Clinical trials
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Clinical research involves systematically studying new drugs on human subjects to discover or verify their clinical effects, pharmacology, and potential adverse reactions, with the goal of determining a drug's safety and efficacy. Clinical trials, which follow predefined plans or protocols, allow participants to play an active role in their healthcare by accessing new treatments and contributing to medical research that can help others.
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Clinical trials for product developement
Clinical trials for new drug development involve several phases. Phase 1 trials involve small groups of people to determine safety and side effects of a new drug. Phase 2 trials administer the drug to larger groups of people to identify effective dosages and further evaluate safety. Phase 3 trials administer the drug to even larger groups of between 500 to 15,000 people to confirm effectiveness, monitor side effects, and collect information to allow safe use of the drug. After approval, Phase 4 trials continue investigating the drug's long-term effects, risks, benefits, and optimal use.
Clinical trials & phases of clinical trials
#Clinical trials
#Phases of clinical trials
#Phase 1 of clinical trial
#Phase 2 of clinical trial
#Phase 3 of clinical trial
#Phase 4 of clinical trial
Clinical research course
Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry. There are more than 2, 50,000 positions unemployed in global Pharmaceutical industry.
Scope of Pharmacy and Clinical Research
By students of Sir Dr. M S GOSAVI COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH, Nashik
The ppt will provide wide overview of career opportunities in pharmacy and basic knowledge of clinical research.
FDA, IRB, EMA… What Role Do Agencies Play In Clinical Trials?
At first glance, it’s abbreviation soup – EMA, FDA, NIHR, OHRP, IRB – but this collection of organizations is responsible for making sure clinical trials are run properly, to protect patients and develop medicines that are safe and effective.
Design and evaluation of bioequivalence
This document summarizes the key elements of designing and evaluating a bioequivalence study. It outlines the common study designs used in bioequivalence studies including two-period crossover, replicate crossover, and parallel group designs. It describes the objectives of establishing bioequivalence by comparing the pharmacokinetic parameters Cmax, Tmax, and AUC of a test and reference product. Statistical tests are used to analyze the data and determine if the 90% confidence interval of these parameters falls within the range of 80-125% to conclude bioequivalence. Important aspects like subject selection criteria, clinical procedures, and ethical review are also covered.
Preclinical studies
Preclinical studies are conducted before human trials to assess pharmacological and toxicological effects. Both in vitro and in vivo studies characterize these effects. Preclinical testing aims to detect toxicity, understand hazards, establish dose responses, and assess distribution, metabolism, and carcinogenicity. It involves short and long term animal studies in two species, as well as safety pharmacology, toxicology, developmental and reproductive toxicity testing, and genetic and carcinogenicity studies. The steps of preclinical trials include identifying a drug target, developing a bioassay, screening compounds, establishing effective and toxic doses, and filing for investigational new drug approval.
Introduction to clinical trial
In these slides you can get the information of clinical trials which have four phase I,II,III, IV. before clinical trials, Pre-clinical studies should be completed.
Recommended
Clinical trials for product developement
Clinical trials for new drug development involve several phases. Phase 1 trials involve small groups of people to determine safety and side effects of a new drug. Phase 2 trials administer the drug to larger groups of people to identify effective dosages and further evaluate safety. Phase 3 trials administer the drug to even larger groups of between 500 to 15,000 people to confirm effectiveness, monitor side effects, and collect information to allow safe use of the drug. After approval, Phase 4 trials continue investigating the drug's long-term effects, risks, benefits, and optimal use.
Clinical trials & phases of clinical trials
#Clinical trials
#Phases of clinical trials
#Phase 1 of clinical trial
#Phase 2 of clinical trial
#Phase 3 of clinical trial
#Phase 4 of clinical trial
Clinical research course
Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry. There are more than 2, 50,000 positions unemployed in global Pharmaceutical industry.
Scope of Pharmacy and Clinical Research
By students of Sir Dr. M S GOSAVI COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH, Nashik
The ppt will provide wide overview of career opportunities in pharmacy and basic knowledge of clinical research.
FDA, IRB, EMA… What Role Do Agencies Play In Clinical Trials?
At first glance, it’s abbreviation soup – EMA, FDA, NIHR, OHRP, IRB – but this collection of organizations is responsible for making sure clinical trials are run properly, to protect patients and develop medicines that are safe and effective.
Design and evaluation of bioequivalence
This document summarizes the key elements of designing and evaluating a bioequivalence study. It outlines the common study designs used in bioequivalence studies including two-period crossover, replicate crossover, and parallel group designs. It describes the objectives of establishing bioequivalence by comparing the pharmacokinetic parameters Cmax, Tmax, and AUC of a test and reference product. Statistical tests are used to analyze the data and determine if the 90% confidence interval of these parameters falls within the range of 80-125% to conclude bioequivalence. Important aspects like subject selection criteria, clinical procedures, and ethical review are also covered.
Preclinical studies
Preclinical studies are conducted before human trials to assess pharmacological and toxicological effects. Both in vitro and in vivo studies characterize these effects. Preclinical testing aims to detect toxicity, understand hazards, establish dose responses, and assess distribution, metabolism, and carcinogenicity. It involves short and long term animal studies in two species, as well as safety pharmacology, toxicology, developmental and reproductive toxicity testing, and genetic and carcinogenicity studies. The steps of preclinical trials include identifying a drug target, developing a bioassay, screening compounds, establishing effective and toxic doses, and filing for investigational new drug approval.
Introduction to clinical trial
In these slides you can get the information of clinical trials which have four phase I,II,III, IV. before clinical trials, Pre-clinical studies should be completed.
Clinical Trial Phase 3 And 4
Phase 3 clinical trials involve large patient groups of 300-3,000 people to further evaluate safety and efficacy. They are randomized, controlled, and multi-center. Phase 3 trials are divided into two parts: Phase 3A confirms regulatory requirements for approval while Phase 3B extends trials after approval but before launch. Post-marketing surveillance continues safety evaluation after approval and involves pharmacovigilance, pharmacoeconomics, and pharmacoepidemiology with no fixed duration. Adverse events are monitored through spontaneous reporting systems, case reports, cohort studies, and cross-sectional studies.
The Four Phases of Clinical Trials Before Market Approval
Trek Therapeutics co-founder Robert Hindes, MD was previously a member of the faculty at Yale University in Connecticut. A consultant with a strong background in the pharmaceutical industry, Robert Hindes, MD consults with drug manufacturers on clinical trials for new drugs.
Clinical trials
Clinical trials go through several phases to evaluate the safety and efficacy of new medical treatments. Phase I trials involve small groups of people to determine basic safety and dosages. Phase II trials administer the treatment to groups of patients to identify common short-term side effects and gather preliminary data on effectiveness. Phase III trials involve large groups of people and can last several years to confirm effectiveness, monitor side effects, and collect additional information to evaluate the treatment's risks and benefits. Phase IV trials occur after marketing approval and involve post-marketing surveillance to provide additional information on a treatment's risks, benefits, and optimal use.
clinical research some basic terms
Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis, or for relieving symptoms of a disease. here some basic terms associated with clinical research are mentioned in the presentation, which proves helpful to understand the basic knowledge about research.
Drug development and_approval
The document outlines the complex multi-step process of drug discovery and development from laboratory testing through FDA approval. It takes an average of 12 years and $350 million to get a new drug from initial discovery to pharmacy shelves. Drugs undergo preclinical testing followed by clinical trials in three phases with FDA review and approval required before market introduction. The FDA evaluates drugs based on evidence from clinical research to determine safety and efficacy.
Drug discovery infoghraph
Drug discovery is a process that involves target identification, validation, lead identification and optimization, and preclinical and clinical testing in humans. The goal is to identify compounds that can safely and effectively treat diseases. Preclinical testing assesses safety and efficacy in cells and animals. If promising, an Investigational New Drug application is filed with the FDA and clinical trials in humans begin. Clinical trials have phases to test safety, efficacy, side effects, and optimal dosage in healthy volunteers and patients. If successful, a New Drug Application is filed with the FDA to verify the drug is safe and effective for its proposed use.
Ct ppt
This presentation discusses the various phases of clinical trials for drug development. It explains that clinical trials are conducted in phases (1-4) to evaluate a drug's safety, efficacy, optimal dosage and monitor long-term effects. Phase 1 trials test safety on a small group. Phase 2 assesses effectiveness on patients with the disease. Phase 3 studies the overall benefit-risk ratio on a large patient group. Phase 4 occurs after marketing approval to collect additional safety data from a larger population over a longer period. Regulatory approval from bodies like DCGI and FDA is required by submitting investigational documents and new drug applications between phases.
phases of clinical trial
Clinical drug trials occur in four phases:
Phase I trials test drug safety in healthy volunteers. Phase II trials evaluate drug efficacy and side effects in patients. Phase III trials compare the drug to standard treatments in large patient groups. Phase IV trials monitor drug safety after marketing in real-world clinical settings. Each phase helps develop necessary data before drugs can be approved or their uses expanded to improve patient care.
Drug development process and phases of clinical trials
Drug development involves bringing a new drug to market through clinical trials with human participants to test safety and efficacy. Clinical trials have multiple phases, starting with preclinical animal studies in Phase 0 followed by early human trials in Phases 1 and 2 to test safety and efficacy at low doses. Phase 3 trials involve a larger group of participants to further confirm efficacy is achieved. If approved, Phase 4 trials may continue after marketing to further monitor long-term safety. The FDA reviews Investigational New Drug applications to permit shipping drugs across states for trials and Abbreviated New Drug Applications allow for review and approval of generic drugs.
Phases in clinical trial
The document outlines the phases of clinical trials:
- Phase 0 involves microdosing to determine pharmacokinetics and pharmacodynamics.
- Phase 1 studies a drug's safety on 20-100 healthy volunteers and finds the optimal dose.
- Phase 2 trials on 100-300 people study a drug's biological effects and continues safety monitoring. It has two types: 2a determines dosing and 2b is pivotal, blinded, and multicenter.
- Phase 3 are large randomized controlled trials on 300-3000 people comparing a drug to standard treatment. It has two types: 3a tests different indications and 3b continues trials pending regulatory approval.
- Phase 4 occurs after approval to detect rare adverse effects
Stages of drug development by Dr Joseph Oyepata Simeon (Ph.D)
The document outlines the stages of drug development from discovery through clinical trials and FDA approval. It discusses 4 main stages: 1) Discovery and preclinical research involving animal testing, 2) Clinical research consisting of 4 phases starting with small safety trials and increasing in size, 3) Filing an Investigational New Drug Application with the FDA to begin clinical trials, and 4) Final FDA review and potential approval or denial to market the drug. Only about 25-30% of drugs make it through the entire process, which can take 10-15 years and costs over $2 billion on average.
Drug development team
Drug discovery project team, preclinical drug development project team, clinical drug development team
Clinical trials
Clinical trials involve systematic testing of new drugs in human subjects to evaluate safety and efficacy. They are conducted in multiple phases. Phase 0 involves microdosing to speed up the drug development process. Phase 1 establishes a safe dose range in healthy volunteers. Phase 2 evaluates therapeutic efficacy and side effects in a larger group of subjects. Phase 3 determines safety and efficacy in a large patient population using double-blind methods. Phase 4 involves post-marketing surveillance of an approved drug's use in practice. Randomized controlled trials are a common clinical trial design that compares intervention groups through random assignment to evaluate treatments or preventions.
Explanation of the Four Phases of Clinical Trials
Before clinical trials, tests and treatments are assessed in preclinical research. There is a need to carry all four phases of clinical trials
Drug development process
process of discovery of a new drug
what are clinical trials
why clinical trials are conducted
overview of phases in a clinical trial
details about every phase
focus and purpose of conducting clinical trial
Phases of clinical trials 1,2,3 &4
This document discusses the various phases of clinical trials for drug development. It begins with preclinical testing on animals. Next is the investigational new drug application (IND) to obtain approval for human testing. Clinical trials then proceed through four phases to evaluate a drug's safety, efficacy, and dosing in humans. Phase 1 involves initial safety and dosing tests on healthy volunteers. Phase 2 expands to more subjects to further assess safety and efficacy. Phase 3 involves large-scale trials to confirm effectiveness. After approval, Phase 4 involves post-marketing surveillance. The overall goal is to generate sufficient data to submit a new drug application (NDA) and gain regulatory approval to market a new pharmaceutical drug.
Bioinformatics in drug discovery
Introduction
History
How are new drug discovered?
Bioinformatics in drug discovery
Tools for drug discovery
Successful drug
Software for drug discovery
Conclusion
References
Phases of clinical trial 11.9.14
This document discusses the phases of clinical trials. It begins by defining a clinical trial and explaining their importance. It then outlines the typical phases:
Phase I trials involve small groups of healthy volunteers and focus on safety, tolerability and pharmacokinetics. Phase II trials enroll larger numbers of patients to study efficacy and further evaluate safety. Phase III trials involve thousands of patients and aim to confirm efficacy and further monitor safety. Phase IV trials occur after marketing approval to further monitor long-term safety and efficacy.
The document provides details on the objectives, features, sample sizes, and information gained from each phase of trials. It discusses microdosing studies, pharmacogenomics studies, and post-marketing surveillance. In summary
Clinical research
The document outlines the multi-step process for new drug development from research and discovery through clinical trials and regulatory approval. It involves early research, preclinical testing in labs and animals, and four phases of clinical trials in humans to test safety, efficacy, and get regulatory clearance. Phase 1 trials test safety in a small group, Phase 2 expands to test biological activity and potential efficacy, and Phase 3 tests therapeutic effects in large trials to confirm efficacy and comparative effectiveness for regulatory approval and launch.
Phase 0 clinical trial
This document discusses phase 0 clinical trials, also known as microdosing studies. Phase 0 trials involve administering very low, non-therapeutic doses of an experimental drug to small groups of subjects to obtain preliminary pharmacokinetic and pharmacodynamic data before proceeding to full phase 1 trials. The goals are to accelerate drug development, eliminate unsuitable drug candidates early to save costs and reduce unnecessary risk to subjects and use of animals in testing. Regulatory guidelines have been established for microdosing studies. While microdosing offers benefits, limitations include potential for false predictions and difficulty motivating subject participation due to lack of intended therapeutic benefit. Ethical considerations also need to be addressed for these early-stage trials.
Bacterail culture methods by prajith .v
The document discusses bacterial culture methods. It covers bacterial nutrition and designing culture media based on metabolism, pH, oxidation-reduction potential, and gas requirements. It also discusses oxygen concentrations for aerobic, anaerobic, and microaerophilic bacteria. The purposes of culturing bacteria and various isolation methods using plates, enrichment media, and indicators are outlined. Temperature effects on growth and requirements for physical growth are briefly mentioned. Counting bacteria using plates and cell counters is also summarized.
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Clinical pharmacology is the study of drugs in humans, applying basic pharmacological principles and methods to real-world situations. It focuses on how drugs act in the body, how the body affects drug actions, and how both can vary between individuals. Clinical pharmacology differs from clinical pharmacy, which involves optimizing medication use and promoting patient health through pharmacists providing direct patient care.
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Clinical Trial Phase 3 And 4
Phase 3 clinical trials involve large patient groups of 300-3,000 people to further evaluate safety and efficacy. They are randomized, controlled, and multi-center. Phase 3 trials are divided into two parts: Phase 3A confirms regulatory requirements for approval while Phase 3B extends trials after approval but before launch. Post-marketing surveillance continues safety evaluation after approval and involves pharmacovigilance, pharmacoeconomics, and pharmacoepidemiology with no fixed duration. Adverse events are monitored through spontaneous reporting systems, case reports, cohort studies, and cross-sectional studies.
The Four Phases of Clinical Trials Before Market Approval
Trek Therapeutics co-founder Robert Hindes, MD was previously a member of the faculty at Yale University in Connecticut. A consultant with a strong background in the pharmaceutical industry, Robert Hindes, MD consults with drug manufacturers on clinical trials for new drugs.
Clinical trials
Clinical trials go through several phases to evaluate the safety and efficacy of new medical treatments. Phase I trials involve small groups of people to determine basic safety and dosages. Phase II trials administer the treatment to groups of patients to identify common short-term side effects and gather preliminary data on effectiveness. Phase III trials involve large groups of people and can last several years to confirm effectiveness, monitor side effects, and collect additional information to evaluate the treatment's risks and benefits. Phase IV trials occur after marketing approval and involve post-marketing surveillance to provide additional information on a treatment's risks, benefits, and optimal use.
clinical research some basic terms
Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis, or for relieving symptoms of a disease. here some basic terms associated with clinical research are mentioned in the presentation, which proves helpful to understand the basic knowledge about research.
Drug development and_approval
The document outlines the complex multi-step process of drug discovery and development from laboratory testing through FDA approval. It takes an average of 12 years and $350 million to get a new drug from initial discovery to pharmacy shelves. Drugs undergo preclinical testing followed by clinical trials in three phases with FDA review and approval required before market introduction. The FDA evaluates drugs based on evidence from clinical research to determine safety and efficacy.
Drug discovery infoghraph
Drug discovery is a process that involves target identification, validation, lead identification and optimization, and preclinical and clinical testing in humans. The goal is to identify compounds that can safely and effectively treat diseases. Preclinical testing assesses safety and efficacy in cells and animals. If promising, an Investigational New Drug application is filed with the FDA and clinical trials in humans begin. Clinical trials have phases to test safety, efficacy, side effects, and optimal dosage in healthy volunteers and patients. If successful, a New Drug Application is filed with the FDA to verify the drug is safe and effective for its proposed use.
Ct ppt
This presentation discusses the various phases of clinical trials for drug development. It explains that clinical trials are conducted in phases (1-4) to evaluate a drug's safety, efficacy, optimal dosage and monitor long-term effects. Phase 1 trials test safety on a small group. Phase 2 assesses effectiveness on patients with the disease. Phase 3 studies the overall benefit-risk ratio on a large patient group. Phase 4 occurs after marketing approval to collect additional safety data from a larger population over a longer period. Regulatory approval from bodies like DCGI and FDA is required by submitting investigational documents and new drug applications between phases.
phases of clinical trial
Clinical drug trials occur in four phases:
Phase I trials test drug safety in healthy volunteers. Phase II trials evaluate drug efficacy and side effects in patients. Phase III trials compare the drug to standard treatments in large patient groups. Phase IV trials monitor drug safety after marketing in real-world clinical settings. Each phase helps develop necessary data before drugs can be approved or their uses expanded to improve patient care.
Drug development process and phases of clinical trials
Drug development involves bringing a new drug to market through clinical trials with human participants to test safety and efficacy. Clinical trials have multiple phases, starting with preclinical animal studies in Phase 0 followed by early human trials in Phases 1 and 2 to test safety and efficacy at low doses. Phase 3 trials involve a larger group of participants to further confirm efficacy is achieved. If approved, Phase 4 trials may continue after marketing to further monitor long-term safety. The FDA reviews Investigational New Drug applications to permit shipping drugs across states for trials and Abbreviated New Drug Applications allow for review and approval of generic drugs.
Phases in clinical trial
The document outlines the phases of clinical trials:
- Phase 0 involves microdosing to determine pharmacokinetics and pharmacodynamics.
- Phase 1 studies a drug's safety on 20-100 healthy volunteers and finds the optimal dose.
- Phase 2 trials on 100-300 people study a drug's biological effects and continues safety monitoring. It has two types: 2a determines dosing and 2b is pivotal, blinded, and multicenter.
- Phase 3 are large randomized controlled trials on 300-3000 people comparing a drug to standard treatment. It has two types: 3a tests different indications and 3b continues trials pending regulatory approval.
- Phase 4 occurs after approval to detect rare adverse effects
Stages of drug development by Dr Joseph Oyepata Simeon (Ph.D)
The document outlines the stages of drug development from discovery through clinical trials and FDA approval. It discusses 4 main stages: 1) Discovery and preclinical research involving animal testing, 2) Clinical research consisting of 4 phases starting with small safety trials and increasing in size, 3) Filing an Investigational New Drug Application with the FDA to begin clinical trials, and 4) Final FDA review and potential approval or denial to market the drug. Only about 25-30% of drugs make it through the entire process, which can take 10-15 years and costs over $2 billion on average.
Drug development team
Drug discovery project team, preclinical drug development project team, clinical drug development team
Clinical trials
Clinical trials involve systematic testing of new drugs in human subjects to evaluate safety and efficacy. They are conducted in multiple phases. Phase 0 involves microdosing to speed up the drug development process. Phase 1 establishes a safe dose range in healthy volunteers. Phase 2 evaluates therapeutic efficacy and side effects in a larger group of subjects. Phase 3 determines safety and efficacy in a large patient population using double-blind methods. Phase 4 involves post-marketing surveillance of an approved drug's use in practice. Randomized controlled trials are a common clinical trial design that compares intervention groups through random assignment to evaluate treatments or preventions.
Explanation of the Four Phases of Clinical Trials
Before clinical trials, tests and treatments are assessed in preclinical research. There is a need to carry all four phases of clinical trials
Drug development process
process of discovery of a new drug
what are clinical trials
why clinical trials are conducted
overview of phases in a clinical trial
details about every phase
focus and purpose of conducting clinical trial
Phases of clinical trials 1,2,3 &4
This document discusses the various phases of clinical trials for drug development. It begins with preclinical testing on animals. Next is the investigational new drug application (IND) to obtain approval for human testing. Clinical trials then proceed through four phases to evaluate a drug's safety, efficacy, and dosing in humans. Phase 1 involves initial safety and dosing tests on healthy volunteers. Phase 2 expands to more subjects to further assess safety and efficacy. Phase 3 involves large-scale trials to confirm effectiveness. After approval, Phase 4 involves post-marketing surveillance. The overall goal is to generate sufficient data to submit a new drug application (NDA) and gain regulatory approval to market a new pharmaceutical drug.
Bioinformatics in drug discovery
Introduction
History
How are new drug discovered?
Bioinformatics in drug discovery
Tools for drug discovery
Successful drug
Software for drug discovery
Conclusion
References
Phases of clinical trial 11.9.14
This document discusses the phases of clinical trials. It begins by defining a clinical trial and explaining their importance. It then outlines the typical phases:
Phase I trials involve small groups of healthy volunteers and focus on safety, tolerability and pharmacokinetics. Phase II trials enroll larger numbers of patients to study efficacy and further evaluate safety. Phase III trials involve thousands of patients and aim to confirm efficacy and further monitor safety. Phase IV trials occur after marketing approval to further monitor long-term safety and efficacy.
The document provides details on the objectives, features, sample sizes, and information gained from each phase of trials. It discusses microdosing studies, pharmacogenomics studies, and post-marketing surveillance. In summary
Clinical research
The document outlines the multi-step process for new drug development from research and discovery through clinical trials and regulatory approval. It involves early research, preclinical testing in labs and animals, and four phases of clinical trials in humans to test safety, efficacy, and get regulatory clearance. Phase 1 trials test safety in a small group, Phase 2 expands to test biological activity and potential efficacy, and Phase 3 tests therapeutic effects in large trials to confirm efficacy and comparative effectiveness for regulatory approval and launch.
Phase 0 clinical trial
This document discusses phase 0 clinical trials, also known as microdosing studies. Phase 0 trials involve administering very low, non-therapeutic doses of an experimental drug to small groups of subjects to obtain preliminary pharmacokinetic and pharmacodynamic data before proceeding to full phase 1 trials. The goals are to accelerate drug development, eliminate unsuitable drug candidates early to save costs and reduce unnecessary risk to subjects and use of animals in testing. Regulatory guidelines have been established for microdosing studies. While microdosing offers benefits, limitations include potential for false predictions and difficulty motivating subject participation due to lack of intended therapeutic benefit. Ethical considerations also need to be addressed for these early-stage trials.
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Role of Mukta Pishti in the Management of Hyperthyroidism
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
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Clinical trials
- 2. What is Clinical Research? Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamics and pharmacokinetic) or adverse effects with the objective of determining safety and efficacy of the new drug. A clinical trial is one type of clinical research that follows a pre- defined plan or protocol. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research.