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Informații esențiale cu privire la cercetarea clinică!

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Acest site oferă informații esențiale cu privire la cercetarea clinică – modul în care se desfășoară studiile clinice, care sunt etapele de dezvoltare ale medicamentelor, protecția medicilor, protecția pacienților, legislație, etc.

În prezent, peste 700 de medicamente și vaccinuri se află în fază de cercetare și tot atâtea speranțe pentru persoanele care suferă de diverse afecțiuni. (sursa www.arpim.ro)

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Noțiuni de bază

Ce este un Studiu Clinic?

Un studiu clinic presupune observarea oamenilor în situații normale, cu scopul de a obține informații medicale suplimentare.

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Considerații participare

De ce merită să luați în considerare oportunitatea de a participa la un studiu clinic?

Prin faptul că participați la un studiu clinic, vă aduceți contribuția la descoperirea de noi informații medicale privind beneficiile și riscurile tratamentului, prevenției și diagnosticului pentru anumite afecțiuni.

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Studii intervenționale și observaționale

În studiile intervenționale, participanții sau voluntarii primesc un tratament specific, trecut în planul de cercetare sau în protocolul realizat de cercetători. Persoanele care iau parte la acest tip de studii clinice pot fi tratate cu medicamente sau dispozitive medicale, proceduri sau modificări introduse în stilul de viață, cum ar fi dieta.

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Ce sunt studiile „blind”?

Studiile „blind” se mai întâlnesc și sub denumirea de studii „mascate”. În studiile „blind”, unui grup de pacienți li se administrează fie un medicament, fie un tratament experimental, pe când un alt grup de control primește fie un tratament standard pentru afecțiunea vizată, fie un placebo (definit ca un medicament „fals” deoarece este inofensiv, denumit și „pastilă de zahăr”), fie niciun tip de tratament.

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Ce sunt grupurile de comparație?

În cadrul studiilor clinice, sunt necesare mai multe grupuri de comparație pentru a putea evalua eficiența unui medicament testat. Astfel, echipa de cercetare împarte toți participanții la studii clinice în mai multe grupuri similare, însă fiecare grup este abordat conform unei strategii medicale diferite.

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Ce este randomizarea?

Randomizarea este o metodă de repartiție aleatoare a participanților în diferite grupuri de comparație, cu scopul de a garanta faptul că diferențele observate de către investigatori sau echipa de cercetare se datorează strategiilor diferite la care au fost supuși participanții, și nu pentru că există anumite diferențe între ei. Un program computerizat este cel care efectuează împărțirea aleatoare a participanților în grupuri de comparație.

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Ce este un protocol de studiu

Pentru a conduce un studiu clinic, este nevoie de alcătuirea unui plan de cercetare denumit protocol. Acesta conține răspunsuri specifice la întrebările cercetătorilor și participanților la studii, în vederea menținerii sănătății lor

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Protecția participanților la studiu

În momentul în care i se cere consimțământul, pacientul sau voluntarul trece printr-o etapă de informare referitoare la studiul clinic respectiv. Informațiile oferite îl vor ajuta să se decidă dacă dorește să participe sau nu la studiul clinic.

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Relația cu sistemul de sănătate

Chiar dacă un pacient se înscrie într-un studiu clinic, acesta poate continua să se sfătuiască și cu propriul medic de familie. O mare parte din studiile clinice pune la dispoziția participanților produse medicale sau intervenții care au legătură cu patologia studiată, însă fără a le oferi și acces la un sprijin medical mai amplu.

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Dicționar de termeni

În cadrul prezentului ghid privind buna practică în studiul clinic sunt valabile următoarele definiţii

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