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Transcript of Clinical studies
Development Candidate Market Sources:
Wikipedia “Clinical Trial” Clinical
Phase III Clinical
Phase I Clinical
Phase II Phase 0: “microdosing” “dose finding” “efficacy” “large scale” Phase IV: “surveillance” You have been hired by Lutics Pharma, Tromsø for organising a phase I-III clinical study evaluating their novel cancer compound which in preclinical studies has been shown to bind PKA, PDGF-R, EGF-R and a few others in micromolar concentrations. The compound has been evaluated for ADMET and Lipinski rule for five.
The Boss tells you to work fast and get things done quickly! You are new in the field, but extremely motivated and approach the problem as usually... by checking wikipedia Wikipedia tells you that normally
an investigator/sponsor identifies medication to be tested
a panel of expert investigators identifies which disease to be tested and the comparator (placebo, standard medication for the specific disease etc)
clinical investigators recruit patients with predetermined characteristics and collect data on patients health
the investigators send data to the trial sponsor who then performs statistical tests You (and the boss) decide that EGF-R is a promising target and since EGF-R is activated in a subset of lung cancer patients... You decide to initiate a clinical study comparing your compound with standard treatment in lung cancer Next stepsss? clinical trial protocol
study design (randomized, blind, placebo-controlled, standard of care)
authorities You are about to give up the job!
Good friends advice you to use professional partners to get the job done Too expansive, so you have to trust local resources You convinced a clinician treating lung cancer patients that your compound should be tested in his patients. Together you find out that
an initial phase I study has to be performed
you have to apply the regional ethical comitee
application to other authorities dy Finally, you have recruited
a well experienced phase I study facility
a principal investigator
the study has been applied to REK and REK has no objections to the study
SLV (statens legemiddelverk) has been informed and a EUDRACT file has been admitted
the study has been submitted to www.clinicaltrials.gov
according to your clinical trial protocol 20 patients with cancer disease will be included in the study The compound has successfully passed phase I and you and the company know more about dosing and side effects. As a next step you want to find out if the compound is effective against lung cancer and you want to evaluate the frequeny of initial side effects.
What to do now? Phase II clinical study
to show that your compound is better than standard treatment
a statistician tells you that if your study aims at power of 80% you should include at least 50 patients in each arm
need for clinical study protocol, new study centers, multicenter study
Lutics Pharma need partners in order to perform this type of studies Lutics signs a contract with "Shark pharmaceutical" in Nevada and the new bosses tell you to hurry up and organise a phase III clinical study You recruit even more clinical study centers, write a new clinical trial protocol and prepare all applications to REK, SLV, Eudract files etc. The phase III clinical studies have to be performed european-wide in order to include enough patients.
At the same time the bosses tell you to prepare applications to FDA and EMEA in case studies are succesfull! Yipppieeeee!
Phase III study shows that the compound increases survival for lung cancer patients by 2,5 months and is not to toxic. FDA and EMEA accept the drug for third line treatment of lung cancer and at the same time ask for biomarkers. According to one of the research veterans in Lutics initial studies on the compound have shown that cells expressing EGF-R highly on the surface immediatly went into apoptosis when exposed to the compound. On the basis of that observation "good responders" from clinical studies where sequenced for EGF-R and other candidate genes and an identical point mutation in the EGF-R kinase domain is identified in 50% of these cases. Clinical Studies You are bored of all protocoles, biomarkers, clinical investigators, power calculations, study phases, decide to sell your Lutics stocks and become a writer... Finally
the compound represents first line treatment for all patients with lung cancer harbouring an EGF-R mutation or overexpressing EGF-R
Lutics pharma was after successful phase II bought by big pharma
and You were asked to organise more phase III and IV studies by the new bosses, but...