FAQ - For Trial Patients

  • Why do cancer patients participate in clinical trials and why is it beneficial? Patients may participate in clinical trials because they are looking for alternatives to help cure their cancer or to help them live longer. There is no guarantee, however, that an experimental treatment will be effective, particularly in phase I trials.
  • Who are the medical professionals involved in clinical trials? A clinical trial is carried out by a multidisciplinary research team composed of basic science researchers and clinicians.

    • The Principal Investigator is the professional who is responsible for the scientific integrity of the study.

    • In clinical trials of new cancer therapies, physicians who are cancer specialists (oncologists) and research nurses manage the clinical elements of the study. This might include counseling and examining patients, giving medication, or performing procedures depending on the study and its structure.

    • A team of laboratory researchers and scientists may also be involved behind the scenes analyzing material and information obtained during the study.

  • What are NCI Community Oncology Research Program (NCORP) trials? A program whose overall goal is to bring cancer clinical trials, as well as cancer care delivery research, to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes and a reduction in cancer disparities.

  • Do I receive Compensation? The consent form for each study should tell you specifically what the financial costs are for each study. In most cases there is no cost for anything directly related to the study. Procedures that you would have if you were not in the trial are usually billed to you or your insurance company.

  • What are Expanded access / Compassionate use trials? Trials done in conjunction with industry sponsors in an effort to make effective investigational agents available to patients on a compassionate use basis before approved by the FDA and become widely available

  • What is an Institutional Review Board (IRB)? They are specialized review boards that safeguard the rights and welfare of human subjects. IRBs determine “the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.” Major roles include; initial review and approval or disapproval of the proposed research activity, ensuring proposed informed consent process meets all requirements and provide continuing oversight for progress reports and protocols for ongoing research studies.

  • What is Coercion? Influencing an individual’s decisions about whether or not to do something by using explicit or implied threats (loss of good standing in a job, poor grades, etc.) Potential research subjects must be informed that their willingness to participate will not influence their medical care or result in a loss of benefits which they are otherwise entitled.

  • What is Diminished Autonomy? An individual with restricted capability of deliberation about personal goals and or limited ability to act under the direction of their deliberations.

  • What is HIPAA? It stands for Health Insurance Portability and Accountability Act

  • What is Informed consent? It is a legally effective, voluntary agreement given to a prospective research participant or a legally authorized representative of the participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study.

  • What is a Legally Authorized Representative? An individual, judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

  • What does Minimal Risk mean? Is the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.