Transcript Slide 1

Comparing emerging ethical issues
and legal differences impacting on
European clinical trials
David L Edbrooke, Veselina KanatovaBuchkova, Josef Kure, Gary H Mills, Fruzsina
Molnar-Gabor, Maria Nastac, Daniel Sinclair,
Judith Sinclair-Cohen, Sandy Smith, Guido Van
Steendam, Darina Zinovieva.
A PowerPoint summary of
“Comparing emerging ethical issues and legal
differences impacting on European clinical trials”
A framework 6 EU project
“TWR”
PL016621
Powerpoint compiled by Gary H Mills and MERCS
This PowerPoint presentation is intended as a read through
learning guide and aid to the project and associated areas.
It is intended that it can be translated and adapted to the
needs of individual researchers in the group. If you aim to
use it as a lecture guide, you may wish to first summarise
the points made for ease of presentation.
(TWR Project PL016621)
•
This qualitative study was a specific support
action of FP6.
•
Its purpose was to explore emerging ethical
differences during the design, conduct and
analysis of clinical trials in a representative
section of countries in the EU, with an
emphasis on New Member States (NMS).
•
In all, almost a hundred researchers from
some fifty institutions in twenty countries
were recruited, for the identification and
comparison of emerging ethical issues and
legal differences in clinical trials
•These issues should assume greater
importance with closer working of
member states.
•Networks in relevant disciplines were
formed across countries and new
academic relationships were forged.
•Advisory groups were formed from
experts in the fields of ethics, clinical
practice, law, health economics,
theology, culture and technology. A
multi-disciplinary group of young
researchers was also created.
Group coordinators
• David L Edbrooke: economics
• Veselina Kanatova-Buchkova:
law
• Josef Kure: ethics
• Gary H Mills: clinical practice
• Fruzsina Molnar-Gabor: young
people
• Maria Nastac: culture
• Daniel Sinclair: theology
• Judith Sinclair-Cohen: report
coordinator
• Sandy Smith: project
coordinator
• Guido Van Steendam:
philosophy
• Darina Zinovieva: law
History of clinical trials
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4.
Probably the first record of a
clinical trial is in the bible in
The Book of Daniel.
King Nebuchadnezzar,
ordered that several youths
be brought to his palace, to
be fed and taught just like his
own children.
This included Daniel, who
proposed that they be
allowed to eat "pulses" and
to drink water instead of wine
and meat.
After ten days they appeared
healthier than the other
children.
Therapeutic
interventions
1.
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3.
The first clinical trial of a
therapeutic interve is
attributed to Ambroise
Paré (1510 -1590),
who used egg yolk and
turpentine to heal a
wound.
He found that turpentine,
was far more efficient at
healing the wounds of
soldiers, than the stateof-the-art remedy:
boiling oil!
Limes and clinical controlled trials
1. In the 18th century clinical trials began to be
used routinely to test new medical treatments.
2. Often consent not truly implemented at this time
3. James Lind used control groups, when he
showed that citrus fruit prevents scurvy.
4. A group of sailors in the British Navy who had
oranges and lemons added to their diet
improved dramatically in just 6 days, in
comparison with a group that didn't get the fruit.
5. Later replaced by cheaper limes
Physicians testing remedies on
themselves
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2.
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4.
Often physicians would first
test potential remedies on
themselves, or on relatives.
The English physician
Edward Jenner developed
the smallpox vaccine in
1789
he first tried inoculating his
own son, who caught
smallpox anyway.
Several months later, he
inoculated a neighbour's
child, who didn't get the
disease
Childbed fever
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3.
4.
During the 19th Century, clinical
trials became larger and more
organised.
Ignaz Semmelweis (1818-1865)
from Hungary, observed that the
mortality rate of mothers from
childbed fever was far lower
among patients treated by
midwives rather than doctors.
He dramatically reduced the
death rate of new mothers by a
simple experiment that started a
hand washing policy for doctors
and medical students.
And in a controlled trial using a
chloride of lime solution, the
mortality rate fell to about 2%,
which was about the same level
as the women delivered by
midwives.
Trials where case history says
death without treatment is likely
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2.
3.
In France, Louis Pasteur
(1822-1895) was aware of
the ethical implications of his
work.
He spent many years
developing an antidote for
rabies.
Yet he only tried it out on a
nine-year-old boy, who had
been bitten by a rabid dog,
after two colleagues assured
him that the child would
certainly die without
treatment. The boy lived.
Yellow fever and healthy volunteers
1.
Dr Carlos Finlay believed the Aedes aegypti
mosquito carried yellow fever
2. The mosquito was carrying the disease by
biting infected people and then when healthy
people were bitten, they received the
disease
3. However, the virus needed to incubate for
12 days inside the mosquito
4. Unfortunately Finlay was attempting to
inoculate volunteers using mosquitoes that
had only recently been infected
5. Dr Walter Reed tested this work further to
determine the mode of transmission:
6. He built two small buildings through which
air could circulate freely to determine
whether the disease was airborne.
7. In one building volunteers slept on the
sheets of yellow fever patients
8. In the second building, volunteers slept next
to infected mosquitoes, but were protected
by screens
9. Unlike Finlay work these had been infected
for a long period
10. Then one volunteer was directly exposed to
infected mosquitoes
11. He was the only one to develop yellow fever;
demonstrating the link
19th and-20th centuries: placebos
and randomisation
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6.
There was enormous progress
in Medicine during the 19th
century.
Placebos were first used in the
1860s
Randomisation of clinical trials
started later in the 1920s
Yet cures were still largely based
on clinical observation – such as
the dramatic effect of insulin
given by Banting and Best to a
dying boy
In the 1800s and early 1900s
many dangerous medical
practices, such as bloodletting,
were still common.
During the late 20th century the
double blind randomised
controlled trials became
common where feasible
Vulnerable populations
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2.
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4.
In the years before World War II
many doctors, believed it
acceptable to conduct
experiments on vulnerable
populations
Infants, condemned prisoners,
and mentally handicapped
people were frequently used in
medical experiments
These experiments were not
regarded as unethical at the
time
As late as the 1950s seminal
studies on the development of
dental caries were carried out in
institutions for the mentally
handicapped in Sweden and
Australia
The Helsinki declaration
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6.
The experiments imposed on inmates of
Nazi concentration camps during World War
II led to the development of a strict ethical
code for the conduct of clinical trials: the
Nuremburg Code (1947).
This primarily included the principle of
voluntary consent.
It also stated that studies should be based
on the results of animal experimentation, be
well designed, be conducted by qualified
personnel and have a degree of risk
appropriate to the humanitarian importance
of the problem to be solved.
In 1964, the World Medical Association
issued the Helsinki Declaration which further
promoted ethical, legal, and procedural
protection for patients
Under certain circumstances, it allowed for
experimentation on children and on those
unable to give consent. This, for example,
allowed for trials on patients with mental
illness, and in paediatrics
Yet ethical questions surrounding clinical
trials remain and regulation is always
necessary to ensure a balance between
medical progress and patient safety
The present position in the EU
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6.
The expansion of Europe has lead to
inconsistencies in European research
ethics
The European Research Area (ERA)
relies on the transfer of knowledge
between countries
It is important for Europe to harmonize
ethical standards of all its researchers
Such comparative research of these
issues is at present limited
The challenge is to discern variations
in local, national and international
customs and practice, whilst
developing new ways of discovering
and understanding the emerging
ethical and legal issues for clinical
trials in Europe today
Failure to understand these
differences could mean that the
results of clinical trails, and their
interpretation, could be compromised
and biased
The project
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6.
There are differences in ethics between countries,
there are also differences across disciplines
So for this study a scientific committee of leading
European researchers was formed to represent a
broad spectrum of disciplines: ethics, law, culture,
clinical practice, theology, economics and
technology
Intensive networking – through meetings and email
- allowed advisory groups in each of these
disciplines to be formed across thirteen countries in
Europe, with a particular emphasis on New Member
States (NMS)
During this process it became apparent that citizens
of New Member States, who reached adulthood
after the fall of communism, held different
perspectives to their older peers, so a further
advisory group for ''young persons'' was set up
A set of questions, on the subject of clinical trials,
was developed by the team of experts, which were
then adapted to each of the relevant disciplines
Responses were collated via the networks to
produce working documents for discussion and
qualitative analysis at a meeting in the Czech
Republic
Three ethical approaches: Communitarianism,
Utilitarianism, Liberalism.
1. This project also
explored the source of
ethical arguments and
the common ethical
framework applied to
the area of clinical trials.
2. A basic comparative
ethical analysis was
undertaken using three
different paradigmatic
frameworks, namely
communitarianism,
liberalism, and
utilitarianism.
Communitarianism and clinical
trials
1. One would expect that a non-extreme form of classical
communitarianism, whether in its broad or narrow sense, but
always focussed on the concept of the good of society as a
whole, would play a vital role in these countries today.
2. However, we did not find this to be the case.
3. It seems that a form of relativist communitarianism i.e. the
belief in the need to respect for individual societies, and their
cultural, moral, and religious traditions, is more prevalent
than classical communitarianism with its emphasis on the
good of a single universal society.
4. In the context of clinical trials, for example, this means that
the development of new therapies, new drugs or new
medical devices for the common good - with a universal
impact and global contribution - is regarded with a great deal
of scepticism.
Utilitarianism and clinical trials
1. It was also evident that liberal and libertarian views carried greater weight
in ethical arguments regarding clinical trials than the pure utilitarian
position
2. The classical pure utilitarian thesis i.e. the greatest happiness for the
greatest number of people does not, therefore, provide support for
participation in clinical trials in Europe.
3. Moreover, pure utilitarianism runs counter to the scepticism we mentioned
above with regard to the principle of the greatest happiness, or for that
matter benefit or profit, for the greatest number,
4. In the context of clinical trials, it seems, therefore, that popular
perceptions justifying participation in clinical trials are not driven by pure
utilitarian philosophy.
5. Similarly the second thesis of utilitarianism, about diminishing pain and
the health-related troubles of the greatest number (the maximum good
over the minimum pain) does not fit the rather skeptical expectations of
the general availability of new medical tools developed by clinical trials.
6. In general the theory that the morality of any action is defined by its utility
is not used as the common ethical argument in favour of clinical trials.
Liberalism and pragmatism
1. The findings of the project demonstrate that the most popular approach to clinical
trials, was liberalism. Liberalism is especially accepted in its negative form.
2. This approach respects the rights of the individual, but insists that the realisation of
such rights cannot be achieved at the expense of the rights of another individual.
3. Thus, pure egalitarian liberalism is of less importance in Central and Eastern
European countries than the libertarian approach.
4. For the libertarian approach, regulation in general - and particularly in the area of
clinical trials - is often perceived as restrictive.
5. Similarly the need for harmonisation and standardisation with respect to clinical trials
on the European or global level is not in line with the libertarian approach.
6. This approach, enables the maximization of profit for some entities involved in
clinical trials, but does not necessarily bring profit for all patients, such as access to
the new therapies that are developed.
7. We also found pragmatism to play a significant role. We asked why it is that so many
people in NMS take part in clinical trials. For despite skepticism about the profit of
the universal community, people in many Central and Eastern European countries
decide to take part in clinical trials for pragmatic reasons: they perceive that they will
get substantially better medical care, by taking part, than through standard health
care in their countries.
8. In conclusion, we perceive this pragmatic motivation as a challenge both on a
national level for health care systems; and on a European level with respect to
harmonisation of ethical standards.
Ethics issues that were considered
1. Are there any specific Ethical influences in your country, which would have an effect on the
design, conduct and analysis of clinical trials?
2. Informed consent:
How is the concept of informed consent perceived by patients, physicians (medical
personel), and researchers in general?
Describe how the principle of informed consent is being implemented in your country for
clinical trials?
How could the practice of informed consent be improved in your country?
3. Ethical standards:
How (international/European) ethical standards are implemented in clinical trials?
How European standards could improve ethical quality of clinical trials in New Member and
Candidate States?
4. Ethics Committees:
How do see the current role of Ethics Committees?
How is the responsibility to the community of Ethics Committee members perceived in
your country?
How could their role be improved?
5. Conflict of interests:
How is conflict of interests perceived (e.g., social acceptance) and regulated in your
country?
Are conflicts of interests increasing/decreasing/remaining the same)
Ethics responses: key points
1. Many issues were identified in a qualitative assessment of the ethics of clinical trials in
NMS. The most important were found to be the principle of informed consent, ethical
standards, the workings of ethics committees, conflicts of interest and lack of
education.
2. The principle, not just the practice, of informed consent is more important than ever.
Consent should be truly informed and the researcher has a duty to make sure that the
patient understands the potential risks and benefits of taking part in a trial. Alternatives
to the trial should also be pointed out.
3. International standards can improve the standards of ethics in NMS but this is a long
process still in its infancy. Further work is needed in order to implement ethical
principles effectively.
4. Specific emerging issues need to be identified for each country and there is a need for
hard data rather than anecdotal evidence.
5. There is a need to improve the workings of research ethics committees. Members
should have the relevant professional, or lay, background yet be free of any conflict of
interest.
6. There is a need for transparency, appropriate training in ethics and accountability.
Members of ethics committees need to be socially aware.
7. More public involvement is needed in the debate on ethical issues, so that the
perceptions and sensitivities of ordinary people can be included in this process.
8. Education for the public on ethics is a necessary precursor to such involvement.
Clinical Practice issues considered
1. Are there any specific Clinical Practice influences in your country,
which would have an effect on the design, conduct and analysis of
clinical trials?
2. Does the availability of provision of healthcare in your country and
the type of provision such as private, state, insurance based affect
the design, conduct and analysis of clinical trials or affect medical
research
3. Do the hospitals support research and clinical trials for example by
providing insurance protection “indemnity”, time, peer review,
statistical advice and a research friendly atmosphere?
4. Are patients in your country generally willing to take part in clinical
trials/medical research and why? Does this vary with different types
of research or the type and severity of illness or the age and sex of
the patient?
5. Are there any traditional or established medical or clinical practises
or clinical organisational issues that affect the design, conduct and
analysis of clinical trials or research
6. How has European law and its local national implementation
affected the design conduct and analysis of clinical trials and
research?
Clinical Practice: key points
1.
Standards of ethics committees and procedures may be improving, but this is not universal and the
process is not uniform; nor is it consistently applied across member states. For example, in Latvia,
ethics committee approval only covers drug trials. This is an astonishing inconsistency
2. Research is becoming disproportionately bureaucratic in some states, which:
-discourages research and impedes the success of some legitimate projects
-diverts effort away from good project design - indeed some abandon research or go overseas
-deters researchers from taking part in clinical research and makes them more likely to carry out
animal or molecular research, where productivity is greater as bureaucracy is less
3. The composition of ethics committees varies greatly between member states. Some are
knowledgeable and demonstrate independence others lack both knowledge and independence
4. Ethics committees are afforded low professional status; if there is remuneration for members it is low.
Yet this is an onerous and responsible role that should be valued by professionals and public
5. Commercial research, by pharmaceutical companies, predominates in new member states
6. There is a both a lack and decline in funding, time, support and facilities for independent scientific
research. Hospital support for independent scientific research is declining, concentrating on cost
versus patient turnover.
7. Private medicine is taking a greater hold on health care, but in this sector research is virtually absent
8. EU law has not produced a uniform approach to the adult who is unable to give consent. As a result
research in fields such as intensive care and emergency medicine is impossible in some states
9. Standardised ethics forms, processes and documentation are needed within member states, and
throughout the EU, in order to make the ethics application process less bureaucratic and more
uniform and effective.
10. This should avoid the need for complex, different and multiple applications, when various institutions
consider the same study
Law issues that were considered
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2.
3.
4.
5.
Are there any specific Law influences
in your country, which would have an
effect on the design, conduct and
analysis of clinical trials?
Concerning clinical trials legislation
how is the Protection of Subjects of
clinical trials – inform consent,
procedures, persons with disability
dealt with in your country
Does the law in your country deal with
Personal data and its protection?
Does the law of your country ensure
the Implementation of good clinical
practices in the conduct of clinical
trials on medicinal products for human
use?
How does the law affect the
Management of Ethics Committees –
organization of activity, financial
organization, other problems?
Law: key points
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4.
The main legal principle involved in clinical trials is
that of the patient's informed consent to the
procedure to be carried out.
In most countries the individual should consent to the
trial explicitly and in written form.
This is once he/she is acquainted with the essence
of the procedure, the desired effect and all possible
side effects from the trial or from any medication.
Another main legal principle that should be followed
in the process of clinical trials is that the individual
should be a legally capable person; that is, a person
who is able to understand the legal consequences of
their actions.
In most countries there is an exception to this
principle when informed consent is given by a
guardian or other legal representative, but there are
also countries in which such a clinical trial carried out
on legally incapable persons is forbidden.
In each of the countries, the main requirement of the
administrative procedure regarding clinical trials, is
obtaining the permission of an ethics committee.
This committee appraises the ethical issues arising
form a specific trial. In most countries the permission
of the Ministry of Health, or head of a certain
department or hospital is also required.
The question of liability in cases of death or damage
to a person's health is legally regulated in each of the
countries in this study.
However, it became clear that, in some of the
countries in question, there is a problem with
enforcement.
The application of legally prescribed penalties
legislation is not effective and this allows for “nonpunishable” actions of the medical staff towards the
patients.
Economic issues that were
considered
1. Are there any specific Economic influences in your
country, which would have an effect on the design,
conduct and analysis of clinical trials?
2. Should hospitals and health care professionals benefit
directly from undertaking clinical trials? How should this
be done?
3. The answers suggest that the enthusiasm about clinical
trials is inversely proportional to the GDP of an individual
country. Is this ethical and how can this best be
managed?
4. Should there be stringent regulation in the EC about
management and conduct of clinical trials? If so what
form should it take?
5. Should commercial companies have to pay a fixed price
in all EC countries to avoid pricing to market?
Economics: key points
1. Patients in NMS can be eager to participate in clinical trials as they feel that they will
gain access to treatment, medication, diagnostics and medical attention that might
otherwise be unavailable.
2. Setting up clinical trials in NMS can be attractive to companies.
3. The majority of clinical trials in NMS seem to be drug trials sponsored by
pharmaceutical companies.
4. A clinician's decision to conduct a trial can be influenced by financial incentives.
5. Remuneration for trials can be direct or indirect and there was some discussion as
to whether the level of remuneration should be the same for all countries.
6. Participation of clinicians from NMS in clinical trials, can provide, prestige,
continuing education and professional opportunities for researchers.
7. Patients in NMS may only be able to obtain certain medication if they enroll in a trial.
8. Clinicians deserve to be paid for conducting trials as they are carrying out work and
are shouldering responsibility.
9. It was observed that the enthusiasm for clinical trials appears to be inversely
proportional to the GDP for a country which can predispose to exploitation. Some
creative solutions were proposed.
10. All felt that there should be uniform and effective regulation by the EC. The question
was what form this should take and to what degree it could be enforced.
11. A need was identified for an international system for compensation for patients, in
the case of an adverse outcome.
Theology issues that were
considered
1. Are there any specific Theological influences in your country, which would
have an effect on the design, conduct and analysis of clinical trials?
2. Is the basic attitude of the religious establishment in your country towards
clinical trials totally negative, entirely positive, or permitted within certain
Limits? Please explain your answer.
3. What is the position of the religious establishment in your country on the
following issues?
(a) Clinical trials using healthy subjects with minimal risk
(b) Clinical trials using healthy subjects with significant risk
(c) Clinical trials using terminal patients which are designed to produce a
cure
(d) Clinical trials holding out the promise of improved quality of life to
chronically, but not terminally ill patients
(e) informed consent in clinical trials
(f) The commercial aspects of clinical trials
4. What actual influence, if any, does established religion have on clinical
trials, and what, if anything can be done in order to improve the dialogue
between religion and science in this area?
5. Under which conditions, if any, is your religious establishment prepared to
permit embryonic experimentation, and in particular, stem cell research?
Theology: key points
1. It was generally agreed that principle of running clinical trials was not fundamentally
problematic from a religious perspective, provided they complied with the ethical
safeguards laid down in the Declaration of Helsinki.
2. In principle there is not a religious opposition to the paying of subjects participating in
clinical trials.
3. In many countries the participation of religious experts in medical ethics committees, is
ubiquitous. In some countries, such participation is mandated by law or statutory
regulations. This may reflect a widely held assumption that religious experts, by dint of their
strong convictions, are likely to be trustworthy ethical watchdogs.
4. There are certain substantive areas in which there is strong religious opposition to
research; most notably in research involving gamete manipulation, embryonic tissue and
stem cells.
-It is important to emphasize that there are differences amongst the religions in these
areas.
-Many religious traditions have a long history of primary and secondary principles in these
areas, and often employ a sophisticated casuistic approach in order to apply them to the
case under discussion. Sometimes the result is unexpected.
5. It is important to develop a dialogue between scientists and religious experts in order that
both disciplines are able to co-operate in a fruitful fashion. Scientists can help religious
experts understand the intricacies of their field, and theologians can share their values and
principles with scientists.
6. Today, there are many temptations to cut ethical corners, hence the need for a sense of the
"sacred" as well as the ethical in relation to these issues.
7. In Europe an open and serious dialogue in an atmosphere that is conducive both to
science and religion is imperative. A religious cadre, educated in science would help this
process
Cultural issues that were
considered
• Are there any specific Cultural influences in your country, which
would have an effect on the design, conduct and analysis of
clinical trials?
• How much do the patients in your country agree with medical
experiment on them?
• How much are people willing to accept medical experiment on sick
persons: either themselves, relatives, or close friends?
• How does the press (in your country), the media react – generally,
to experiments made by human beings?
• Do doctors easily recommend medicines and techniques
insufficiently known, or with uncertain results?
Culture: key points
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9.
The meaning of culture was explored and found to be of a national humanistic intangible nature.
Culture is more broadly based than Science.
There don't appear to be cultural influences that affect the design, conduct and analysis of
clinical practice, that are country specific. Although there are cultural characteristics, common to
the Czech Republic and Romania that emerged, such as implicit trust of patients in their doctors;
in Romania, this results in relatively high patient compliance for clinical trials.
The sensitivities of medical experimentation on individuals was discussed. It was found that
people are more cautious with medical experimentation on close ones, than on themselves.
The press can be distrustful of human experimentation, sometimes with good reason.
Doctors are usually wary of recommending medicines and techniques that are insufficiently
known or that have uncertain side effects on patients.
Cultural aspects are often associated with religious traditions.
More work is needed for a deeper understanding of cultural influences on the practice of clinical
trials in Europe. It is hard to cover the differences between countries in just a few questions.
Research involving a greater number of countries is needed. Such research should be
quantitative as well as qualitative.
The impact of globalisation on culture cannot be ignored.
Scientists are used to the concepts of uncertainty and debate. However this does not fit well with
sound bite journalism. Scientists need to be more aware of the limitations of the press and the
need to prepare media-friendly statements. Such statements should not overdramatise findings
and should be communicated in language that is clear to the non- expert.
Technology issues that were
considered
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2.
3.
4.
5.
Are there any specific technological
influences in your country, which
would have an effect on the design,
conduct and analysis of clinical
trials?
Do new medical technologies go
through a controlled clinical trial
process before general use in your
country?
Is ethical approval obtained before
the use of newly designed medical
equipment on patients?
Is there any exemption for locally
(University or hospital) designed
equipment (as apposed to that
produced by a large manufacturer).
Are there any local (government or
charitable bodies) grants available
for the development of new medical
equipment?
Technology: key points
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10.
11.
12.
13.
No specific technologies were found to have an effect on the conduct and analysis of clinical
trials.
The CE mark is accepted as the quality standard for technological devices.
In all EU countries new medical technologies go through a controlled clinical trial process before
general use; apart for Slovenia, where only a CE mark is necessary.
CE marking is helpful as a quality standard across Europe, although this is expensive and difficult
to obtain for a new product. This makes local development more complicated and difficult. Some
potential products have disappeared rather than go through the lengthy process.
In most countries ethical approval is obtained before the use of newly designed medical
equipment on patients.
Sometimes there is exemption for locally - University or hospital - designed equipment, as
opposed to that produced by a large manufacturer.
In almost every country there are, either government or public funds available for the development
of new medical equipment, although competition is usually fierce.
It is important to facilitate European projects that enable citizens of NMS to gain expertise and
access to finance to conduct clinical trials on medical technology.
Ethics requirements for the development of medical technologies are diverse across Europe. It
would be helpful to have more information on this subject, but as change is rapid in this area any
data collected would quickly become out of date.
The cost and complexity of obtaining patents is high; this makes EU technology vulnerable.
The formation of a European Ethics Committee, upholding minimal, basic ethical standards could
help harmonize standards for all states, especially NMS.
To register a technological device in Europe is difficult; it is a much more complicated process
than for a new drug. A standardised registration process is needed to facilitate full European
economic potential and competitiveness
In some countries there can be a discrepancy between official regulations and what actually
happens.
Young People's Advisory Group
1. This group considered the ethics of clinical trials in Europe a hot topic for
debate.
2. They considered that Europeans usually take an individualistic approach and
therefore put individual safety before the benefits of society as a whole.
3. This attitude is not helped by the media which generates mistrust of the medical
profession.
4. In the cultural context, religion has a small but significant role to play in ethics.
5. Historical influences can be strong; citizens of post communist countries
perceive themselves as narrow-minded. This can express itself in the distrust of
governments, conservativism and fear.
6. Apart from inter-country variations in ethics, there are also differences between
the views of professionals and the perceptions of the public. Little value is put
on these perceptions and the public is largely excluded from the debate.
7. Often factors that influence the agenda are political and economic rather than
ethical.
8. There are always fresh issues emerging which cannot be anticipated. Laws are
usually made in response to an ethical dilemma, rather than the other way
round.
9. There is a need to educate health professionals and the public on ethical
issues.
RECOMMENDATIONS
• Were made for the major stakeholders in
clinical trials, namely researchers, ethics
committees, policy makers and the public
Researchers
1. There is a clear gulf between the demands for documentation required in
different states of the EU
2. In some it is prohibitively bureaucratic and hampers, or in some cases
prevents clinical research from taking place
3. In others documentation is inadequate; a situation that can compromise the
quality of research as well as patients' dignity, health and safety.
4. To overcome this, the following investment by the EC should be considered:
5. Basic research infrastructure to be made in all EU countries. This should be
available, accessible and affordable (preferably without charge) to the
researcher. This would for example, include access to academic libraries
6. National networks of experts in statistical analysis and clinical trail design to
be made available in each EU country.
7. Lists of experienced researchers, willing to mentor less experienced
colleagues in NMS, to be made available on an official EU website
Ethics Committees
1. The composition, standards and functioning of ethics committees vary widely
between countries. To overcome this, the following recommendations
should be considered
2. Guidelines for the formation and conduct of ethics committees in the EU.
These need to be general enough to be applicable enough to all EU
countries, yet flexible and sensitive to varying contexts and sensitivities
3. A quality assurance programme needs to be developed to review the
structure, process and outcome of these committees. Such a programme
should first be piloted in a number of representative member states
4. Reasonable targets need to be set for efficiency and effectiveness. For
example, time-related goals for processing of applications to ethics
committees, with an option of a fast track, under certain conditions
5. Members of Ethics Committees should receive appropriate professional
training. For example, training and guidance of religious representatives of
ethics committees in science, and vice versa: guidance on religious issues
for health professionals and lay members
6. Members of Ethics Committees should receive appropriate remuneration
Policy suggestions
1.
2.
3.
4.
5.
6.
7.
8.
Research governance should be consistent in
all EU countries
The development of standardized and simple
ethics committee application process for all
member states.
Separate forms could be developed for different
clinical/ research contexts eg an observational
study looking at an anonymised database may
need a less complicated approach to a
randomized drug study. However not at the
expense of more bureaucracy. These could be
validated in all EU countries
A central registration/ database for all European
clinical trials
An identification number to be assigned to each
clinical trial; this would be a necessary
requirement for publication in a professional
journal
Development of an international agreement on
the running of clinical trials to include a clause
that any misconduct abroad can be prosecuted
in a researcher's home country
Issues should be approached in an interdisciplinary manner to examine matters from all
angles and garner all the relevant expertise
Where possible, bureaucratic elements should
be kept to a minimum
The public
1.
2.
This section relates to the wider public as
well as patients who take part in clinical
trials
The conduct of clinical trials should be a
transparent process. To achieve this, the
following recommendations are made:
1.
2.
3.
3.
Successful applications to ethics committees
should be made available to the public forum
to allow opportunities for communication and
debate
Documentation released should be clearly
worded and capable of being understood by
the general public
A synopsis of the results should be made
available in a similar manner
For patients:
1.
2.
3.
4.
Additional measures to enhance the
'informed' part of informed consent need to be
considered
Any documentation for patients should be
written in clear language, at the relevant
reading level
Any vested interests of those carrying out the
trial need to be declared
Patients' rights should be protected at policy
level and by law