An interview with Dr. Ayat Ahmadi
Type of article: Interview
How to cite this article:
Ahmadi A. Should clinical trials be covered by insurance? Electron. physician, March 28, 2016, doi: http://dx.doi.org/10.19082/RCT-Interview
Clinical trials are regarded as the most reliable studies in the medical sciences and a base for the development or improvement of treatment processes, including medical and surgical treatments. Policymakers in the medicine sector, pharmaceutical companies, and clinicians are always awaiting the results of clinical trials so they can use these reliable studies to enhance the quality of medical services. Dr. Ayat Ahmadi, who has a Ph.D. degree in epidemiology and is a researcher at the Clinical Trial Center of Tehran University of Medical Sciences, has abundant experience in clinical trials especially from the insurance perspective. His activities are related mainly to studies conducted at the Clinical Trial Center of Tehran University of Medical Sciences and collaboration with the Ethics Committee concerning biomedical studies as well as the Clinical Studies Committee of the Food and Drug Administration. Dr. Ahmadi provides advice in terms of the insurance of clinical trials to pharmaceutical companies that refer to the Food and Drug Administration to conduct studies. The following is an interview conducted with Dr. Ahmadi by the Electronic Physician Journal.
Do you have any statistics of the number and percentage of clinical trials in Iran and other countries that are under insurance coverage? Please give us statistics in detail. If your statistics are documented or mentioned in a paper or state statistics, please let us know.
There are no insurance requirements for all clinical trials and it is conducted for studies that are regarded as risky based on risk assessment methods. Therefore, there are no developed statistics. In most countries, including members of the EU, clinical trials with certain conditions are required to insure their subjects. Until recently in Iran, only studies conducted by foreign sponsors were considered in terms of insurance coverage, and their insurance was in the form of common insurance. Obviously, we have some history of foreign insurers providing insurance. However, in general, only a few studies have been insured before legislative organizations, and the Ethics Committee is considering institutionalizing insurance for clinical trials.
What is your opinion of the importance of providing insurance for clinical trials and what reasons can you list that indicate the necessity of providing such insurance? In addition, please give us a list of all services provided by this type of insurance for researcher or the research itself.
The importance of such insurance lies mainly in the compensation it provides for research studies. Some reasons include:
1) Ethical aspects of conducting the study: The main reason of considering compensation in Iran is observing ethical issues in studies. The nature of compensation is an ethical issue in clinical trials, and lack of sufficient attention to it could undermine the ethical standards of research. Therefore, compensation in studies is considered in the ethics domain of research, and professionals of ethical issues and the Ethics Committee have paid more attention to this case.
2) Regulatory institutions: Another factor is considering standards of good clinical practice (GCP) by regulatory institutions of this domain in the country (especially the Food and Drug Administration). One such aim is conducting clinical studies based on universal standards and ensuring compliance of these studies with the principles that would ensure that they are conducted correctly and accurately. Administrators of the studies, including domestic and foreign administrators, who have found conditions in the country suitable to conduct their study, are required to follow these principles. Therefore, regulatory institutions consider it important to observe the rights of the participants and provide compensation as imposed by the administrators of studies.
3) Considering the quality of studies conducted inside the country: With regard to the significant increase in the number of studies conducted in Iran in recent years, an issue has been raised concerning the quality of the studies that are being conducted. Increasing the quality of research requires the consideration of all of the aspects involved with conducting a study. Supporting participants in the studies is strongly dependent on correct and quality implementation of the studies. In fact, the quality of research is completely verified when we observe all professional principles of conducting a study (including methodological and ethical principles).
4) Researchers: Principal investigators (PIs) are those who take direct responsibility for conducting a study. They usually are experienced professionals in a scientific field related to the research. The participants typically are patients with specific diseases and characteristics that the corresponding author must be aware of. Due to the fact that these investigators are directly responsible for protecting subjects against risks of participating study, the issue of compensation both in terms of research responsibility and their general responsibility toward patients is regarded to be important according to them. In addition, when participation in a study results in injuries to the participants, in case there is a compensation mechanism available, the corresponding author should report the issue to the related institutions (without any conflict of interest) or explain the issue for the patients more freely.
5) Sponsors: Commonly, the initial opinion is that the expenses that result from considering compensation would cause the sponsors to lose interest in the research. Contrary to this belief, one of the factors that affect the compensation issue in the country is considering compensation for participants by (producing or importing) pharmaceutical companies. As mentioned in the literature, considering compensation in clinical trials would result in many benefits for the sponsors. Various issues, such as being engaged in judicial issues and complaints and lawsuits related to injuries created for participants, are regarded as challenges for the sponsors of clinical studies that result in spending a lot of time and money, produce financial and credit losses, and even could result in negative public attitude toward the related study and/or medicine being studied. These types of challenges would make sponsors consider part of the general expenditures of the study to prevent these issues from the beginning. Considering this certain cost and predicting such expenditures before initiating the study would ensure more accurate financial management of the study and reduce unanticipated expenditures significantly. Along with the financial issue, passing through legal and ethical filters and obtaining required licenses before conducting the study are easier when compensation measures are considered for the participants of the study. Other benefits of this issue for sponsors of studies are acceptability of most results of studies for others (inside or outside the country) after conducting the study, since a study that considers compensation for participants creates a positive attitude in its potential customers. Also, it could have a positive effect on obtaining commercial and market licenses for the medicine verified in that study. Some studies have addressed compensation in clinical trials, justice for the patients who participated in these studies, and accelerating the process of selecting patients.
6) Insurance companies: Insuring clinical trials is a new domain in the insurance market that could bring good profitability for the insurance industry.
7) Increase in public awareness: Increasing public awareness and considering civil rights, along with more attention to compensation in studies in advanced countries and nations similar to Iran, create social demand for the researchers and administrative personnel of the studies to follow scientific and ethical principles in conducting the studies. In this regard, the role of the media, communications, and social networks is completely effective.
What risks threaten a study if the clinical trial is not insured?
The most important risk is in terms of ethical considerations. However, there are other risks, e.g., questioning the validity of the study and legal issues that may occur that could threaten a certain study specifically. In addition, some high-risk and low-quality studies may be conducted. In some cases when the public’s awareness is high, patient selection for studies with no insurance would diminish.
Would you give us some reasons why this issue is not welcomed in Iran or other countries if it has been so?
In Iran, in particular, the main reason is the absence of people familiar with this issue in insurance companies who avoid dealing with this issue, and this usually is observed among the higher levels of management. The lack of a statute concerning the terms of the insurance policy and studies requiring insurance policies add to the issue of the guidelines of which may be notified soon. Obviously, there is resistance against the problems this issue creates for a study. However, reliable sources have shown that, in general, this issue is financially profitable for the study and prevents many risky and low-quality studies from being conducted.
What are your applicable and practical suggestions to extend insurance for all types of these projects?
Transferring the concept of minimal risk of clinical studies by the research department to insurance companies and the fact that clinical trials are conducted in conditions that involve a minimum risk for patients along with transferring basic concepts of risk and insurance industry to sponsors could reduce the current gap and provide the field with a win-win activity. Of course, the current views on managers’ who create obstacles to prevent studies from being conducted could be changed by explanations that are based on observations and descriptions related to the terms of this insurance.
Is there any other thing important to point that should be made in terms of insuring clinical trials?
Countries such as Iran, have appropriate conditions for clinical trials to be conducted by foreign pharmaceutical companies. Considering insurance for clinical trials reduces the possible risks for citizens, and it maintains this opportunity for the country, thereby preventing low-quality studies from being conducted. However, appropriate documentation of the terms of the insurance must be available for studies with domestic companies, since sponsorship would result in easier acceptance of their products in other countries and provide the background for exporting domestic products.
Dr. Ayat Ahmadi, is an epidemiologist and a researcher at the Clinical Trial Center of Tehran University of Medical Sciences.ΝΕΕΣ ΠΑΡΑΛΑΒΕΣ 2020Nike