Good Clinical Research Practice guidelines and PK-PD modelling without twitch stabilisation

2008 ◽  
Vol 52 (4) ◽  
pp. 577-578 ◽  
Author(s):  
D. J. Eleveld ◽  
J. H. Proost ◽  
A. De Haes ◽  
J. M. K. H. Wierda
2012 ◽  
Vol 40 (3) ◽  
pp. 441-451 ◽  
Author(s):  
Bernard Lo

Financial relationships between physicians and industry are widespread. Highly publicized financial relationships between physicians and industry raised disturbing questions about the trustworthiness of clinical research, practice guidelines, and clinical care decisions. Recent incidents spurred calls for stricter conflict of interest policies and led to new federal laws and NIH regulations. These stricter policies have evoked praise, concerns, and objections. Because these new federal requirements need to be interpreted and implemented, spirited discussions of conflicts of interest in medicine will continue.


2018 ◽  
Vol 14 (1) ◽  
pp. 33-48 ◽  
Author(s):  
Sanna-Maria Nurmi ◽  
Mari Kangasniemi ◽  
Arja Halkoaho ◽  
Anna-Maija Pietilä

With changes in clinical research practice, the importance of a study-subject’s privacy and the confidentiality of their personal data is growing. However, the body of research is fragmented, and a synthesis of work in this area is lacking. Accordingly, an integrative review was performed, guided by Whittemore and Knafl’s work. Data from PubMed, Scopus, and CINAHL searches from January 2012 to February 2017 were analyzed via the constant comparison method. From 16 empirical and theoretical studies, six topical aspects were identified: the evolving nature of health data in clinical research, sharing of health data, the challenges of anonymizing data, collaboration among stakeholders, the complexity of regulation, and ethics-related tension between social benefits and privacy. Study subjects’ privacy is an increasingly important ethics principle for clinical research, and privacy protection is rendered even more challenging by changing research practice.


2018 ◽  
Vol 129 (9) ◽  
pp. 2056-2057
Author(s):  
Riitta Hari ◽  
Sylvain Baillet ◽  
Gareth Barnes ◽  
Nina Forss ◽  
Joachim Gross ◽  
...  

2019 ◽  
Vol 122 (2) ◽  
pp. 1221-1235 ◽  
Author(s):  
Magnus Eriksson ◽  
Annika Billhult ◽  
Tommy Billhult ◽  
Elena Pallari ◽  
Grant Lewison

AbstractAlthough there are now several bibliographic databases of research publications, such as Google Scholar, Pubmed, Scopus, and the Web of Science (WoS), and some also include counts of citations, there is at present no similarly comprehensive database of the rapidly growing number of clinical practice guidelines (CPGs), with their references, which sometimes number in the hundreds. CPGs have been shown to be useful for the evaluation of clinical (as opposed to basic) biomedical research, which often suffers from relatively low counts of citations in the serial literature. The objectives were to introduce a new citation database, clinical impact®, and demonstrate how it can be used to evaluate research impact of clinical research publications by exploring the characteristics of CPG citations of two sets of papers, as well as show temporal variation of clinical impact® and the WoS. The paper includes the methodology used to retain the data and also the rationale adopted to achieve data quality. The analysis showed that although CPGs tend preferentially to cite papers from their own country, this is not always the case. It also showed that cited papers tend to have a more clinical research level than uncited papers. An analysis of diachronous citations in both clinical impact® and the WoS showed that although the WoS citations showed a decreasing trend after a peak at 2–3 years after publication, this was less clear for CPG citations and a longer timescale would be needed to evaluate their impact on these documents.


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