| Clinical trials are experiments done in clinical research. |
Esè klinik yo se eksperyans ki fèt nan klinik rechèch |
| Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. |
Jan de etid byomedikal oubyen etid rechèch sou konpòtman sa yo fèt sou moun. Yo fè yo pou reponn kesyon espesifik sou entèvansyon byomedikal oubyen konpòtman, men tou nouvo trètman (tankou nouvo vaksen, medikaman, chwa rejim alimantè, sipleman alimantè, ak sèvis medikal) ak entèvansyon yo konnen ki garanti plis etid ak konparezon. |
| Clinical trials generate data on safety and efficacy. |
Esè klinik yo jenere done sou sekirite ak efikasite. |
| They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. |
Yo mennen yo sèlman apre yo fin resevwa apwobasyon komite otorite/etik sante nan peyi kote y ap chache apwobasyon pou fè terapi a. |
| These authorities are responsible for vetting the risk/benefit ratio of the trial - their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted. |
Otorite sa yo responsab pou kontwole pousantaj riks/benefis esè a - apwobasyon yo pa vle di ke terapi a 'san danje' oubyen efikas, sa vle di sèlman ke yo ka fè esè a. |
| Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. |
Tou depan de pwodui a ak nivo nan devlopman an, pou kòmanse envestigatè yo anboche volontè ak/oubyen pasyan pou fè yon ti etid pilòt, epi answit mennen pwogresivman etid konparativ ak plis moun. |
| Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. |
Esè klinik yo ka varye nan gwosè ak nan depans ki fèt pou yo, epi yo ka enplike yon sèl sant rechèch oubyen plizyè sant, nan yon peyi oubyen plizyè peyi. |
| Clinical study design aims to ensure the scientific validity and reproducibility of the results. |
Objektif etid klinik yo se pou asire validite syantifik ak asire ke rezilta yo ka repwodui. |
| Trials can be quite costly, depending on a number of factors. |
Esè yo ka koute chè, tou depann de plizyè faktè. |
| The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. |
Pwomotè a ka yon òganizasyon gouvènman oubyen famasi, yon konpayi byoteknoloji oubyen yon konpayi aparèy medikal. |
| Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. |
Pou kèk fonksyon nesesè nan esè a, tankou swivi ak travay laboratwa, se gendwa yon patnè ekstèn ki jere yo, tankou yon òganizasyon ki fè kontra rechèch ak yon laboratwa santral. |
