Faith Holmes, MD

Offering clinical research as a care option to your patients is a huge step in your practice’s journey. And, as you get started, it might seem difficult to navigate the conversation. Here are a few tips on how to seamlessly fit that discussion into your current approach of treatment options with your patients. 

Make it part of your normal treatment option conversation


	As a physician, it can be easy to forget to offer research as a care option. It’s not that you’ve dismissed it as a viable option, but when you are following your typical process for a clinical encounter with a patient-where research hasn’t always been a focus-you may overlook it. But, because you discuss treatment options with your patients every day, you have a great opportunity to make that conversation part of your routine. 
	
	As physicians, it is our job to stay informed of changing medical guidelines and best practices. It’s also our job to keep a pulse on the ongoing studies that we decide to participate in. Your role as principal investigator is to review protocols and medical records to determine which patients fit the study criteria, then begin a dialogue about research as care with those who are a good match.
	 

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	With so much information available online, some patients will have done their own research on available studies and treatment options before meeting with you. Preparing ahead of time for this conversation will help you manage their questions. Your patients trust you to be aware of the treatment options available to them; doing so starts with a thorough understanding of the clinical studies currently available at your practice. Read and understand the study design, investigational product, and potential benefits and risks. Be prepared to address your patients’ questions and hesitations regarding participation. Common topics include the necessary time commitment, study safety, and compensation. 
	 


	Clinical research offers patients access to novel medications and treatments, giving them hope when nothing else has worked. When you find a study that looks promising for one of your patients, it’s okay to be excited about it and to relay your enthusiasm, but it’s also important to ensure you are telling the full story.

Discuss the opportunity with your patient, including its potential to give access to a new treatment while conveniently remaining under your care. Explain that the care would not be billed to insurance or subject to copays or deductibles and that it could likely require additional visits to your practice so that his or her health can be monitored regularly throughout the duration of the study. 
	
	The informed consent process for anyone enrolling in a study starts with the first conversation you ever have. Use the Institutional Review Board-approved materials for the study to support your discussions with your patient. Share the benefits, including the additional care and possible patient stipends, but also be upfront about the risks. Explain clearly that there are no guarantees that there will be a change in his or her condition as a result of the study drug or procedure. And don’t forget to have the other hard conversations: For example, discuss whether the research involves a placebo, and be sure to explain the kinds of procedures and number of visits involved.

When your conversation comes to an end, your patient should understand the commitment required (time, travel, reporting requirements, etc.) as well as all the potential benefits and risks. 


	For many of your patients, the study opportunity you are proposing will be their first exposure to clinical research. As you know, learning about the clinical research process and agreeing to participate in a study can be overwhelming, so, navigating your conversation with care is key to your success. 

Rely on the trusted relationship you have developed with your patient. Watch for verbal and nonverbal cues to gauge the level of interest. If you see hesitation, step back and give your patient an opportunity to think it over and ask questions. It’s important not to force any patient to decide quickly, even if it means a missed window of opportunity to participate. Consider sending your patient home with an IRB-approved handout with information on the study you have just explained. 

Remember, you are a partner in your patients’ healthcare journey. Your existing relationship will give them the comfort and trust necessary to carefully consider clinical research as part of their treatment.

Partner with a healthcare-enabling research partner

An expert clinical research partner can ensure you have strong support on your journey. Connect a study manager or coordinator to your patients early so they too can start building a trusted relationship with the patient. Your research team is your resource, and their job is to help you be successful in identifying and navigating patients through the course of the study. 

Faith Holmes, M.D., brings more than 30 years of experience in direct patient care, and 11 years of medical practice management to her role as Elligo’s medical director. Her unique perspective plays an important part in building the company’s network of Research Ready physician practices and preparing them to conduct research. Holmes’ experience in family medicine and hospice and palliative medicine that spans solo practice and single specialty and multispecialty group practices - allows her to build rapport with study managers, site staff, and investigators, and provide medical and scientific knowledge to support future growth.

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How you can fit the discussion into your current treatment approach.

Author | Faith Holmes, MD

Articles

Navigating the clinical research treatment conversation