Participating in research allows people to contribute to medical knowledge and offers the opportunity to receive cutting-edge care.
Read below for answers to frequently asked questions on research participation. Learn why participating in research is so important, how participants are protected from harm, and how new drugs and technologies are developed and tested.
Research saves lives. Every advancement made in treatment, prevention or care has come from research.
Everything we understand about cancer reflects the results of thousands of research studies that provide the answers we need to make informed medical decisions. Yet too many unanswered medical questions remain. We need more research to answer these questions and to develop new technologies that will improve the quality of life and survival of all people affected by hereditary cancer.
Physicians and scientists carefully design studies to uncover the benefits, limitations, and risks of different treatments, surveillance methods, and lifestyle choices. These studies represent a significant effort that depends not only on these experts, but also on the voluntary participation of patients. As more people participate in research, scientists and health care providers can develop new evidence-based guidelines to help people make health care decisions.
Critically important clinical trials could not be conducted without the commitment of FORCE to the development and completion of cancer prevention, detection, treatment and quality of life research.
Experts design and conduct many different types of medical research to answer different types of questions.
Clinical trials are designed to determine whether a new drug, laboratory test, or other intervention is effective, and how it compares to what is currently available. Examples of an intervention include:
Clinical trials measure different outcomes. Some determine whether or not an intervention helped patients to live longer, caused a tumor to shrink, or delayed the return of a disease. Other clinical trials look at whether the treatment lessened symptoms or improved the well-being of patients. Clinical trials may record objective outcomes, such as patient survival, tumor size or spread, or may involve more subjective “patient reported outcomes,” including degree of pain, fatigue, emotional, social, or sexual function; sleep disturbance; or general sense of well-being. Some clinical trials measure both types of outcomes.
In clinical trials designed to demonstrate whether or not an intervention is effective, participants are assigned to one of two groups:
Participants in a randomized control trial are randomly assigned to either the experimental or control group. The chance of being assigned to one or the other is the same.
In trials that test specific surgeries, lifestyle changes, or devices, patients and researchers typically know whether they are in the experimental group or the control group. Clinical trials that test drugs are often double-blind studies, where neither the participants or the researchers are aware of who is in which group, thereby eliminating the potential for bias on the part of researchers and participants.
Research surveys ask participants questions concerning their demographics, health, and lifestyle information. Surveys may ask participants about their current state of health, past experiences and decisions, personal preferences, and future plans. These “patient reported outcomes” help medical professionals to understand participants’ concerns regarding their health care needs; they also help people make informed health care decisions.
Patient registries are used to observe how an individual’s health changes over time. Registry participants complete questionnaires about their health history and lifestyle choices, and may also provide samples of their blood, saliva, or tissue. Patients enrolled in registries may be asked to update their history or provide more samples over time so that researchers can assess the outcome of their treatments and/or lifestyle choices. Some registries also allow researchers to contact and inform enrolled patients of new research opportunities.
Comparative effectiveness studies compare two known effective treatments to find out which works best for all patients or for a particular group of patients. This type of research is particularly important for people who face a variety of HBOC-related risk-management options. Comparative effectiveness research allows patients to better understand the risks and benefits of each medical option and decide which is best for them given their personal preferences, and their individual and family health history.
Participation in research sometimes carries risk; some studies carry very small risks, while other studies — particularly those involving new medications — may carry significant risks.
Researchers in the United States and most other developed countries must follow stringent guidelines to assure that all individuals are aware of the risks and their rights before they participate in research.
Study guidelines require that researchers provide an "informed consent form” for anyone who is interested in participating. This document explains key elements of the research to potential participants:
In the United States, an Institutional Review Board (IRB) must approve any study that is supported by federal research funds or is used to apply for drug approval to the FDA, before any patients are enrolled. The IRB includes physicians, researchers, and consumers who assure that:
All approved clinical research studies have plans for protecting the privacy of participants’ medical records and any information they provide, including their responses to study questionnaires.
Once a clinical trial begins, a data monitoring committee watches the results to further monitor patient safety and ensure no harm is done. Committee members may include physicians, scientists, ethicists, statistical experts, and in some cases, patient advocates. If one or more patients has a serious side effect, the data monitoring committee may decide to end the trial prematurely. The trial might also be ended early if the drug being tested is shown to be more beneficial than expected.
Researchers conduct clinical trials to test a new drug for treatment, relief of symptoms, or for prevention of disease.
The systematic process to assure that the drug is safe and effective usually involves three testing phases:
Drug trials often measure multiple outcomes. Even when the overall goal is to determine whether a drug leads to longer disease-free survival, a trial may measure other “early endpoints,” such as whether a tumor shrinks in response to a drug. Monitoring early endpoints helps researchers to design larger trials involving more patients.
Participants in trials involving drugs often question whether or not they will receive a placebo, an intervention whose appearance, administration and delivery schedule is the same as the medication, but lacks the drug’s active ingredient.
Trials may involve placebos in different ways:
For diseases where there is a well-established treatment, patients are often randomly assigned to one of two groups:
In studies involving diseases or conditions for which there is no known effective therapy, participants may be randomly assigned to the group that receives the drug being tested or to the group that receives the placebo.
Before a clinical trial begins, participants are advised when a placebo is involved, but they will not know whether they are included in the group that receives the placebo.
Every day, people facing HBOC search for answers to questions about their cancer risk, the measures they can take to manage that risk, and the potential consequences of different options. We need more research to answer these questions, but that research will not happen if families who face HBOC do not participate. You can help accelerate research by participating in clinical research studies.
At any given time many ongoing studies are recruiting participants. Each study has specific eligibility requirements. Some require healthy participants, while others require patients with specific health conditions or genetic mutations. Living near a major medical center is sometimes required, although some studies recruit patients from all areas of the country.
To find out which clinical studies you might be eligible to participate in, please see our Studies Enrolling Patients page.