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Medical Research for Hire
Today, more than 75 percent of pharmaceutical drug trials in the United States are being conducted in the private sector. Once the sole province of academic researchers, these important studies are now being outsourced to non-academic physicians.
According to Jill A. Fisher, this major change in the way medical research is performed is the outcome of two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. As physicians report diminishing income due to restrictive relationships with insurers, increasing malpractice insurance premiums, and inflated overhead costs to operate private practices, they are attracted to pharmaceutical contract research for its lucrative return. Clinical trials also provide limited medical access to individuals who have no or inadequate health insurance because they offer \"free\" doctors' visits, diagnostic tests, and medications to participants. Focusing on the professional roles of those involved, as well as key research practices, Fisher assesses the risks and advantages for physicians and patients alike when pharmaceutical drug studies are used as an alternative to standard medical care.
A volume in the Critical Issues in Health and Medicine series, edited by Rima D. Apple and Janet Golden
eBook
Blockchain and clinical trial : securing patient data
\"This book aims to highlight the gaps and the transparency issues in the clinical research and trials processes and how there is a lack of information flowing back to researchers and patients involved in those trials. Lack of data transparency is an underlying theme within the clinical research world and causes issues of corruption, fraud, errors and a problem of reproducibility. Blockchain can prove to be a method to ensure a much more joined up and integrated approach to data sharing and improving patient outcomes. Surveys undertaken by creditable organisations in the healthcare industry are analysed in this book that show strong support for using blockchain technology regarding strengthening data security, interoperability and a range of beneficial use cases where mostly all respondents of the surveys believe blockchain will be important for the future of the healthcare industry. Another aspect considered in the book is the coming surge of healthcare wearables using Internet of Things (IoT) and the prediction that the current capacity of centralised networks will not cope with the demands of data storage. The benefits are great for clinical research, but will add more pressure to the transparency of clinical trials and how this is managed unless a secure mechanism like, blockchain is used\"--Publisher's description.
Book
Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis
Recruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies.
This study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods.
Data on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and P<.05 was considered significant.
In total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, P=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, P=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, P=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, P=.02).
Targeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate.
Journal Article
Adaptive Designs for Clinical Trials
Investigators use adaptive trial designs to alter basic features of an ongoing trial. This approach obtains the most information possible in an unbiased way while putting the fewest patients at risk. In this review, the authors discuss selected issues in adaptive design.
Randomized clinical trials serve as the standard for clinical research and have contributed immensely to advances in patient care. Nevertheless, several shortcomings of randomized clinical trials have been noted, including the need for a large sample size and long study duration, the lack of power to evaluate efficacy overall or in important subgroups, and cost. These and other limitations have been widely acknowledged as limiting medical innovation.
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Adaptive trial design has been proposed as a means to increase the efficiency of randomized clinical trials, potentially benefiting trial participants and future patients while reducing costs and enhancing the likelihood of finding . . .
Journal Article
Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study
AbstractObjectivesTo study the impact of blinding on estimated treatment effects, and their variation between trials; differentiating between blinding of patients, healthcare providers, and observers; detection bias and performance bias; and types of outcome (the MetaBLIND study).DesignMeta-epidemiological study.Data sourceCochrane Database of Systematic Reviews (2013-14).Eligibility criteria for selecting studiesMeta-analyses with both blinded and non-blinded trials on any topic.Review methodsBlinding status was retrieved from trial publications and authors, and results retrieved automatically from the Cochrane Database of Systematic Reviews. Bayesian hierarchical models estimated the average ratio of odds ratios (ROR), and estimated the increases in heterogeneity between trials, for non-blinded trials (or of unclear status) versus blinded trials. Secondary analyses adjusted for adequacy of concealment of allocation, attrition, and trial size, and explored the association between outcome subjectivity (high, moderate, low) and average bias. An ROR lower than 1 indicated exaggerated effect estimates in trials without blinding.ResultsThe study included 142 meta-analyses (1153 trials). The ROR for lack of blinding of patients was 0.91 (95% credible interval 0.61 to 1.34) in 18 meta-analyses with patient reported outcomes, and 0.98 (0.69 to 1.39) in 14 meta-analyses with outcomes reported by blinded observers. The ROR for lack of blinding of healthcare providers was 1.01 (0.84 to 1.19) in 29 meta-analyses with healthcare provider decision outcomes (eg, readmissions), and 0.97 (0.64 to 1.45) in 13 meta-analyses with outcomes reported by blinded patients or observers. The ROR for lack of blinding of observers was 1.01 (0.86 to 1.18) in 46 meta-analyses with subjective observer reported outcomes, with no clear impact of degree of subjectivity. Information was insufficient to determine whether lack of blinding was associated with increased heterogeneity between trials. The ROR for trials not reported as double blind versus those that were double blind was 1.02 (0.90 to 1.13) in 74 meta-analyses.ConclusionNo evidence was found for an average difference in estimated treatment effect between trials with and without blinded patients, healthcare providers, or outcome assessors. These results could reflect that blinding is less important than often believed or meta-epidemiological study limitations, such as residual confounding or imprecision. At this stage, replication of this study is suggested and blinding should remain a methodological safeguard in trials.
Journal Article