Factors influencing willingness to participate in ophthalmic clinical trials and strategies for effective recruitment

AIM:To explore the factors influencing individuals’willingness to participate in ophthalmic clinical trials.METHODS:A questionnaire survey was conducted from January to April 2021 among patients and their family members at Zhongshan Ophthalmic Center,Sun Yat-sen University,in Guangzhou,China.The survey gathered data on respondents’willingness,demographic and socioeconomic profiles,as well as their reasons and concerns regarding engagement in clinical trials.RESULTS:Of the 1078 residents surveyed(mean age 31.2±13.1y;65.8%females)in Guangzhou,749(69.5%)expressed a willingness to participate in future ophthalmic clinical trials.Specific characteristics associated with greater willingness included a younger age,lower annual income,higher education,prior participation experience,previous ophthalmic treatment,and a better understanding of clinical trials.With the exception of age,these characteristics were significantly linked to a higher willingness.The primary barrier to participation,expressed by 64.8%of those willing and 54.4%of those unwilling,was“Uncertain efficacy”.In terms of motivations,the willing group ranked“Better therapeutic benefits”(35.0%),“Professional monitoring”(34.3%),and“Trust in healthcare professionals”(33.1%)as their top three reasons,whereas the unwilling participants indicated“Full comprehension of the protocol”(46.2%)as the key facilitator.CONCLUSION:This study reveals a substantial willingness to participate in ophthalmic clinical trials and demonstrates the predictive role of demographic and socioeconomic factors.Variations in motivators and concerns between willing and unwilling participants highlight the significance of tailored recruitment strategies.Importantly,the need for and trust in healthcare professionals stand out as powerful motivations,underscoring the importance of enhancing physician-patient relationships,adopting patient-centered communication approaches,and addressing individualized needs to improve accrual rates.

Problems and Countermeasures to Improve Clinical Trial Participants’Compensation Rights in China

Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights.Methods The literature related to the participants’right to compensation at home and abroad was searched to study the inadequacy of the compensation right for clinical trial participants in China from four aspects:insurance system,principle of attribution,legal relationship and compensation regulations.Then,some suggestions to improve the participants’right to compensation were proposed.Results and Conclusion China lacks clear legal norms for participants’right to compensation.There are problems such as unclear insurance rules and compensation rules,unclear contractual relationships between parties to clinical trials,and no laws and regulations to rely on for attribution and compensation.China should issue regulatory guidelines related to the right to compensation of participants in clinical trials,so that all parties in clinical trials can have rules to follow if there is the occurrence of injury,which can better protect the rights and interests of the participants.

The Construction of Mistake-tolerant Democracy Based on the Practical Right ＂Right to Trial and Error＂

The law ＂Trial and Error Ordinance＂ enacted in 2006 and spreading throughout China especially since 2016 is the best starting point for China＇s democratization, because Chinese government officials cannot be confronted with their new challenges directly without the right to trial and error. This study has tried to build a new democratic theory, mistake-tolerant democracy based on the right to trial and error with Chinese characteristics and Western value to guide Chinese democratized way. The right theory of mistake-tolerant democracy is the new right paradigm, ＂the right to trial and error as an original right and mutual empowerment theory＂ proposed by the combination of the state of nature and the scientific method of trial and error rather than natural right theory and social contract theory. Mistake-tolerant democracy emphasizes that the people have the equal right to trial and error as an original right, and the officials＇ right to trial and error are granted ＂from the people and should empower the corresponding rights to them, which is the meaning of mutual empowerment theory.

Legal protection of the rights of clinical trial subjects in China

Subjects in clinical trials, either patients with the target disease or healthy vohmteers, inevitably run a risk of injury or even death. To protect human subjects＇ rights to life and health, the Declaration of Helsinki has been developed as ＂a statement of ethical principles for medical research involving human subjects. Though widely regarded as a milestone in human research ethics, it is not a law or regulation, and is unable to effectively protect human subjects＇ rights. In this context, China beefs up its legal protection of clinical trial subjects.

On the Expansion and Realization of the Right to Environmental Information in Environmental Protection Supervision

As an innovation in the environmental governance system that breaks the traditional hierarchical structure,environmental protection supervision has not only played a significant role in protecting tangible environmental rights but also expanded the basic scope of the right to environmental information—part of procedural environmental rights.In the supervision of environmental protection,the objects of the right to environmental information and the subjects of the obligation to provide environmental information have been both expanded,with the focus shifting from government information to Party information and from administrative organs to Party organs.This vividly demonstrates the Communist Party of China’s concrete efforts to protect human rights in the field of the endeavor to build an ecological civilization.At present,the realization of the right to environmental information in environmental protection supervision still faces problems such as insufficient standards and norms,disordered practice and operation,and lack of liability guarantee.In this context,based on renewing relevant subjects’cognition of the right to know in environmental protection supervision,we should further improve and specify the rule for disclosing information about environmental protection supervision,rationally distribute the obligations for information disclosure in environmental protection supervision,and clarify the accountability rules for violating relevant requirements for information disclosure,so as to promote the overall development of the environmental protection supervision system while guaranteeing the realization of the right to environmental information.

Legal Protection of the Right of Informed Consent of the Subjects of Human Clinical Trials in China

The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedical research. In recent years, the legal protection of the right to informed consent for research subjects has been gradually improved in China. The right to informed consent for research subjects has been improved from an ethical norm to a legal norm. The legal status of legal norms has also been gradually improved. Based on the public law regulations, private law relief has been added to the legal relief system for the infringement of the right to informed consent for research subjects. As a result, the protection of rights has been enhanced. The domestic informed consent protection system is partially in line with international norms. The protection of the right to informed consent depends on the perfection of the legal system and the social consensus to respect human rights and the right to self-determination.

The Three Principles of Institutional Safeguards for Women's Participation in Legislation in China

The participation of women in legislation is an important aspect and means of safeguarding women’s rights.Feminist theory,based on criticism of both the“citizenship identity theory as rights”and the“citizenship identity theory as responsibilities,”proposes the“citizenship identity theory as subjectivity.”Observing the current practice of women’s participation in legislation in China,two institutional safeguard principles can be summarized:the“minimum proportion”and the“influence evaluation.”However,each of these principles has its inherent limitations.Therefore,it is necessary to supplement them with the principle of“subjective participation”in a reflective manner.This principle requires women to participate substantively in the legislative process as subjects,express women’s needs and demands,input women’s perspectives and experiences,and reconstruct the distribution of rights and responsibilities in the existing legislation.The three principles complement each other and work together to comprehensively constitute the institutional structure of women’s participation in legislation,thereby promoting the reproduction of corresponding action structures.

Solving the Century Problem“Modern Transformation of China’s Traditional Confucianism”—A Mistake-Tolerant Democracy Perspective

The reason why Chinese scholars cannot bridge between Confucianism and democracy as a century problem since 1920s is that liberal democracy has two fundamental defects:Human beings born with wisdom have known rights before entering societies,which is contrary to Confucianism;separation between politics and religions has led to religious ceremony of confession far away from politics.Mistake-tolerant democracy whose right theory is the right to trial and error as an original right and mutual empowerment theory can overcome above defects.Liberty is divided into the right to trial and error as an original right in innovative fields which can be transferred by contract and unalienable liberties in non-innovative ones.The spirit and behavior of self-criticism to people like confession is a virtue which meets Confucian moral requirements of becoming a Saint and politician’s obligation required in mistake-tolerant democracy,which can solve the century problem at utmost.

Patient Recruitment in Clinical Trials: Areas of Challenges and Success, a Practical Aspect at the Private Research Site

Enrolling in clinical trials could be time-sensitive and time-demanding tasks for the research site, especially if it is a private research organization compared to the research conducted at an academic or medical center. Every study differs in various aspects, such as phases, study indication, eligibility criteria, etc. In terms of meeting the enrollment deadline, typically, the study indication and availability of the patient’s population at the geographical area of the research site would decide if the trial could be time-consuming. Patient recruitment and retention are critical for the success of every clinical trial;however, worldwide, this area is facing tremendous pressure and challenges. Globally 55% of clinical trials terminated due to low recruitment, with an average enrollment success rate of 40% for Phase III and IV trials. Over 80% of clinical trial attempts fail to enroll, extending the study and adding new study sites. In the United States, more than 80% of clinical trials fail to achieve targeted patient enrollment, and 30% of study participants discontinue participation. This article reviewed various factors hindering clinical trial recruitment and retention and suggested strategies to make the research site successful.

“With This Disease, You Take Whatever Chances There Are”—A Study on Socio-Cultural and Psychological Aspects of Experiments Regarding Huntington’s Disease

Although relatively rare, Huntington’s disease (HD) has fatal consequences. There is no cure for the disease, which leads to an early death. Worldwide, scientists are trying to develop therapeutic methods that could cure the disease, including new molecular gene therapeutic methods. At Lund University, research on HD is now about to step from animal models to trials with humans. The project is special in its design since it involves both medical studies and socio-cultural and psychological research to explore and meet the many challenges that experimental trials with HD patients give rise to. The aim of the present study was to investigate the viewpoints of individuals affected by HD on the issues of participation and exerting influence if taking part in a medical study on gene therapy that has not previously been tested on humans. A total of 16 participants, recruited through the national association for HD and through the neurological clinic at Lund University in Sweden, took part in a focus group or in a survey study. A thematic analysis, to explore the transcribed text from the focus groups as well as from the written mail responses, was conducted by means of Nvivo, a program for qualitative data analysis. Results showed three main themes expressing reasons for participation: participation as a last resort, as an activity of hope, and as a way to take responsibility for the development of a cure that will benefit future generations. The responses relating to the question about affected individuals’ view of exerting influence resulted in two themes. The first theme was having a voice when researchers design experiments, which may give a sense of receiving respect. The second was that influence is an essential part of the information process before agreeing to take part in an experimental trail.

Equality, Participation and Sharing: 70 Years of Protecting the Rights and Interests of Persons with Disabilities in the PRC

July 2019 Contents Preamble I.Development of the Cause of Persons with Disabilities II.Mechanisms for the Protection of Rights and Interests of Persons with Disabilities III.Health and Rehabilitation IV.Special Education and Inclusive Education V.Employment and Entrepreneurship VI.Basic Life and Social Security VII.Creating an Accessible Environment and Enabling Mobility.

Pursuit of Excellence:The Past Development and New Progress of the Human Rights Action Plans of China

Since the Vienna Declaration and programme of Action in 1993 recommended that countries formulate national human rights action plans,many countries have carried out relevant explorations.Since 2009,China has formulated four series of Human Rights Action plan of China,which is significant for promoting the development of human rights,enhancing the say in international human rights,reducing social risks and protecting individual rights.The formulation of the plan adheres to the principles of being laws and policies-based and human rights-oriented,and taking into account both the country and society.The first three series of the Action plans have undergone such evolution as upgrade of guiding principles and goals,refinement of rights content and measures,diversification of responsible subjects,increasingly reasonable framework structure,and more human rights consideration in discourse expression.The fourth series of the Action plan pays more attention to expanding public participation and the content,improving the supervision mechanism,and further promoting the formulation and implementation of the Action plan.

Human Rights NGOs and the United Nations Human Rights Council——Participation by the China Society for Human Rights Studies in the Universal Periodic Review Mechanism

Since its founding in 1993, the China Society for Human Rights Studies （CSHRS） has extensively participated inthe human rights work of the United Nations （UN） and has actively carried out international exchange and cooperation. In May 2012, the UN Human Rights Council （UNHRC） initiated the second round of country reviews on human rights.

On the Value of the Legalization of Political Participation in Protecting Human Rights

It＇s necessary to legalize political participation in contemporary China because of its value in protecting human rights in terms of function and value. That is, the legalization of political participation aims to promote human rights protec- tion. What＇s more, the legalization of political participation in contemporary China and the maturity of the pro- motion of interest coordination and the rule of law, also show the great development of democracy and politi- cal stability in China.

Comparative analysis of breast and lung cancer survival rates and clinical trial enrollments among rural and urban patients in Georgia

Objectives:Rural patients have poor cancer outcomes and clinical trial(CT)enrollment compared to urban patients due to attitudinal,awareness,and healthcare access differential.Knowledge of cancer survival disparities and CT enrollment is important for designing interventions and innovative approaches to address the stated barriers.The study explores the potential disparities in cancer survival rates and clinical trial enrollments in rural and urban breast and lung cancer patients.Our hypotheses are that for both cancer types,urban cancer patients will have longer 5-year survival rates and higher enrollment rates in clinical trials than those in rural counties.Methods:We compared breast and lung cancer patients’survival rates and enrollment ratios in clinical trials between rural(RUCC 4-9)and urban counties in Georgia at a Comprehensive Cancer Center(CCC).To assess these differences,we carried out a series of independent samples t-tests and Chi-Square tests.Results:The outcomes indicate comparable 5-year survival rates across rural and urban counties for breast and lung cancer patients,failing to substantiate our hypothesis.While clinical trial enrollment rates demonstrated a significant difference between breast and lung cancer patients at CCC,no significant variation was observed based on rural or urban classification.Conclusion:These findings underscore the need for further research into the representation of rural patients with diverse cancer types at CCC and other cancer centers.Further,the findings have considerable implications for the initiation of positive social change to improve CT participation and reduce cancer survival disparities.

Recruitment of older adults into randomized controlled trials:Issues and lessons learned from two community-based exercise interventions in Shanghai

Background: With the increasing need for high-quality exercise interventions in China, relatively little is known about issues and challenges related to recruitment of older Chinese adults into exercise-based disease prevention interventions. This study aims to describe the recruitment process and outcomes of 2 exercise interventions conducted in Shanghai, China.Methods: Recruitment information was ascertained from 2 community-based randomized controlled trials for 2 exercise interventions, the first designed to improve health outcomes for older women with knee osteoarthritis and the second to study changes in cognitive function in adults with mild cognitive impairment. Results were summarized in terms of recruitment sources, number screened, screening-to-enrollment ratios, and costs.Results: Recruitment was primarily achieved through working with local residential divisions(i.e., neighborhood associations and residential committees). Both studies achieved their planned target number of older adults(45 and 46, respectively) within a 1-year time frame, with a screening-to-randomized ratio of 5:1 and demonstrated excellent retention rates(range 87%–93%) at 6 months. The recruitment cost for the 2studies averaged RMB 189(about USD 30) per initial recruit and RMB 738(about USD 119) per participant randomized. Some major issues encountered during the recruitment process included(1) the use of community neighborhoods to support the conduct of the projects,(2) access to participants, and(3) feasibility.Conclusion: Analysis of the 2 randomized controlled trials has provided valuable insights into the recruitment process and identified resources that can help better planning and recruitment for future interventions. Recommendations aimed at increasing the success of future recruitment efforts are provided.

Melatonin for Pre- and Postoperative Pain and Anxiety: A Cancelled Clinical Trial

Designing and completing clinical intervention trials can be challenging. Many aspects must be considered to ensure that patients who fulfill the inclusion criteria for the intervention are identified and recruited effectively. The aim of this paper was to disseminate the results of a cancelled trial and present unpredictable barriers met underway, so future researchers can learn from these. The trial examined perioperative analgesic and anxiolytic effects of melatonin. It was registered at https://clinicaltrials.gov/ (NCT02386319) and a study protocol was published a priori. Participants were recruited from the plastic surgery ward of a Danish private hospital. The intended sample size of the trial was 72 patients based on power calculations of the outcome measures. During the six-month recruitment period, six patients were included, with only three completing the trial. Unpredictable barriers were poor communication between investigators and facility staff, lack of access to booking and operation schedules at the recruitment facility, the patient group being unwilling to participate, and the timing of recruitment conversations being unsuited as patients often did not have time to talk to the investigators. Too few data were collected to make any meaningful statistical analyses. Our trial was cancelled prematurely because of unpredictable barriers after commencing recruitment. Considering these barriers when designing a clinical trial may help future researchers avoid cancelling trials. Transparency of research is important and even prematurely cancelled trials should publish their findings.

The Scientific School of Philosophical and Legal Thought in Criminal Proceedings of Marian Cieslak

The aim of the article is to show that Professor Cie?lak is the founder of the scientific school of philosophical and legal thought in criminal proceedings and five thoughts belonging to this school regarding the subject of the criminal process, the identity of a deed, participants in the process, the burden of the proof, the obligation of proving, and division the grounds for detention. Professor Cie?lak was one of the most distinguished Polish lawyers and scientists, and had a great influence on shaping views on the law, primarily in theory, but also in practice. His concepts result from his theoretical and philosophical research on the law and are also timeless, remotely dependent on the legislation currently in existence.

Knowledge, Understanding and Attitude Toward Civic Rights and Duties in Administrative Affairs and People＇s Participation in Local Administration of Mahasarakham Municipality

This research aimed to study on the people and the local government. The samples were 395 respondents over 18 years old, selected locally of Mahasarakham Municipality, Thailand. The research found that the level of knowledge, understanding, and attitudes toward civic rights and duties of administrative affairs was at a high level but participation in the local administration was rated at a low level. The relationship between knowledge, understanding, and attitudes toward civic rights and duties of administrative affairs of the community was positive correlated. The relationship between knowledge and understanding toward civic rights and duties and participation in the community administration and the relationship between attitudes toward civic rights and duties in administrative affairs and participation in the local government administration were not correlated. Some recommendations were the local government organizations should promote and provide more information to build the right understandings and improve good attitudes toward civic rights and duties in administrative affairs. Local administrators and local leaders should play an important role to advocate and encourage public opinions toward a political ideology to ensure the public mind and make the vision ＂people-centered＂. Most importantly, the State shall pursue directive principles of State policies in relation to public participation.

A Balance Between Court Security and Fair Trials:Court Cages in Criminal Cases——Using European Court of Human Rights Cases for Reference

In response to the 'cages in courts' issue in criminal trials,after reviewing a series of cases such as 'Svinarenko and Slyadnev v.Russia',the European Court of Human Rights has gradually clarified that the 'human dignity of the accused and his right to a fair trial are higher than the value of court security',thus found that putting the accused in a cage dock or improper use of a glass cabin dock are in breach of Article 3 and Article 6 of the European Convention on Human Rights,constitutes degrading treatment and violates the right to a fair trial.This position is in line with the international overall trend,which is of significance as a reference for China’s courts.Domestic courts should take the initiative to change the current use of the 'low fence dock' to further enhance China’s judicial civilization.