About
Clinical
Studies

Clinical Studies are Important to Improve Treatment Options

Modern medicines have changed the lives of millions of people. However, those life-changing benefits can only happen after extensive research. Every breakthrough in medicine, before it is approved for use, must be tested in clinical studies to prove that the medicine is safe and effective in treating a disease or condition.

Clinical trial volunteers are critical to making potential new cures a reality. We need volunteers to help stop sickle cell disease!

Learn more about the MOMENTUM study for sickle cell disease.

About
Clinical
Studies

Why take part in a clinical study?

  • Development of new treatments to improve the lives of patients depends upon patient participation in clinical studies.
  • Individuals participating in a clinical study gain access to a new therapy before it is broadly available to the public.
  • Clinical studies may not just help the study participant but also other patients with the condition, and in the case of a genetic disease like sickle cell disease, this includes potentially helping family members.
  • Eligible clinical trial participants receive care at no cost, including reimbursement for travel and study-related expenses.
  • There are risks in taking part in any study.

There are risks in taking part of any study. All patients enrolling in trials must have a full discussion with their physician of the potential benefits and risks of participating in a trial.

To Join a Study

Anyone interested in joining a study will need to answer some questions to find out if the study is right for them. These screening questions help researchers figure out if the person who is interested in taking part in the study meets a few basic requirements.

About
Clinical
Studies

Why take part in a clinical study?

  • Development of new treatments to improve the lives of patients depends upon patient participation in clinical studies.
  • Patients gain access to an investigational product before it is broadly available to the public.
  • Clinical studies may not just help the study participant but also other patients with the condition, and in the case of a genetic disease like sickle cell disease, this includes potentially helping family members.
  • Eligible clinical trial participants receive care at no cost, including reimbursement for travel and study-related expenses.

There are risks in taking part in any study. All patients enrolling in trials must have a full discussion with their physician of the potential benefits and risks of participating in a trial.

To Join a Study

Anyone interested in joining a study will need to answer some questions to find out if the study is right for them. These screening questions help researchers figure out if the person who is interested in taking part in the study meets a few basic requirements.

About
Clinical
Studies

Study Participants are Protected in Several Ways

  • In response to a history of devastating ethical abuses in past clinical trials, in 1974, the U.S. government adopted a law which requires every clinical study of human patients to be reviewed by an Institutional Review Board (IRB).
  • The IRB includes medical and scientific experts and members of the community who represent research subjects.
  • Researchers follow strict rules to protect the health, safety and privacy of participants.
  • The first time a new, experimental treatment is used in humans, the safety of the treatment is reviewed immediately after each participant gets the therapy by an independent safety committee.
  • Joining a clinical study is voluntary.
  • Every participant may join a study only after they discuss with their physician the risks and benefits of participating in the study.
  • Participants who enroll can leave at ANY time and for ANY reason.

About
Clinical
Studies

Ethical Principles of IRBs

  • IRB review ensures research is conducted in an ethical manner, protecting the rights and welfare of the human subjects.
  • The basic ethical principles used by IRBs to review research are:
    • Respect for persons.
    • Individuals should be treated as free thinking people and are capable of making their own informed decisions.
    • Persons with reduced free-thinking abilities are entitled to protection.
  • Beneficence
    • Do not harm.
    • Make the most of benefits while reducing risks.
  • Justice
    • No one group is singled out either to exclude them with no cause from research, or to include them because they are more accessible than other populations.