logging in or signing up Clinical paper jainsahib Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 1525 Category: Education License: All Rights Reserved Like it (1) Dislike it (0) Added: February 27, 2009 This Presentation is Public Favorites: 0 Presentation Description How to read a medical article Comments Posting comment... By: debbie10 (15 month(s) ago) good info...how do i download the presentation Saving..... Post Reply Close Saving..... Edit Comment Close By: CB12 (20 month(s) ago) Great presentation please can i down load Saving..... Post Reply Close Saving..... Edit Comment Close By: waseem14pk (35 month(s) ago) Its realy a nice presentation.Kindly allow me to down load the presentation Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript HOW TO READ & INTERPRET A CLINICAL PAPER…. : Stancare Rexcel HOW TO READ & INTERPRET A CLINICAL PAPER…. Why Use Clinical reprints : Why Use Clinical reprints Evidence Based / Scientific Marketing Independent Opinion Differential communication Positioning Academic input OBJECTIVE OF USE OF A CLINICAL PAPER : OBJECTIVE OF USE OF A CLINICAL PAPER Its a strategy of promotion. To highlight key benefits of our products v/s competitor Brands / other standard treatments To address a doubt / question / issue raised by a doctor To favorably incline & motivate doctors to write our product What is Clinical Trial : What is Clinical Trial Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or To identify any adverse reactions to an investigational product(s), and/or To study absorption, distribution, metabolism, and excretion of an investigational product(s), with the object of ascertaining its safety and/or efficacy. What is Placebo? : What is Placebo? A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the Control group will receive a placebo instead of an active drug or treatment. Double Blind/ Open Label : Double Blind/ Open Label Double Blind: The patient nor the researchers (investigator, coordinator, etc.) know who is getting the experimental drug. Open Label: Well Controlled Randomized : Well Controlled Randomized One group of patients (subjects) will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Placement of the subject into the drug treatment or placebo group is by random chance (as if by the flip of a coin). What is Protocol : What is Protocol A protocol is a study plan on which all clinical trials are based. Inclusion Criteria Exclusion criteria Drugs and Dosages Follow up of patients at regular intervals Action Plan to take care of toxicity Review article : Review article Article is based on the Literature which is available( Published). The acceptance for such kind of papers is very high Meta Analysis : Meta Analysis Data is taken from the published studies and analysis is done. High Acceptance by the Doctors Terms used in Clinical Papers : Terms used in Clinical Papers Response rate ( Complete response, Partial response, No response, Stable diseases and Overall response) Median Survival Period DFS QOL Historical Data????? Stages-New Drug : Stages-New Drug Development of Compound (NCE) Pre Clinical Studies Clinical Trials/Studies in Humans WHAT ARE PHASE STUDY & IT’S RELAVENCE : WHAT ARE PHASE STUDY & IT’S RELAVENCE PRECLINICAL STUDY: Conduct laboratory and animal testing studies to show biological activity of the compound against the targeted disease The Compound is also evaluated for safety Phase 1 : Phase 1 Phase I studies are primarily concerned with the drug's safety, and are the first time the drug is tested in humans. These studies are typically done in a small number of healthy volunteers (20-100), usually in a hospital setting where the volunteers can be closely watched and treated. Observation:Drug absorption, metabolism, and excreta ion. Additionally, they determine what types of side effects occur as the dosage levels (that is, the amount of drug) are increased, as well as to obtain early evidence on drug effectiveness. Phase 2 : Phase 2 In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. Randomized controlled and at times Double blind Phase II studies are also designed to evaluate the effectiveness of the drug. The second phase of testing may last from several months to a few years. Additionally, Phase II studies are often designed to determine the correct dosage, that is the dosage with the least number of side effects that is most effective. Provide data on Comparative studies Phase 3 : Phase 3 In Phase III study, an experimental drug is tested in several hundred to several thousand patients. Most Phase III studies continue to be randomized and blinded. The large-scale testing provides the pharmaceutical company as well as the FDA with a more thorough understanding of the drug's effectiveness, benefits/risks, and range/severity of possible adverse side effects. Phase III studies typically last several years. Seventy to 90 percent of drugs that enter Phase III studies successfully complete this phase of testing. Phase IV Studies (Therapeutic Use / Post Marketing Studies) : Phase IV Studies (Therapeutic Use / Post Marketing Studies) Studies that are conducted after marketing of the NME Conducted in a large population of about 10,000 patients The main objective of Phase IV studies is to identify any rare serious adverse event which can be causally related to the new product Phase IV studies can be open label single group studies KEY FACTORS : KEY FACTORS Title of the Study Authors of the study Published in / Presentated at ? Year of Publish ? Place / Institution of the Study Your opening statement should be something like “ Dear Sir, here is a paper titled Imatinib mesylate therapy for Philadelphia chromosome positive CML in blast phase authors by a group of eminent doctors like Kantarjian , Talpaz etc and sir this paper is published in Blood 2002. KEY FACTORS : Type of paper: Abstracts / Single Center study / Multicentric study / Review article / Meta Analysis Objective of the study Methods: - Randomized: Method used to for selection of patients - Double Blinded: Both patients & investigator is blind to the identity and allocation of the treatment - Placebo controlled: - Open labeled: Both patients & investigator is aware of the identity and allocation of the treatment Randomized double blinded study is the Gold standard in terms of assessing the value of a medical intervention. KEY FACTORS KEY FACTORS : KEY FACTORS Total number of patients enrolled: Participants should be large enough so that investigators can be reasonably certain that the chances of detecting beneficial effects or common adverse effects are high Total duration of the study: - Enrollment - Follow-up In terms of study length, this also needs to be commensurate with primary outcome sought. KEY FACTORS : Dosage & duration of treatment Adjuvant: Use of chemotherapy (secondarily) after the prior surgical treatment, to improve the overall outcome of the therapy Neoadjuvant:Use of chemotherapy prior to local treatment to reduce the tumor bulk. This makes application of the local therapies easier and may reduce their severity. KEY FACTORS KEY FACTORS : Results: Complete Response (CR): Resolution of all clinical disease, confirmed by two observations not less than 4 wks apart. Partial Response(PR): Reduction of at least 50% of measurable lesion, lasting at least one month, no new lesions and no progression of any new lesion. Stable disease (SD): No change in the tumor size or a reduction by less than 50% or an increase by less than 25% of the original disease KEY FACTORS KEY FACTORS : Results: Progressive disease: 25% or more increase in the size of at least one measurable or evaluable lesion or the appearance of new lesions Time to disease progression (TTP): Completion of last dose (In Week / Months/ Years) Rate & Duration of survival: Quality of life (QOL): A state of complete, mental & social well-being, and not merely the absence of disease. GOLDEN WORDS SAFETY, TOLERABILITY & EFFICACY KEY FACTORS KEY FACTORS : RESULTS: Statistical significance: Result is statistically significant if the difference between groups could have occurred by chance alone in less than 1 time in 20.This is expressed as a p value › 0.05. A sample size of 30 patients are minimum required to draw out a statistical co-relation. Confidence Interval: Often expressed as 95% confidence interval.It gives us some idea of how likely the sample mean represents the population mean. KEY FACTORS KEY FACTORS : Discussion & Conclusion: Read the abstract and the discussion section of the paper last, not first. Highlight the key results & message of the study The objective of the study should be concluded from the study KEY FACTORS Slide 26: Gone are the days of rehearsed routine sales calls….. Evidence based consultative selling is the next thing Actual Practice : Actual Practice Dr. I want to discuss the role of XYZ in Upper respiratory infection. In this study the response rate is better than all the Antibiotic which are currently available. This study has been done by Dr. John, Hammersmith, London. This is a latest paper which was was published in “ NEJM” January issue 2004 No. of patients, Dosage, P value and response rate Take commitment Follow up call with the last paper discussed ESSENTIAL POINTS TO BE HIGHLIGHTED WHILE GIVING A CLINICAL PAPER TO A DOCTOR : ESSENTIAL POINTS TO BE HIGHLIGHTED WHILE GIVING A CLINICAL PAPER TO A DOCTOR Title of the study Author of the study Journal and year published in Objective of the study Results of the study You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Clinical paper jainsahib Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 1525 Category: Education License: All Rights Reserved Like it (1) Dislike it (0) Added: February 27, 2009 This Presentation is Public Favorites: 0 Presentation Description How to read a medical article Comments Posting comment... By: debbie10 (15 month(s) ago) good info...how do i download the presentation Saving..... Post Reply Close Saving..... Edit Comment Close By: CB12 (20 month(s) ago) Great presentation please can i down load Saving..... Post Reply Close Saving..... Edit Comment Close By: waseem14pk (35 month(s) ago) Its realy a nice presentation.Kindly allow me to down load the presentation Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript HOW TO READ & INTERPRET A CLINICAL PAPER…. : Stancare Rexcel HOW TO READ & INTERPRET A CLINICAL PAPER…. Why Use Clinical reprints : Why Use Clinical reprints Evidence Based / Scientific Marketing Independent Opinion Differential communication Positioning Academic input OBJECTIVE OF USE OF A CLINICAL PAPER : OBJECTIVE OF USE OF A CLINICAL PAPER Its a strategy of promotion. To highlight key benefits of our products v/s competitor Brands / other standard treatments To address a doubt / question / issue raised by a doctor To favorably incline & motivate doctors to write our product What is Clinical Trial : What is Clinical Trial Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or To identify any adverse reactions to an investigational product(s), and/or To study absorption, distribution, metabolism, and excretion of an investigational product(s), with the object of ascertaining its safety and/or efficacy. What is Placebo? : What is Placebo? A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the Control group will receive a placebo instead of an active drug or treatment. Double Blind/ Open Label : Double Blind/ Open Label Double Blind: The patient nor the researchers (investigator, coordinator, etc.) know who is getting the experimental drug. Open Label: Well Controlled Randomized : Well Controlled Randomized One group of patients (subjects) will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Placement of the subject into the drug treatment or placebo group is by random chance (as if by the flip of a coin). What is Protocol : What is Protocol A protocol is a study plan on which all clinical trials are based. Inclusion Criteria Exclusion criteria Drugs and Dosages Follow up of patients at regular intervals Action Plan to take care of toxicity Review article : Review article Article is based on the Literature which is available( Published). The acceptance for such kind of papers is very high Meta Analysis : Meta Analysis Data is taken from the published studies and analysis is done. High Acceptance by the Doctors Terms used in Clinical Papers : Terms used in Clinical Papers Response rate ( Complete response, Partial response, No response, Stable diseases and Overall response) Median Survival Period DFS QOL Historical Data????? Stages-New Drug : Stages-New Drug Development of Compound (NCE) Pre Clinical Studies Clinical Trials/Studies in Humans WHAT ARE PHASE STUDY & IT’S RELAVENCE : WHAT ARE PHASE STUDY & IT’S RELAVENCE PRECLINICAL STUDY: Conduct laboratory and animal testing studies to show biological activity of the compound against the targeted disease The Compound is also evaluated for safety Phase 1 : Phase 1 Phase I studies are primarily concerned with the drug's safety, and are the first time the drug is tested in humans. These studies are typically done in a small number of healthy volunteers (20-100), usually in a hospital setting where the volunteers can be closely watched and treated. Observation:Drug absorption, metabolism, and excreta ion. Additionally, they determine what types of side effects occur as the dosage levels (that is, the amount of drug) are increased, as well as to obtain early evidence on drug effectiveness. Phase 2 : Phase 2 In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. Randomized controlled and at times Double blind Phase II studies are also designed to evaluate the effectiveness of the drug. The second phase of testing may last from several months to a few years. Additionally, Phase II studies are often designed to determine the correct dosage, that is the dosage with the least number of side effects that is most effective. Provide data on Comparative studies Phase 3 : Phase 3 In Phase III study, an experimental drug is tested in several hundred to several thousand patients. Most Phase III studies continue to be randomized and blinded. The large-scale testing provides the pharmaceutical company as well as the FDA with a more thorough understanding of the drug's effectiveness, benefits/risks, and range/severity of possible adverse side effects. Phase III studies typically last several years. Seventy to 90 percent of drugs that enter Phase III studies successfully complete this phase of testing. Phase IV Studies (Therapeutic Use / Post Marketing Studies) : Phase IV Studies (Therapeutic Use / Post Marketing Studies) Studies that are conducted after marketing of the NME Conducted in a large population of about 10,000 patients The main objective of Phase IV studies is to identify any rare serious adverse event which can be causally related to the new product Phase IV studies can be open label single group studies KEY FACTORS : KEY FACTORS Title of the Study Authors of the study Published in / Presentated at ? Year of Publish ? Place / Institution of the Study Your opening statement should be something like “ Dear Sir, here is a paper titled Imatinib mesylate therapy for Philadelphia chromosome positive CML in blast phase authors by a group of eminent doctors like Kantarjian , Talpaz etc and sir this paper is published in Blood 2002. KEY FACTORS : Type of paper: Abstracts / Single Center study / Multicentric study / Review article / Meta Analysis Objective of the study Methods: - Randomized: Method used to for selection of patients - Double Blinded: Both patients & investigator is blind to the identity and allocation of the treatment - Placebo controlled: - Open labeled: Both patients & investigator is aware of the identity and allocation of the treatment Randomized double blinded study is the Gold standard in terms of assessing the value of a medical intervention. KEY FACTORS KEY FACTORS : KEY FACTORS Total number of patients enrolled: Participants should be large enough so that investigators can be reasonably certain that the chances of detecting beneficial effects or common adverse effects are high Total duration of the study: - Enrollment - Follow-up In terms of study length, this also needs to be commensurate with primary outcome sought. KEY FACTORS : Dosage & duration of treatment Adjuvant: Use of chemotherapy (secondarily) after the prior surgical treatment, to improve the overall outcome of the therapy Neoadjuvant:Use of chemotherapy prior to local treatment to reduce the tumor bulk. This makes application of the local therapies easier and may reduce their severity. KEY FACTORS KEY FACTORS : Results: Complete Response (CR): Resolution of all clinical disease, confirmed by two observations not less than 4 wks apart. Partial Response(PR): Reduction of at least 50% of measurable lesion, lasting at least one month, no new lesions and no progression of any new lesion. Stable disease (SD): No change in the tumor size or a reduction by less than 50% or an increase by less than 25% of the original disease KEY FACTORS KEY FACTORS : Results: Progressive disease: 25% or more increase in the size of at least one measurable or evaluable lesion or the appearance of new lesions Time to disease progression (TTP): Completion of last dose (In Week / Months/ Years) Rate & Duration of survival: Quality of life (QOL): A state of complete, mental & social well-being, and not merely the absence of disease. GOLDEN WORDS SAFETY, TOLERABILITY & EFFICACY KEY FACTORS KEY FACTORS : RESULTS: Statistical significance: Result is statistically significant if the difference between groups could have occurred by chance alone in less than 1 time in 20.This is expressed as a p value › 0.05. A sample size of 30 patients are minimum required to draw out a statistical co-relation. Confidence Interval: Often expressed as 95% confidence interval.It gives us some idea of how likely the sample mean represents the population mean. KEY FACTORS KEY FACTORS : Discussion & Conclusion: Read the abstract and the discussion section of the paper last, not first. Highlight the key results & message of the study The objective of the study should be concluded from the study KEY FACTORS Slide 26: Gone are the days of rehearsed routine sales calls….. Evidence based consultative selling is the next thing Actual Practice : Actual Practice Dr. I want to discuss the role of XYZ in Upper respiratory infection. In this study the response rate is better than all the Antibiotic which are currently available. This study has been done by Dr. John, Hammersmith, London. This is a latest paper which was was published in “ NEJM” January issue 2004 No. of patients, Dosage, P value and response rate Take commitment Follow up call with the last paper discussed ESSENTIAL POINTS TO BE HIGHLIGHTED WHILE GIVING A CLINICAL PAPER TO A DOCTOR : ESSENTIAL POINTS TO BE HIGHLIGHTED WHILE GIVING A CLINICAL PAPER TO A DOCTOR Title of the study Author of the study Journal and year published in Objective of the study Results of the study