Abstract
Public health institutions are involved in human experimentations, which is a specific phase of pharmaceutical industry’s production process. These medical centers collect clinical evidence about experimental treatments and, at the same time, they have to guarantee patients’ safety through appropriate Institutional Review Boards. Taking human experimentation into account, this work aims at estimating a public policy designed to reduce transaction costs that are related to the protection system of patients’ rights, with both a normative and positive approach. On the one hand, considering a sample of European countries as counterfactual, an empirical analysis is performed in order to estimate the impact of a national law aimed at harmonizing the procedure to obtain opinions on clinical trials. On the other hand, an alternative law, which might be able to favor the exchange between pharmaceutical companies and patients, is proposed.
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Notes
Clinical trials are conducted in phases. Each phase has a different purpose and helps scientists answer different questions. For each step of this clinical investigation, a specific ethical opinion must be provided by the competent IRB. In details, there are three phases in pharmaceutical clinical research with, according to the National Health Institute, the following features: “…Studies of phase I in which researchers test an experimental drug or treatment on a small group of healthy people (20–80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects… in phase II trials, the experimental study drug or treatment is given to a larger group of people (100–300) to see if it is effective and to further evaluate its safety… in phase III trials, the experimental study drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely…”.
From this prospective, the Informed Consent can be seen as a contract between companies and patients. Upon signing the contract, research subjects become responsible for all the expected risks listed in the document. Obviously, note that all adverse events that are not included in the Informed Consent could be potential unexpected ones. For this reason, the bargaining on this information might be significant. For a deeper analysis of this issue, see Ippoliti (2010).
The European Directive has been applied by all European countries, i.e. both EU members and no members (e.g. Croatia, Switzerland, Norway, Turkey, Iceland and Macedonia).
In case of a negative single opinion, the trial cannot be proposed in that country again. Alternatively, the Directive suggests the possibility of obtaining an opinion from each territorially competent IRB.
For instance, let us assume a clinical trial with 4 medical centers: one coordinator center and three satellite centers. According to the Italian rule, a single opinion from the coordinator center is necessary and, afterwards, other three second opinion from each competent IRB is necessary. The reader can see the National Monitoring Centre for Clinical Trials to explore this phenomenon: http://oss-sper-clin.agenziafarmaco.it.
The average time the coordinator of an Italian Institutional Review Board takes to come to a decision is 35 days, while the satellite takes 50 days. Considering also that the authorization from the institution where the trial is conducted takes time, this means that it usually takes at least 4 months before an exchange can be performed. See AIFA, La sperimentazione clinica dei medicinali in Italia, 8° Rapporto Nazionale, 2009.
Studies of phase I are not considered since healthy subjects are enrolled, whereas studies of phase IV are post marketing trials to gather additional information including the drug’s risks, benefits, and optimal use.
International Monetary Fund, World Economic Outlook Database, April 2010.
Dataset can be download at http://www.freetheworld.com/release.html, whereas published works using the Economic Freedom can be viewed at http://www.freetheworld.com/papers.html#2011 .
According to Hilbe (2011), “…Random-effects estimators are more efficient than fixed-effects estimators when the data come from within a larger population of observations, as well as when there are more panels in the data…”, and “…data coming from a smaller complete data set, with relatively few panels, prefer the fixed-effects estimator…”. This paper assumes that the considered sample could be thought of as the sub-sample of a given potential population.
The author suggests that the pseudo R-square is equal to 1 − (LF/LI), with LF as the log-likelihood of the full model and LI as the log-likelihood of the intercept-only model. Applying the random-effect option to the model, we obtain a pseudo R-square equal to 0.4353 (Medical centers as dependent variable) This result suggests an acceptable level of fit.
The EFGCP report suggests that in Switzerland “…the Lead Ethic Commission makes the ethical decision on the study and the secondary RECs can accept or refuse this decision or eventually add locally determined minor supplements…”; whereas in the Czech Republic “…single-site trial ethical review is done by the relevant Local ethics committee; multi-site clinical trial ethical review is done by an ethics committee for multi-site studies (MEC) (and also by each of the Local ECs)…” .
The reports analyzed to estimate the protection systems of patients’ rights refer to the period from 5/2006 to 8/2009. These reports can be downloaded from the Drug Agency’s website: http://www.agenziafarmaco.gov.it/ .
According to the 5th Report of the Italian National Drug Agency (2007), 78 % of Italian IRbs have been instituted by these general managers. Obviously, these managers are also competent for the appointment of IRBs’ members, which is strictly related.
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Ippoliti, R., Falavigna, G. Public Health Institutions, Clinical Research and Protection System of Patients’ Rights: An Impact Evaluation of Public Policy. Public Organiz Rev 14, 109–125 (2014). https://doi.org/10.1007/s11115-012-0208-5
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DOI: https://doi.org/10.1007/s11115-012-0208-5
Keywords
- Public policy
- Public health organizations
- Transaction costs
- International Review Boards (IRB)
- Clinical research