scholarly journals Clinical trials in geriatrics: actual status and international regulatory guidlines

Author(s):  
I. P. Malaya

The number of old and very old people is increasing every year. Geriatric population is considered as the most growing age group. By different estimations about 60% of medicines are prescribed to patients of 65 and older. In the same time this age group is underrepresented in clinical trials. Participation of elderlies in clinical trials is really actual now and requires further development form regulatory authorities, drug manufactures and investigators. This review summarizes actual international guidelines on clinical trials in geriatric population.

2002 ◽  
Vol 4 (4) ◽  
pp. 470-474 ◽  

Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only temporary. The future of drug development lies in multinational clinical trials and simultaneous submission to the major regulatory authorities.


Geriatrics ◽  
2021 ◽  
Vol 6 (3) ◽  
pp. 66
Author(s):  
Henk Koppelaar ◽  
Parastou Kordestani-Moghadam ◽  
Sareh Kouhkani ◽  
Farnoosh Irandoust ◽  
Gijs Segers ◽  
...  

Falls in the geriatric population are one of the most important causes of disabilities in this age group. Its consequences impose a great deal of economic burden on health and insurance systems. This study was conducted by a multidisciplinary team with the aim of evaluating the effect of visuo-spatial-motor training for the prevention of falls in older adults. The subjects consisted of 31 volunteers aged 60 to 92 years who were studied in three groups: (1) A group under standard physical training, (2) a group under visuo-spatial-motor interventions, and (3) a control group (without any intervention). The results of the study showed that visual-spatial motor exercises significantly reduced the risk of falls of the subjects.


2019 ◽  
Author(s):  
Waheed Atilade Adegbiji ◽  
Shuaib Kayode Aremu ◽  
AbdulAkeem Adebayo Aluko

BACKGROUND Issues of geriatric otolaryngologic emergency have not been widely applied despite increase in geriatric population. OBJECTIVE This study aimed at determining prevalence, sociodemographic features, aetiology, clinical features, Complications and sources ofreferral of geriatric otorhinolaryngological, head and neck emergency in our center. METHODS This was a prospective hospital based study of geriatric otorhinolaryngology emergency in the Ear, Nose and Throat Department of Ekiti State University Teaching Hospital. The study was carried out between October 2016 and September 2018. Data were obtained by using pretested interviewers questionnaire.All data were collated and analyzed using SPSS version 18.0. The data were expressed by frequency table, percentage, bar charts and pie charts. RESULTS Geriatric otorhinolaryngology, head and neck emergency accounted for 5.3%. Major prevalence age group was 43.9% in the age group (60-64). There were 38.6% males with male to female ratio of 1:1.5. The main aetiology of geriatric otorhinolaryngology emergency was 29.5% trauma/road traffic accident/foreign body impaction and 25.8% tumour. Main anatomical distribution of geriatric otorhinolaryngology emergency were 38.6% throat diseases and 31.1% ear diseases. The most frequent clinical features were pain in 27.3%, hearing loss in 21.2%, tinnitus in 15.9%, bleeding in 14.4%, difficulty breathing in 12.9% and discharge in 11.4%. Common diagnosis in this study were 15.9% sinonasal tumour, 14.4% upper aerodigestive foreign body impaction, 10.6% earwax impaction and 19.8% otitis externa. Acute presentation (<13 weeks) occurred in 1 week in 74.2% and 2-13 weeks In 19.7%. Commonest time of presentation was daytime in 65.9%. Major sources of referral were 43.2% general practitioner and 31.1% casualty officers. Presentation of geriatric otorhinolaryngology emergency were mainly ear, nose and throat clinic in 59.8% with accident and emergency in 28.8%. Commonest associated comorbid illnesses among the geriatric patients were 18.2% hypertension, 14.4% arthritis and 9.8% diabetes mellitus. CONCLUSIONS Geriatric otorhinolaryngological emergency are common pathology with associated with comorbid illnesses. Detailed clinical assessment are mandatory for effective management outcome.


Molecules ◽  
2021 ◽  
Vol 26 (8) ◽  
pp. 2173
Author(s):  
Grace Gar-Lee Yue ◽  
Clara Bik-San Lau ◽  
Ping-Chung Leung

The immune modulating effects of selected herbs deserve careful studies to gain evidence-based support for their further development. We have been working hard on many items of medicinal herbs to gain insight into their immunomodulatory effects relevant to cancer treatment in particular, while infection control is not excluded. Nine of them have been selected to give the results of our exploration on their biological, particularly immunomodulatory activities. Since Hong Kong people especially favor one medicinal mushroom, viz. Coriolus versicolor, a number of clinical trials using Coriolus for cancer-related studies are included in this review. While immune modulation platforms are being built for relevant studies, a brief account on the research targets and related procedures are given.


Vaccines ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 359
Author(s):  
Thai Thanh Hoang Thi ◽  
Estelle J. A. Suys ◽  
Jung Seok Lee ◽  
Dai Hai Nguyen ◽  
Ki Dong Park ◽  
...  

COVID-19 vaccines have been developed with unprecedented speed which would not have been possible without decades of fundamental research on delivery nanotechnology. Lipid-based nanoparticles have played a pivotal role in the successes of COVID-19 vaccines and many other nanomedicines, such as Doxil® and Onpattro®, and have therefore been considered as the frontrunner in nanoscale drug delivery systems. In this review, we aim to highlight the progress in the development of these lipid nanoparticles for various applications, ranging from cancer nanomedicines to COVID-19 vaccines. The lipid-based nanoparticles discussed in this review are liposomes, niosomes, transfersomes, solid lipid nanoparticles, and nanostructured lipid carriers. We particularly focus on the innovations that have obtained regulatory approval or that are in clinical trials. We also discuss the physicochemical properties required for specific applications, highlight the differences in requirements for the delivery of different cargos, and introduce current challenges that need further development. This review serves as a useful guideline for designing new lipid nanoparticles for both preventative and therapeutic vaccines including immunotherapies.


2006 ◽  
Vol 7 (3) ◽  
pp. 78-79
Author(s):  
O.D. Vasovic ◽  
L.J. Zikic ◽  
G. Sevo ◽  
M. Zamaklar ◽  
D. Milosevic

2009 ◽  
Vol 8 (2) ◽  
pp. 105-110 ◽  
Author(s):  
Julie Davies ◽  
Christine Rawlings

AbstractIn the UK, radiotherapy research is being conducted at national and international levels which include multi-centre clinical trials. Local initiatives and trials are also ongoing where work is being performed to develop techniques or protocols for new technologies and service development. Active participation within these studies is now leading to a culture change with radiographers (radiation therapists) becoming an integral part of the research process. There are currently 70 radiographers in the UK participating in research. This accounts for 2.5% of the UK profession. With the extension of role diversification, research radiographers are undertaking many new roles; however, there is still scope for further development. The therapists’ role in working within this research environment is to ensure improved standards of care focussed on evidence-based practice.


2007 ◽  
Vol 62 (6) ◽  
pp. 636-640 ◽  
Author(s):  
U. Lindemann ◽  
R. Muche ◽  
M. Stuber ◽  
W. Zijlstra ◽  
K. Hauer ◽  
...  
Keyword(s):  
Very Old ◽  

2015 ◽  
pp. 1-7
Author(s):  
H.-J. DONG ◽  
E. WRESSLE ◽  
J. MARCUSSON

Background: Selection bias is often inevitable in epidemiologic studies. It is not surprising that study conclusions based on participants’ health status are frequently questioned. Objective: This study aimed to assess whether the non-participants affected the characteristics of a general population of the very old people. Design, Setting and Participants: Prospective, cross-sectional (N=650, aged 85 years old) analysis and 1-year follow-up (n=273), in Linköping, Sweden. Measurements: We analysed data on health-related factors from a postal questionnaire, a home visit and a clinic visit at baseline and at the 1-year follow-up. We calculated the effect size to evaluate the degree of differences between the groups. Results: A greater proportion of non-participants resided in sheltered accommodation or nursing homes (participants vs non-response vs refusal, 11% vs 22% vs 40, P<0.001, φ=0.24). During the home visit or clinic visit, a higher proportion of dropouts reported mid-severe problems in EQ-5D domains (mobility and self-care) and limitations in personal activities of daily living, but the differences between participants and dropouts were very small (φ<0.2). No significant difference was found between the groups with regard to emergency room visits or hospital admissions, despite the fact that more participants than dropouts (φ=0.23) had multimorbidities (≥2 chronic diseases). Living in sheltered accommodation or a nursing home (odds ratio (OR), 2.8; 95% confidence interval (CI), 1.5-5), female gender (OR, 1.8; 95% CI, 1.1-3.1) and receiving more home visits in primary care (OR, 1.03; 95% CI, 1-1.06) contributed positively to drop out in the data collection stages over the study period. Conclusion: Non-participants were not considered to be a group with worse health. Mobility problems may influence very old people when considering further participation, which threatens attrition.


2015 ◽  
Vol 31 (3) ◽  
pp. 1008 ◽  
Author(s):  
Ana B. Navarro ◽  
Belén Bueno

<p>This paper assesses the strategies for coping with health problems in advanced old age and their contribution in terms of several performance results. 159 people aged 75 or over and living at home identified their most recent health problem, the strategies used to deal with it, their perception of self-efficacy in handling the problem and their degree of satisfaction with life. The results confirm the use of a range of strategies, with the active-behavioural approach to solving the problem being the one most widely used. In addition, together with active coping strategies of both a cognitive and behavioural nature, correlational analyses indicate that very old people resort to passive and avoidance coping methods. Furthermore, multiple regression analyses highlight the fact that the use of direct and rational actions for solving health problems predicts self-efficacy in dealing with the problem and protects satisfaction with life at this stage. These results confirm that very old people retain the ability to deal effectively with their health problems and, at the same time, uphold their well-being, providing evidence of the adaptive role of coping in very old age.</p>


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