The term “Antiviral agents” has been defined in very wide terms as substances other than a virus or virus containing vaccine or specific antibody which can build either a protective or therapeutic effect to the direct measurable advantage of the virus infected host. Viruses are simple in form which are very tiny germs. They comprise of genetic material inside of a protein coating. Viruses cause amicable infectious diseases like common cold, flu and warts. They also cause severe diseases such as HIV/AIDS, Ebola, avian influenzas, dengue virus and COVID-19. Viral diseases are very complex and are easily spread. Herbs and herbal medicines were the foremost in treating infections from centuries over the world in every civilization. Modern science has narrowed the importance of herbal medicine in the past two centuries. But, the side effects and new varieties of diseases creating challenges to modern science. So, usage of herbal medicines is again attaining interests these days. Herbal products for different treatments have achieved a lot of popularity in the last couple of decades. Thus, discovering novel antiviral drugs is of extremely important and natural products are an excellent source for such discoveries. There are many herbs which are excellent sources for the antiviral properties to treat viral infections. This review provides the verified data on the herbal substances with antiviral activity, and some of the herbal marketed antiviral agents like CORONIL TABLETS from Patanjali and different companies had made an attempt to treat viral infections in this pandemic situation. Therefore, herbal plants proved to be a major resort for the treatment of diseases and sickness by traditional healers in many societies.
{"title":"Herbal Medicine for the Treatmentof Viral Infections: A Systemic Review","authors":"A. Krishna sailaja, Amand Alekhya","doi":"10.31579/2692-9406/088","DOIUrl":"https://doi.org/10.31579/2692-9406/088","url":null,"abstract":"The term “Antiviral agents” has been defined in very wide terms as substances other than a virus or virus containing vaccine or specific antibody which can build either a protective or therapeutic effect to the direct measurable advantage of the virus infected host. Viruses are simple in form which are very tiny germs. They comprise of genetic material inside of a protein coating. Viruses cause amicable infectious diseases like common cold, flu and warts. They also cause severe diseases such as HIV/AIDS, Ebola, avian influenzas, dengue virus and COVID-19. Viral diseases are very complex and are easily spread. Herbs and herbal medicines were the foremost in treating infections from centuries over the world in every civilization. Modern science has narrowed the importance of herbal medicine in the past two centuries. But, the side effects and new varieties of diseases creating challenges to modern science. So, usage of herbal medicines is again attaining interests these days. Herbal products for different treatments have achieved a lot of popularity in the last couple of decades. Thus, discovering novel antiviral drugs is of extremely important and natural products are an excellent source for such discoveries. There are many herbs which are excellent sources for the antiviral properties to treat viral infections. This review provides the verified data on the herbal substances with antiviral activity, and some of the herbal marketed antiviral agents like CORONIL TABLETS from Patanjali and different companies had made an attempt to treat viral infections in this pandemic situation. Therefore, herbal plants proved to be a major resort for the treatment of diseases and sickness by traditional healers in many societies.","PeriodicalId":72392,"journal":{"name":"Biomedical research and clinical reviews","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46758646","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}
Michelot Michel, Noelle Lucke-Wold, Mohammad Reza Hosseini, Eric Panther, Ramya Reddy, Brandon Lucke-Wold
Primary CNS lymphoma presents unique challenges for the clinician. New evidence has emerged regarding the appropriate workup, management considerations, and treatment. In this paper, we highlight the clinical presentations, disease prognosis, and management considerations. We place specific emphasis on the decision tree for immunocompetent and immunocompromised. The key imaging characteristics are discussed. Once biopsy prove lymphoma, important management considerations are addressed. We highlight need for follow up and role for surgery verse radiation. Finally, we present emerging treatment options and pre-clinical work that will be making its way through the pipeline. This up-to-date review will serve as a key learning tool for clinicians and researchers.
{"title":"CNS Lymphoma: Clinical Pearls and Management Considerations.","authors":"Michelot Michel, Noelle Lucke-Wold, Mohammad Reza Hosseini, Eric Panther, Ramya Reddy, Brandon Lucke-Wold","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Primary CNS lymphoma presents unique challenges for the clinician. New evidence has emerged regarding the appropriate workup, management considerations, and treatment. In this paper, we highlight the clinical presentations, disease prognosis, and management considerations. We place specific emphasis on the decision tree for immunocompetent and immunocompromised. The key imaging characteristics are discussed. Once biopsy prove lymphoma, important management considerations are addressed. We highlight need for follow up and role for surgery verse radiation. Finally, we present emerging treatment options and pre-clinical work that will be making its way through the pipeline. This up-to-date review will serve as a key learning tool for clinicians and researchers.</p>","PeriodicalId":72392,"journal":{"name":"Biomedical research and clinical reviews","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40503495","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 : 2022-01-01Epub Date: 2022-09-08DOI: 10.31579/2692-9406/128
Yusuf Mehkri, Brandon McDonald, Sai Sriram, Ramya Reddy, Savannah Kounelis-Wuillaume, Jeffrey Alexander Roberts, Brandon Lucke-Wold
Neurotrauma has been well linked to the progression of neurodegenerative disease. Much work has been done characterizing chronic traumatic encephalopathy, but less has been done regarding the contribution to Alzheimer's Disease. This review focuses on AD and its association with neurotrauma. Emerging clinical trials are discussed as well as novel mechanisms. We then address how some of these mechanisms are shared with CTE and emerging pre-clinical studies. This paper is a user-friendly resource that summarizes the emerging findings and proposes further investigation into key areas of interest. It is intended to serve as a catalyst for both research teams and clinicians in the quest to improve effective treatment and diagnostic options.
{"title":"Recent Treatment Strategies in Alzheimer's Disease and Chronic Traumatic Encephalopathy.","authors":"Yusuf Mehkri, Brandon McDonald, Sai Sriram, Ramya Reddy, Savannah Kounelis-Wuillaume, Jeffrey Alexander Roberts, Brandon Lucke-Wold","doi":"10.31579/2692-9406/128","DOIUrl":"10.31579/2692-9406/128","url":null,"abstract":"<p><p>Neurotrauma has been well linked to the progression of neurodegenerative disease. Much work has been done characterizing chronic traumatic encephalopathy, but less has been done regarding the contribution to Alzheimer's Disease. This review focuses on AD and its association with neurotrauma. Emerging clinical trials are discussed as well as novel mechanisms. We then address how some of these mechanisms are shared with CTE and emerging pre-clinical studies. This paper is a user-friendly resource that summarizes the emerging findings and proposes further investigation into key areas of interest. It is intended to serve as a catalyst for both research teams and clinicians in the quest to improve effective treatment and diagnostic options.</p>","PeriodicalId":72392,"journal":{"name":"Biomedical research and clinical reviews","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10668425","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}
F. Unawunwa, N. Hyriavenko, A. Korobchanska, M. Lyndin, V. Sikora
Aim: immunohistochemical analysis of apoptosis markers in the tissue of PFTC. Introduction: Primary fallopian tubes carcinoma is a rare case among oncological diseases of female genital organs, but the mortality rate is rather high. Nowadays, the prognostic factors of this neoplasia are not fully determined. The data on the p53 and bcl2 proteins expression and their use as prognostic factors in patients with malignant tumors of many locations are contradictory. Methods: the study was conducted on 66 samples of fallopian tubes tumor tissue. To study the apoptosis peculiarities of tumor cells the mouse monoclonal antibodies for bcl-2 (clone 100/D5) and p53 (clone SP5) were used. Mathematic calculations were done using Microsoft Excel 2010 with AtteStat 12.0.5. Results: The high expression of p53 was found in patients of all clinical stages. Mutations of p53 increased with spreading of the neoplastic process. Strong correlation of p53 presence in tumor samples and clinical stage of the disease was determined (r=0.77). In contrast to the abovementioned protein the study of bcl-2 showed the moderate negative correlation between this protein and the stage of the disease (r=−0.54). Analysis of the dependence of p53 expression with the presence or absence of lymph nodes metastasis showed a direct correlation between the indicators (r=0.25). Thus the level of p53 expression in patients with N1 was 80.6±2.7% compared with the N0 group (29.7±3.6%). The stage of neoplasia differentiation is in moderate direct correlation with p53 expression (r=0.58) and in inverse with – bcl-2 (r=−0.64). Conclusion: Expression of p53 depends on neoplasia spreading and stage of tumor differentiation. The expression of p53 is an independent prognostic marker for N-status and helps to classify the patients into “risk” groups.
{"title":"Reprint: Peculiarities of expression of apoptosis markers in the tissues of primary fallopian tubes carcinoma","authors":"F. Unawunwa, N. Hyriavenko, A. Korobchanska, M. Lyndin, V. Sikora","doi":"10.31579/2692-9406/084","DOIUrl":"https://doi.org/10.31579/2692-9406/084","url":null,"abstract":"Aim: immunohistochemical analysis of apoptosis markers in the tissue of PFTC. Introduction: Primary fallopian tubes carcinoma is a rare case among oncological diseases of female genital organs, but the mortality rate is rather high. Nowadays, the prognostic factors of this neoplasia are not fully determined. The data on the p53 and bcl2 proteins expression and their use as prognostic factors in patients with malignant tumors of many locations are contradictory. Methods: the study was conducted on 66 samples of fallopian tubes tumor tissue. To study the apoptosis peculiarities of tumor cells the mouse monoclonal antibodies for bcl-2 (clone 100/D5) and p53 (clone SP5) were used. Mathematic calculations were done using Microsoft Excel 2010 with AtteStat 12.0.5. Results: The high expression of p53 was found in patients of all clinical stages. Mutations of p53 increased with spreading of the neoplastic process. Strong correlation of p53 presence in tumor samples and clinical stage of the disease was determined (r=0.77). In contrast to the abovementioned protein the study of bcl-2 showed the moderate negative correlation between this protein and the stage of the disease (r=−0.54). Analysis of the dependence of p53 expression with the presence or absence of lymph nodes metastasis showed a direct correlation between the indicators (r=0.25). Thus the level of p53 expression in patients with N1 was 80.6±2.7% compared with the N0 group (29.7±3.6%). The stage of neoplasia differentiation is in moderate direct correlation with p53 expression (r=0.58) and in inverse with – bcl-2 (r=−0.64). Conclusion: Expression of p53 depends on neoplasia spreading and stage of tumor differentiation. The expression of p53 is an independent prognostic marker for N-status and helps to classify the patients into “risk” groups.","PeriodicalId":72392,"journal":{"name":"Biomedical research and clinical reviews","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47991232","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}
A. Sakalecha, Parameshwar Keerthi B H, Varun S, Shivaprasad G Savagave
Tuberculosis is an important public problem worldwide from 19th century. Manifestations of tuberculosis widely classified as pulmonary and extra pulmonary manifestations. Central nervous system (CNS) tuberculosis is a serious condition where patients most often present with seizure. Tuberculoma is one of the CNS manifestations of tuberculosis. The imaging feature of tuberculoma is ring enhancing lesions. Tuberculoma should be differentiated from other diseases with ring enhancing lesions like neurocysticercosis, coccidiomycosis, toxoplasmosis and malignancies.
{"title":"Re-Print: An Interesting Case of Disseminated Tuberculoma of Brain and Spinal Cord Type of Study: Case Report","authors":"A. Sakalecha, Parameshwar Keerthi B H, Varun S, Shivaprasad G Savagave","doi":"10.31579/2692-9406/083","DOIUrl":"https://doi.org/10.31579/2692-9406/083","url":null,"abstract":"Tuberculosis is an important public problem worldwide from 19th century. Manifestations of tuberculosis widely classified as pulmonary and extra pulmonary manifestations. Central nervous system (CNS) tuberculosis is a serious condition where patients most often present with seizure. Tuberculoma is one of the CNS manifestations of tuberculosis. The imaging feature of tuberculoma is ring enhancing lesions. Tuberculoma should be differentiated from other diseases with ring enhancing lesions like neurocysticercosis, coccidiomycosis, toxoplasmosis and malignancies.","PeriodicalId":72392,"journal":{"name":"Biomedical research and clinical reviews","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46028187","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}
Currently, almost all urgently hospitalized patients immediately get access to the venous bed and begin to receive an infusion of solutions. This priority of this procedure is due not only to the need to have the most effective way of administering medications, but also to compensate for the loss of fluid, which in acute diseases has many reasons for this. Further recommendations for the correction of water-electrolyte and volume losses and the choice of the infusion rate are determined by the general criteria for their diagnosis in accordance with the parameters of the large circle of blood circulation. Considering AP, first of all, as a result of infection and not focusing on the localization of the process, modern medicine does not make exceptions in this therapeutic direction for patients with inflammation of the lung tissue.
{"title":"Why do Patients with Acute Pneumonia Receive Intravenous Infusions?","authors":"I. Klepikov","doi":"10.31579/2692-9406/085","DOIUrl":"https://doi.org/10.31579/2692-9406/085","url":null,"abstract":"Currently, almost all urgently hospitalized patients immediately get access to the venous bed and begin to receive an infusion of solutions. This priority of this procedure is due not only to the need to have the most effective way of administering medications, but also to compensate for the loss of fluid, which in acute diseases has many reasons for this. Further recommendations for the correction of water-electrolyte and volume losses and the choice of the infusion rate are determined by the general criteria for their diagnosis in accordance with the parameters of the large circle of blood circulation. Considering AP, first of all, as a result of infection and not focusing on the localization of the process, modern medicine does not make exceptions in this therapeutic direction for patients with inflammation of the lung tissue.","PeriodicalId":72392,"journal":{"name":"Biomedical research and clinical reviews","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45087801","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}
In our daily practice, we have heard more and more frequent reports of people infected with SARS-CoV-2, even having received one or two doses of vaccine for COVID-19. In the article written by Angel et al. (2021) entitled Association Between Vaccination with BNT162b2 and Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infections Among Health Care Workers, the authors concluded that the effectiveness of the vaccine in symptomatic SARS-CoV-2 infection reduced the incidence of this infection if you compared with unvaccinated health care worker. But the incidence was not reduced in the asymptomatic health care workers, where they found that vaccinated people were more likely to have SARS-CoV-2 if compared to unvaccinated people.
{"title":"What We Need to Do to Improve Our Immune System Despite the Use of Vaccination for COVID-19?","authors":"Huang Wei Ling","doi":"10.31579/2692-9406/081","DOIUrl":"https://doi.org/10.31579/2692-9406/081","url":null,"abstract":"In our daily practice, we have heard more and more frequent reports of people infected with SARS-CoV-2, even having received one or two doses of vaccine for COVID-19. In the article written by Angel et al. (2021) entitled Association Between Vaccination with BNT162b2 and Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infections Among Health Care Workers, the authors concluded that the effectiveness of the vaccine in symptomatic SARS-CoV-2 infection reduced the incidence of this infection if you compared with unvaccinated health care worker. But the incidence was not reduced in the asymptomatic health care workers, where they found that vaccinated people were more likely to have SARS-CoV-2 if compared to unvaccinated people.","PeriodicalId":72392,"journal":{"name":"Biomedical research and clinical reviews","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47153041","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}
The growing impact of type 2 diabetes in the majority of the population requires the introduction of better and more secure treatments, but also requires the development of new prevention strategies to reduce the incidence and prevalence of the disease. Significantly, type 2 diabetes is an important preventable disease and can be prevented or delayed by lifestyle intervention. Edible and medicinal macrofungi, mushrooms have been reported having diabetes ameliorating effects. Current study reviews the potentiality of both edible and medicinal mushrooms in preventing and ameliorating the diabetic complications as well as the future aspects of mushrooms against this metabolic disorder.
{"title":"Diabetes Ameliorating Effect of Mushrooms","authors":"M. Azizur Rahman, Rabeya Akter","doi":"10.31579/2692-9406/086","DOIUrl":"https://doi.org/10.31579/2692-9406/086","url":null,"abstract":"The growing impact of type 2 diabetes in the majority of the population requires the introduction of better and more secure treatments, but also requires the development of new prevention strategies to reduce the incidence and prevalence of the disease. Significantly, type 2 diabetes is an important preventable disease and can be prevented or delayed by lifestyle intervention. Edible and medicinal macrofungi, mushrooms have been reported having diabetes ameliorating effects. Current study reviews the potentiality of both edible and medicinal mushrooms in preventing and ameliorating the diabetic complications as well as the future aspects of mushrooms against this metabolic disorder.","PeriodicalId":72392,"journal":{"name":"Biomedical research and clinical reviews","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47609594","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}
Prabir Mandal, T. Andrews, Quinlin Bisbee, Asiah Cheek, DeLisa Davis, Jada V. Harvey, Armani B Hayes, Steven Hopkins, Jeannette Mack, Gianni Narcisse, Brianna Pendergrass, Janai Poullard, Nathaniel Schirmer, Caytlin Willis
The new coronavirus, SARS-CoV-2, which causes the disease COVID-19, has had a serious worldwide impact on human health. The virus was virtually unknown at the beginning of 2020. Since then, intense research efforts have resulted in sequencing the coronavirus genome, identifying the structures of its proteins, and creating a wide range of tools to search for effective vaccines and therapies. Also, there’s a chance that the COVID-19 contraction rate could get higher than the COVID-19 vaccination rate. In other words, the virus continues to spread while very little people actually get vaccinated. This only makes the job of scientists even harder. In order to stop the spread of COVID-19, citizens must get vaccinated more frequently than citizens are contracting COVID-19. The coronavirus attacks and kills healthy cells, causing detrimental damage to the respiratory system and immune system. It was then discovered that COVID-19 can be terribly fatal for those with already fragile immune systems and preexisting health conditions. Back in March, when COVID-19 was clearly becoming a critical threat to many countries around the world, the evidence indicated that the virus spreads from person to person through small respiratory droplets produced when people cough or sneeze, or even breathe. Surfaces can serve as an intermediary for the virus when looking for a host. Instead of contracting the virus directly from a person, it is possible to receive the virus from touching an object that an infected person sneezed on. It has been discovered that the virus can last up to three 3 days on a surface. Proceeding to rub one’s eyes, mouth, or nose after such contact is also a mode of transmission.
{"title":"Coronavirus Variants of Concern: An Insight","authors":"Prabir Mandal, T. Andrews, Quinlin Bisbee, Asiah Cheek, DeLisa Davis, Jada V. Harvey, Armani B Hayes, Steven Hopkins, Jeannette Mack, Gianni Narcisse, Brianna Pendergrass, Janai Poullard, Nathaniel Schirmer, Caytlin Willis","doi":"10.31579/2692-9406/080","DOIUrl":"https://doi.org/10.31579/2692-9406/080","url":null,"abstract":"The new coronavirus, SARS-CoV-2, which causes the disease COVID-19, has had a serious worldwide impact on human health. The virus was virtually unknown at the beginning of 2020. Since then, intense research efforts have resulted in sequencing the coronavirus genome, identifying the structures of its proteins, and creating a wide range of tools to search for effective vaccines and therapies. Also, there’s a chance that the COVID-19 contraction rate could get higher than the COVID-19 vaccination rate. In other words, the virus continues to spread while very little people actually get vaccinated. This only makes the job of scientists even harder. In order to stop the spread of COVID-19, citizens must get vaccinated more frequently than citizens are contracting COVID-19. The coronavirus attacks and kills healthy cells, causing detrimental damage to the respiratory system and immune system. It was then discovered that COVID-19 can be terribly fatal for those with already fragile immune systems and preexisting health conditions. Back in March, when COVID-19 was clearly becoming a critical threat to many countries around the world, the evidence indicated that the virus spreads from person to person through small respiratory droplets produced when people cough or sneeze, or even breathe. Surfaces can serve as an intermediary for the virus when looking for a host. Instead of contracting the virus directly from a person, it is possible to receive the virus from touching an object that an infected person sneezed on. It has been discovered that the virus can last up to three 3 days on a surface. Proceeding to rub one’s eyes, mouth, or nose after such contact is also a mode of transmission.","PeriodicalId":72392,"journal":{"name":"Biomedical research and clinical reviews","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48640317","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}
Designing a study for independent confirmation of a treatment effect is sometimes not practical due to required large sample size. Post hoc pooling of studies including those for learning purposes is subject to selection bias and therefore generally not suitable for confirmation of a treatment effect. We propose a Bayesian approach which calibrates the role of prior information from historical studies for learning and confirming purposes. The amount of prior information to be combined with current study data for the purpose of hypothesis confirmation depends on the overall strength of prior information for hypothesis generation. The method is illustrated in the analysis of mortality data for the pirfenidone NDA. The Bayesian analysis provides a formal method to calibrate the role of information from historical evidence in the overall interpretation of results from both historical and concurrent clinical studies. The increased efficiency of using all available data is especially important in drug development for rare diseases with serious consequences, where limited patient source prohibits large trials, and unmet medical needs demand rapid access to treatment options.
{"title":"Re-Print: Developing and then Confirming a Hypothesis Based on a Chronology of Several Clinical Trials: A Bayesian Application to Pirfenidone Mortality Results","authors":"Zhengning Lin, Donald A Berry","doi":"10.31579/2692-9406/066","DOIUrl":"https://doi.org/10.31579/2692-9406/066","url":null,"abstract":"Designing a study for independent confirmation of a treatment effect is sometimes not practical due to required large sample size. Post hoc pooling of studies including those for learning purposes is subject to selection bias and therefore generally not suitable for confirmation of a treatment effect. We propose a Bayesian approach which calibrates the role of prior information from historical studies for learning and confirming purposes. The amount of prior information to be combined with current study data for the purpose of hypothesis confirmation depends on the overall strength of prior information for hypothesis generation. The method is illustrated in the analysis of mortality data for the pirfenidone NDA. The Bayesian analysis provides a formal method to calibrate the role of information from historical evidence in the overall interpretation of results from both historical and concurrent clinical studies. The increased efficiency of using all available data is especially important in drug development for rare diseases with serious consequences, where limited patient source prohibits large trials, and unmet medical needs demand rapid access to treatment options.","PeriodicalId":72392,"journal":{"name":"Biomedical research and clinical reviews","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44929802","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}
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