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International Clinical Trials
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As innovative pharmaceutical companies looking for the next blockbuster
become more active in the clinical trials market in Poland,
understanding the nuances of the legislative landscape in the country is
a critical component for successful drug development.
Recently, the pharmaceutical industry has been facing major issues
because of the patent expiry of many of their blockbuster drugs. Once
drugs lose patent protection, low-price generics are likely to enter
their market and grab a large portion of their sales. With that in mind,
innovative firms have been looking for replacements for their pipelines
and so have been more active in the clinical trials market.
Pharmaceutical companies seeking to control costs have increased their
presence in the central and eastern Europe (CEE) market, an increasingly
popular region in which to conduct clinical trials. Poland is the
largest market in this region, and has the potential to meet this
ever-growing demand. Currently, Phase 3 studies are particularly popular
in Poland, although one can see a gradual increase in Phases 1-2.
Poland’s potential can be measured primarily against the size of the
potential trial subjects’ population and a raised profile of
participation in clinical studies due to the chance to access better
quality medical services and innovative therapies. Poland is also known
to have a substantial number of specialist clinical centres with good
technical bases and well qualified personnel. It is first among the
emerging clinical markets in terms of site numbers. Sponsors are often
impressed by the relatively low costs of such studies, quick patient
recruitment and high clinical standards, which are essential within the
EU.
Poland’s accession to the EU in 2004 triggered an adjustment of Polish
law to meet EU standards. This has made Poland more attractive for
sponsors compared to other CEE countries with similar populations of
potential study subjects, such as Ukraine or Russia. This is due to the
implementation of ICH-GCP standards and approximation of regulations
related to clinical trials and IP rights to European standards, which
have reassured sponsors and guarantee that clinical studies are carried
out to those standards, making the whole process more predictable.
The fact that a large number of studies are carried out in Poland also
affects public perception towards the process of drug testing; potential
study subjects are more willing to participate. Polish legislative and
administrative bodies are more open to adjusting regulations
accordingly, recognising the advantages that clinical trials can bring
to Polish society and its economy.
Use of Clinical Research Organisations (CROs)
In Poland, clinical studies are carried out either directly by sponsors
or through specialist CROs. In recent years, CROs have become more
active in the market and are currently engaged in the majority of
clinical trials in Poland. The co-operation between CRO and sponsor can
be different to elsewhere. Sponsors that are interested in clinical
studies in Poland, and which are not established in any of the EEA
countries must nominate a legal representative in Poland. Such legal
representatives act in the name of, and on behalf of, the sponsor. Often
CROs themselves act as legal representatives; they are party to the
agreements with sites and investigators. On the other hand, some
sponsors, mainly those from the EU, use CROs only for study monitoring,
including in-sourcing when employees of CRO are seconded to a specific
clinical study and work in the sponsor’s offices.
Procedure
A clinical trial can only commence following positive feedback from the
ethics committee and a permit from the president of the drug
registration agency. These should be issued within 60 days from the date
of application, and should comprise the full set of required
documentation. This term can be extended by up to a maximum of 90 days
if there is a need to supplement data or consult an expert. If the
president of drug registration gives a negative decision or the ethics
committee gives a negative opinion, sponsors have the right to appeal.
Informed Consent Form and Case Report Form
The documentation should include information on the study drug, study
protocol, template of the Informed Consent Form (ICF) and Case Report
Form, as well as information related to the site and investigators,
sponsor’s and investigator’s insurance policies and relevant contracts
signed with investigators and sites. The proof of payment of the
application fee must be attached to the application. These documents can
be supplied in English. The only exception relates to the documents
that are to be read by patients – for example the ICF, which must be in
Polish. From the sponsor’s perspective, it is crucial to make sure that
the ICF includes provisions allowing the sponsor and other persons
authorised by the sponsor to have access to the medical records of the
study subject, both during the clinical trial and after its completion.
Costs
Submission of the application is subject to an application fee.
Currently, for clinical trials from Phase 1 through to Phase 3, this is
8000 zł. In the case of bioequivalence studies and Phase 4 clinical
trials, fees are lower. Before commencing a clinical study, both
sponsors and investigators need to have an insurance policy against
civil liability arising in connection with the clinical study. This
obligation arises at the moment of submission of such application. In
practice, the insurance cost is covered by the sponsor. Minimum
guarantee sums are determined in the Decree of the Minister of Health
and are dependent upon the planned number of study subjects. As an
example, if there are fewer than 10 study subjects, the minimum
guaranteed sum will be €500,000.
Sponsors will also be obliged to cover the cost of the purchase and
delivery to the site of the study drug, comparators and devices
necessary to administer both. Additional costs will include any medical
treatment that is indispensable to qualify the patient for the clinical
study, covering the cost of treatment at the stage of screening and the
cost of medical procedures which have to take place in connection with
the study drug or which are necessary to eliminate the effects of health
complications resulting from the application of the study drug. Where
the given medical procedures do not take place in connection with the
recruitment to the clinical study or bear no relation to the
administration of the study drug, their cost should be covered by the
National Health Fund.
Clinical Trials Agreements
Unlike British legal jurisdictions, where clinical trials are conducted
by the sites employing medical doctors-investigators who conduct the
clinical studies, in Poland it is the investigator him or herself who is
responsible for conducting such studies. The role of clinical centres,
most commonly major hospitals or clinics, is only of a supportive
nature. It is worth pointing out that specialist sites are also being
established where doctors are only employed to conduct clinical studies.
Such centres, however, are engaged mostly in less complicated clinical
studies that, in principle, do not require the patients’
hospitalisation.
It is a legal requirement that the sponsor should sign a clinical trial
agreement with both investigators and the site. These can be two
separate agreements (a contract between sponsor and investigator and a
contract between sponsor and the site) or, as is becoming more and more
popular, a tripartite agreement.
Under Polish legislation there is no official template for clinical
trial agreements. However, after years of practice certain standards
have been developed and are in common use. Apart from obvious
confidentiality provisions (in particular as regards statutory audits)
and provisions aimed at protection of intellectual property rights, the
contract should primarily focus on the rights and obligations of the
parties. The principal obligations of the investigator are to:
- Conduct the clinical study in compliance with the protocol
- Run study documentation in a timely manner
- Secure the proper storage and supervision of the study drug
It is the investigator who selects the team of co-investigators and is
responsible for their performance. In light of the significance of IP
protection and confidentiality requirements, sponsors often sign
separate agreements with co-investigators. The site, on the other hand,
commits to give access to hospital premises/wards and to the equipment
needed for the purpose of About the authors conducting clinical trials.
The site is also obliged to allow monitors to monitor the whole process
and to allow hospital employees to perform duties connected with
clinical trials during their working hours.
In the early days, the negotiation process with clinical centres and
investigators was very difficult and time consuming. This has changed
during recent years – both sites and investigators have become more
familiar with the whole process and gained the necessary knowledge and
experience, which allows them to approach contracting and conducting
clinical studies in a more professional manner.
New Regulation
Currently some changes are under way at the European level in relation
to the regulation of clinical trials in medicinal products for human
use, with the proposed adoption of a new regulation repealing Directive
2001/20/EC. As a regulation is binding directly with no need to
implement at a national level, all EU countries will have to comply with
the same provisions for clinical trials that are covered by the
regulation. The regulation will be effective from 2016. |
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