Frequently Asked Questions

Frequently asked questions about clinical trials

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What is Clinical Research?
Clinical research is medical research that involves people like you. People volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose, and understand human disease. Clinical research includes trials that test new treatments and therapies, which provide valuable information about how disease and health progress.

How Volunteers are protected?

  • To protect the rights and welfare of clinical research participants, U.S. Federal Agencies including the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) oversee much of the medical research in the U.S.
  • Institutional Review Boards (IRBs) oversee the centers where clinical research studies are conducted. IRBs review and approve study protocols to ensure that a clinical trial is ethical and that volunteers’ rights are protected.
  • A participant in a clinical trial has access to the IRB that is overseeing the research and access to a volunteer advocate, the physician, and staff conducting the trial.
  • Federal agencies inspect individuals and institutions conducting research. They also inspect IRBs.

How does Clinical Research make a difference?
Only through clinical research can we gain insights and answers about the safety and effectiveness of drugs and therapies. Groundbreaking scientific advantages in the present and the past were possible only because of participation of volunteers, both healthy and those diagnosed with an illness, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease. As clinical research opens new doors to finding ways to diagnose, prevent, treat and cure disease and disability, clinical trial participation of volunteers is essential to help us find the answers.

What Questions should I ask if offered a Clinical Trial?
If you are offered a clinical trial, feel free to ask any questions or bring up any issues concerning the trial at any time.

  • What is the purpose of the study?
  • Who will fund the study?
  • Who has reviewed and approved the study?
  • How long will the study last?
  • What will be my responsibilities be if I participate?
  • What are my possible short-term and long-term benefits?
  • What are my short-term risks, such as side effects?
  • What are my possible long-term risks?
  • How could being in this study affect my daily life?

What are Clinical Trials?

  • A research study involving human volunteers to answer specific health questions.
  • Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and new ways to improve health.
  • Clinical trials are conducted according to a plan called a protocol.
  • A protocol describes what types of patients may enter the study, the outcomes that will be measured, the length of study, the schedules of the tests and procedures as well as the drugs used and the dosages.
  • Each person participating in the study must agree to follow the protocol.

SOURCE clinicaltrials.gov