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

To watch a video about what is clinical research, please visit this website:

https://www.youtube.com/watch?time_continue=2&v=kziQ2b8bgSU

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:

• Professional development: Be on the cutting edge of your therapeutic area of expertise, meet other investigators, exchange ideas, plan future collaborations, and work with investigational medications and processes that are not yet approved by the FDA.
• Professional recognition: Use your role as an investigator to co-author articles for publication and be recognized as a thought leader within the medical community.
• Personal satisfaction: Offer your patients new medical treatments that may only be available through participation in clinical trials
• New revenue stream: Add additional revenue to your medical practice, based on compensation provided by sponsors for your time spent conducting clinical trials.
• Role in the advancement of medicine: Be a leader in your field by potentially bringing breakthrough drugs and medical devices – products that could impact the health of people around the world – to market.

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:

• Does this trial fit my patient population?
• Is there an adequate patient population to meet enrollment goals?
• Do I have the necessary equipment to conduct this trial?
• Does my practice have the ability to store investigational products properly?
• Do I have adequate staff to perform the responsibilities of this trial?
• What would be the compensation to me for participating?
• Am I, along with my staff, committed to all that will be involved in this trial?

An investigator ensures that a study is conducted according to the:

• Protocol
• Signed statement of investigator (Form FDA 1572)
• Applicable regulations

An investigator is also responsible for:

• Protecting the rights, safety and welfare of all study participants
• Controlling and accounting for the drugs being studied/stored at the study site
• Obtaining the informed consent of each study participant

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:

https://www.nih.gov/health-information/nih-clinical-research-trials-you/need-awareness-clinical-research

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:

• Provide an empowering environment by inviting the prospective participant to select who will attend this discussion.
• Increase your prospective participant’s ability to focus on the discussion by holding the meeting in a private location without interruptions.
• Communicate respect and the importance of this meeting by acknowledging trauma of diagnosis (if appropriate) and empathizing with emotional reactions.
• Simplify information by avoiding medical jargon and a laundry list of medications and side effects. Summarize often, and repeat important points.
• Provide a pen and paper to take notes and write down questions, invite them to make comments or ask questions at any time, and encourage them to share their thoughts and feelings. Tell them that all questions are good questions.
• Stress the importance of information-seeking and elicit questions in an open-ended manner. (“What questions do you have?”)
• Avoid interrupting.
• Check that questions were answered to your patients’ satisfaction.
• Talk about how disease treatments have improved over time due to clinical research and participation of patients in clinical trials.
• Avoid pushing the recommendation of clinical trial, but if asked, respond accordingly.

To learn more, please visit this website:

https://www.nih.gov/health-information/nih-clinical-research-trials-you/talking-your-patient-about-clinical-trial

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
https://bioethics.nih.gov/education/FNIH_BioethicsBrochure_WEB.PDF

https://www.nih.gov/health-information/nih-clinical-research-trials-you/guidelines-communicating-informed-consent-individuals-who-are-deaf-or-hard-hearing-scientists

https://www.nih.gov/sites/default/files/health-info/clinical-trials/infographic-why-researchers-different-kinds-clinical-studies.pdf

https://www.nih.gov/sites/default/files/health-info/clinical-trials/infographic-why-researchers-different-kinds-clinical-studies-espanol.pdf