- Email: [email protected]
Barriers to conducting clinical research in reproductive medicine: Greece
Barriers to conducting clinical research in reproductive medicine: Greece Basil C. Tarlatzis, M.D., Ph.D., and Efstratios M. Kolibianakis, M.D., Ph.D. First Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Greece
In Greece, procedures for obtaining funding and/or state approval for a research project are lengthy, hinder collaboration between centers, and may render projects outdated. (Fertil Steril 2011;96:807–8. 2011 by American Society for Reproductive Medicine.)
What do you see as the most significant barriers to research? One of the most important issues in designing and performing research is the acquirement of adequate funding. National grants may vary between European countries; however, European grants specifically for pursuing clinical research in human reproduction are very limited. In Greece, although not numerous, the opportunities for obtaining grants for this purpose do exist. Unfortunately, following the submission of a research project for funding, the process until acceptance or rejection is lengthy and sometimes may even render the project outdated. Moreover, any clinical trial that involves administration of medications needs to be approved by the state. This is a procedure which takes considerable time to be completed. PhD students are not always being paid by grants and occasionally need to support their own research by concomitantly working as residents or in the private sector. Apparently a clinical research project funded by a pharmaceutical company bypasses some of the above problems, which makes it, in this respect, a more attractive option. However, this inevitably leads to a kind of research in which priorities are not always compatible with the research interests of the clinicians.
Do institutional review boards/ethics panels present a significant barrier to your research? This mainly depends on the legislation present. National legislation may impose strong restrictions to research in certain counties, as in Italy and Germany. In Greece, the law for reproduction is quite liberal. Moreover, in Greek universities there is a strong central motivation to raise the research productivity. Despite a rigorous approach adopted by most review boards, unjustified creation of problems at this level is not favored, since it makes research even more difficult to pursue.
Alternately, do you feel that the input from such panels has a significant benefit in developing your research protocols in any way? Improvement of research protocols by review boards or expert panels should be encouraged as a good research practice. In Greece, this may occur following protocol submission, especially when maReceived August 31, 2011; accepted August 31, 2011. B.C.T. has nothing to disclose. E.M.K. has nothing to disclose. Reprint requests: Basil C. Tarlatzis, M.D., Ph.D., Aristotle University of Thessaloniki, 1st Department of Obstetrics and Gynecology, Thessaloniki 54603, Greece (E-mail: [email protected]).
0015-0282/$36.00 doi:10.1016/j.fertnstert.2011.08.046
jor ethical problems have been overlooked. The time required for an institutional review board approval is usually 1 to 2 months.
How are research personnel and projects generally funded? Research projects may require minimal funding as in the case of observational, not interventional studies, may be funded by research grants, if available, or may be funded by the pharmaceutical industry.
How much research is self-initiated as opposed to solicited by industry or pharmaceutical companies? Most of the clinical research in Greece is performed in the context of doctoral theses, independently of the industry or pharmaceutical companies. In recent years, however, pharmaceutical initiated research is also carried out in an increasing proportion of projects.
Do the hospitals and medical facilities where you do research represent a barrier to your research (e.g., by charging you for use of facilities), are they neutral, or do they actively support your research efforts? As a rule, hospitals in Greece, neither represent a barrier to research not they actively support it. Hospital approval is mandatory for the conduction of a research project. Occasionally, depending on the nature of the research project, hospitals may charge for the use of their facilities for research.
What challenges do you face in recruiting research subjects? The rationale for conducting a clinical trial is to address a research question for which there is not a clear answer (or no answer at all). Although patients may think that this is not unusual regarding new medications or new schemes of treatment, the truth is that for several basic aspects of clinical practice, evidence is frequently inadequate to allow solid conclusions to be drawn and clinical recommendations to be made. Thus, recruiting patients when such questions are being addressed may be more difficult. Apparently, recruitment is easier when the patient benefits from his/her participation in a clinical trial. This usually occurs in pharmaceutically sponsored trials.
Fertility and Sterility Vol. 96, No. 4, October 2011 Copyright ª2011 American Society for Reproductive Medicine, Published by Elsevier Inc.
807
Could you describe the informed consent process you generally follow? Is the principal investigator allowed to consent his/her own patient to participate in a trial, and is the principal investigator allowed to treat the patient once enrolled in the trial?
the success of PhD stems from the experience and training of the faculty involved, faculty members, supervising PhD students, are also trained periodically regarding the proper conduction of scientific research in the context of university organized courses.
A detailed consent form is developed for a specific clinical trial and is subsequently submitted for approval to the Hospital’s review board as well to the ethics committee of the University. When this stage is completed and the trial begins, the researchers present the consent form to the eligible patients. The principal investigator is allowed to consent his/her own patient to participate in a trial, and can also treat the patients, once enrolled in the trial.
Are investigators required to have specific training by institutional review boards? This is not required, however faculty members are encouraged to follow courses on good research practice, evidence based medicine and teaching, organized by the University.
Are you prohibited from doing some types of research? What, if any, are the barriers to collaboration in multicenter trials? The lack of funding sources and the lengthy procedures involved in acquiring funding do not enhance collaboration between university centers. Despite these problems, multicenter trials are being performed. The difficulty in managing such trials increases with the number of centers involved. This is especially true when the trial represents an initiative of researchers as compared to a trial sponsored and managed by the pharmaceutical industry. Difficulties in conducting multicenter large trials have to be balanced against the advantage of the increased sample size, which is essential for the solidity of the conclusions drawn.
How are junior investigators trained in doing research? Junior investigators are encouraged to follow a master course at the University, prior to pursuing a doctoral thesis. In Greece, PhD theses represent the major pathway for conducting research. PhD students are obliged to follow training courses during the period of their research, which is usually more than three years. Since major part in
808
Tarlatzis and Kolibianakis
In Greece, the law of reproduction poses some restrictions on the type of research that can be pursued. Human reproductive cloning, creation of chimeras or hybrids as well as research involving embryo culture for more than 14 days are not allowed. There is a considerable variation, however, between European countries, regarding the type of research that is possible to undertake.
If you could, what would you change to enhance research opportunities and productivity? 1. Increase the opportunities for funding both at the national and at the European level. In Europe, research in human reproduction should not be conceived as research field of low priority. 2. Shorten the time required for a funding proposal to be processed. 3. Increase the requirements for completion of a doctoral thesis by establishing criteria for the research performed, such as the number of publications produced and their impact factor. 4. Associate research productivity of faculty members with their promotion in the University.
Conducting clinical research in Greece
Vol. 96, No. 4, October 2011
In Greece, procedures for obtaining funding and/or state approval for a research project are lengthy, hinder collaboration between centers, and may render projects outdated. (Fertil Steril 2011;96:807–8. 2011 by American Society for Reproductive Medicine.)
What do you see as the most significant barriers to research? One of the most important issues in designing and performing research is the acquirement of adequate funding. National grants may vary between European countries; however, European grants specifically for pursuing clinical research in human reproduction are very limited. In Greece, although not numerous, the opportunities for obtaining grants for this purpose do exist. Unfortunately, following the submission of a research project for funding, the process until acceptance or rejection is lengthy and sometimes may even render the project outdated. Moreover, any clinical trial that involves administration of medications needs to be approved by the state. This is a procedure which takes considerable time to be completed. PhD students are not always being paid by grants and occasionally need to support their own research by concomitantly working as residents or in the private sector. Apparently a clinical research project funded by a pharmaceutical company bypasses some of the above problems, which makes it, in this respect, a more attractive option. However, this inevitably leads to a kind of research in which priorities are not always compatible with the research interests of the clinicians.
Do institutional review boards/ethics panels present a significant barrier to your research? This mainly depends on the legislation present. National legislation may impose strong restrictions to research in certain counties, as in Italy and Germany. In Greece, the law for reproduction is quite liberal. Moreover, in Greek universities there is a strong central motivation to raise the research productivity. Despite a rigorous approach adopted by most review boards, unjustified creation of problems at this level is not favored, since it makes research even more difficult to pursue.
Alternately, do you feel that the input from such panels has a significant benefit in developing your research protocols in any way? Improvement of research protocols by review boards or expert panels should be encouraged as a good research practice. In Greece, this may occur following protocol submission, especially when maReceived August 31, 2011; accepted August 31, 2011. B.C.T. has nothing to disclose. E.M.K. has nothing to disclose. Reprint requests: Basil C. Tarlatzis, M.D., Ph.D., Aristotle University of Thessaloniki, 1st Department of Obstetrics and Gynecology, Thessaloniki 54603, Greece (E-mail: [email protected]).
0015-0282/$36.00 doi:10.1016/j.fertnstert.2011.08.046
jor ethical problems have been overlooked. The time required for an institutional review board approval is usually 1 to 2 months.
How are research personnel and projects generally funded? Research projects may require minimal funding as in the case of observational, not interventional studies, may be funded by research grants, if available, or may be funded by the pharmaceutical industry.
How much research is self-initiated as opposed to solicited by industry or pharmaceutical companies? Most of the clinical research in Greece is performed in the context of doctoral theses, independently of the industry or pharmaceutical companies. In recent years, however, pharmaceutical initiated research is also carried out in an increasing proportion of projects.
Do the hospitals and medical facilities where you do research represent a barrier to your research (e.g., by charging you for use of facilities), are they neutral, or do they actively support your research efforts? As a rule, hospitals in Greece, neither represent a barrier to research not they actively support it. Hospital approval is mandatory for the conduction of a research project. Occasionally, depending on the nature of the research project, hospitals may charge for the use of their facilities for research.
What challenges do you face in recruiting research subjects? The rationale for conducting a clinical trial is to address a research question for which there is not a clear answer (or no answer at all). Although patients may think that this is not unusual regarding new medications or new schemes of treatment, the truth is that for several basic aspects of clinical practice, evidence is frequently inadequate to allow solid conclusions to be drawn and clinical recommendations to be made. Thus, recruiting patients when such questions are being addressed may be more difficult. Apparently, recruitment is easier when the patient benefits from his/her participation in a clinical trial. This usually occurs in pharmaceutically sponsored trials.
Fertility and Sterility Vol. 96, No. 4, October 2011 Copyright ª2011 American Society for Reproductive Medicine, Published by Elsevier Inc.
807
Could you describe the informed consent process you generally follow? Is the principal investigator allowed to consent his/her own patient to participate in a trial, and is the principal investigator allowed to treat the patient once enrolled in the trial?
the success of PhD stems from the experience and training of the faculty involved, faculty members, supervising PhD students, are also trained periodically regarding the proper conduction of scientific research in the context of university organized courses.
A detailed consent form is developed for a specific clinical trial and is subsequently submitted for approval to the Hospital’s review board as well to the ethics committee of the University. When this stage is completed and the trial begins, the researchers present the consent form to the eligible patients. The principal investigator is allowed to consent his/her own patient to participate in a trial, and can also treat the patients, once enrolled in the trial.
Are investigators required to have specific training by institutional review boards? This is not required, however faculty members are encouraged to follow courses on good research practice, evidence based medicine and teaching, organized by the University.
Are you prohibited from doing some types of research? What, if any, are the barriers to collaboration in multicenter trials? The lack of funding sources and the lengthy procedures involved in acquiring funding do not enhance collaboration between university centers. Despite these problems, multicenter trials are being performed. The difficulty in managing such trials increases with the number of centers involved. This is especially true when the trial represents an initiative of researchers as compared to a trial sponsored and managed by the pharmaceutical industry. Difficulties in conducting multicenter large trials have to be balanced against the advantage of the increased sample size, which is essential for the solidity of the conclusions drawn.
How are junior investigators trained in doing research? Junior investigators are encouraged to follow a master course at the University, prior to pursuing a doctoral thesis. In Greece, PhD theses represent the major pathway for conducting research. PhD students are obliged to follow training courses during the period of their research, which is usually more than three years. Since major part in
808
Tarlatzis and Kolibianakis
In Greece, the law of reproduction poses some restrictions on the type of research that can be pursued. Human reproductive cloning, creation of chimeras or hybrids as well as research involving embryo culture for more than 14 days are not allowed. There is a considerable variation, however, between European countries, regarding the type of research that is possible to undertake.
If you could, what would you change to enhance research opportunities and productivity? 1. Increase the opportunities for funding both at the national and at the European level. In Europe, research in human reproduction should not be conceived as research field of low priority. 2. Shorten the time required for a funding proposal to be processed. 3. Increase the requirements for completion of a doctoral thesis by establishing criteria for the research performed, such as the number of publications produced and their impact factor. 4. Associate research productivity of faculty members with their promotion in the University.
Conducting clinical research in Greece
Vol. 96, No. 4, October 2011