalul medical folose\u0219te un limbajul academic), faptul c\u0103 nu sunt alocate zile de concediu medical pentru acest proces \u0219i lipsa suportului din partea mass-mediei. Iar toate aceste provoc\u0103ri sunt cu at\u00e2t mai mari \u00een mediul rural unde oamenii au \u0219i mai pu\u021bin acces la informa\u021bie.<\/p>\n<p style=\"text-align: justify;\">Simpozionul s-a \u00eencheiat cu o serat\u0103 muzical\u0103 al\u0103turi de cvintetul vocal ANATOLY din Bra\u0219ov, c\u00e2\u0219tig\u0103tor a numeroase premii na\u021bionale \u0219i interna\u021bionale.<\/p>\n<p style=\"text-align: justify;\">\n","protected":false},"excerpt":{"rendered":"<p>Simpozionul Anual de Studii Clinice, edi\u021bia a XVI-a, cu tema \u201cFii cu un pas \u00eenainte: Transformarea studiilor clinice \u00een era Inteligen\u021bei Artificiale,\u201d organizat de AVANTYO Institute of Clinical Research, sub [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":16622,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-16621","post","type-post","status-publish","format-standard","has-post-thumbnail","category-stiri-noutati"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - 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