FAQs | VCU Massey Comprehensive Cancer Center

Understanding the Basics

A clinical trial, referred to as a clinical study or research study, involves a few or thousands of patients and is used to explore better ways to prevent, detect or treat diseases with new drugs or emerging technology.

Clinical Trials at Massey

Every day, VCU Massey Comprehensive Cancer Center is discovering new and better ways to prevent, detect and treat cancer. With over 150 cancer clinical trials offered annually, Massey has one of the largest selections of cancer clinical studies in Virginia.

Clinical trials for cancer are designed to answer specific questions about new treatments and therapies. They help scientists understand if a new treatment is effective and safe. Millions of patients have taken part in clinical trials, and nearly all of today’s cancer drugs were tested this way. Thanks, in large part, to clinical trials of new cancer treatments and prevention approaches, the cancer death rate has dropped by more than 34% over the past 30 years.

Learn more about how we conduct clinical trials and demystify the study process at Massey.

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Facts
There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies:
- In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants.
- In an observational trial, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial)
Clinical trial protocols are the action plans or guidelines that must be followed during the course of any study. Guidelines may cover:
- The design of the study – what it will study and how
- Who may participate – criteria for participants who enter the study
- What medications and medical tests will be used with the participants
- What information is being researched
Several research centers may be involved in the study, and each uses the same protocols to ensure that information from all centers can be combined and compared.

Most clinical trials progress in an orderly series of steps or phases.
- Phase 0/Exploratory Phase: Involves dosing a very small and limited number of subjects (patients) with a very small and limited range of doses for a specific period of time
- Phase I/Early Phase: Tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage
- Phase II: Uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
- Phase III: Gathers more information about safety and effectiveness, studying different populations. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
- Phase IV: Takes place after the FDA approves use or drug/device. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
Participation in a clinical trial is completely voluntary and a personal decision. It is important to talk to your care team about the potential benefits and risks of enrollment. Here are some reasons to consider a clinical trial:
- It provides early access to a promising treatment
- Other treatment options did not work
- There is no other treatment option
- You want help researchers learn more about certain health problems
- You want to be able to help future patients based on the outcomes of the clinical trial
Clinical trials are offered to patients as an additional treatment option to consider. In health care, offering clinical trials is standard and is not exclusive to a certain type of patient or condition. Clinical trial options are typically presented to patients when discussing treatment options based on the study’s eligibility criteria. It is important to know that clinical trial participation is always up to the patient:
- Patients can be engaged through open communication and education
- Patients should never be coerced into participating in a clinical trial
- Patients can also look for clinical trials via https://clinicaltrials.gov
After patients consent to participate, a physician or advanced practice provider trained in clinical research will complete screening procedures to determine eligibility based on the set parameters in the clinical trial protocol or research plan.
Large cancer centers, university hospitals, local medical centers or physician offices may offer clinical trials. There may be only one or two locations involved in a particular study, or hundreds around the country.

Many of the clinical trials at VCU Massey are offered as part of a collaborative effort among multiple cancer centers and research facilities organized into national or regional groups. Working in unison, members of these groups offer the same studies and follow the same protocols for each trial. The protocol is a study’s game plan that each researcher follows to the letter in order to ensure the consistency of the data collected and the integrity of the results drawn from the data.

With strength in numbers, NCI networks and cooperative groups help expand the number of patients on studies and can collect more data to evaluate the effectiveness of the trial. Also, enrolling participants in multiple locations means a trial can reach its enrollment goals sooner, accelerating the research.

Currently, VCU Massey participates in or has access to trials from numerous networks.
Many insurers cover the normal costs of treatment for cancer clinical trials and many states, including Virginia, have mandatory coverage for certain types of trials. The cost to a patient on a clinical trial will vary dependent on various factors:
- If it is standard of care, it will be billed to patient’s insurance
- If solely being done for research purposes, it is usually covered by trial funding
- Some studies may compensate patients for their time or travel. The informed consent form will explain any costs or payments if applicable
Common Myths
Generally, clinical trials involve inherent risk because the drug or treatment being tested is often new. However, patients on clinical trials are monitored very closely by their physicians and care team. In fact, many patients have said they appreciated the extra attention they received while participating in a clinical trial.

In addition, trials are overseen by an independent data and safety monitoring board as well as by any cooperative group study teams through which the trials are offered. Patient data — without individual identifiers — is reported and shared among the cooperative group members.

As part of the monitoring and data-sharing process, clinical researchers can identify any irregularities in symptoms. If a problem arises, the trial can be altered or stopped, and a patient may opt out at any time for any reason. Just like all medical treatments, cancer clinical trials are not risk-free. However, the safety of patients is of utmost importance to the clinical research team. There are several procedures in place as part of the protocols to protect the safety of the people who participate. Groups that oversee the safety procedures include:
- The organization that sponsors the study (for example, the National Cancer Institute).
- The Institutional Review Board (IRB) that oversees clinical research in the health care institution. The IRB includes physicians, other health care providers, consumers and sometimes members of the clergy, who do not have any personal interest in the results of the study. As neutral reviewers, they ensure that the study is conducted fairly and that participants are not likely to be harmed.
- The Data Safety and Monitoring Committee, a committee that looks at the test results, monitors the safety of the participants and decides whether the study should go forward as originally planned.
Learn more about Massey’s Clinical Research Committees
Sugar pills (placebos) are seldom used in clinical trials, and are only considered if there are currently no standard treatments or if a new cancer prevention measure is being tested for people without cancer.

Patients in clinical trials always get the best treatment available. If a new drug is being tested as part of a trial, one group of patients might receive the current best standard treatment plus the new drug, while another group may receive the current best standard treatment plus a placebo. Either way, everyone is getting the best treatment available. Comparing the results of the two groups enables researchers to determine if the new drug is more effective than the current standard treatment.

It’s important for people of all races and backgrounds to join clinical trials because it helps researchers develop new treatments and interventions that work for everyone. Medical treatments, tests, and approaches work slightly differently in each person. If a new advance is only studied in one group of people, there is a risk that it won’t work as well in other groups of people.

You don’t need to be diagnosed with cancer to join a clinical trial. Several cancer prevention and control studies are available for people without cancer. Many participants in these trials are people who have a strong family health history of cancer and want to explore ways that may reduce their chances of developing cancer.

There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies:

In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants.
In an observational trial, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial)

Clinical trial protocols are the action plans or guidelines that must be followed during the course of any study. Guidelines may cover:

The design of the study – what it will study and how
Who may participate – criteria for participants who enter the study
What medications and medical tests will be used with the participants
What information is being researched

Several research centers may be involved in the study, and each uses the same protocols to ensure that information from all centers can be combined and compared.

Most clinical trials progress in an orderly series of steps or phases.

Phase 0/Exploratory Phase: Involves dosing a very small and limited number of subjects (patients) with a very small and limited range of doses for a specific period of time
Phase I/Early Phase: Tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage
Phase II: Uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
Phase III: Gathers more information about safety and effectiveness, studying different populations. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
Phase IV: Takes place after the FDA approves use or drug/device. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.

Participation in a clinical trial is completely voluntary and a personal decision. It is important to talk to your care team about the potential benefits and risks of enrollment. Here are some reasons to consider a clinical trial:

It provides early access to a promising treatment
Other treatment options did not work
There is no other treatment option
You want help researchers learn more about certain health problems
You want to be able to help future patients based on the outcomes of the clinical trial

Clinical trials are offered to patients as an additional treatment option to consider. In health care, offering clinical trials is standard and is not exclusive to a certain type of patient or condition. Clinical trial options are typically presented to patients when discussing treatment options based on the study’s eligibility criteria. It is important to know that clinical trial participation is always up to the patient:

Patients can be engaged through open communication and education
Patients should never be coerced into participating in a clinical trial
Patients can also look for clinical trials via https://clinicaltrials.gov

After patients consent to participate, a physician or advanced practice provider trained in clinical research will complete screening procedures to determine eligibility based on the set parameters in the clinical trial protocol or research plan.

Large cancer centers, university hospitals, local medical centers or physician offices may offer clinical trials. There may be only one or two locations involved in a particular study, or hundreds around the country.

Many of the clinical trials at VCU Massey are offered as part of a collaborative effort among multiple cancer centers and research facilities organized into national or regional groups. Working in unison, members of these groups offer the same studies and follow the same protocols for each trial. The protocol is a study’s game plan that each researcher follows to the letter in order to ensure the consistency of the data collected and the integrity of the results drawn from the data.

With strength in numbers, NCI networks and cooperative groups help expand the number of patients on studies and can collect more data to evaluate the effectiveness of the trial. Also, enrolling participants in multiple locations means a trial can reach its enrollment goals sooner, accelerating the research.

Currently, VCU Massey participates in or has access to trials from numerous networks.

Many insurers cover the normal costs of treatment for cancer clinical trials and many states, including Virginia, have mandatory coverage for certain types of trials. The cost to a patient on a clinical trial will vary dependent on various factors:

If it is standard of care, it will be billed to patient’s insurance
If solely being done for research purposes, it is usually covered by trial funding
Some studies may compensate patients for their time or travel. The informed consent form will explain any costs or payments if applicable

Generally, clinical trials involve inherent risk because the drug or treatment being tested is often new. However, patients on clinical trials are monitored very closely by their physicians and care team. In fact, many patients have said they appreciated the extra attention they received while participating in a clinical trial.

In addition, trials are overseen by an independent data and safety monitoring board as well as by any cooperative group study teams through which the trials are offered. Patient data — without individual identifiers — is reported and shared among the cooperative group members.

As part of the monitoring and data-sharing process, clinical researchers can identify any irregularities in symptoms. If a problem arises, the trial can be altered or stopped, and a patient may opt out at any time for any reason. Just like all medical treatments, cancer clinical trials are not risk-free. However, the safety of patients is of utmost importance to the clinical research team. There are several procedures in place as part of the protocols to protect the safety of the people who participate. Groups that oversee the safety procedures include:

The organization that sponsors the study (for example, the National Cancer Institute).
The Institutional Review Board (IRB) that oversees clinical research in the health care institution. The IRB includes physicians, other health care providers, consumers and sometimes members of the clergy, who do not have any personal interest in the results of the study. As neutral reviewers, they ensure that the study is conducted fairly and that participants are not likely to be harmed.
The Data Safety and Monitoring Committee, a committee that looks at the test results, monitors the safety of the participants and decides whether the study should go forward as originally planned.

Learn more about Massey’s Clinical Research Committees

Sugar pills (placebos) are seldom used in clinical trials, and are only considered if there are currently no standard treatments or if a new cancer prevention measure is being tested for people without cancer.

Patients in clinical trials always get the best treatment available. If a new drug is being tested as part of a trial, one group of patients might receive the current best standard treatment plus the new drug, while another group may receive the current best standard treatment plus a placebo. Either way, everyone is getting the best treatment available. Comparing the results of the two groups enables researchers to determine if the new drug is more effective than the current standard treatment.

It’s important for people of all races and backgrounds to join clinical trials because it helps researchers develop new treatments and interventions that work for everyone. Medical treatments, tests, and approaches work slightly differently in each person. If a new advance is only studied in one group of people, there is a risk that it won’t work as well in other groups of people.

You don’t need to be diagnosed with cancer to join a clinical trial. Several cancer prevention and control studies are available for people without cancer. Many participants in these trials are people who have a strong family health history of cancer and want to explore ways that may reduce their chances of developing cancer.

Learn About Clinical Trials

Understanding the Basics

Clinical Trials at Massey