On Clinical Trials1.What are clinical trials? Why are they important?1) A new drug must pass through a series phrases ofcontrolled testings in humans, which are the three phases of clinical trial. Theaim of the clinical trials is to demonstrate the efficacy and the safety of theexperimental drugs or treatments (Pandit, 2007). A clinical trial of a drug is an investigation or series ofinvestigations that have been defined inthe UK Medicines Act (Koh and Woo, 2000).2) The clinical trial is an important stage afternew drug development, starting with preclinical testing, which can determinedoes range, efficacy, toxicity, side effects and side effects with long-termuse (Pandit, 2007). These aims are very important to makesure that the new drug is safe enough to be used and post into the market (Pandit, 2007). 2.
What are the different types of clinical trials? (do not discuss the differentphases of clinical trials – what can clinical trials examine (e.g. treatment(through new drugs), prevention – there are others, what are they?)TreatmentResearch: Treatment research usually includes an intervention which may includemedication, psychotherapy, new devices, new surgicalapproaches or radiation therapy (FDA, 2018)PreventionResearch: Prevention research searches for different ways to prevent thedevelopment of the disease, then find out a better way and develop it.Investigate changes in medicines, vitamins, vaccines, minerals or lifestylethrough different kinds of preventative research.DiagnosticResearch:Diagnostic research is a process to finda better method to search for and identify the details of a specific disease.ScreeningResearch: The purpose of Screening Research is to look for the best ways todetect specific diseases or disorders.
Qualityof Life (QoL) Research: Quality of Life Research aims to improve the score ofthe individuals’ scores who have a long-term disease or poor health conditions bydiscovering and evaluating different treatment methods.Geneticstudies: The aim of this kind of study is to improve the prediction of aspecific health condition by identifying and understanding the relationship between genes and diseases. Bydetecting an individual’s genes to develop a method and identify how thismethod can make this person less likely to develop the disease. The geneticstudies may lead to the development of specially-made treatments based on themakeup of a patient’s genes. Epidemiologicalstudies: it aims to identify the patterns, causes, and control of disease in a smallcertain population.FourPhase of clinical trials:PhaseI trials: the aim of phase I trials is to evaluate the efficacy and safety,determine the range of the safe dosage and make sure of the adverse effects ofa specific experimental drug by testing.PhaseII trials: By providing the experimental drug or the treatment to a largerpopulation in order to further assess its safety and effectiveness.
PhaseIII trials: the researchers will makesure of the safety, monitor the adverse effects and make comparisons to regulartreatments so that to collect the information that allows this drug or treatment to be used safely by testing this experimental drug or the treatment in a largerpopulation compared to Phase II trials.PhaseIV trials: it is a research happened when the drugwas approved by the FDA and posted to the market, which providing the risks andbenefits of the drug or the treatment and the best use (FDA, 2018). 3.How are clinical trials funded?Clinical trials are generally funded by four mainorganizations, which are drug companies, charities, the NHS and the Government departmentsor agencies in the UK (Cancer Research UK, 2015). Generally, clinical trials need a lot of money tobe continued.
The government is the organization who spend the largestproportion of the funds for the tests and the costs of hospital stays. The NHScovers the costs of trials that are part of the National Institute for HealthResearch Clinical Research Network’s portfolio of clinical trials. If apharmaceutical company is conducting trials, they must pay the hospital fortesting and hospitalization.Drug companies:Pharmaceutical companies have had funded a vast ofmoney for cancer research in the UK.
Companies test and try the drugs developed by themselves. Sometimes the alsoprovided free grants or trial drugs for use by other organizations.Charities:In the UK, many charities also fund cancerresearch. Government:The Government currently provides funds for health-related research and clinical trialsthrough some organizations. Meanwhile,the government helps to coordinate cancerresearch nationally through the National Cancer Research Institute (NCRI) (CancerResearch UK, 2015). 4.
How are the patients/participants protected?It is important for clinical researchers to protectthe safety of the patients who take part in the clinical trials (NIH, 2017). Allclinical trials should be checked and monitored in similar ways to make surethat every participant should be protected. Each trial has scientificoversight, and patients also have them own rights that help protect them (NIH,2017).
Patients have the informed consent right. It meansthat patients have his or her own rights to decide whether to take part in theclinical trials. Before the patients agree to take part in the clinical trialsand also during the trials, they should be told all of the facts and thedetails of the clinical trials.
This process is called informed consent. In thesame way, the medical care personnel should also give the patients informedconsent form that presents the key facts of the trials, if patients agree withthat, they will be asked to sign the form(NIH, 2017).What’s more, there are many organizations to protect participants. Institutional review board(IRB) is to make sure that clinical trials are ethical and the patients’ right is protected. Office for human researchprotections (OHRP) is responsible for allthe research done by Health and Human Services (HHS). The aim of the datasafety monitoring board (DSBM) is to review data from clinical trials forsafety problems and reveal unknownpatient risks. Food and drug administration (FDA) by testing and monitoring theexperimental drug to guarantee the safety of the treatment.
They also reviewthe new drug applications and provide supervision and guidance during all thestages of the research (NIH, 2017). 5.What are eligibility criteria, and why is this important?Eachprogram has guidelines for the patients who can or cannot take part in thestudy. These guidelines were known as eligibility criteria and describe thenecessary characteristics of all participants. Standards vary by study, includingage, gender, medical history, and current health status. Eligibility criteriafor treatment studies often require patients have a particular type and stageof cancer.Recruitingparticipants with similar characteristics to ensure that the results dependonly on what is being researched, rather than other factors.
In this way,eligibility criteria will help researchers obtain more accurate and meaningfulresults. Eligibility criteria also determine that those involved in researchmay get worse do not take this risk. (Kamauuet.al, 2013). 6.
What is informed consent?Patientshave his or her own rights to decide whether to take part in the clinicaltrials (NIH, 2017). Before thepatients agree to take part in the clinical trials and also during the trials,they should be told all of the facts and the details of the clinical trials.This process is called informed consent.
In the same way, the medical carepersonnel should also give the patients informed consent form that presents thekey facts of the trials, if patients agree with that, they will be asked to sign the formInformedconsent is the process of obtaining permission before engaging in a person’shealth care or disclosing personal information. It is based on the guidance ofmedical ethics and research ethics (NIH, 2017). 7.Describe the Phases of clinical trials and what each phase attempt to prove?1) Phase I trials:The aim of phase I trials is to evaluate thesafety, determine the range of the safe dosage and make sure of the adverseeffects of a specific experimental drug by a series of initial safety and toxicitytests (FDA, 2018).2) Phase II trials: Byproviding the experimental drug or the treatment to a larger population inorder to further assess its safety, effective and side effects.3) Phase III trials:The researches will make sure of the safety,monitor the adverse effects also along with long-term use and make comparisonsto regular treatments so that to collect the information that allows this drug or treatment to be used safety by testing this experimental drug or thetreatment in a larger population compared to Phase II trials.4)Phase IV trials:This happenedwhen the drug was approved by the FDA andposted to the market, which provides therisks and benefits of the drug or the treatment and the best use (FDA, 2018).
8.Briefly, explain what should happen to the data once a clinical trial has finished?Atthe end of a trial, the results should be available to all involved if theywant it. The results should also be published so that others can use thisinformation to help them make decisions about treatment and healthcare.Researchersshould publish the results, no matter what they show, but also show how theresults add to existing knowledge.Governmentsand charities often publish the results of the trials they have funded, andsome pharmaceutical companies now promise to publicly register the trial andpublish the results as well.The Ministry of Health / National Institutes of Health insists that allresearch funded by them be published.AtNIHR, the organization publishes the results of all medical research.
Sincesome tests may last for decades years, it may take some time to know the testresults. (NHS, 2017) References:Pandit, N.K., 2007. Introduction to thepharmaceutical sciences.
Lippincott Williams & Wilkins.Koh, H.L. andWoo, S.
O., 2000. Chineseproprietary medicine in Singapore. Drug safety, 23(5),pp.351-362.Kamauu, A.
, Agbor, S. and Kamauu, A.W., 2013,October. Conformity between protocol eligibility criteria for electronicpatient identification: a comparison of clinical trials.
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ac.uk/clinical-trials/Onlineresources:U.S. Food and Drug Administration (2018) What Arethe Different Types of Clinical Research? Online. Available from: https://www.
fda.gov/ForPatients/ClinicalTrials/Types/default.htm Accessed 12/01/2018 Nation Institute for Health Research (2017) Whathappens during and after a clinical trial? Online. Available from: https://www.ukctg.nihr.ac.uk/clinical-trials/what-happens-during-and-after-a-clinical-trial/ Accessed 05/12/2017Cancer Research UK (2015) How clinical trials arefunded Online Available from: http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/how-clinical-trials-are-planned-and-organised/how-clinical-trials-are-funded accessed 05/12/2017National Heart, Lung,and Blood Institute (2017) About Clinical Trials Online Available from:https://www.nhlbi.nih.gov/health-topics/about-clinical-trials Accessed 08/12/2017Roswell Park comprehensivecancer center (2017) What are eligibility criteria, and why are they important?Online Available from: https://www.roswellpark.org/clinical-trials/eligibility-criteria Accessed 08/12/2017UK Clinical Trials (2017) Whathappens during and after a clinical trial? Online Available from: https://www.ukctg.nihr.ac.uk/clinical-trials/what-happens-during-and-after-a-clinical-trial/ Accessed 08/12/2017