In this overview, we seek to appraise recent experimental and observational studies investigating THC and its potential role as adjunctive therapy in various medical illnesses. Recent clinical trials are suggestive of the diverse pharmacologic potentials for THC but suffer from small sample sizes, short study duration, failure to address tolerance, little dose variation, ill-defined outcome measures, and failure to identify and/or evaluate confounds, all of which may constitute significant threats to the validity of most trials. However, the existing work underscores the potential therapeutic value of THC and, at the same time, calls attention to the critical need for better-designed protocols to fully explore and demonstrate safety and efficacy. In the most general sense, the present brief review illuminates some intriguing findings about THC, along with the basic threats to the validity of the research that supports those findings. The intent is to highlight existing generic weaknesses in the existing randomized controlled trial literature and, most importantly, provide guidance for improved clinical research.

OBJECTIVE: Group-2 reviewed the scientific evidence in the field of «Technology». Focused research questions were: (1) additive versus subtractive manufacturing of implant restorations; (2) survival, complications, and esthetics comparing prefabricated versus customized abutments; and (3) survival of posterior implant-supported multi-unit fixed dental prostheses.
METHODS: Literature was systematically screened, and 67 publications could be critically reviewed following PRISMA guidelines, resulting in three systematic reviews. Consensus statements were presented to the plenary where after modification, those were accepted.
RESULTS: Additively fabricated implant restorations of zirconia and polymers were investigated for marginal/internal adaptation and mechanical properties without clear results in favor of one technology or material. Titanium base abutments for screw-retained implant single crowns compared to customized abutments did not show significant differences concerning 1-year survival. PFM, veneered and monolithic zirconia implant-supported multi-unit posterior fixed dental prostheses demonstrated similar high 3-year survival rates, whereas veneered restorations exhibited the highest annual ceramic fracture and chipping rates.
CONCLUSIONS: For interim tooth-colored implant single crowns both additive and subtractive manufacturing are viable techniques. The clinical performance of additively produced restorations remains to be investigated. Implant single crowns on titanium base abutments show similar clinical performance compared to other type of abutments; however, long-term clinical data from RCTs are needed. The abutment selection should be considered already during the planning phase. Digital planning facilitates 3D visualization of the prosthetic design including abutment selection. In the posterior area, monolithic zirconia is recommended as the material of choice for multi-unit implant restorations to reduce technical complications.

With the upsurge of artificial intelligence (AI) technology in the medical field, its application in ophthalmology has become a cutting-edge research field. Notably, machine learning techniques have shown remarkable achievements in diagnosing, intervening, and predicting ophthalmic diseases. To meet the requirements of clinical research and fit the actual progress of clinical diagnosis and treatment of ophthalmic AI, the Ophthalmic Imaging and Intelligent Medicine Branch and the Intelligent Medicine Committee of Chinese Medicine Education Association organized experts to integrate recent evaluation reports of clinical AI research at home and abroad and formed a guideline on clinical research evaluation of AI in ophthalmology after several rounds of discussion and modification. The main content includes the background and method of developing this guideline, an introduction to international guidelines on the clinical research evaluation of AI, and the evaluation methods of clinical ophthalmic AI models. This guideline introduces general evaluation methods of clinical ophthalmic AI research, evaluation methods of clinical ophthalmic AI models, and commonly-used indices and formulae for clinical ophthalmic AI model evaluation in detail, and amply elaborates the evaluation methods of clinical ophthalmic AI trials. This guideline aims to provide guidance and norms for clinical researchers of ophthalmic AI, promote the development of regularization and standardization, and further improve the overall level of clinical ophthalmic AI research evaluations.

Reasonable and standard application of sham acupuncture control is the key to determine the quality of acupuncture clinical trials, and is also a difficult problem faced by acupuncture clinical research. The UK National Institute for Health Research and the Medical Research Council jointly published the Applying Surgical Placebo in Randomised Evaluation (ASPIRE) guidelines on the application of placebo surgical operation in randomized evaluation, which includes 4 parts: rationale and ethics, design, conduct, and interpretation and translation, providing comprehensive guidance for the application of placebo controls in surgical trials. As an operational intervention, acupuncture is similar to surgery, so, ASPIRE guidelines can also provide certain guidance for the application of sham acupuncture. In the present paper, we introduce the ASPIRE guidelines, and put forward its enlightenment and reference to the application of sham acupuncture control in combination with retrospecting the current situations of sham acupuncture research. We hold that future studies should strengthen the consideration of the rationality and ethics of sham acupuncture, standardize the design of sham acupuncture control, and convey the information related to sham acupuncture to patients with appropriate descriptions.
合理、规范地应用假针刺对照是决定针刺临床研究质量的关键，亦是针刺临床研究面临的主要难题。英国国家健康研究所和医学研究委员会联合发表了随机化评价中外科安慰手术应用指南——ASPIRE指南，包括合理性与伦理、设计、实施、转化4个部分，为外科安慰手术的应用提供了全面的指导。同为操作性干预措施，针刺干预与外科手术有相似之处，故ASPIRE指南也可为假针刺对照的应用提供一定的指导。本文对ASPIRE指南进行了介绍，并结合假针刺对照研究的现状提出了其对假针刺对照应用的启示与借鉴。未来的研究应加强对假针刺对照合理性与伦理问题的考虑，规范地设计假针刺对照，并以合适的描述向患者传递假针刺相关的信息。.

Clinical research is complex, and research-related terms can be challenging to understand. Clear, supportive communication with patients, potential study participants, and their caregivers must be prioritized by healthcare providers as well as investigators and their research teams. In clinical research, health literacy best practices support the ethical tenets of respect, justice, and beneficence. Plain language advances the understanding of informed consent documents, as well as comprehension of educational information, recruitment materials, study instructions, and study results summaries, among others. Further, a more collaborative research partnership is fostered when study participants are given understandable materials, while a lack of understanding can delay accrual and decrease adherence. We launched a pilot initiative to develop a consensus-driven, plain language clinical research glossary to promote clarity, consistency, and transparency across clinical research stakeholder groups. The resulting resource, described herein, is intended to be used widely to support a greater understanding of clinical research and empower study participants. Considerations for expansion are also discussed.

The new national guidelines for clinical research, the Ethical Guidelines for Medical and Biological Research Involving Human Subjects, were implemented in Japan in June 2021. The guidelines were developed by integrating two ethical guidelines: Ethical Guidelines for Medical and Health Research Involving Human Subjects and Ethical Guidelines for Human Genome/Gene Analysis Research. The Ethical Guidelines for Clinical Research were originally developed as three separate guidelines: Ethical Guidelines for Human Genome/Gene Analysis Research formulated in 2001, Ethical Guidelines for Epidemiological Research in 2002 and Ethical Guidelines for Clinical Research in 2003. They have undergone several amendments and integration in response to the government\'s policy changes, such as the protection of personal information, conflicts of interest and reliability of clinical research. The three major changes introduced in the New Integrated Guidelines in 2021 are centralized review, electromagnetic informed consent and research cooperating organization. These are expected to be used as tools to facilitate the conduct of research. This review discusses the regulations of academic clinical research in Japan, the history of ethical guidelines and the three major changes introduced in the New Integrated Guidelines.

UNASSIGNED: The success of any clinical research team is dependent on hiring individuals with the experience and skill set needed for a specific research project. Strategies to improve the ability of human resource (HR) recruiters to screen and advance qualified candidates for a project will result in improved initiation and execution of the project.
UNASSIGNED: HR recruiters play a critical role in matching research applicants to the posted job descriptions and presenting a list of top candidates to the PI/hiring manager for interview and hiring consideration.
UNASSIGNED: Creating guidelines to screen for applicant qualification based on resumes when clinical research positions have multiple levels of expertise required is a complex process of discovery, moving from subjective rationale for rating individual resumes to a more structured less biased evaluation process. To improve the hiring process of the research workforce, we successfully developed guidelines for categorizing research coordinator applications by level from beginner to advanced.
UNASSIGNED: Through guideline development, we provide a framework to reduce bias and improve the matching of applicant resumes to job levels for improved selection of top candidates to advance for interviewing. Improved applicant to job matching offers an advantage to reduce hiring time, anticipate training needs, and shorten the timeline to active project engagement. These guidelines can form the basis for initial screening and ultimately matching individual qualities to project-specific needs.

OBJECTIVE: To report assessments of four systematic reviews (SRs) on (i) clinical outcomes of all-ceramic implant-supported crowns (iSCs), (ii) production time, effectiveness, and costs of computer-assisted manufacturing (CAM), (iii) computer-assisted implant planning and surgery (CAIPS) time and costs, and (iv) patient-reported outcome measures (PROMS).
METHODS: An author group consisting of experienced clinicians and content experts discussed and evaluated the SRs and formulated consensus on the main findings, statements, clinical recommendations, and need for future research.
RESULTS: All four SRs were conducted and reported according to PRISMA and detailed comprehensive search strategies in at least three bibliometric databases and hand searching. The search strategies were deemed reproducible. Variation was noted regarding language restrictions and inclusion of grey literature, but the search comprehensiveness appeared persuasive. The SRs included bias risk assessments of the primary studies, and their study methodology impacted the interpretations of the extracted data.
CONCLUSIONS: (i) There is limited evidence (49 NRCT) showing that veneered and monolithic all-ceramic iSCs have excellent outcomes observed up to 3 years. (ii) There is no evidence evaluating production time and effectiveness comparing subtractive and additive CAM of implant models, abutments and crowns. (iii) There is limited evidence (4 RCT) that CAIPS involves more time and costs when considering the entire workflow and for diagnostics, manufacturing, and insertion of the restoration. Time seems to be the decisive factor for higher costs. (iv) Patients\' comfort increases when optical compared to conventional impressions are used for fabricating iSCs and short-span FPDs (2 RCT, 5 NRCT).

BACKGROUND: In line with Good Clinical Practice and the Declaration of Helsinki, it is the investigator\'s responsibility to ensure that research participants are sufficiently informed, to enable the provision of informed consent. The Participant Information Leaflet/Informed Consent Form is key to facilitating this communication process. Although studies have indicated that clinical research Participant Information Leaflets/Informed Consent Forms are not optimal in terms of accessibility, there is little or no specific guidance available. The aim of this research was to propose and agree a set of guidelines for academic researchers and sponsors for preparing accessible and understandable Participant Information Leaflets/Informed Consent Forms.
METHODS: A literature review identified guidance for the preparation of patient-facing documents. Following critical appraisal, key recommendations were extracted and a set of recommendations which can be applied to clinical research Participant Information Leaflets/Informed Consent Forms were prepared. These recommendations were evaluated and amended by an Expert Consensus Conference consisting of a group of key stakeholders. The stakeholders included members of a Research Ethics Committee (both lay and expert), a patient advocate, experienced clinical researchers, a plain English editor and a Data Protection Officer. Consensus was reached regarding a final set of recommendations.
RESULTS: 44 recommendations were agreed upon and grouped into five categories: Layout, Formatting, Content, Language and Confirming Readability. These recommendations aimed to maximize accessibility for lay participants, including readers with dyslexia, literacy or numeracy challenges, thereby improving the quality of the consent process.
CONCLUSIONS: More empirical research is needed to further improve the informed consent process for research participants. However, these recommendations are informed by the current literature and have been ratified by expert stakeholders. It is hoped that these recommendations will help investigators and sponsors to consistently and efficiently produce more accessible clinical research Participant Information Leaflets/Informed Consent Forms.
Researchers must make sure that research participants are given all of the relevant information about a research study or trial. This information helps research people to decide if they wish to take part. The Participant Information Leaflet/Informed Consent Form is an important source of information for potential research participants and their families and friends. However, Participant Information Leaflets/Informed Consent Forms are often not easy for lay readers to understand. They can be especially difficult for readers with dyslexia or those who have problems with reading, or understanding numbers. There are guidelines available for designing information leaflets for lay readers, for example, leaflets about medicines or different health problems. But it would be helpful for researchers if these guidelines were applied to clinical research Participant Information Leaflets/Informed Consent Forms.We searched for and gathered guidance for designing and writing information leaflets for adult, lay readers and checked to see if the sources of the guidance were reliable. We then put together some recommendations for designing and writing information leaflets for research studies or trials. We formed an expert group, made up of both laypersons and researchers, who reviewed and discussed these recommendations. The expert group agreed on a final set of recommendations. We hope that these recommendations will help researchers to prepare Participant Information Leaflets/ Informed Consent Forms that are consistently easier to for participants to read and understand.

Clinical research is an important part in responding to public health emergencies, reducing epidemic hazards, and protecting public health and life safety. However, different from the general clinical research, there are many uncertainties and knowledge gaps in the clinical research of public health emergencies, and there is no unified standard for the clinical research ethics of public health emergencies in the world, which poses a new challenge to the practice of ethical research in China. In this article, we will combine with the ethical experience of clinical research on public health emergencies in China, propose the ethical guidelines for clinical research related to public health emergencies, including fast and efficient ethical review mechanism, scientific and reasonable research design, a reasonable balance of risk and benefit, adhere to the fundamental value of bioethics, to ensure that fully informed consent, to protect the subject\'s privacy, and recruiting fairly and reasonably. Further emphasized the prioritizing of public health and clinical emergency treatment, that is, under the situation of outbreak, all kinds of relevant public health clinical research can\'t affect the priority of epidemic prevention and control and clinical supportive treatment measures.
临床研究是应对突发公共卫生事件，降低疫情危害，保护公众健康和生命安全的重要环节。然而，不同于一般情况下的临床研究，突发公共卫生事件临床研究存在诸多不确定性和知识缺口，全球关于突发公共卫生事件临床研究伦理尚无统一标准，这对我国伦理研究实践提出了新的挑战。本文结合我国突发公共卫生事件临床研究伦理经验，提出突发公共卫生事件临床研究伦理指南应包括快速高效的伦理审查机制，科学合理的研究方案，风险与受益的合理权衡，坚持生命伦理的基本价值，确保充分知情同意，保护受试者个人隐私，以及公正合理地招募受试者等内容，进一步强调了保证公共卫生和临床应急处理的优先性，即在疫情暴发的情境下，各类公共卫生事件临床研究不能影响疫情防控和临床支持性治疗措施的优先性。.