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Lecture 1
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Lecture notes of 5 pages for the course Clinical Trials and Clinical Development at VU (HC1 van CTCD)
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Lecture 1 Monday morningGCP = good clinical practice = the best guideline ever
There is a commercial side & research side they are co-dependent; You have to research this
because otherwise you will not earn any money. You cannot research this because there is
no money for this.
Most companies are publically owned; they have to keep shareholders happy.
Media does a really good job sketching a skewed image of the big pharma.
1:4 new drugs earn back their development costs -> 75% of the developed products do not
earn back their development costs.
When the pipeline is not interesting enough you have to merge, or buy in new products,
‘licensing’. It is not enough to only have one blockbuster in your pipeline.
Economic downfall triggers big pharma to innovate
The clinical trials are highly regulated.
Development of biotech can be cheaper because the effect rate is higher.
Limiting development
-Availability of products (the lack of knowledge how to use these)
-Availability of money
-> more subjects in clinical trials is not a limiting factor
The pharmaceutical industry is disaster driven.
Only two big things went wrong lately. These both went wrong because of human error not
regulation.
-Normally in phase 1 trials they start with a really low dose in the first patient,
increasing the dose with every patient. This went wrong in the elephant trial. The first
dose was already too high, they reduced time between treatment. By the time they
realized something went wrong they already treated five people.
-2016- France. Without taking into account the patient was hospitalized the next
patient was already treated.
In the Netherlands, there was a problem with a probiotic trial. The control group was
healthier than the case group.
It is not always the product that is to blame. Sometimes other things have to be
taken into account.
Products that are successful are not being used because it is too expensive and not
reimbursed.
, -Heparine example: no idea how it dilutes, effect blood clotting -> patients are not
safe. The new product can accurately dilute but is not reimbursed therefore it is not
used in the Netherlands
There are examples of overprized products but generally pricing is challenged.
PLC (product life cycle) at the end of patent life, it jumps down because of generics.
Companies will do whatever they can to increase patent life.
Import licenses are very hard to get
-If a physician knows to ask, the patients who need it can get free samples. If it is not
going to be reimbursed, you are not going to authorize it on the market because that
is expensive and if people are not going to buy it anyway because they cannot afford
it.
Introduction to clinical research
-Ethical standards
-Sound scientific proof
Facts from the past are not the facts from now, facts that used to be can be proven
otherwise
-Hysteria for woman
It is a society concept, something that we hold to be true but it does not have to be true.
When is something scientifically proven?
-Replicability -> same outcome
-If you try to prove that it is not true, you can’t
CI = 95% in clinical trials
There is a 10-20% chance for a product being rejected if the effectiveness is not high enough.
Companies can decide that even though it is effective it might be very expensive and
therefore not to follow through with development.
What is a clinical trial?
One step in drug development process
Involving human subjects
Investigate new methods of preventing, diagnosing or treating a disease
-Mostly interventional trials
-Sometimes observational trials
-(Non)-industry
Off-label use is mostly not done in non-industry.
Which parties are involved?
-Sponsor
-Investigator/site
-Institutional Review Board/Independent Ethics Committee (IRB/IEC)
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