1. What are clinical trials?
Why are they important?
refers to any systematic study of medications in human subjects (healthy
volunteers or patients), which aims at improving diagnostic treatments and/or
existing treatments or reviewing new
drugs and also confirming or revealing the effect, adverse reaction, and/or
absorption, distribution, metabolism, and excretion of test drugs in order to confirm
the efficacy and safety of the test drug (Clincaltrials.gov, 2017). Clinical trials can
be used not only in the new drug treatments, but also it can be understood as a
human prospective or human behavioral study, which aims
to study biomedical and behavioral interventions when subjects are receiving
external interventions, including vaccines, drugs, treatments, devices, or new
ways of using known drugs. Through clinical trials, people can better
understand the way the treatment works, its
strengths and side effects. Clinical trials of test drug or treatment can be
divided into four phases: phase I, phase II, phase III, phase IV (Clincaltrials.gov,
can be used to confirm the efficacy and side effects of a new drug and
determine which treatment is more effective for a certain patient population through the comparison
with other treatments (Clincaltrials.gov, 2017). Through the
research of the efficacy and adverse effects of a new drug and the characteristics
of different treatments, it can help doctors choose a more accurate treatment
for patients in real clinical treatment.
2. What are the different
types of clinical trials?
(What are the different types of clinical research,
n. d.) claimed that according to different purposes of the experiment, clinical
trials are divided into the following types:
Treatment Research: Treatment research focuses on the impact of drugs, new surgical
procedures, or medical devices on patients.
Prevention Research: The prevention research aims to find ways to prevent the disease. These trials are of significance
in studying drugs, vaccines, vitamins and human lifestyles.
This study is designed to help researchers find a better method to identify
Screening Research: The purpose of the screening
research is to identify the best ways to diagnose
certain diseases. In cancer studies, screening
research can be conducted in the general population and the population with a high
incidence of disease, which aims to determine the type of cancer (Types of
clinical trials, n. d.).
Quality of Life Research: The purpose of this research is to find
ways 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 genes
make him or her more or less likely to develop a disorder. This may lead to the development of tailor-made treatments based on
a patient’s genetic make-up.” (What are the different types of clinical research,
studies: The study is designed to study the patterns and causes of diseases and how
to prevent these diseases.
3. How are clinical trials
In the UK, the
sources of funding for a clinical trial may come from the government, private
industries and charities (National Institute of
Health, n. d.). The clinical trials are funded by the government organisations, such as the National Health
Service (NHS), the National Institute for Health Research (NIHR), Medical
Research Council (MRC), the Department of Defense and the Department of
Veteran’s Affairs. The private industry includes
pharmaceutical companies, biotech companies, medical institutions, and foundations. For example, for the cancer
research 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 the
trials and collect data, analysis of
results, administrative costs – paperwork, the overseeing
of the protocol, data collection,
production of results, costs for extra tests and hospital stay fee of patients. Many British charities
fund the cancer research, among which Cancer Research UK is the largest funder of cancer research in the UK. Furthermore, some
international trials are also recruiting in the UK, which are likely to be run by some organization
outside the UK, such as, the European Organization for Research and Treatment
for Cancer (EORTC) and American organizations like the National Cancer
4. How are the
researchers attach great importance to the safety of those involved in clinical
trials (Clincaltrials.gov, 2017). Each trial has
scientific supervision and patients have the rights to protect themselves.
Potential and enrolled participants will be provided with information about
clinical trials before the clinical trial by researchers. This is known as the
informed consent process. Informed consent procedures are designed to protect
participants and provide each participant
with sufficient information to understand the benefits and risks of studies. Such information
helps participants decide whether they want to join or continue clinical
trials. In general, before taking parting in the study, all participants must
sign an informed consent document to indicate that they have understood the
risks and potential benefits of the
clinical trials. Moreover, in this way, the privacy of participants can be
protected and respected. Participants can also ask any question they want and
they can stop their participation at any time (Clincaltrials.gov, 2017).
Institutional review board (IRBs). IRBs will provide
scientific supervision of clinical trials. An IRB is constituted by doctors,
researchers and members of the community. The responsibility of IRBs is to
protect the rights and welfare of participants and to ensure that the study is
ethical. Ethics Review Boards (ERBs) and IRBs play a similar role in clinical
trials (Clincaltrials.gov, 2017).
Office for Human Research Protections.
In the USA, the U.S. Department of Health and Human Services’ (HHS’) Office for
Human Research Protections (OHRP) are responsible for supervising all studies
done or supported by HHS (Clincaltrials.gov, 2017).
Food and Drug Administration. In
the United States, the Food and Drug Administration (FDA) oversees clinical
trials and the testing of new drugs or medical devices (Clincaltrials.gov,
Rights and Protection for Children. Children
(under 18 years of age) receive special protection as participants. Children
participants in clinical trials should get the permission of their parents. (Clincaltrials.gov,
5. What are eligibility
criteria, and why is this important?
The protocol for
each clinical trial describes the population for whom the study is eligible and
the population for whom it is not suitable and these guidelines are called
eligibility criteria (What are eligibility
criteria, and why are they important?, n. d.). Moreover, for different
clinical trials, there are different eligibility criteria. They can include
many factors such as age, gender, current health status, medical history, type
and stage of disease and whether the patient has received some treatments.
Eligibility criteria ensure that clinical trials are conducted among similar
populations. For example, in cancer research, eligibility criteria have
requirements on the cancer type and the stage of participants. Eligibility
criteria can help researchers get more accurate and meaningful results. Since
participants have similar characteristics, this ensures the experimental
results can exclude other factors and only due to the study. Furthermore,
eligibility criteria are also a safety measure which can avoid some potential
risks for participants. Thus, the situation that people become worse by participating
clinical trials and risks may overweigh the potential benefits can be excluded.
6. What is informed consent?
Before the start
of clinical trials, participants will be provided with information about
clinical trials and given the opportunities to ask questions (What is informed consent?, n. d.). This
process is known as informed consent. Informed consent allows participants to
fully understand all the details about clinical trials to help them to decide whether
to participate in the study. Informed
consent starts from before participants agree to take part in clinical trials
and runs through the entire study.
The process of
informed consent provides the patient with details about the clinical trials, including
the purpose, length, procedure, potential risks, and benefits of the study which participants should know. If these
volunteers agree to participate in the study,
they will be asked to sign the informed consent. However, this does not mean
that participants must stay in experiments until the study is over, and they
can choose to leave at any time. Moreover, participants must be informed if new
benefits or adverse effects are found during the study and they must sign a new
inform consent to decide whether to continue participating in the study.
7. Describe the phase of
clinical trials and what each phase attempts to prove?
are essential steps for the confirmation of the efficacy and safety of a new
drug. Only after the Food and Drug Administration (FDA) and the Local
Institutional Review Board (IRB) have reviewed the Investigational New Drug
Application (IND), the study can be tested in human. In general, clinical trials
are usually be classified into four or
five 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, in
order to collect some preliminary data on the agent’s pharmacokinetics.
Phase I trials mainly assess the safety of a drug and identify the safe dosage
range, generally conducted in a small number of healthy
subjects (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 of
absorption, distribution, metabolism, and
excretion, and identify adverse effects (About
clinical trials, n. d.).
Phase II: Phase II
studies are conducted in a large group of people (20~80) (About clinical trials, n. d.). The purpose is to test the
efficacy of a drug and ensure the safety of further studies (National Institute of Health, n. d.).
Phase III: Phase
III studies are conducted in a larger group of
people (1,000~3,000) (About clinical trials, n. d.).
The purpose is to collect more information to confirm the safety and
effectiveness of a new drug by studying in different populations and different
dosages together with other drugs (Clinicaltrials.gov, n. d.).
Phase IV: After a
new drug was approved for marketing, further research is still required to test
its efficacy and side effects. Phase IV trials are long-term studies, which aim
to find some rare and long-term adverse effects (Clinicaltrials.gov,
8. Briefly explain what
should happen to the data once a clinical trial has finished?
When a clinical
trial is over, the trial data and results should be available to all the
participants if they need (UK Clinical Trials
Gateway, n. d.). Moreover, these data should be published for further
About clinical trials, n.d. Online. Available at:
https://www.alz.co.uk/clinical-trials/about Accessed 2017.
Clincaltrials.gov, 2017. Learn about clinical trials.
Online. Available at: https://clinicaltrials.gov/ct2/about-studies/learn#ClinicalTrials
Clinicaltrials.gov, n.d. Glossary Definition.
Online. Available at: https://clinicaltrials.gov/ct2/help/glossary/phase
National Insititue of Health, n.d. National Insititue
of Health. Online. Available at:
Overview of Clinical Trials, n.d. Online. Available
at: https://www.centerwatch.com/clinical-trials/overview.aspx Accessed 2017.
UK Clinical Trials Gateway , n.d. What happens during
and after a clinical trial?. Online. Available at:
What are eligibility criteria, and why are they
important?, n.d. Online. Available at:
What are the different type of clinical research?, n.
d. Online. Available at: https://www.fda.gov/ForPatients/ClinicalTrials/Types/default.htm Accessed 2017.
is informed consent?, n.d. What is informed consent?. Online. Available at:
https://www.roswellpark.org/clinical-trials/informed-consent Accessed 2017.