| Clinical trials are experiments done in clinical research. |
Il-provi kliniċi huma esperimenti li jsiru fir-riċerka klinika. |
| 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. |
Studji tar-riċerka prospettivi bħal dawn dwar il-bijomediċina jew l-imġiba fuq parteċipanti umani huma mfassla biex iwieġbu mistoqsijiet speċifiċi dwar l-interventi bijomediċi jew dwar l-imġuba, inkluż kuri ġodda (bħal vaċċini, mediċina, għażliet tad-dieta, supplimenti tad-dieta ġodda u apparat mediku ġdid) u interventi magħrufa li jippermettu aktar studju u tqabbil. |
| Clinical trials generate data on safety and efficacy. |
Il-provi kliniċi jiġġeneraw dejta dwar is-sigurtà u l-effikaċja. |
| They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. |
Dawn isiru bss wara li jkunu rċivew approvazzjoni mill-kumitat tal-awtorità tas-saħħa/tal-etika fil-pajjiż fejn tkun imfittxija l-approvazzjoni tat-terapija. |
| 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. |
Dawn l-awtoritajiet huma responsabbli biex jinvestigaw il-proporzjon bejn ir-riskju u l-benefiċċju tal-prova - l-approvazzjoni tagħhom ma tfissirx li t-terapija hija "sigura" jew effettiva, iżda biss li tkun tista' ssir il-prova. |
| 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. |
Skont it-tip tal-prodott u l-istadju tal-iżvilupp, l-ewwel l-investigaturi jirreġistraw voluntiera u/jew pazjenti fi studji piloti żgħar, u sussegwentement iwettqu studji komparattivi progressivament ta' skala ikbar. |
| 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. |
Il-provi kliniċi jistgħu jvarjaw fid-daqs u fl-ispiża, u dawn jistgħu jinvolvu ċentru wieħed ta' riċerka jew ċentri multipli, f'pajjiż wieħed jew f'pajjiżi multipli. |
| Clinical study design aims to ensure the scientific validity and reproducibility of the results. |
It-tfassil tal-istudju kliniku għandu l-għan li jiżgura l-validità xjentifika u r-riproduċibilità tar-riżultati. |
| Trials can be quite costly, depending on a number of factors. |
Il-provi jistgħu jiswew ftit flus mhux ħażin, skont numru ta' fatturi. |
| The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. |
L-isponsor jista' jkun organizzazzjoni governattiva jew kumpanija farmaċewtika, tal-bijoteknoloġija jew tal-apparat mediku. |
| 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. |
Ċerti funzjonijiet meħtieġa għall-prova, bħall-monitoraġġ u x-xogħol fil-laboratorju, jista' jiġi mmaniġġjat minn sieħeb estern, bħal organizzazzjoni ta' riċerka ta' kuntratt jew laboratorju ċentrali. |
