Clinical research aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples.
A clinical trial involves research participants. It follows a pre-defined plan or protocol to evaluate the effects of a medical or behavioral intervention on health outcomes. By taking part in clinical trials, participants not only play a more active role in their own health care, but they also can access experimental treatments and help others by contributing to medical research. To learn more about what is clinical research, please visit this website: https://www.nichd.nih.gov/health/clinical-research
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Clinical trial investigators play an integral role in the development of new medicines and medical devices used to help combat disease, treat chronic and degenerative diseases, and improve the health of people worldwide. There is a continual need for physicians in private practice to join in the pursuit of advancing medicine as clinical trial investigators. Advantages of conducting clinical trials include:
You must have a basic understanding of good clinical practice (GCP) before you can participate as a clinical trial investigator. GCP refers to the principles and processes investigators worldwide are expected to follow. Good clinical practices are in place to ensure the safety and privacy of study participants. You will also need a thorough understanding of the principles of conducting clinical trials as well as the ethical and regulatory requirements.
The most important factor in determining if you are a good fit for overseeing clinical trials is a thorough understanding of the commitment needed to conduct a clinical trial. Many physicians find that being an investigator can be a challenging, but rewarding, experience. When considering a specific trial, you may want to ask yourself:
An investigator ensures that a study is conducted according to the:
An investigator is also responsible for:
Clinical research should be seen as the social good that it is. The first step in tackling this challenge is regularly getting the public to think about participating in clinical research. People need to consider how they can help advance the prevention, diagnosis, and treatment of disease. It is never too early to consider participation whether or not someone ultimately chooses to join a study. To learn more, please go to this website:
Clinical trials are essential for identifying and characterizing interventions to prevent, diagnose, and treat disease. Educational efforts aimed at the public and health care providers raise awareness of the concept of clinical research and the important role it plays in improving health and quality of life. Prior knowledge of clinical research helps patients consider a clinical trial as an option at the time treatment decisions are being made. Poor accrual rates to clinical trials can be addressed through increased awareness of the benefits of clinical research. To learn more, please visit this website: https://www.nih.gov/health-information/nih-clinical-research-trials-you/opportunities-education-awareness
Talking with prospective participants about enrollment in a clinical trial is not always easy and there are few evidence-based strategies to help us.
When speaking with potential participants, consider the following:
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The goal of clinical research is to develop generalizable knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible to secure that knowledge. The path to finding out if a new drug or treatment is safe or effective, for example, is to test it on patient volunteers. But by placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science.
To learn more, please visit this website: https://clinicalcenter.nih.gov/recruit/ethics.html