All medical investigations carried out on human are considered to be a clinical trial which are done at one or more invstigation places and have a purpose to search information about one or more medicinal products.
identification of adverse effects triggered by the examined preparation
examination of absorption, distribution, metabolism and elimination, harmlessness,
effectiveness, proving of risk-benefit rate of the preparation (non-invasive
examination are not included);
multi-centered clinical trials with the same investigation plan, but at
more than one investigation place in the European Economic Area - EEA, with
more than one investigator, and/or in a third country based on an international
contract with the EEA or EC where the legal status is the same as in the EEA.
Phase I clinical trial: examination of tolerability, pharmacokinetics,
pharmacodinamic effects of the examined preparation on healthy volunteers, or
with a preparation with disadvantageous characteristics from the aspect of relative
harmlessness on patients who will probably show good response to the preparation.
Phase II clinical trial: examination of the pharmacological effect concerning
a particular therapeutic indication with the purpose of proving the therapeutic
effect of the preparation, ascertainment of the dose-effect correlation, determination
of the optimal single and daily dose, observation of side effects.
Phase III clinical trial: proving of safety of the preparation on numerous
patients; controlled, randomized investigation; comparing examinations with
medicinal products owning a marketing authorisation.
Phase IV clinical trial: examinations with medicinal products owning
a marketing authorisation which have already had authorised therapeutic indications,
dose range and approved Summary of Product Characteristics with the aim to collect
further information concerning the risk-benefit rate, to adjust dosing and recognize
the side effects occuring rarely.
Clinical trials which are carried out without the pharmaceutical industry taking
part, by independent investigators from the pharmaceutical industry are
not considered to be commercial investigations. The following criteria have
to be fulfilled:
• concerning the sponsor:
o university, hospital, scientific organization, non-profit institution
or a research worker may act as a sponsor
o owner of the data has to be one of the above mentioned entities
o there cannot be any contract between the sponsor and a third person with
regards to application of the data for a marketing authorisation or marketing
of the product
o sponsor is responsible for planning, coordinating, recording data and reporting
• concerning the clinical trial:
o the investigation cannot be a part of a development programme
o the investigation cannot be applied for a marketing authorisation
In case of non-commercial clinical trials please refer to the §13 and §14 of
Decree No. 35 of 26 August, 2005 of the Minister of Health with the difference
that the following information has to be submitted to the National Institute
of Pharmacy as a simplified investigation plan: reason for the investigation,
number of participants, planned time and method of recruitment.
A rendszeres vizsgálat fontosságáról… Az életkor előrehaladtával egyre több időt kell foglalkoznunk az egészségünkkel és a táplálkozásunkra is oda kell figyelni. Sajnos a modern életformából egyre inkább kiszorul a mozgás és egyre több gyorsétel kerül a gyomrunkba, hiszen a munka és család mellett kevés idő jut a testedzésre és a főzésre.
Virtuális világ és valóságos kapcsolatok Egy vizsgálati jelentés szerint a tizenévesek és barátaik, valamint családjuk közti kapcsolat megsínyli, ha a serdülők sokat nézik a TV-t vagy ülnek a számítógép előtt.
Egészséges étkezés májbetegségben Egyaránt egészségtelen, ha valaki túl kövér vagy túl sovány, ám a hepatitis C-vel fertőzött májbetegeknek különösen ügyelniük kell mindkét véglet kerülésére. Irányadó lehet itt a testtömeg-index, a BMI, a 20 alatti és 30 feletti érték egyaránt kóros.
Achilles-ín szakadás Az angol válogatott sztárja, David Beckham vasárnap este súlyos sérülést szenvedett az AC Milan Chievo elleni mérkőzésén. A 34 éves középpályásnak minden valószínűség szerint elszakadt az Achillese a bal lábában. Mit is jelent ez?
Metakereső
Főoldal
Levél a szerkesztőségnek 
