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AUSTIN, TEX. – The way , because not everyone is cut out for it.
“This is not something you take lightly,” Dr. Hebert, chief of pediatric dermatology at the University of Texas Health Science Center, Houston, said at the annual meeting of the Society for Pediatric Dermatology. “There will be days when you feel like you are going into combat. If you are not prepared for that, maybe stick to clinical practice. That plan might be a bit simpler.”
For more than 30 years, Dr. Hebert has been engaged in dermatology clinical research, with a focus on atopic dermatitis, psoriasis, and hyperhidrosis. Her team includes a full-time research fellow, a full-time nurse practitioner, and a part-time clinical trials coordinator. “We work very hard, and I am responsible for their salaries,” she said. “There is considerable pressure from year to year, but they work hard and are very loyal. They represent a great portion of the success that we have in clinical research. You need a team, and you have to be a team leader in order to undertake this.”
Dr. Hebert offered the following tips for incorporating clinical research into your practice:
• Set aside allocated time. “This is not a side job within your current occupation,” she emphasized. “You really need allocated time to do research, and you need protected academic time if you work in that environment. You also need protected academic time for your staff to conduct research.”
• Get to know the players involved. This includes forming professional relationships with internal and external review boards, and understanding contract and grants. “This collaboration is a lot like getting into a sport,” she explained. “You have to know the rules, you have to know how to play with strategy, and you have to be very effective.”
Review boards that work with academic centers include the Western Institutional Review Board (WIRB) and Advarra. “You also need to understand time lines, what it takes to go from submission to implementation,” Dr. Hebert said. “That time cannot be too long, or you will be off the list of desired investigators because you cannot get up and running in a timely fashion. Your team has to be behind you in order to make this happen.” [She recommended the National Association of Healthcare Revenue Integrity publication, “The Practical Guide to Clinical Trials Billing.”]
• Consider space and equipment needs. This includes space for patient charts, cameras, scales, electronic devices for data capture, computer equipment, and other instruments you may need to carry out your work. Dr. Hebert’s clinic houses about a half-dozen EKG machines dedicated to research projects. “You also need a lot of storage,” she added. “Our university requires us to save every piece of paper, every communication for 15 years. Our university does allocate that space.”
Sponsored research opportunities include working with the National Institutes of Health, Department of Defense, pharmaceutical companies, and over-the-counter product companies. “You can also initiate your own research,” she said. “One way to get started is to partner with an established researcher. That could be someone in your department, in a different department, or in a clinical research unit within your institution. They can help you with infrastructure and they can sometimes do your research submissions for you.”
Other ways to explore research opportunities include reaching out to medical science liaisons and clinical trial research organizations, and hiring fellows with research experience. “The bottom line is, talk to a lot of people you do not know,” Dr. Hebert said. “That is the real secret to getting research studies.”
There is another player in the field to become familiar with: contract research organizations (CROs), which provide support to pharmaceutical industries in the form of research services outsourced on a contract basis. They receive payment from the sponsor to conduct clinical research operations. “Many times the sponsor does not entirely know what the CRO is doing with regard to the interface with you as an investigator,” said Dr. Hebert, who has conducted more than 160 trials, including 65 in atopic dermatitis alone. “Sometimes you have to go over the head of the CRO to address issues that come up. The reality is, if the sponsor does not know you are not getting paid or having obstacles put in front of you that may not be in your contract, that constitutes a problem. You have to learn to be a bit shrewd in this game of research.”
She added that clinicians who choose to conduct clinical research come to learn “a whole new language,” such as what a confidential disclosure agreement is. “You also have to undergo CITI [Collaborative Institutional Training Initiative] training to meet the principles of good clinical practice,” she said. Other specifics include infectious substance shipping training per International Air Transport Association shipping guidelines, protocol training in arenas such as Eczema Area and Severity Index scoring and Psoriasis Area Severity Index scoring, and electronic case report form/electronic data–capture report training. “We also have a lot of equipment training because we are constantly getting new tablets for recording patient data and so forth,” she said. “This is something that has helped me become more technically equipped to handle all of this data capture.”
Dr. Hebert closed her remarks by noting that conducting clinical research can be a rewarding endeavor. “You really do address unmet needs, and you give a lot of education to residents, students, and fellows,” she said. “Clinical research provides research opportunities for those interested in dermatology. You have those moments when you see patients get better, and this represents the best patient encounter you could ever hope for.”
She reported having no relevant financial disclosures.
AUSTIN, TEX. – The way , because not everyone is cut out for it.
“This is not something you take lightly,” Dr. Hebert, chief of pediatric dermatology at the University of Texas Health Science Center, Houston, said at the annual meeting of the Society for Pediatric Dermatology. “There will be days when you feel like you are going into combat. If you are not prepared for that, maybe stick to clinical practice. That plan might be a bit simpler.”
For more than 30 years, Dr. Hebert has been engaged in dermatology clinical research, with a focus on atopic dermatitis, psoriasis, and hyperhidrosis. Her team includes a full-time research fellow, a full-time nurse practitioner, and a part-time clinical trials coordinator. “We work very hard, and I am responsible for their salaries,” she said. “There is considerable pressure from year to year, but they work hard and are very loyal. They represent a great portion of the success that we have in clinical research. You need a team, and you have to be a team leader in order to undertake this.”
Dr. Hebert offered the following tips for incorporating clinical research into your practice:
• Set aside allocated time. “This is not a side job within your current occupation,” she emphasized. “You really need allocated time to do research, and you need protected academic time if you work in that environment. You also need protected academic time for your staff to conduct research.”
• Get to know the players involved. This includes forming professional relationships with internal and external review boards, and understanding contract and grants. “This collaboration is a lot like getting into a sport,” she explained. “You have to know the rules, you have to know how to play with strategy, and you have to be very effective.”
Review boards that work with academic centers include the Western Institutional Review Board (WIRB) and Advarra. “You also need to understand time lines, what it takes to go from submission to implementation,” Dr. Hebert said. “That time cannot be too long, or you will be off the list of desired investigators because you cannot get up and running in a timely fashion. Your team has to be behind you in order to make this happen.” [She recommended the National Association of Healthcare Revenue Integrity publication, “The Practical Guide to Clinical Trials Billing.”]
• Consider space and equipment needs. This includes space for patient charts, cameras, scales, electronic devices for data capture, computer equipment, and other instruments you may need to carry out your work. Dr. Hebert’s clinic houses about a half-dozen EKG machines dedicated to research projects. “You also need a lot of storage,” she added. “Our university requires us to save every piece of paper, every communication for 15 years. Our university does allocate that space.”
Sponsored research opportunities include working with the National Institutes of Health, Department of Defense, pharmaceutical companies, and over-the-counter product companies. “You can also initiate your own research,” she said. “One way to get started is to partner with an established researcher. That could be someone in your department, in a different department, or in a clinical research unit within your institution. They can help you with infrastructure and they can sometimes do your research submissions for you.”
Other ways to explore research opportunities include reaching out to medical science liaisons and clinical trial research organizations, and hiring fellows with research experience. “The bottom line is, talk to a lot of people you do not know,” Dr. Hebert said. “That is the real secret to getting research studies.”
There is another player in the field to become familiar with: contract research organizations (CROs), which provide support to pharmaceutical industries in the form of research services outsourced on a contract basis. They receive payment from the sponsor to conduct clinical research operations. “Many times the sponsor does not entirely know what the CRO is doing with regard to the interface with you as an investigator,” said Dr. Hebert, who has conducted more than 160 trials, including 65 in atopic dermatitis alone. “Sometimes you have to go over the head of the CRO to address issues that come up. The reality is, if the sponsor does not know you are not getting paid or having obstacles put in front of you that may not be in your contract, that constitutes a problem. You have to learn to be a bit shrewd in this game of research.”
She added that clinicians who choose to conduct clinical research come to learn “a whole new language,” such as what a confidential disclosure agreement is. “You also have to undergo CITI [Collaborative Institutional Training Initiative] training to meet the principles of good clinical practice,” she said. Other specifics include infectious substance shipping training per International Air Transport Association shipping guidelines, protocol training in arenas such as Eczema Area and Severity Index scoring and Psoriasis Area Severity Index scoring, and electronic case report form/electronic data–capture report training. “We also have a lot of equipment training because we are constantly getting new tablets for recording patient data and so forth,” she said. “This is something that has helped me become more technically equipped to handle all of this data capture.”
Dr. Hebert closed her remarks by noting that conducting clinical research can be a rewarding endeavor. “You really do address unmet needs, and you give a lot of education to residents, students, and fellows,” she said. “Clinical research provides research opportunities for those interested in dermatology. You have those moments when you see patients get better, and this represents the best patient encounter you could ever hope for.”
She reported having no relevant financial disclosures.
AUSTIN, TEX. – The way , because not everyone is cut out for it.
“This is not something you take lightly,” Dr. Hebert, chief of pediatric dermatology at the University of Texas Health Science Center, Houston, said at the annual meeting of the Society for Pediatric Dermatology. “There will be days when you feel like you are going into combat. If you are not prepared for that, maybe stick to clinical practice. That plan might be a bit simpler.”
For more than 30 years, Dr. Hebert has been engaged in dermatology clinical research, with a focus on atopic dermatitis, psoriasis, and hyperhidrosis. Her team includes a full-time research fellow, a full-time nurse practitioner, and a part-time clinical trials coordinator. “We work very hard, and I am responsible for their salaries,” she said. “There is considerable pressure from year to year, but they work hard and are very loyal. They represent a great portion of the success that we have in clinical research. You need a team, and you have to be a team leader in order to undertake this.”
Dr. Hebert offered the following tips for incorporating clinical research into your practice:
• Set aside allocated time. “This is not a side job within your current occupation,” she emphasized. “You really need allocated time to do research, and you need protected academic time if you work in that environment. You also need protected academic time for your staff to conduct research.”
• Get to know the players involved. This includes forming professional relationships with internal and external review boards, and understanding contract and grants. “This collaboration is a lot like getting into a sport,” she explained. “You have to know the rules, you have to know how to play with strategy, and you have to be very effective.”
Review boards that work with academic centers include the Western Institutional Review Board (WIRB) and Advarra. “You also need to understand time lines, what it takes to go from submission to implementation,” Dr. Hebert said. “That time cannot be too long, or you will be off the list of desired investigators because you cannot get up and running in a timely fashion. Your team has to be behind you in order to make this happen.” [She recommended the National Association of Healthcare Revenue Integrity publication, “The Practical Guide to Clinical Trials Billing.”]
• Consider space and equipment needs. This includes space for patient charts, cameras, scales, electronic devices for data capture, computer equipment, and other instruments you may need to carry out your work. Dr. Hebert’s clinic houses about a half-dozen EKG machines dedicated to research projects. “You also need a lot of storage,” she added. “Our university requires us to save every piece of paper, every communication for 15 years. Our university does allocate that space.”
Sponsored research opportunities include working with the National Institutes of Health, Department of Defense, pharmaceutical companies, and over-the-counter product companies. “You can also initiate your own research,” she said. “One way to get started is to partner with an established researcher. That could be someone in your department, in a different department, or in a clinical research unit within your institution. They can help you with infrastructure and they can sometimes do your research submissions for you.”
Other ways to explore research opportunities include reaching out to medical science liaisons and clinical trial research organizations, and hiring fellows with research experience. “The bottom line is, talk to a lot of people you do not know,” Dr. Hebert said. “That is the real secret to getting research studies.”
There is another player in the field to become familiar with: contract research organizations (CROs), which provide support to pharmaceutical industries in the form of research services outsourced on a contract basis. They receive payment from the sponsor to conduct clinical research operations. “Many times the sponsor does not entirely know what the CRO is doing with regard to the interface with you as an investigator,” said Dr. Hebert, who has conducted more than 160 trials, including 65 in atopic dermatitis alone. “Sometimes you have to go over the head of the CRO to address issues that come up. The reality is, if the sponsor does not know you are not getting paid or having obstacles put in front of you that may not be in your contract, that constitutes a problem. You have to learn to be a bit shrewd in this game of research.”
She added that clinicians who choose to conduct clinical research come to learn “a whole new language,” such as what a confidential disclosure agreement is. “You also have to undergo CITI [Collaborative Institutional Training Initiative] training to meet the principles of good clinical practice,” she said. Other specifics include infectious substance shipping training per International Air Transport Association shipping guidelines, protocol training in arenas such as Eczema Area and Severity Index scoring and Psoriasis Area Severity Index scoring, and electronic case report form/electronic data–capture report training. “We also have a lot of equipment training because we are constantly getting new tablets for recording patient data and so forth,” she said. “This is something that has helped me become more technically equipped to handle all of this data capture.”
Dr. Hebert closed her remarks by noting that conducting clinical research can be a rewarding endeavor. “You really do address unmet needs, and you give a lot of education to residents, students, and fellows,” she said. “Clinical research provides research opportunities for those interested in dermatology. You have those moments when you see patients get better, and this represents the best patient encounter you could ever hope for.”
She reported having no relevant financial disclosures.
EXPERT ANALYSIS FROM SPD 2019