Pub Date : 2021-01-01DOI: 10.35248/2167-0870.21.S10.E002
W. Rose
The shift from empiricism and observational studies to experimental methods as the basis for advancing the treatment of human disease has occurred only recently. The modern age of clinical trials, born with the British Medical Research Council’s study of streptomycin treatment of tuberculosis in 1948, has provided the substrate for evidence-based medicine. Clinical trials have been credited with “three of the seven years of increased life expectancy over that time and an average of five additional years of partial or complete relief from the poor quality of life associated with chronic disease”. The enormous expansion of clinical trials has paralleled the event of latest therapies. With the massive number of medicine in development and therefore the requirement for controlled clinical trials for approval, the expanding number of clinical trials isn't expected. Despite the obvious benefits of bringing scientific methods to the evaluation of therapies, the need for clinical trials has recently been challenged. Proponents of epidemiological studies as substitutes for clinical trials have suggested that conclusions from observational studies, including meta-analyses, often give similar answers as clinical trials. Although empirical data may provide useful information regarding established therapies, it should be obvious that they play a very different role from clinical trials.
作为推进人类疾病治疗的基础，从经验主义和观察研究到实验方法的转变只是最近才发生的。1948年，英国医学研究委员会(British Medical Research Council)对链霉素治疗结核病的研究开创了现代临床试验时代，为循证医学奠定了基础。临床试验被认为是“在这段时间里，预期寿命增加了七年中的三年，平均额外五年部分或完全缓解了与慢性疾病相关的生活质量低下”。临床试验的巨大扩展与最新疗法的发展是同步的。由于大量药物正在开发中，因此需要进行对照临床试验以获得批准，因此临床试验的数量不会增加。尽管将科学方法引入治疗评估有明显的好处，但临床试验的必要性最近受到了挑战。流行病学研究替代临床试验的支持者认为，观察性研究(包括荟萃分析)得出的结论往往与临床试验给出的答案相似。虽然经验数据可能会提供关于已建立的治疗方法的有用信息，但很明显，它们与临床试验起着非常不同的作用。
{"title":"Influence of Clinical Trials on the Treatment of Diabetes Mellitus","authors":"W. Rose","doi":"10.35248/2167-0870.21.S10.E002","DOIUrl":"https://doi.org/10.35248/2167-0870.21.S10.E002","url":null,"abstract":"The shift from empiricism and observational studies to experimental methods as the basis for advancing the treatment of human disease has occurred only recently. The modern age of clinical trials, born with the British Medical Research Council’s study of streptomycin treatment of tuberculosis in 1948, has provided the substrate for evidence-based medicine. Clinical trials have been credited with “three of the seven years of increased life expectancy over that time and an average of five additional years of partial or complete relief from the poor quality of life associated with chronic disease”. The enormous expansion of clinical trials has paralleled the event of latest therapies. With the massive number of medicine in development and therefore the requirement for controlled clinical trials for approval, the expanding number of clinical trials isn't expected. Despite the obvious benefits of bringing scientific methods to the evaluation of therapies, the need for clinical trials has recently been challenged. Proponents of epidemiological studies as substitutes for clinical trials have suggested that conclusions from observational studies, including meta-analyses, often give similar answers as clinical trials. Although empirical data may provide useful information regarding established therapies, it should be obvious that they play a very different role from clinical trials.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"1 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78533245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2167-0870.21.11.459
Carvallo Héctor, H. Roberto
From the first outbreak in Wuhan (China) in December 2019, until today (05/28/2020), the number of deaths worldwide due to the coronavirus pandemic exceeded 2.5 millions. Only in Argentina, 50,000 deaths have been confirmed so far. There haven’t been so far any clear diagnostic pattern for this exceptional entity except unilateral skin involvement, early onset of symptoms, positive ANA and negative tests for Borrelia burgdorferi. Hence, we report a new case of a young Moroccan man. No treatment tested worldwide has shown unquestionable efficacy in the fight against COVID-19, according to W.H.O, NIH and NICE reports and accumulated data. Our proposal consists of the combination of drugs, based on the pathophysiology of the virus. We have designed a treatment called I.D.E.A., based on four affordable drugs already available on the pharmacopoeia in Argentina, on the following rationale: -Ivermectin (IVM) solution to lower the viral load in all stages of COVID-19. -Dexamethasone 4 mg injection, as anti-inflammatory drug to treat hyperinflammatory reaction to COVID-infection. -Enoxaparin injection as anticoagulant to treat hypercoagulation in severe cases. -Aspirin 250 mg tablets to prevent hypercoagulation in mild and moderate cases. Except for Ivermection oral solution, which was used in a higher dose than approved for parasitosis, all other drugs were used in the already approved dose and indication. Regarding Ivermectin safety, several oral studies have shown it to be safe even when used at daily doses much higher than those approved already. A clinical study has been conducted on COVID-19 patients at Eurnekian Hospital in the Province of Buenos Aires, Argentina. The study protocol and its final outcomes are described in this article. Results were compared with published data and data from patients admitted to the hospital receiving other treatments. None of the patient presenting mild symptoms needed to be hospitalized. Only one patient died (0.59% of all included patients vs. 2.1% overall mortality for the disease in Argentina today, 3.1% of hospitalized patients vs. 26.8% mortality in published data). I.D.E.A. protocol has proved to be a very effective alternative to prevent disease progression of COVID-19 when applied to mild cases, and to decrease mortality in patients at all stages of the disease with a favorable risk-benefit ratio.
{"title":"Safety and Efficacy of the Combined Use of Ivermectin, Dexamethasone, Enoxaparin and Aspirina against COVID-19 the I.D.E.A. Protocol","authors":"Carvallo Héctor, H. Roberto","doi":"10.35248/2167-0870.21.11.459","DOIUrl":"https://doi.org/10.35248/2167-0870.21.11.459","url":null,"abstract":"From the first outbreak in Wuhan (China) in December 2019, until today (05/28/2020), the number of deaths worldwide due to the coronavirus pandemic exceeded 2.5 millions. Only in Argentina, 50,000 deaths have been confirmed so far. There haven’t been so far any clear diagnostic pattern for this exceptional entity except unilateral skin involvement, early onset of symptoms, positive ANA and negative tests for Borrelia burgdorferi. Hence, we report a new case of a young Moroccan man. No treatment tested worldwide has shown unquestionable efficacy in the fight against COVID-19, according to W.H.O, NIH and NICE reports and accumulated data. Our proposal consists of the combination of drugs, based on the pathophysiology of the virus. We have designed a treatment called I.D.E.A., based on four affordable drugs already available on the pharmacopoeia in Argentina, on the following rationale: -Ivermectin (IVM) solution to lower the viral load in all stages of COVID-19. -Dexamethasone 4 mg injection, as anti-inflammatory drug to treat hyperinflammatory reaction to COVID-infection. -Enoxaparin injection as anticoagulant to treat hypercoagulation in severe cases. -Aspirin 250 mg tablets to prevent hypercoagulation in mild and moderate cases. Except for Ivermection oral solution, which was used in a higher dose than approved for parasitosis, all other drugs were used in the already approved dose and indication. Regarding Ivermectin safety, several oral studies have shown it to be safe even when used at daily doses much higher than those approved already. A clinical study has been conducted on COVID-19 patients at Eurnekian Hospital in the Province of Buenos Aires, Argentina. The study protocol and its final outcomes are described in this article. Results were compared with published data and data from patients admitted to the hospital receiving other treatments. None of the patient presenting mild symptoms needed to be hospitalized. Only one patient died (0.59% of all included patients vs. 2.1% overall mortality for the disease in Argentina today, 3.1% of hospitalized patients vs. 26.8% mortality in published data). I.D.E.A. protocol has proved to be a very effective alternative to prevent disease progression of COVID-19 when applied to mild cases, and to decrease mortality in patients at all stages of the disease with a favorable risk-benefit ratio.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"20 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89357869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2167-0870.21.11.453
A. Garu, Yuri Shiota, A. Shibly, A. Sheikh, S. Yano, T. Araki, Xiaojing Zhou, A. Azad, A. Nagai
Background: Pueraria Decoction (PD) is a Japanese herbal medicine of Kampo tradition, which is used for acute febrile diseases, inflammatory disease and allergic rhinitis. Moreover, PD is reported to have beneficial effects on autonomic disturbance in patients. Objective: The objective of the study is to investigate the effects of PD on autonomic nervous system of healthy adult subjects using spectral analysis of heart rate and blood pressure variability during Head-Up Tilt Test (HUTT). Here, we investigated the effects of PD on autonomic nervous system of healthy adults using spectral analysis of heart rate and blood pressure variability during Head-Up Tilt Test (HUTT). Methods: Twenty healthy subjects were divided into young and middle-aged groups, and examined twice with HUTT, before and 5 minutes after taking 5 g of PD. Spectral analysis of RR interval and Systolic Blood Pressure (SBP) variability was then used to measure the changes in autonomic functions. Results: As for all study participants, low frequency power of the SBP (SBP-LF) was increased, and high frequency power of RR interval (RR-HF) was decreased by tilt. However, PD did not show any effect on SBP-LF or RR-HF both at supine and tilt positions. Tilting did not change the ratio of low and high frequency power of RR interval (RRLF/ HF) before taking PD, which was increased after taking it. When analyzed separately by age, RR-HF was decreased in middle-aged group compared to the young counterpart in all conditions. Interestingly, PD increased RR-HF in middle-aged group at supine position, and a significant reduction of the value appeared at tilt similar like young group. After taking PD, tilt increased RR-LF/HF in both young and middle-aged groups. Conclusion: Our study finds that PD has a function to stimulate sympathetic nerve, and simultaneously restores the decreased parasympathetic functions in both young and elderly groups. Such findings suggest that PD might have a combined effect to protect the whole autonomic nervous system.
背景:葛根汤是一种日本汉布传统草药，用于治疗急性发热性疾病、炎症性疾病和变应性鼻炎。此外，据报道PD对患者的自主神经障碍有有益的作用。目的:通过平视倾斜试验(HUTT)中心率和血压变异性的频谱分析，探讨帕金森病对健康成人自主神经系统的影响。在这里，我们通过平视倾斜试验(HUTT)中心率和血压变异性的频谱分析来研究PD对健康成人自主神经系统的影响。方法:20名健康受试者分为中青年组，分别在服用5 g PD前和5 min后进行两次HUTT检查。然后使用频谱分析RR间期和收缩压(SBP)变异性来测量自主神经功能的变化。结果:所有研究对象的收缩压低频功率(SBP- lf)升高，RR间期高频功率(RR- hf)降低。然而，PD对仰卧位和俯卧位的SBP-LF和RR-HF均无影响。倾斜在服用PD前未改变RR区间(RRLF/ HF)低频功率与高频功率之比，服用PD后则升高。当按年龄分开分析时，在所有情况下，中年组的RR-HF均低于年轻组。有趣的是，PD增加了中年组仰卧位时的RR-HF值，倾斜时的RR-HF值出现明显下降，与年轻组相似。服用PD后，倾斜使中青年组RR-LF/HF升高。结论:我们的研究发现PD具有刺激交感神经的功能，同时恢复年轻和老年组下降的副交感神经功能。这些发现表明帕金森病可能具有保护整个自主神经系统的综合作用。
{"title":"Age-Dependent Analysis of the Effects of Pueraria Decoction on Autonomic Nerve Activities using Head-Up Tilt Test","authors":"A. Garu, Yuri Shiota, A. Shibly, A. Sheikh, S. Yano, T. Araki, Xiaojing Zhou, A. Azad, A. Nagai","doi":"10.35248/2167-0870.21.11.453","DOIUrl":"https://doi.org/10.35248/2167-0870.21.11.453","url":null,"abstract":"Background: Pueraria Decoction (PD) is a Japanese herbal medicine of Kampo tradition, which is used for acute febrile diseases, inflammatory disease and allergic rhinitis. Moreover, PD is reported to have beneficial effects on autonomic disturbance in patients. Objective: The objective of the study is to investigate the effects of PD on autonomic nervous system of healthy adult subjects using spectral analysis of heart rate and blood pressure variability during Head-Up Tilt Test (HUTT). Here, we investigated the effects of PD on autonomic nervous system of healthy adults using spectral analysis of heart rate and blood pressure variability during Head-Up Tilt Test (HUTT). Methods: Twenty healthy subjects were divided into young and middle-aged groups, and examined twice with HUTT, before and 5 minutes after taking 5 g of PD. Spectral analysis of RR interval and Systolic Blood Pressure (SBP) variability was then used to measure the changes in autonomic functions. Results: As for all study participants, low frequency power of the SBP (SBP-LF) was increased, and high frequency power of RR interval (RR-HF) was decreased by tilt. However, PD did not show any effect on SBP-LF or RR-HF both at supine and tilt positions. Tilting did not change the ratio of low and high frequency power of RR interval (RRLF/ HF) before taking PD, which was increased after taking it. When analyzed separately by age, RR-HF was decreased in middle-aged group compared to the young counterpart in all conditions. Interestingly, PD increased RR-HF in middle-aged group at supine position, and a significant reduction of the value appeared at tilt similar like young group. After taking PD, tilt increased RR-LF/HF in both young and middle-aged groups. Conclusion: Our study finds that PD has a function to stimulate sympathetic nerve, and simultaneously restores the decreased parasympathetic functions in both young and elderly groups. Such findings suggest that PD might have a combined effect to protect the whole autonomic nervous system.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"82 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77466501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2167-0870.21.11.454
M. Thunecke
In spite of huge progress in understanding disease biology and technological advances in patient selection and clinical study design, the failure rates of clinical trials are still very high. According to Hay et al. [1] the probability of drugs in phase III to get approved across different indications was only 50%. This is noteworthy in light of the fact that most drugs that make it into phase III have successfully completed phase II, this implies that they met the primary efficacy endpoint and had an acceptable safety profile. There are several possible reasons for this discrepancy between phase II and III success, sometimes drug company sponsors have such a strong financial and strategic interest to advance projects into phase III that they are willing to accept or even overlook obvious issues and risks. Alternatively, the phase II results may have simply been false positive as phase II studies are not always powered for significance, or the power may have been too low. In some rare cases, phase II may have been skipped altogether, this happens especially in indications where patients are enrolled in phase I, such as oncology. For clinical phases I and II the likelihood of approval is much lower (10.4%, 16.2%). These issues are exacerbated by the common practice to use adjusted historical success probabilities for go/no go decisions, although such historical averages can at best give a sense of direction. If agency issues and historical data not reflecting the candidates real profile come together, one gets a dangerous mixture leading to risky clinical trials. The effect of a failed phase III can be disastrous for smaller biotech companies (and their investors) but also larger companies are sometimes seriously affected and pushed into merger situations as a consequence of high profile phase III failures. But it is most disappointing for those patients who saw the participation in a clinical study as a real chance of improving their condition.
{"title":"Predicting Success of Clinical Trials","authors":"M. Thunecke","doi":"10.35248/2167-0870.21.11.454","DOIUrl":"https://doi.org/10.35248/2167-0870.21.11.454","url":null,"abstract":"In spite of huge progress in understanding disease biology and technological advances in patient selection and clinical study design, the failure rates of clinical trials are still very high. According to Hay et al. [1] the probability of drugs in phase III to get approved across different indications was only 50%. This is noteworthy in light of the fact that most drugs that make it into phase III have successfully completed phase II, this implies that they met the primary efficacy endpoint and had an acceptable safety profile. There are several possible reasons for this discrepancy between phase II and III success, sometimes drug company sponsors have such a strong financial and strategic interest to advance projects into phase III that they are willing to accept or even overlook obvious issues and risks. Alternatively, the phase II results may have simply been false positive as phase II studies are not always powered for significance, or the power may have been too low. In some rare cases, phase II may have been skipped altogether, this happens especially in indications where patients are enrolled in phase I, such as oncology. For clinical phases I and II the likelihood of approval is much lower (10.4%, 16.2%). These issues are exacerbated by the common practice to use adjusted historical success probabilities for go/no go decisions, although such historical averages can at best give a sense of direction. If agency issues and historical data not reflecting the candidates real profile come together, one gets a dangerous mixture leading to risky clinical trials. The effect of a failed phase III can be disastrous for smaller biotech companies (and their investors) but also larger companies are sometimes seriously affected and pushed into merger situations as a consequence of high profile phase III failures. But it is most disappointing for those patients who saw the participation in a clinical study as a real chance of improving their condition.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"13 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75214093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2167-0870.21.11.444
K. Fujioka
Atherosclerosis status as an inflammatory disease has been suggested and anti-inflammatory therapy with canakinumab for atherosclerotic disease has been recently reported. The author previously described the relationship between APRI (aspartate aminotransferase to platelet ratio index) and endothelial function assessed by Flow-Mediated Vasodilation (FMD), thereby suggesting that APRI may reflect systemic atherosclerosis condition in elderly patients without hepatic-related causes. Some reports of the relationship between NAFLD/NASH and atherosclerosis status and between chronic Hepatitis C Virus (HCV) infection and atherosclerotic state have been described. As both chronic liver disease and atherosclerosis involve severe inflammatory processes, at least common pathway may be present for the development and treatment of these inflammatory diseases. The current knowledge of the relationship between chronic liver diseases (NAFLD/NASH and HCV infection) and atherosclerosis and a novel therapeutic strategy is reviewed. Based on the several evidences, the author suggests that an association between chronic liver disease and systemic atherosclerosis may be present due to the presence of the inflammation as a common pathway. It is plausible that direct acting antivirus therapy is a potential strategy for not only liver disease but also endothelial dysfunction and atherosclerosis in patient with HCV infection. It has been suggested that momelotinib as a novel treatment may play a potential therapeutic benefit to a high-risk patients with NAFLD/NASH.
{"title":"Association between Chronic Liver Disease and Atherosclerosis: An Inflammation as Common Pathway","authors":"K. Fujioka","doi":"10.35248/2167-0870.21.11.444","DOIUrl":"https://doi.org/10.35248/2167-0870.21.11.444","url":null,"abstract":"Atherosclerosis status as an inflammatory disease has been suggested and anti-inflammatory therapy with canakinumab for atherosclerotic disease has been recently reported. The author previously described the relationship between APRI (aspartate aminotransferase to platelet ratio index) and endothelial function assessed by Flow-Mediated Vasodilation (FMD), thereby suggesting that APRI may reflect systemic atherosclerosis condition in elderly patients without hepatic-related causes. Some reports of the relationship between NAFLD/NASH and atherosclerosis status and between chronic Hepatitis C Virus (HCV) infection and atherosclerotic state have been described. As both chronic liver disease and atherosclerosis involve severe inflammatory processes, at least common pathway may be present for the development and treatment of these inflammatory diseases. The current knowledge of the relationship between chronic liver diseases (NAFLD/NASH and HCV infection) and atherosclerosis and a novel therapeutic strategy is reviewed. Based on the several evidences, the author suggests that an association between chronic liver disease and systemic atherosclerosis may be present due to the presence of the inflammation as a common pathway. It is plausible that direct acting antivirus therapy is a potential strategy for not only liver disease but also endothelial dysfunction and atherosclerosis in patient with HCV infection. It has been suggested that momelotinib as a novel treatment may play a potential therapeutic benefit to a high-risk patients with NAFLD/NASH.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"28 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74799108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2167-0870.21.S10.E003
Elizabet Garce
{"title":"A Clinical Trial Study on Diabetes Mellitus","authors":"Elizabet Garce","doi":"10.35248/2167-0870.21.S10.E003","DOIUrl":"https://doi.org/10.35248/2167-0870.21.S10.E003","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"21 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85504010","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2167-0870.21.11.469
A. Pinho, K. Weingard, M. Efros
Objective: Annually, billions of dollars are spent worldwide on drug development and the associated clinical trials conducted. Therefore, it is vital that pharmaceutical companies who sponsor clinical trials ensure that their data is accurate and timely. Numerous challenges for clinical trials exist and include recruitment and enrollment of appropriate research subject. Potential candidates for these studies are recruited and incentivized to participate in trials. While a great number of people participate in clinical trials solely for altruistic reasons, compensation for time and travel does motivate many potential research subjects. For others without adequate health insurance, the impetus is the evaluation and treatment with investigational products at no charge for their own potential health conditions. For both safety reasons and purposes of data integrity, it has long been held that research subjects should not volunteer in more than one study at a time. Also, there is typically a minimum 30-day waiting period or “washout period” between studies. These criteria are difficult to verify and thus we explored the development of a global regulatory compliant database that collects information on the exact research subject’s study history to detect multiple potential pitfalls and protocol violations that would be of immeasurable benefit to strengthen clinical trial data. Our study shows that subjects are neither always compliant nor forthcoming. There are attempts to screen more than once; there are age violations, washout period violations, and other violations that might cause poor quality data in a trial. Verified Clinical Trials (VCT) is the world’s largest and most comprehensive research subject database. By utilizing VCT, a sponsor can ensure that their subjects are verified and are not either enrolled in another clinical trial, still in their washout period, or in violation of any other protocol criterion.
{"title":"Improving Safety and Preventing Failure in Clinical Trials by Detecting and Preventing Duplicate and Professional Research Subjects: The Case for Use of a Research Subject Database Registry","authors":"A. Pinho, K. Weingard, M. Efros","doi":"10.35248/2167-0870.21.11.469","DOIUrl":"https://doi.org/10.35248/2167-0870.21.11.469","url":null,"abstract":"Objective: Annually, billions of dollars are spent worldwide on drug development and the associated clinical trials conducted. Therefore, it is vital that pharmaceutical companies who sponsor clinical trials ensure that their data is accurate and timely. Numerous challenges for clinical trials exist and include recruitment and enrollment of appropriate research subject. Potential candidates for these studies are recruited and incentivized to participate in trials. While a great number of people participate in clinical trials solely for altruistic reasons, compensation for time and travel does motivate many potential research subjects. For others without adequate health insurance, the impetus is the evaluation and treatment with investigational products at no charge for their own potential health conditions. For both safety reasons and purposes of data integrity, it has long been held that research subjects should not volunteer in more than one study at a time. Also, there is typically a minimum 30-day waiting period or “washout period” between studies. These criteria are difficult to verify and thus we explored the development of a global regulatory compliant database that collects information on the exact research subject’s study history to detect multiple potential pitfalls and protocol violations that would be of immeasurable benefit to strengthen clinical trial data. Our study shows that subjects are neither always compliant nor forthcoming. There are attempts to screen more than once; there are age violations, washout period violations, and other violations that might cause poor quality data in a trial. Verified Clinical Trials (VCT) is the world’s largest and most comprehensive research subject database. By utilizing VCT, a sponsor can ensure that their subjects are verified and are not either enrolled in another clinical trial, still in their washout period, or in violation of any other protocol criterion.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"82 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83931516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2167-0870.21.11.457
Timothy Y. Kim, D. Mathios, S. Srivastava, M. Lim
In general, high grade gliomas have a dismal prognosis. However, recent advances in disease classification, surgical treatment, and adjuvant therapy have increased the overall survival of this patient population. While a significant number of resources is used to improve treatment for high grade gliomas, there are few advancements in technology development towards an accurate non-invasive assessment of response to these therapeutic modalities. The advent of new treatment modalities and especially the increasing number of immunotherapy clinical trials for high grade gliomas necessitate the development of new approaches for accurate and timely assessment of treatment response in brain tumors. Conventional MRI assessment of response to immunotherapy is inadequate to guide treatment leading to a high number of surgical procedures for definitive assessment. In this review, we are outlining the evolution of imaging criteria as well as the advancements in imaging technology and computational analysis to address the challenges of disease monitoring in the setting of immunotherapy for high grade gliomas. We give particular emphasis on radiomics, a new field on image analysis that algorithmically assesses a large number of imaging features for an accurate diagnosis.
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Pub Date : 2021-01-01DOI: 10.35248/2167-0870.21.11.446
S. Ms, P. Sathiyarajeswaran
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