How Are Clinical Trials Conducted?
Updated: Aug 25, 2020
Clinical trials are carefully performed with volunteers to learn more about the impact of a particular intervention or treatment. Such trials seek to have a better understanding of how a medical intervention works, its effectiveness in comparison to other alternatives and how it may improve quality of life. There are many dimensions of clinical trials to explore.
Who Runs a Clinical Trial?
You may think that clinical trials are run only by scientists and their assistants in white lab coats. While scientists are a part of the process, a clinical trial has administrative and medical personnel all working together to ensure the best outcomes for their participants while meeting the study’s objectives.
At Insight Clinical Trials, each of our clinical trials is performed according to a detailed plan or protocol. This plan outlines some critical elements such as:
Types of patients who are allowed to enter the trial
Schedule of tests and procedures, as well as drugs and dosages
The necessary follow-up during and after the clinical trial
Length of the study that describes the results (endpoints) that will be measured
Type of information that will be collected
Support from regulatory authorities to get marketing approval
Are Clinical Trials Safe?
Clinical trials are often conducted in several phases. Each phase has its unique set of objectives, or a series of questions to be answered, while still being proactive in preserving the volunteers’ health and holistic well-being.
For each new treatment, testing is completed in three phases of clinical trials before regulatory agencies may deem it safe. All clinical trials are conducted under the same set of international guidelines or Good Clinical Practice (GCP) standards to ensure patient safety. These standards focus on the rights, safety, and well-being of volunteers in the clinical trials. The GCP standards also serve as a guide to ensure the credibility of a clinical trial’s data.
What are the 4 Phases of Clinical Trials?
There are 4 main phases of a clinical trial. Each phase has its set of criteria that has to be met. Let’s take a look at each of these phases:
Phase I is characterized by a small number of participants (6-10 healthy volunteers, or critically ill patients who have few to no treatment options). The main objective of Phase I trials is to enable scientists, doctors, and other professionals to have a better understanding of the impact of medical intervention in humans. The data from this phase gives insights about the safety and tolerance of treatment when it is swallowed, injected, infused, or used. Participants are also monitored for any side effects.
These Phase II trials are usually conducted once the initial safety of medical intervention has been confirmed in Phase I. Phase II trials also tend to have larger groups of participants and can range from 20 to 300 persons (depending on the type of disease).
These studies are designed to assess the safety and effectiveness of possible treatment in a wide and varied pool of participants. This is often done to discover if different doses or usage levels have different effects. This helps the clinical researchers to figure out the best dosage or usage level for the treatment option.
Phase III trials have large numbers of participant groups that range from 300 to 3000 persons (depending on the illness that’s being studied).
Clinical researchers use a Phase III trial to confirm their findings from the previous phases. Since there are large numbers of participants involved, the results from such studies are more applicable to a wider population.
Phase III trials may also involve one or more versions of the treatment that’s being studied. This gives researchers more data to evaluate and confirm the safety and effectiveness of the medical intervention under consideration. The results of this phase determine how medical intervention is best prescribed to patients in the future.
Phase IV clinical trials occur after a medical intervention has received regulatory approval from the relevant government agency.
These Phase IV trials are designed to help the clinical team provide more comprehensive information about the safety and efficacy of the new treatment. More details can also be shared about how the treatment affects different subpopulations (such as ethnic groups and age ranges), and possible interactions with other treatments. Phase IV trials serve to evaluate the long-term impact of medical intervention.
How Long Do Clinical Trials Take?
The length of a clinical trial depends on what is being studied as well as the particular phase of the trial. However, the process of informed consent will ensure that each participant is told about the length of the study before they participate.
Clinical trials may not go so far as absolute success resulting in a cure to a disease. Furthermore, the length of a trial tends to increase with each phase. As an approximate guide:
Phase I trials often last for several months
Phase II clinical trials can be anywhere from several months to 2 years
Phase III trials last from 1 to 4 years
Phase IV clinical trials tend to have a similar duration as Phase III trials, or even longer
However, you should always remember that participation in a clinical trial is voluntary, and you can choose to withdraw at any time.
Exploring the Ethical Principles that Govern Clinical Trials
Although clinical trials follow the GCP guidelines, there are other ethical considerations as well. Let’s briefly consider each ethical principle:
This refers to the duty of medical and other clinical research professionals to cause no harm. This principle originates from the familiar Hippocratic Oath. The core ethical issue of all clinical trials is to ensure that the results of the given trial provide a reasonable benefit to society without harming the study participants.
Respect: This respect for persons is shown in the clinical trial by:
Getting informed consent
Providing information about the study in a detailed and yet easy-to-understand manner
Understanding that participants’ cooperation is completely voluntary
Maintaining the privacy of participants’ data
Beneficence: This principle is illustrated by a clinical study by:
Conducting a detailed risk/benefit evaluation
Accounting for all physiologic, psychological, and socioeconomic risks
Identifying a clear medical need and distinct ways in which research can generate benefits
Recognizing that these benefits are direct, collateral, and/or altruistic
Protect the health, safety, and holistic wellbeing of all study participants
Justice: This ethical principle accounts for all the processes that are used to recruit participants for a clinical study. These processes must be fair, not exploit vulnerable populations, including persons most likely to benefit, and ensure that the study’s results benefit the community at large.
How Does Insight Clinical Trials Ensure That its Studies are Legal and Ethical?
Insight Clinical Trials conducts studies in the areas of depression, Alzheimer’s, agitation, and ADHD. We follow a holistic approach to caring for the health and well-being of our participants.
We have created and refined our internal standards and systems to maintain and even exceed all guidelines, regulations, and legal obligations. All employees that work in our clinical trials and all external contractors must follow the local laws and global guidelines. Furthermore, they must conduct their duties with integrity, and provide the best standards of medical care and respect for the study participants.
Insight Clinical Trials ensures this compliance by facilitating the training of all employees in the GCP guidelines. Additionally, we have clear internal processes to encourage early discussion and consultation on important issues. Furthermore, each employee is legally required to report any suspected non-compliance with regulatory and/or ethical standards.
We also have procedures in place to discuss and resolve any potential ethical issues that may arise during our clinical trials. This system makes it possible for our employees to contact the clinical researchers and quickly escalate any issue.
Participants’ Rights in a Clinical Trial
All clinical trials must comply with legal and ethical requirements. Furthermore, participants have the right to:
A clear and transparent process for informed consent before agreeing to join the trial
Withdraw from a clinical trial at any time
This informed consent process should answer all questions that may influence a participant’s decision to join (or not join) a clinical trial. Only fully informed participants should sign an informed consent form to enter a trial of their own free will.
It is important to note that this informed consent document is not a contract. So a participant is free to change his/her mind and can withdraw from the study at any time. Furthermore, this withdrawal doesn’t affect the participant’s relationship with his/her doctor, nor result in any loss of benefits that (s)he was entitled to from participating in the trial. The informed consent form will also outline any potential medical risks that may arise from sudden withdrawal from a clinical trial.
Protecting the Privacy of Participants
Once a person decides to join a clinical trial, then it’s incumbent upon the administrators of the trial to protect his/her privacy. But some key personnel must know about the person participating in the trial:
The participant’s primary physician who’s responsible for their daily customary healthcare
The doctor and clinical research team that will care for the participant during the trial
A person participating in a clinical trial will have a note included in the participant’s medical file. However, researchers can tell no one else about the person participating in the trial except if the participant gives consent.
All information collected during a trial and personal medical records are held in the strictest confidence. Furthermore, participants are never identified in any subsequent reports or publications arising from the clinical trial.
A trial’s protocol will determine what happens to samples and the participants’ personal information. Some samples and information may be held for a predetermined length of time before they are destroyed. If any samples and/or information will be further used, this fact will be either:
Outlined in the original trial protocol
Be a part of the informed consent document the participant signed before joining the study
Stated in a specific informed consent document that the patient will need to sign
The End of a Clinical Trial
Insight Clinical Trials follows the Good Clinical Practice (GCP) in all aspects of our trials. Therefore, we store select portions of the records for a fixed period (as outlined in our trial protocol). But you can be assured that we will always protect the confidentiality of our participants through secure storage of all records and non-disclosure to third parties.
We will always maintain a high standard of quality and ethical conduct in all areas of our clinical trials. Insight Clinical Trials will also continue to provide access to the study’s medical intervention to its participants after the trial is completed.
Explore Our Latest Clinical Trials
You should now be clear about the basics of how clinical trials are conducted. Our team of dedicated professionals at Insight Clinical Trials study areas such as depression, Alzheimer’s, agitation, and ADHD as well as other psychiatric illnesses. We care about each participant’s mental health and that of their family members.
We invite you to explore our existing trials. Please feel free to contact us so that we can discuss if any of these trials are right for you. Come and assist the medical research process as you get access to the most innovative interventions and improve your health.