1. What are clinical trials?Why are they important?Clinical trialrefers to any systematic study of medications in human subjects (healthyvolunteers or patients), which aims at improving diagnostic treatments and/orexisting treatments or reviewing newdrugs and also confirming or revealing the effect, adverse reaction, and/orabsorption, distribution, metabolism, and excretion of test drugs in order to confirmthe efficacy and safety of the test drug (Clincaltrials.gov, 2017). Clinical trials canbe used not only in the new drug treatments, but also it can be understood as ahuman prospective or human behavioral study, which aimsto study biomedical and behavioral interventions when subjects are receivingexternal interventions, including vaccines, drugs, treatments, devices, or newways of using known drugs. Through clinical trials, people can betterunderstand the way the treatment works, itsstrengths and side effects. Clinical trials of test drug or treatment can bedivided into four phases: phase I, phase II, phase III, phase IV (Clincaltrials.gov, 2017).Clinical trialscan be used to confirm the efficacy and side effects of a new drug anddetermine which treatment is more effective for a certain patient population through the comparisonwith other treatments (Clincaltrials.
gov, 2017). Through theresearch of the efficacy and adverse effects of a new drug and the characteristicsof different treatments, it can help doctors choose a more accurate treatmentfor patients in real clinical treatment.2. What are the differenttypes of clinical trials?(What are the different types of clinical research,n.
d.) claimed that according to different purposes of the experiment, clinicaltrials are divided into the following types:Treatment Research: Treatment research focuses on the impact of drugs, new surgicalprocedures, or medical devices on patients.Prevention Research: The prevention research aims to find ways to prevent the disease. These trials are of significancein studying drugs, vaccines, vitamins and human lifestyles. Diagnostic Research:This study is designed to help researchers find a better method to identifyspecific diseases.Screening Research: The purpose of the screeningresearch is to identify the best ways to diagnosecertain diseases. In cancer studies, screeningresearch can be conducted in the general population and the population with a highincidence of disease, which aims to determine the type of cancer (Types ofclinical trials, n.
d.).Quality of Life Research: The purpose of this research is to findways to improve the quality of life of patients with chronic diseases.
Genetic studies: Genetic studies aim to explore the link between human genes and diseases.”Research in this area is intended to explore ways in which a person’s genesmake him or her more or less likely to develop a disorder. This may lead to the development of tailor-made treatments based ona patient’s genetic make-up.” (What are the different types of clinical research,n. d.) Epidemiologicalstudies: The study is designed to study the patterns and causes of diseases and howto prevent these diseases. 3.
How are clinical trialsfunds?In the UK, thesources of funding for a clinical trial may come from the government, privateindustries and charities (National Institute ofHealth, n. d.). The clinical trials are funded by the government organisations, such as the National HealthService (NHS), the National Institute for Health Research (NIHR), MedicalResearch Council (MRC), the Department of Defense and the Department ofVeteran’s Affairs.
The private industry includespharmaceutical companies, biotech companies, medical institutions, and foundations. For example, for the cancerresearch in the UK, the government, drug companies, and charities have invested heavily in clinical trials. The investment is used in many ways, including treatments, researchers to run thetrials and collect data, analysis ofresults, administrative costs – paperwork, the overseeingof the protocol, data collection,production of results, costs for extra tests and hospital stay fee of patients. Many British charitiesfund the cancer research, among which Cancer Research UK is the largest funder of cancer research in the UK. Furthermore, someinternational trials are also recruiting in the UK, which are likely to be run by some organizationoutside the UK, such as, the European Organization for Research and Treatmentfor Cancer (EORTC) and American organizations like the National CancerInstitute (NCI). 4.
How are thepatients/participants protected?Clinicalresearchers attach great importance to the safety of those involved in clinicaltrials (Clincaltrials.gov, 2017). Each trial hasscientific supervision and patients have the rights to protect themselves.Potential and enrolled participants will be provided with information aboutclinical trials before the clinical trial by researchers.
This is known as theinformed consent process. Informed consent procedures are designed to protectparticipants and provide each participantwith sufficient information to understand the benefits and risks of studies. Such informationhelps participants decide whether they want to join or continue clinicaltrials. In general, before taking parting in the study, all participants mustsign an informed consent document to indicate that they have understood therisks and potential benefits of theclinical trials.
Moreover, in this way, the privacy of participants can beprotected and respected. Participants can also ask any question they want andthey can stop their participation at any time (Clincaltrials.gov, 2017). Institutional review board (IRBs). IRBs will providescientific supervision of clinical trials.
An IRB is constituted by doctors,researchers and members of the community. The responsibility of IRBs is toprotect the rights and welfare of participants and to ensure that the study isethical. Ethics Review Boards (ERBs) and IRBs play a similar role in clinicaltrials (Clincaltrials.gov, 2017).
Office for Human Research Protections.In the USA, the U.S. Department of Health and Human Services’ (HHS’) Office forHuman Research Protections (OHRP) are responsible for supervising all studiesdone or supported by HHS (Clincaltrials.gov, 2017).Food and Drug Administration. Inthe United States, the Food and Drug Administration (FDA) oversees clinicaltrials and the testing of new drugs or medical devices (Clincaltrials.
gov, 2017).Rights and Protection for Children. Children(under 18 years of age) receive special protection as participants.
Childrenparticipants in clinical trials should get the permission of their parents. (Clincaltrials.gov, 2017). 5.
What are eligibilitycriteria, and why is this important?The protocol foreach clinical trial describes the population for whom the study is eligible andthe population for whom it is not suitable and these guidelines are calledeligibility criteria (What are eligibilitycriteria, and why are they important?, n. d.).
Moreover, for differentclinical trials, there are different eligibility criteria. They can includemany factors such as age, gender, current health status, medical history, typeand stage of disease and whether the patient has received some treatments.Eligibility criteria ensure that clinical trials are conducted among similarpopulations. For example, in cancer research, eligibility criteria haverequirements on the cancer type and the stage of participants.
Eligibilitycriteria can help researchers get more accurate and meaningful results. Sinceparticipants have similar characteristics, this ensures the experimentalresults can exclude other factors and only due to the study. Furthermore,eligibility criteria are also a safety measure which can avoid some potentialrisks for participants.
Thus, the situation that people become worse by participatingclinical trials and risks may overweigh the potential benefits can be excluded. 6. What is informed consent?Before the startof clinical trials, participants will be provided with information aboutclinical trials and given the opportunities to ask questions (What is informed consent?, n.
d.). Thisprocess is known as informed consent. Informed consent allows participants tofully understand all the details about clinical trials to help them to decide whetherto participate in the study.
Informedconsent starts from before participants agree to take part in clinical trialsand runs through the entire study.The process ofinformed consent provides the patient with details about the clinical trials, includingthe purpose, length, procedure, potential risks, and benefits of the study which participants should know. If thesevolunteers agree to participate in the study,they will be asked to sign the informed consent. However, this does not meanthat participants must stay in experiments until the study is over, and theycan choose to leave at any time. Moreover, participants must be informed if newbenefits or adverse effects are found during the study and they must sign a newinform consent to decide whether to continue participating in the study.
7. Describe the phase ofclinical trials and what each phase attempts to prove?Clinical trialsare essential steps for the confirmation of the efficacy and safety of a newdrug. Only after the Food and Drug Administration (FDA) and the LocalInstitutional Review Board (IRB) have reviewed the Investigational New DrugApplication (IND), the study can be tested in human.
In general, clinical trialsare usually be classified into four orfive phases according to different purposes and characteristics of participants (Overview of Clinical Trials, n. d.).
Early phase I(phase 0): An early phase 1 study usually includes a small number of people(10~15) who will be given the new drug in single sub-therapeutic doses, inorder to collect some preliminary data on the agent’s pharmacokinetics.Phase I:Phase I trials mainly assess the safety of a drug and identify the safe dosagerange, generally conducted in a small number of healthysubjects (Overview of Clinical Trials, n. d.
).Phase I clinical trials include tolerance tests and pharmacokinetic studies.The purpose of phase I trials is to study the tolerance of the new drug in the human body, understand its process ofabsorption, distribution, metabolism, andexcretion, and identify adverse effects (Aboutclinical trials, n. d.).Phase II: Phase IIstudies are conducted in a large group of people (20~80) (About clinical trials, n. d.
). The purpose is to test theefficacy of a drug and ensure the safety of further studies (National Institute of Health, n. d.). Phase III: PhaseIII studies are conducted in a larger group ofpeople (1,000~3,000) (About clinical trials, n.
d.).The purpose is to collect more information to confirm the safety andeffectiveness of a new drug by studying in different populations and differentdosages together with other drugs (Clinicaltrials.
gov, n. d.).Phase IV: After anew drug was approved for marketing, further research is still required to testits efficacy and side effects. Phase IV trials are long-term studies, which aimto find some rare and long-term adverse effects (Clinicaltrials.
gov,n. d.). 8. Briefly explain whatshould happen to the data once a clinical trial has finished? When a clinicaltrial is over, the trial data and results should be available to all theparticipants if they need (UK Clinical TrialsGateway, n. d.). Moreover, these data should be published for furtherresearch.
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ac.uk/clinical-trials/what-happens-during-and-after-a-clinical-trial/Accessed 2017.What are eligibility criteria, and why are theyimportant?, n.
d. Online. Available at:https://www.roswellpark.org/clinical-trials/eligibility-criteria Accessed2017.What are the different type of clinical research?, n.d.
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