Clinical Trials

Clinical trials affect the future of standard care

A clinical trial is a research study that evaluates new approaches in preventing, diagnosing, and treating diseases. This is not theoretical research. Clinical trials are real-world applications of scientific research that require patient participation. They are one stage of a long and careful research process to determine whether a new approach in disease prevention or treatment could be more effective than current standard procedures.

Henry Ford currently is participating in more than 1,300 clinical trials. You can visit our clinical trials office, search all of our research studies or call us for more information at (313) 916-1784.

Clinical trial safety

The safety of patients in clinical trials is our utmost priority. New therapies are carefully studied in a laboratory to determine the safest and most effective ways to use them before we give them to patients. The Institutional Review Board (IRB) -- a government-mandated body that consists of doctors from different specialties, ethicists, administrators, and members of the public -- must approve any clinical trial involving people before it begins. The IRB protects the rights and welfare of patients enrolled in clinical trials and is authorized to review, approve, disapprove, or require changes to these studies.

Clinical trials are voluntary for patients. Before enrolling, patients are guided through the informed consent process to learn about the trial’s treatments, tests, possible benefits, and risks.

Eligibility and qualification for clinical trials

Each clinical trial has its own guidelines for who can participate. These guidelines are in place to ensure the safety of trial participants and make sure the data we collect can be used to evaluate the trial’s effectiveness. Because demographical differences in the trial can potentially cause variance in its outcomes, enrolling similar patients in clinical trials allows researchers to gather more accurate, meaningful data.

Generally, participants are alike in several ways, such as:

  • Age
  • Disease type
  • Gender
  • Medical history
  • Overall health

Who pays for clinical trials?

Although most health plans and managed care providers will cover standard testing in a clinical trial, they don’t always cover all patient care costs in a study. What they cover varies by plan and by study. Patients should ask a doctor, nurse, or social worker to determine in advance what costs are covered. The study sponsor may cover some costs, such as the costs of the research, study drug or extra procedures, certain tests, and doctor’s appointments.

Clinical trial phases

Clinical research to test a new drug or procedure progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions about the drug and protect the enrolled patients. Clinical trials usually are broken down into four phases:

  • Phase I
    This phase is used to evaluate how people should receive a new treatment (for example, surgically, by mouth, or injected into the blood), how often they should receive it, and what doses are safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
  • Phase II
    A phase II trial continues to test the safety of the drug or procedure and begins to evaluate how well it works. Phase II studies usually focus on a particular disease.
  • Phase III
    These studies test the new drug, combination of drugs, or procedure in comparison to the current standard. Many phase III trials are randomized -- meaning the participant will be randomly assigned to either the current (control) treatment group or the study drug treatment group. Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices and clinics nationwide.
  • Phase IV
    Phase IV trials also are known as Post Marketing Surveillance Trials. They involve the safety surveillance and ongoing technical support of a drug or procedure after it is approved to be marketed. The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than is possible during Phase I-III clinical trials.