Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Helsinki Declaration”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 433 records · Page 24Linked to original sources
PubMed2026

A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of vosoritide in children with hypochondroplasia: CANOPY HCH-3 study design.

BACKGROUND: Hypochondroplasia is a skeletal dysplasia characterized by disproportionate short stature that is caused by gain-of-function variants in the fibroblast growth factor receptor 3 gene (FGFR3), which negatively regulates endochondral bone growth. Current treatments are based on symptom management; there are no treatments targeting the signaling pathways that underlie hypochondroplasia. Vosoritide, a C-type natriuretic peptide analog that counteracts overactive FGFR3 signaling to stimulate endochondral bone growth, is approved for the treatment of achondroplasia in children. A phase 1/2 clinical trial demonstrated that vosoritide treatment for 1 year increased growth in children with hypochondroplasia and was well-tolerated. OBJECTIVES: The objectives of CANOPY HCH-3 are to evaluate the efficacy and safety of vosoritide for the treatment of hypochondroplasia in children. DESIGN: CANOPY HCH-3 was a phase 3, randomized, double-blind, placebo-controlled, multicenter study. METHODS AND ANALYSIS: Children aged &#x2265;3 to <18 years with confirmed hypochondroplasia who had &#x2265;6 months of pre-treatment standing height from a prior observational study before randomization were enrolled. Participants were randomized to receive 52 weeks of daily treatment with vosoritide or placebo, followed by 2 weeks of safety follow-up. The primary endpoint is change from baseline in annualized growth velocity at week 52 versus placebo. ETHICS: CANOPY HCH-3 was conducted in accordance with the Council for International Organizations of Medical Sciences International Ethical Guidelines, the principles of the Declaration of Helsinki and of Good Clinical Practice, and applicable laws and regulations. Protocols were approved by relevant local health authorities, ethics committees, and institutions. Written informed consent from the participant, or parent or legal guardian, was obtained prior to any study-related procedures being performed. DISCUSSION: CANOPY HCH-3 will provide further evidence for the efficacy and safety of vosoritide in children with hypochondroplasia.

clinical trial↗
PubMedDate not supplied

Liability and new drug studies. Informed consent and clinical trials at the National Institutes of Health.

The liability risk in carrying out clinical trials can be severely affected if the informed consent process is poorly carried out. A poorly informed patient could prematurely drop out of a costly study. Worse yet, if the patient discovers that information is withheld, the patient could sue the sponsor, physician investigator, or IRB and hold them liable, though this is unlikely for investigational drug studies. These costs can be avoided by making sure the clinical trial is properly carried out according to strict federal regulations. It is also critical that clinicians keep the research participant informed on an ongoing basis. The chain of command is vital: The monitor informs the sponsor, the sponsor in turn informs the investigator, and the investigator in turn informs the patient of any new treatment information that may affect his willingness to stay in the trial. Finally, wherever the clinical trial is conducted, it should conform with the ethical principles outlined in the Declaration of Helsinki or with the latest regulations of that country--whichever guidelines provide the greater protection for the patient.

Clinical Trials as Topic↗
PubMed2006

Knowledge, attitudes and practice of healthcare ethics and law among doctors and nurses in Barbados.

BACKGROUND: The aim of the study is to assess the knowledge, attitudes and practices among healthcare professionals in Barbados in relation to healthcare ethics and law in an attempt to assist in guiding their professional conduct and aid in curriculum development. METHODS: A self-administered structured questionnaire about knowledge of healthcare ethics, law and the role of an Ethics Committee in the healthcare system was devised, tested and distributed to all levels of staff at the Queen Elizabeth Hospital in Barbados (a tertiary care teaching hospital) during April and May 2003. RESULTS: The paper analyses 159 responses from doctors and nurses comprising junior doctors, consultants, staff nurses and sisters-in-charge. The frequency with which the respondents encountered ethical or legal problems varied widely from 'daily' to 'yearly'. 52% of senior medical staff and 20% of senior nursing staff knew little of the law pertinent to their work. 11% of the doctors did not know the contents of the Hippocratic Oath whilst a quarter of nurses did not know the Nurses Code. Nuremberg Code and Helsinki Code were known only to a few individuals. 29% of doctors and 37% of nurses had no knowledge of an existing hospital ethics committee. Physicians had a stronger opinion than nurses regarding practice of ethics such as adherence to patients' wishes, confidentiality, paternalism, consent for procedures and treating violent/non-compliant patients (p = 0.01) CONCLUSION: The study highlights the need to identify professionals in the workforce who appear to be indifferent to ethical and legal issues, to devise means to sensitize them to these issues and appropriately training them.

Barbados↗
PubMed2006

Duodenum preserving pancreatectomy in chronic pancreatitis: design of a randomized controlled trial comparing two surgical techniques [ISRCTN50638764].

BACKGROUND: Chronic pancreatitis is an inflammatory disease which is characterized by an irreversible conversion of pancreatic parenchyma to fibrous tissue. Beside obstructive jaundice and pseudocyst formation, about half of the patients need surgical intervention due to untreatable chronic pain during the course of the disease. In most of the patients with chronic pancreatitis, the head of the pancreas is the trigger of the chronic inflammatory process. Therefore, resection of pancreatic head tissue must be the central part of any surgical intervention. However, it is unclear to which extent the surgical procedure must be radical in order to obtain a favourable outcome for the patients. DESIGN: A single centre randomized controlled, superiority trial to compare two techniques of duodenum preserving pancreatic head resection. SAMPLE SIZE: 65 patients will be included and randomized intraoperatively. ELIGIBILITY CRITERIA: All patients with chronic pancreatitis and indication for surgical resection and signed informed consent. Cumulative primary endpoint (hierarchical model): duration of surgical procedure, quality of life after one year, duration of intensive care unit stay, duration of hospital stay. Reference treatment: Resection of the pancreatic head with dissection of the pancreas from the portal vein and transsection of the gland (Beger procedure). INTERVENTION: Partial Resection of the pancreatic head without transsection of the organ and visualization of the portal vein (Berne procedure). DURATION: September 2003-October 2007. ORGANISATION/RESPONSIBILITY: The trial is conducted in compliance with the protocol and in accordance with the moral, ethical, regulatory and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and the Good Clinical Practice guideline (GCP). The Center for Clinical Studies of the Department of Surgery Heidelberg is responsible for planning, conducting and final analysis of the trial.

Journal Article↗
PubMed2006

Comparison of Venae Sectio vs. modified Seldinger Technique for totally implantable access ports; Portas-trial [ISRCTN:52368201].

BACKGROUND: The insertion of a Totally Implantable Access Port (TIAP) is a routinely employed technique in patients who need a safe and permanent venous access. The number of TIAP implantations is increasing constantly mainly due to advanced treatment options for malignant diseases. Therefore it is important to identify the implantation technique which has the optimal benefit/risk ratio for the patient. STUDY DESIGN: A single-centre, randomized, controlled superiority trial to compare two different TIAP implantation techniques. SAMPLE SIZE: 160 patients will be included and randomized intra-operatively. ELIGIBILITY CRITERIA: Age equal or older than 18 years, patients scheduled for primary elective implantation of a TIAP in local anaesthesia and a signed informed consent. Primary endpoint: Primary success rate of the randomized technique. INTERVENTION: Venae Sectio in combination with the Seldinger Technique (guide wire and a peel away sheath) will be used to place a TIAP. Reference treatment: Conventional Venae Sectio will be used with a direct insertion of the TIAP without guide wire or peel away sheath. Duration of study: Approximately 20 months. ORGANISATION/RESPONSIBILITY: The trial will be conducted in compliance with the protocol and in accordance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The trial will also be carried out in keeping with local and regulatory requirements. The Klinisches Studienzentrum Chirurgie (KSC)--Centre of Clinical Trials in Surgery at the Department of Surgery, University Hospital Heidelberg is responsible for planning and conduction of the trial. Documentation of patient's data will be accomplished via electronical Case Report Files (eCRF) with MACRO-Software by the KSC. Randomization, data management, monitoring and biometry are provided by the independent Koordinierungszentrum für Klinische Studien (KKS)--Coordination Centre for Clinical Trails at the University of Heidelberg.

Journal Article↗
PubMed2006

Understanding privacy in occupational health services.

The aim of this study was to gain a deeper understanding of privacy in occupational health services. Data were collected through in-depth theme interviews with occupational health professionals (n = 15), employees (n = 15) and employers (n = 14). Our findings indicate that privacy, in this context, is a complex and multilayered concept, and that companies as well as individual employees have their own core secrets. Co-operation between the three groups proved challenging: occupational health professionals have to consider carefully in which situations and how much they are entitled to release private information on individual employees for the benefit of the whole company. Privacy is thus not an absolute right of an individual, but involves the idea of sharing responsibility. The findings open up useful new perspectives on ethical questions of privacy and on the development of occupational health practices.

Adult↗
PubMed2004

Regulatory and ethical principles in research involving children and individuals with developmental disabilities.

Children and individuals with developmental disabilities (DD) compared to typical participants are disadvantaged not only by virtue of being vulnerable to risks inherent in research participation but also by the higher likelihood of exclusion from research altogether. Current regulatory and ethical guidelines although necessary for their protection do not sufficiently ensure fair distributive justice. Yet, in view of disproportionately higher burdens of co-occurring physical and mental disorders in individuals with DD, they are better positioned to benefit from research by equitable participation. Greater elucidation of this ethical dilemma is called for by researchers, institutional review boards, and funding agencies to urgently redress the imbalance. This article discusses many of the regulatory principles to ensure better research participation of children and individuals with DD: human rights, validity, distributive justice, beneficence/nonmaleficence, and autonomy.

Adult↗
PubMed2003

Is the use of placebo controls ethically permissible in clinical trials of agents intended to reduce fractures in osteoporosis?

Substantial progress has been made in developing treatments that reduce the risk of fractures in osteoporosis. However, available treatments are only partially effective, they are not widely used, and there is need to search for more effective means of fracture prevention. Currently known effective means of reducing fractures were found using randomized placebo-controlled trials. The use of placebo controls in clinical trials has been a subject of significant controversy in recent years. The Declaration of Helsinki revision of October 2000 caused great concern among clinical investigators about the future use of placebo controls if known effective therapeutic agents are available. A working group of ethicists, clinical trial design experts, and clinical investigators examined the current state of knowledge of osteoporosis treatment and trials. They concluded that if placebo controls put subjects at substantial risk of serious outcomes, they are not ethically permissible. Placebo controls in osteoporosis trials with fracture as the measured outcome are permissible only under narrowly defined conditions. Placebo controls may be used if competent, well-informed patients refuse approved therapies for sound reasons, there is a reasonable basis for substantial disagreement or lack of consensus among professionals about whether approved treatments are better than placebos, or subjects are refractory to known effective agents. Active control trials are permissible and desirable if they can be designed and conducted in ways that overcome the interpretive difficulties often associated with such trials.

Clinical Trials as Topic↗
PubMed2003

Content and classification of clinical trials at a university hospital in Japan.

"Standards on the Implementation of Clinical Trials on Drugs (New GCP)" is a Japanese government policy established in April 1998 with the aim of satisfying scientific and ethical requirements for industry-sponsored research, i.e., registration-directed clinical trials and clinical trials intended to support reexamination or reevaluation applications. Since then, efforts for more effective implementation of clinical trials have been promoted, including establishment of a system to invite more active participation of subjects in clinical trials and improvement of a network of medical institutions conducting clinical trials. These efforts should help to reactivate clinical trials in Japan, which reportedly have become stagnant. Although the New GCP addresses the quality of industry-sponsored clinical trials, investigators also construct study protocols without industry involvement. We reviewed clinical trials submitted by investigators at Gunma University Hospital to institutional review boards (IRBs) from June 1999 to February 2002. Ten clinical research coordinators contributed to the present survey. A total of 151 investigator-initiated clinical trials reviewed included a wide variety of content; and investigators from many institutions and organizations conducted trials. Most of the ethical guidelines for approving proposed trials represented the provisions of the Declaration of Helsinki. However, additional guidelines prepared by the Japanese Ministry of Health, Labour and Welfare were also helpful. Development of a support system for clinical trails requires the contribution of clinical research coordinators. Flexible management and careful attention to both the protocol and its execution by the investigators were also important for promoting clinical trials on the basis of meticulous patient care.

Clinical Trials as Topic↗
PubMedDate not supplied

The centennial of the Yellow Fever Commission and the use of informed consent in medical research.

The year 2000 marked the centennial of the discovery of the mode of transmission of yellow fever. Informed consent was systematically used for the first time in research. This process was the result of a complex social phenomenon involving the American Public Health Association, the US and Spanish Governments, American and Cuban scientists, the media, and civilian and military volunteers. The public health and medical communities face the AIDS pandemic at the beginning of the 21st Century, as they faced the yellow fever epidemic at the beginning of the 20th Century. Current medical research dilemmas have fueled the debate about the ethical conduct of research in human subjects. The AIDS pandemic is imposing enormous new ethical challenges on the conduct of medical research, especially in the developing world. Reflecting on the yellow fever experiments of 1900, lessons can be learned and applied to the current ethical challenges faced by the international public health research community. The English version of this paper is available too at: http://www.insp.mx/salud/index.html.

Advisory Committees↗