Clinical Utilization of Newly Approved Oncology Medications
Clinical Utilization of Newly Approved Oncology Medications in Middle Eastern Population
The efficacy and safety of different medications vary from one individual to another and from one ethnic group to another. Therefore, strong interest in the study of pharmacogenomic and pharmacoepidemiology has evolved recently.
There are multiple examples of oncology drugs being more effective in certain ethnic population compared to other. For example, irinotecan combined with cisplatin was very effective drug in the management of small cell lung cancer in the Japanese patients while an identical study done in the US revealed no major benefit to this combination in American population
Studieoversigt
Detaljeret beskrivelse
Another example is having more benefit drawn from tyrosine kinase inhibitors (Erlotinib or Gefitinib) in Asian patients.
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Many new oncology drugs are being used in Middle Eastern countries including Saudi Arabia for different indications without being studied in the Middle Eastern population. These medications' efficacy and safety profiles may differ from those patients studied for drug development and approval due to difference in population's characteristics.
The goal of this study is to observe, summarize and report the patterns of the use of these drugs and describe their efficacy and safety profile in the early phases of their use.
The investigators aim is to build on the existing experience and knowledge by utilization of classic methodology and approaches on a larger scale and more effective way to paint picture of the performance of a certain therapy in the real life world. The use of prospective design will help evaluate the efficacy and safety of therapies already used in practice, generate new hypothesis, and/or determine the outcome of certain diseases.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Riyadh, Saudi Arabien, 11426
- Rekruttering
- King Abdul Aziz Medical City for National Guard Health Affairs
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Kontakt:
- Oncology Research
- Telefonnummer: 14601 0096612520088
- E-mail: oncologyresearch@ngha.med.sa
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Kontakt:
- Abdularahman Jazieh, MD,MPH
- Telefonnummer: 14688 0096612520088
- E-mail: jazieha@ngha.med.sa
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Riyadh, Saudi Arabien
- Rekruttering
- King Abdul Aziz Medical City for National Guard
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Kontakt:
- Nagham RZ Sheblaq
- Telefonnummer: 53352 009668011111
- E-mail: sheblaqn@ngha.med.sa
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Kontakt:
- Telefonnummer: 53352 009668011111
- E-mail: sheblaqn@ngha.med.sa
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Ledende efterforsker:
- Nagham RZ Sheblaq, BS.c
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- All patients with cancer or hematological malignancies receiving new oncology medications (defined as a medication in the first five years of their introduction to the ME market
- Patient accepts to participate in study and signing consent form
Exclusion Criteria:
- None
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Descriptive measures of the pattern of use of the new medications in our population
Tidsramme: 3 years
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3 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Measuring the efficacy in terms of response
Tidsramme: 3 years
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3 years
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Measuring the efficacy in terms of progression-free survival (PFS)
Tidsramme: 3 years
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3 years
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Measuring the efficacy in terms of overall survival (OS)
Tidsramme: 3 years
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3 years
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- RC15/097/R
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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