scholarly journals PHP132 - CAN BLOCKCHAIN TECHNOLOGY IMPROVE THE QUALITY OF CLINICAL TRIAL EVIDENCE? – A SYSTEMATIC LITERATURE REVIEW

2018 ◽  
Vol 21 ◽  
pp. S172
Author(s):  
M. Koufopoulou ◽  
M. Arregui ◽  
M. Lovelace ◽  
O. Arisa ◽  
S. Abogunrin
2020 ◽  
Vol 8 (6) ◽  
pp. 2174-2180

The distribution process is one of the processes that occur in all industries, including the pharmaceutical industry. The distribution of medicines in the pharmaceutical industry is the most important to provide quality pharmaceutical products to patients or consumers. With several problems that occur in the distribution of drugs in things that currently should be considered. This happens a lot due to the many drugs that disagree with the provisions or such illegal or false drugs. This research investigates the use of blockchain technology for drug distribution in Indonesia. This research uses a systematic literature review method with related literature. The results of this research found 54 blockchain factors that were used to improve nine aspects of good distribution practices and to ensure the good quality of medicines distributed to consumers


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G G Stefanini ◽  
H Naci ◽  
D Cao ◽  
G Malanchini ◽  
M Sturla ◽  
...  

Abstract Background Regulatory approval of drugs and devices follow two different pathways. Whether different approval pathways underlie meaningful differences in quality of clinical trial evidence is unknown. We aimed to compare the quality of evidence of clinical trials that served as a basis for approval by the U.S. Food and Drug Administration (FDA) of drugs and devices used for the treatment of coronary artery disease. Methods FDA databases were searched for devices (i.e., coronary artery drug-eluting stents) and drugs (i.e., agents targeting atherothrombosis) approved between January 1st, 2001 and December 31st, 2017. FDA medical reviews were screened to identify trials that served for approval purposes. The pre-specified primary outcome was the prevalence of randomized trials used for approval (i.e. number of randomized trials/overall number of trials). Results A total of 97 trials were identified, 39 serving for approval of 13 devices and 58 serving for approval of 8 drugs. Devices were evaluated by fewer trials per item as compared with drugs (3.0±1.4 vs. 7.3±5.3, P=0.012) with similar study size (501 [100–1314] vs. 379 [183–904] patients per trial, P=0.55). Trials evaluating devices were less frequently randomized (56.4% vs. 94.8%, P<0.001) and more frequently designed powered for clinical endpoints (53.8% vs. 17.2%, P<0.001) as compared to those evaluating drugs. Use of randomization declined over time among trials supporting FDA approval of devices. In addition, significant differences were present between trials evaluating devices and those evaluating drugs in terms of study design, comparator used, blinding to treatment allocation, primary hypothesis, primary endpoint, and type of patients included. Use of randomized trials for approval Conclusions There are substantial differences in clinical trial evidence serving for FDA approval of devices and drugs used for treatment of coronary artery disease. The lower degree of randomized evidence used for approval of devices as compared to drugs raises some concerns, particularly in view of its decline over time.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1337.2-1337
Author(s):  
T. W. Swinnen ◽  
M. Willems ◽  
I. Jonkers ◽  
F. P. Luyten ◽  
J. Vanrenterghem ◽  
...  

Background:The personal and societal burden of knee osteoarthritis (KOA) urges the research community to identify factors that predict its onset and progression. A mechanistic understanding of disease is currently lacking but needed to develop targeted interventions. Traditionally, risk factors for KOA are termed ‘local’ to the joint or ‘systemic’ referring to whole-body systems. There are however clear indications in the scientific literature that contextual factors such as socioeconomic position merit further scientific scrutiny, in order to justify a more biopsychosocial view on risk factors in KOA.Objectives:The aims of this systematic literature review were to assess the inclusion of socioeconomic factors in KOA research and to identify the impact of socioeconomic factors on pain and function in KOA.Methods:Major bibliographic databases, namely Medline, Embase, CINAHL, Web of Science and Cochrane, were independently screened by two reviewers (plus one to resolve conflicts) to identify research articles dealing with socioeconomic factors in the KOA population without arthroplasty. Included studies had to quantify the relationship between socioeconomic factors and pain or function. Main exclusion criteria were: a qualitative design, subject age below 16 years and articles not written in English or Dutch. Methodological quality was assessed via the Cochrane risk of bias tools for randomized (ROB-II) and non-randomized intervention studies (ROBIN-I) and the Newcastle-Ottawa Scale for assessing the quality of non-randomised studies. Due to heterogeneity of studies with respect to outcomes assessed and analyses performed, no meta-analysis was performed.Results:Following de-duplication, 7639 articles were available for screening (120 conflicts resolved without a third reader). In 4112 articles, the KOA population was confirmed. 1906 (25%) were excluded because of knee arthroplasty and 1621 (21%) because of other issues related to the population definition. Socioeconomic factors could not be identified in 4058 (53%) papers and were adjusted for in 211 (3%) articles. In the remaining papers covering pain (n=110) and/or function (n=81), education (62%) and race (37%) were most frequently assessed as socioeconomic factors. A huge variety of mainly dichotomous or ordinal socioeconomic outcomes was found without further methodological justification nor sensitivity analysis to unravel the impact of selected categories. Although the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was the most popular instrument to assess pain and function, data pooling was not possible as socioeconomic factors estimates were part of multilevel models in most studies. Overall results showed that lower education and African American race were consistent predictors of pain and poor function, but those effects diminished or disappeared when psychological aspects (e.g. discrimination) or poverty estimates were taken into account. When function was assessed using self-reported outcomes, the impact of socioeconomic factors was more clear versus performance-based instruments. Quality of research was low to moderate and the moderating or mediating impact of socioeconomic factors on intervention effects in KOA is understudied.Conclusion:Research on contextual socioeconomic factors in KOA is insufficiently addressed and their assessment is highly variable methodologically. Following this systematic literature review, we can highlight the importance of implementing a standardised and feasible set of socioeconomic outcomes in KOA trials1, as well as the importance of public availability of research databases including these factors. Future research should prioritise the underlying mechanisms in the effect of especially education and race on pain and function and assess its impact on intervention effects to fuel novel (non-)pharmacological approaches in KOA.References:[1]Smith TO et al. The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis J Rheumatol 2019. 46:981–9.Disclosure of Interests:None declared.


2016 ◽  
Vol 22 (Suppl 2) ◽  
pp. A213.1-A213
Author(s):  
Ritva Rissanen ◽  
Hans-Yngve Berg ◽  
Marie Hasselberg

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