What is a Clinical trial?
In a clinical trial, patients receive specific interventions, according to a plan or “protocol” developed by researchers. Said interventions may be medical products, like drugs or devices; procedures; or even changes to participant behavior. Clinical trials can compare a new medical approach to either an existing conventional approach or to a placebo, while other clinical trials compare existing interventions to one another. 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. That said, the goal of clinical trials is to determine the safety and efficacy of the intervention by measuring participant outcomes.
What is a Protocol?
Simply put, a protocol is a study plan on which a clinical trial is based. The protocol is designed namely to safeguard the health of the participants, as well as to help investigators answer specific research questions. A protocol describes who may participate in a specific research trial; the schedule of tests, procedures, medications, and dosages; and the study duration. Participants following a protocol are seen regularly by research staff, both to monitor their health and to determine the safety and effectiveness of their treatment.
What is a Phase I trial?
A phase I trial is often the first time a drug or treatment has been tested on humans. Researchers rely on a small group of subjects to evaluate dose scheduling, toxicity, safety, and feasibility of a treatment, all while monitoring for side effects.
What is a Phase II trial?
In a phase II trial, the drug or treatment is given to a larger group (typically 100-200 participants), and researchers evaluate safety and assess therapeutic effectiveness.
What is a Phase III trial?
Researchers test thousands of participants in phase III trials in order to further establish drug or treatment effectiveness and, most notably, to compare said effectiveness to that of existing standards of treatment.
What is a Phase IV trial?
These large trials occur after the drug has FDA approval and has hit the market, in order to gain a deeper understanding of the long-term effects of said drug.
What are Expanded Access (Compassionate Use)/Single Patient Investigational New Drug (IND) Trials?
These are trials that use an investigational medical product (i.e., one that has not been fully approved by FDA) outside of a clinical trial. However, the process of obtaining an Investigational New Drug for use in this type of trial is intensive and requires approval from both the FDA and an IRB. In some cases, the drug may be supplied by an industry sponsor at no cost to the patient.
What is a Placebo?
A placebo is an inactive, harmless drug or treatment, one designed to resemble the drug or treatment being tested.
What Does Placebo-Controlled Mean?
These are trials that compare a new drug or treatment to a placebo.
What does randomized mean?
This means that patients are randomly assigned to one treatment or another.
What does double-blinded mean?
This means that both study patients and investigators are not aware of which treatment is being given to any one individual until after the study is completed.
Why do cancer patients participate in clinical trials?
Patients often participate in clinical trials because they are looking for alternative cures to their cancer, or simply to help them live longer. There is no guarantee, however, that an experimental treatment will be effective (especially in phase I trials), but patients also participate knowing that involvement in clinical trials is enormously beneficial to help future generations with cancer.
Who are the medical professionals involved in clinical trials?
A clinical trial is carried out by a multidisciplinary research team composed of:
- A Principal Investigator—a professional responsible for the study’s scientific integrity.
- Physicians who are cancer specialists (oncologists) and research nurses who manage the day-to-day elements of the study.
- A team of laboratory researchers and scientists are often involved behind the scenes, analyzing data obtained during the study.
What are NCI Community Oncology Research Program (NCORP) trials?
NCORP trials bring cancer clinical research and cancer care delivery research directly to individuals in their own communities, so that patients aren’t uprooted and can still be part of cutting-edge trials.
Do I receive Compensation?
The consent form for each study should tell you specifically what the financial costs are. 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?
These trials are run in conjunction with industry sponsors in order to make effective investigational drugs available to patients before they’ve been approved by the FDA.
What is an Institutional Review Board (IRB)?
IRBs are review boards that safeguard the rights and welfare of human subjects. They’re involved with the reviewing and approving the proposed research activity, ensuring the proposed informed consent process meets all requirements, and providing continued oversight for ongoing research studies.
What is Informed Consent?
Once a prospective research participant (or their legally authorized representative) fully comprehends and considers all information pertinent to the decision to participate in a study, they are tasked with signing a legally effective, voluntary agreement articulating both their comprehension and consent.
What is Coercion?
Coercion refers to influencing an individual’s decisions by use of explicit or implied threats. Potential research subjects must be informed that their willingness to participate will not influence their medical care or result in a loss of benefits.
What is Diminished Autonomy?
An individual has diminished autonomy if they are unable to make their own decisions or act in their own interests. For example, an unconscious patient or an incarcerated individual has diminished autonomy.
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
What is a Legally Authorized Representative?
An individual, judicial or other body authorized to provide consent on behalf of a prospective subject.
What does Minimal Risk mean?
Minimal risk in a clinical trial refers to reducing the probability and magnitude of harm or discomfort anticipated in the research, namely so that the patient is not in greater risk in the study than they would be going about their daily life or engaging in standard medical examinations or tests.