What Exactly Are Clinical Trials?
Clinical cancer research is human-centered trial investigations. Clinical trials help physicians discover new methods to enhance treatments and the quality of life for patients.
Clinical cancer research are designed by researchers to evaluate innovative approaches to:
- Cancer treatment
- Locate and diagnose cancer
- Cancer prevention
- Manage cancer symptoms and treatment side effects
Clinical cancer researches are the ultimate phase in a lengthy process that starts with laboratory research. Before a novel medication is tested on humans in clinical trials, researchers spend years studying its effects on cancer cells in the lab and on animals. They are also attempting to determine the potential adverse effects.
This publication focuses on clinical cancer research. These studies are intended to provide answers to queries concerning novel medicines or improved methods to use current medications. These studies put a variety of therapies to the test, including new:
Medications or vaccinations
Methods of doing surgery or administering radiation treatment
Treatment combinations
Many modern therapies are the outcome of previous clinical studies.
Why Are Clinical Cancer Researches Necessary?
People are living longer lives as a consequence of effective cancer therapies developed via clinical trials in the past. Clinical trials help physicians evaluate if new medicines are safe and effective, as well as whether they perform better than existing treatments. When you participate in a clinical study, you contribute to our understanding of cancer and help improve cancer treatment for future patients. Clinical trials are critical to achieving progress in the fight against cancer.
Clinical trials are conducted in phases
To become standard (widely recognized), a therapy must first go through a sequence of processes known as phases. The early stages ensure that the therapy is safe. Later rounds will reveal if it performs better than the current therapy. You are not required to participate in all steps.
Phase 1
Purpose:
- To determine a safe dosage.
- To determine how the new therapy should be administered.
- To determine how the new therapy impacts the human body and combats cancer.
15-30 persons are expected to participate.
Phase 2
Purpose:
- To see whether the new therapy has any impact on a certain malignancy.
- To determine how the new therapy impacts the human body and combats cancer.
Number of participants: less than 100
Phase 3
Purpose:
- To contrast the new therapy (or novel application of a treatment) with the present standard treatment.
The number of participants ranges from 100 to several thousand.
Some researchers plan trials in which two stages (phase 1/2 or phase 2/3 trials) are combined into a single study. The smooth transition between trial stages in this combined design may enable research questions to be addressed more rapidly or with fewer subjects.
Clinical cancer research is also divided into early (phase 0) and late (phase 4) stages. These kind of trials are less prevalent. Phase 0 trials are tiny studies that assist researchers determine if a novel medicine should be evaluated in a phase 1 trial. Longterm safety and efficacy are investigated in phase 4 studies. They occur after a new therapy has been authorized and placed on the market.
Clinical trials adhere to strict guidelines.
Clinical cancer research rules explicitly specify who will be eligible to participate in the research and the treatment approach. Every study has a leader, generally a doctor, who is known as the principle investigator. The primary investigator creates a protocol for the research, which is similar to a recipe for performing a clinical trial.
The protocol describes what the trial will perform, how the research will be conducted, and why each component of the study is required. It contains information on:
The purpose for doing the research
Who is eligible to participate in the study?
How many participants are required for the study?
Any medications or other treatments that will be administered, how they will be administered, the dosage, and the frequency
What medical exams they will undergo and how often
What kinds of information will be gathered about the participants?
Who Can Participate in a Clinical Trial? Each clinical trial protocol specifies who may and cannot participate in the study based on the research questions.
The following are common entry requirements for a trial:
Having cancer of a certain kind or stage
Having previously undergone (or not previously received) a certain sort of treatment
The presence of particular genetic alterations in your tumor
Being a certain age group
Medical background
current state of health
Criteria like this assist guarantee that the participants in the experiment are as similar as feasible. This manner, clinicians may be certain that the outcomes are related to the therapy under consideration and not to other causes.
Safety
Some participants have health concerns in addition to cancer that might be exacerbated by the therapies used in the trial. If you decide to participate in a study, you will be subjected to medical testing to ensure that you are not putting yourself at danger.
Study findings that are accurate and significant
If you have previously had another kind of cancer therapy, you may be unable to participate in certain clinical studies. Doctors would not be able to tell if your findings were attributable to the therapy being examined or the previous treatment if this was not done.
Randomization
In certain clinical studies, randomization is employed to avoid bias. Bias arises when the findings of a study are influenced by human decisions or other variables unrelated to the therapies being examined. Randomization assists in ensuring that unknown influences do not influence trial outcomes. 6www.cancer.gov
All phase 3 studies and some phase 2 trials employ randomization. These are known as randomized clinical studies.
If you participate in such a study, you will be randomly allocated to either an investigational or a control group. Your assignment will be decided by a computer algorithm or a random number table.
If you are allocated to the control group, you will get the most commonly acknowledged cancer therapy.
If you are allocated to the experimental group, you will get the newly tested therapy.
When these groups are compared, it is generally evident which medication is more successful or has fewer adverse effects. If you are considering participating in a randomized clinical study, you should be aware that you have an equal chance of being allocated to either group. Neither you nor your doctor have control over which group you will be assigned to.
Will I be given a placebo?
Placebos are seldom used in clinical studies for cancer therapy. They may be utilized when no normal therapy is available. Alternatively, they might be employed in a clinical research comparing conventional therapy plus a placebo to standard treatment plus a novel treatment. The placebo is made to seem like the medication being tested, but it is not. Using a placebo in this manner may aid in preventing patients and clinicians from determining which therapy group they were allocated to. Another method for preventing bias in studies is to use placebos. If a placebo is used in the trial, you will always be informed.
Patient Security
Federal regulations assist to guarantee that clinical studies are conducted ethically. Your rights and safety are safeguarded by:
Consent after being informed
The clinical study was carefully reviewed and approved by two review committees, which included:
These factors also aid in ensuring:
- A scientific review committee
- An IRB (institutional review board)
- Continuous monitoring during the study is given by:
- The IRB
- Phase 3 trial Data and Safety Monitoring Boards (DSMBs)
- The trial’s sponsoring organization
- Your research group
Consent with Knowledge
Informed consent is the process through which you learn about the goal, risks, and benefits of a clinical experiment before choosing whether or not to participate. It is an essential component of guaranteeing patient safety in research. You discover critical information about a clinical study through the informed consent procedure. This information may assist you in deciding whether or not to join.
During the informed consent procedure, you will receive critical facts about the clinical study that will help you decide whether or not to participate.
The study team, which consists of physicians, nurses, and research assistants, initially informs you about the experiment. The team describes the trials:
- Purpose
- Procedures and tests
- Treatment
- Risks and benefits
The team will also discuss your rights, including your right to: Make a decision about participating Leave the study at any time If you decide to leave the study, your doctor will discuss other treatment options with you.
The form contains written specifics on the material that was discussed as well as information regarding the privacy of your data. You sign the form if you accept to participate in the research. However, even after signing the permission form, you are free to exit the research at any moment.
Scientific Review
Most clinical studies must go through several sorts of reviews in order to safeguard all participants. Scientific review panels, IRBs, and DSMBs perform these reviews.
Scientific Review Panels
This panel of specialists reviews a clinical trial protocol before it begins taking participants to ensure that it is based on good research. This review is required for all government-funded clinical studies. Many other clinical trial sponsors, such as pharmaceutical corporations, seek expert input on the scientific validity of their trials as well.
Institutional assess Boards (IRBs)
Institutional assess Boards (IRBs) assess clinical trial protocols before they begin admitting patients. The board members ensure that the risks associated with the study are appropriate in comparison to the potential benefits. They also keep a careful eye on the trial’s progress from start to finish.
According to federal regulations, each IRB must have at least five members. One member must be from a different university than the one hosting the trial. IRBs are often comprised of a combination of medical professionals and representatives of the community in which the study is being conducted. Many members come from a variety of professions and backgrounds. In most circumstances, IRBs are situated near the site of the study. Many clinical research facilities have their own IRBs.
Data and Safety Monitoring Boards (DSMBs)
DSMBs are used in certain clinical studies, particularly phase 3 trials, to monitor the experiment and assist assure your safety. They may also be relevant and required for certain phase 1 and phase 2 clinical investigations. A DSMB is an impartial body comprised of statisticians, doctors, and other subject matter experts.
The board must:
- Ensure that any risks associated with participation in the study are minimized to the greatest extent possible
- Ensure that the data are sound
- Stop a trial if safety concerns arise or as soon as its objectives are met
Office of Human Research Protections (OHRP)
This office protects people participating in research and provides leadership for many federal agencies that conduct research involving people.
The OHRP implements the Common Rule, which is a set of fundamental laws for patient safety in clinical studies. These laws provide requirements for: the informed consent procedure, IRB establishment and operation, and the inclusion of convicts, children, and other vulnerable people in research in the United States
Food and Drug Administration (FDA)
The FDA is also responsible for safeguarding study participants and assuring the integrity of trial data. The FDA has the authority to exclude researchers from conducting clinical studies if they have frequently or purposefully violated the standards designed to safeguard patients. Or when the researcher has not guaranteed the integrity of the data.
Before new pharmaceuticals may be commercialized, they must be approved by the FDA. This helps to:
- Prevent quackery
- Ensure that medications operate as they should
- Ensure that the drug’s health benefits exceed the risks.
Paying for Clinical Trials
If you decide to participate in a clinical trial, you will need to figure out how to pay for your treatment. A clinical trial incurs two sorts of expenditures: patient care costs and research costs.
Patient care expenses are those associated with treating your cancer, whether you are participating in a clinical study or getting normal treatment. These expenses are often reimbursed by health insurance. They include: doctor visits, hospital stays, standard cancer treatments, therapies to minimize or eliminate cancer symptoms or side effects from therapy, lab tests, Xrays, and other imaging tests, and research fees.
These expenses are often not covered by health insurance, however they may be reimbursed by the trial’s sponsor.
- The study medication
- Lab tests conducted primarily for research reasons
- Additional xrays and imaging tests performed solely for the trial
When you participate in a trial, you may have additional doctor visits that you would not have had with conventional therapy. During these appointments, your doctor will keep an eye out for adverse effects and your overall safety in the research. These additional visits may incur additional fees for transportation and child care.
For more information on insurance coverage and working with your insurance company, visit the National Cancer Institute’s website at www.cancer.gov/aboutcancer/treatment/clinicaltrials/paying.
Deciding to Participate in Clinical
Trials Clinical trials may be an option for you whenever you need treatment for your cancer. Only you, people close to you, and your physicians and nurses may decide whether or not to participate in a clinical research. This section contains information that you may use while considering your treatment options and making your decision.
Weighing the Pros and Cons
A clinical study, like any other therapy choice, offers potential benefits as well as downsides. You should address the following topics with your doctor and those close to you.
Potential Benefits
- Clinical trials provide high-quality cancer treatment. If you are enrolled in a randomized trial and do not get the newly tested medicine, you will be given the best-known conventional treatment. This might be just as excellent as, if not better than, the current method.
- If a new therapy is shown to be effective and you are getting it, you might be among the first to benefit.
- By considering all of your treatment options, including clinical trials, you are taking an active part in a life-changing decision.
- You have the opportunity to assist others while also improving cancer therapy.
Potential Drawbacks
- New therapies under investigation are not necessarily superior to, or even comparable to, traditional therapy.
- If you get regular care instead of the novel therapy being evaluated, it may be less successful.
- New therapies may have unanticipated adverse effects or side effects that are worse than normal therapy.
- Even though a new therapy offers advantages, it may not be effective for you. Even conventional therapies, which have been shown to be beneficial for many individuals, may not benefit everyone.
- In research, health insurance and managed care providers may not pay all patient care expenditures. What they cover varies depending on the strategy and the research. Check with your insurance provider and the billing staff at the hospital or doctor’s office ahead of time to find out what expenditures are likely to be covered.
Questions to Ask
- If you are considering participating in a clinical study, here are some questions to consider.
The Trial
- Why is this trial being held?
- Why do the trial’s physicians feel that the medicine being tested is superior to the conventional treatment? Why can’t it be better?
- How long will I be a witness in the trial?
- What kind of testing and treatments are used?
- What are the new treatment’s potential adverse effects or risks?
- What are the potential advantages?
- How will we know whether the therapy is effective?
Costs
- Will I be required to pay for any treatments or tests?
- What expenses would my medical insurance cover?
Daily Life
- How can the trial impact my daily life?
- How often will I have to visit the hospital or clinic?
- Will I have to go a significant distance to participate?
Comparing Treatment Options
- What are my other treatment options, including conventional treatments?
- How does the therapy I would get in this study compare to the other options?
How to Join a Clinical Trial
If you are considering participating in a clinical trial as a treatment option, the best place to begin is with a discussion with your doctor or another member of your healthcare team. Often, your doctor will be aware of a clinical study that might be beneficial to you. He or she may also be able to find a study for you, give information, and answer questions to assist you decide whether or not to participate in a clinical trial.
Some physicians may be unaware of or refuse to propose clinical trials that may be relevant for you. If this is the case, you may wish to get a second opinion on your treatment choices, which may include participating in a clinical study.
If you decide to search for trials on your own, the “How to Join a Cancer Clinical Trial” guide may be useful. The National Cancer Institute’s website has this advice at www.cancer.gov/aboutcancer/treatment/clinicaltrials/search/trialguide.
If you need assistance with your search, you may contact the NCI Contact Center via phone, email, or live chat.
