Cover Story

Clinical trial participation keeps surgeons on cutting edge of technology

Hosting clinical trials has benefits, such as allowing physicians to offer cutting-edge technologies and therapies to their patients and increasing practice marketing opportunities and revenue, but the amount of time and manpower involved, as well as the arduous process of achieving all necessary certifications, can be underestimated.

Participating in clinical trials can give a practice a unique dynamic it otherwise would not have the opportunity to enjoy, OSN Refractive Surgery Board Member Vance M. Thompson, MD, said.

Thompson’s practice, Vance Thompson Vision, has a separate research team with 10 full-time employees dedicated to clinical research.

Arshad M. Khanani, MD, MA
A practice usually needs to be established for several years before having the necessary patient numbers to successfully host clinical trials, according to Arshad M. Khanani, MD, MA.

Source: Arshad M. Khanani, MD, MA

“It brings a neat dynamic to practice as far as the excitement of helping to innovate the future and trying to figure out the technology and drugs of the future for your patients,” Thompson said.

By participating in clinical trials, physicians can research specific areas to benefit their patients, but there are no guarantees of outcomes, Thompson said.

According to ClinicalTrials.gov, every clinical study is led by a principal investigator, often a medical doctor, and conducted by research teams consisting of physicians, nurses and other health care professionals. The studies are typically sponsored or funded by pharmaceutical companies, voluntary groups, academic medical centers or other organizations. Federal agencies such as the U.S. Department of Defense or the National Institutes of Health also sponsor clinical research.

Access to new technologies

Sierra Eye Associates, the practice of Healio/OSN Board Member Arshad M. Khanani, MD, MA, has been hosting clinical trials for the past 7 years.

“I participate in clinical research due to my passion for advancing science and to offer patients cutting-edge treatment options. A common misconception is that clinical trials are an easy way to benefit financially, but there is a lot of work and dedication involved. This work is in addition to the current day-to-day clinic obligations. A lot of time and commitment is required to recruit patients for research, managing the clinical trials department, signing off on lab and safety reports, and other tasks,” he said.

If building a revenue base is the main goal for entering clinical research, physicians may find it is easier to increase their number of surgeries or see more patients rather than engage in clinical studies, OSN Cornea/External Disease Board Member Francis W. Price Jr., MD, said.

Price’s practice, Price Vision Group, has a separate research foundation, the Cornea Research Foundation of America, and participates in about 12 clinical trials a year.

Francis W. Price Jr., MD
Francis W. Price Jr.

These trials require intensive work with extreme dedication to organization and proper documentation to be successful. Often, clinics barely make a profit by hosting trials after the necessary manhours and resources are accounted for, he said.

However, if a product or therapy from a study is approved and becomes a popular treatment, the marketing opportunities for a practice that hosted the successful study can be a big benefit, Price said.

Price Vision Group is one of several clinics participating in STAAR Surgical’s multicenter investigational study of the EVO/EVO+ Visian ICL. The first patient in the study was enrolled at Price Vision Group.

“That’s a great marketing opportunity for us. We’re able to do some really cool things for our patients with the EVO lens. That’s very exciting. It’s been proven around the world, so we have a great shot of that working in this country,” Price said.

Adding workload to a clinic

Clinical trials add chair time for employees outside of normal day-to-day business. Participation requires extra time and effort from physicians, staff and technicians for a treatment or device that may not provide efficacious outcomes after years of testing, Price said.

“You can’t hurry these things when you’re trying to help define the future of a treatment or technology. It needs to be proven safe and efficacious, and for the FDA to do that, you have to put in the time and do it right,” he said.

Not all new developments and clinical trials lead to success. Physicians need to be ready for the mental aspect of enrolling participants into a trial along with the possibility of the product or drug not working as well as expected, OSN Refractive Surgery Editor Emeritus Daniel S. Durrie, MD, of Durrie Vision, said.

Durrie Vision has a separate research group, Durrie Vision Research, which has hosted clinical trials for more than two decades.

“Maybe the market moved on, and then you have a group of patients who have a product that is in their eye, and it doesn’t have a great reputation. What then? All of this needs to be thought of ahead of time before you agree to do any clinical research,” he said.

Hosting clinical trials takes focus, dedication and a high attention to detail, but for physicians who want to make a difference in the field or stay on the cutting edge of technology and innovation, it can be rewarding, OSN Technology Section Editor William B. Trattler, MD, of the Center for Excellence in Eye Care, said.

The Center for Excellence in Eye Care participates in about two to four clinical trials each year, Trattler said.

Applying for trials

William B. Trattler, MD
William B. Trattler

The most important factor when beginning to apply for clinical trials is to have a large patient base in the area that will be studied to ensure trial enrollment is successful, Trattler said.

“Participation in a clinical trial requires that you enroll patients that fit into the study inclusion and exclusion criteria. If you do not have patients that meet the criteria, you will not be able to enroll patients. It is important to understand the study protocols and understand who good candidates are for the study. If you are able to identify candidates that meet the criteria for the study, you can begin recruitment,” he said.

Not having a robust patient base is a common mistake for a physician to make when entering the clinical research field. A practice usually needs to be established for several years before having the necessary numbers to successfully host clinical trials, Khanani said.

Sierra Eye Associates had to build its referral base and patient pool for 3 years before it was attractive to companies to host clinical research, he said.

“If you don’t have a busy clinic, you’re not going to be able to run these trials because companies are looking for very specific populations of patients. You need the numbers,” Khanani said.

Importance of research coordinators

When the numbers and referrals are solid, clinics should hire or appoint a trusted, organized employee to serve as a research coordinator. Research coordinators deal with regulatory and protocol-specific paperwork involved with hosting clinical trials, Khanani said.

A research coordinator will handle the management and documentation of the trial, including submitting institutional review board applications and FDA investigator forms and procuring curricula vitae for the principal investigator and subinvestigators, he said.

“The first step is to have a great coordinator. You can train your own from your clinic or hire someone with experience. Because they’re so in demand, I’ve trained all my coordinators internally. Look for someone who is organized, maybe a certified technician, someone who is meticulous about paperwork,” he said.

Daniel S. Durrie, MD
Daniel S. Durrie

Khanani said he interviews coordinator candidates within his clinic, gauges their experience and interest, and makes his decision. Each research coordinator is then instructed to attend a specialized course to learn how the FDA works, how to host clinical trials, how to complete the necessary paperwork and how to apply for clinical trials. This ensures the clinic has a qualified person to organize and help run the research trials.

The research coordinator ensures each team member has appropriate certification, keeps track of investigational products, schedules protocol training and monitors visits with the trial sponsor.

When the necessary paperwork has been filed, practices need to be sure they are equipped to handle a clinical trial. They need laboratory certification from their state to draw blood during the trials, proper site operating procedure certification and certified visual acuity examiners and photographers on staff, Khanani said.

A practice may need dedicated 20-foot research lanes at its facilities and a dedicated secure room for research equipment. Many studies require a full 20-foot lane to evaluate vision, which many clinics have shortened to make their facility more space efficient, Thompson said.

“Some studies will allow for these shortened lanes, but many really want the full 20-foot lanes. Many facilities don’t have these,” he said.

Having dedicated space to store study documents and paperwork, with additional fire protection, is also a requirement. It is the clinic’s responsibility to properly store all of these documents for a predefined amount of time. This is necessary in case the FDA decides to audit the facility or the clinical trial, Thompson said.

These are all added expenses, not even counting the potential of bringing in personnel to handle the additional day-to-day work involved with the trial. Practices also may need to invest in equipment necessary for certain types of trials, which can include a freezer, a centrifuge, an electrocardiogram machine, a locked refrigerator with an alarmed thermometer, a certified procedure room for blood draws and other pieces of equipment, Khanani said.

Breaking into clinical trials

Procuring a trial can be more difficult than initially thought. If owners do not know how to apply for trials or apply for ones that may not be a good fit for the practice, it will not matter if they have the necessary equipment, certifications or a large patient pool, Durrie said.

Companies tend to trust their trials to practices and physicians they have worked with before and have given them good compliance with the study protocol. Practice owners with no experience in hosting trials need to directly approach companies and pitch their services, he said.

“We’ve done a couple hundred clinical trials at Durrie Vision; companies know we can do this well. If you’re new to clinical research, you need to get some training. You need to participate in other trials, and you have to justify your worth,” Durrie said.

Owners should keep an eye out for potential well-fitting studies on websites such as ClinicalTrials.gov, but they should also take the extra step of applying to or reaching out directly to a company sponsoring a trial.

An established practice with a history of successful clinical research will have one to two studies pitched to them a month, but practices just starting out will receive fewer opportunities, Trattler said.

“If your center enrolls well, follows the protocol and focuses on the completeness of the paperwork, the word will get out, and companies will be knocking on your door. Take advantage of any relationships you may have with companies big and small to possibly be included in future trials,” he said.

Vance M. Thompson
Vance M. Thompson

Selecting the ideal trial

According to the FDA, practices should be prepared for a pre-study visit by a clinical research associate as part of the qualification process. The clinical research associate will evaluate the facility itself, the proper certification of its employees and the potential of its population available for the trial.

Practice owners need to carefully evaluate trials before applying to host. When first starting out, it may be easier to take on a post-approval phase 4 study, which tends to be less rigorous. Practices also have an easier time completing phase 4 studies without hiring new personnel to complete the research, Price said.

Phase 4 trials typically are post-FDA approval marketing studies conducted to provide additional information about possible drug or therapy risks, benefits and best uses.

“There will be roles for practices starting out that are disciplined to do these phase 4 studies and follow protocols. You have to have staff and resources set aside to do this, but it can be a good place to start. Post-approval studies are becoming more popular, so there will definitely be opportunities for these in the future,” Price said.

Any clinical study, regardless of phase, can be an expensive proposition for practices. It is essential for physicians to have strong contract negotiators when study contracts are negotiated, Thompson said.

Whoever is negotiating the contract should be able to understand the value of investigator, coordinator and technician testing time when negotiating, as well as the necessary costs for required equipment, what supplies the company provides vs. what the practice provides and what is covered by insurance, he said.

“Our research lead is very good at contract negotiations and represents our center very well,” he said.

Advertising costs to enroll participants for a trial may also not be covered by the sponsoring company, Thompson said. Without doing quality contract negotiations, practices may lose out on potential profit from hosting the research.

“In the end, though, people may think they make lots of money from clinical trials. But really, it can be an added overhead expense if you’re not careful. Companies are very fair with how they reimburse, but you really want it to pay for itself or have a nice, slight profit,” he said.

Just as important as evaluating the study, physicians need to evaluate the company sponsoring the trial. Companies such as Allergan, Bausch + Lomb or Novartis — larger companies with solid backgrounds — will likely never be a problem to work with, Durrie said.

But if a physician decides to host a trial for a smaller company with an innovative idea, there is the risk of the company declaring bankruptcy or deciding to not take the product to market during the ongoing trial, he said.

Even if the company cannot make payments to the practice as legally agreed upon, the practice still has an obligation to finish the trial.

“It has happened before. If a center makes an obligation to a patient, they need to see them through the clinical trial. You need to evaluate the companies you’re working with to make sure they have the staying power and the resources necessary to do the clinical trial. That’s on you,” Durrie said.

More than a financial benefit

Through it all, the valuation of hosting clinical research is not purely financial. Trattler said just being part of a study that helps advance the field can be the most rewarding aspect.

One of the most significant studies his clinic hosted was a decade ago and led to the publication of the Prospective Health Assessment of Cataract Patients’ Ocular Surface study in Clinical Ophthalmology in 2017.

The study, sponsored by Allergan, concluded the incidence of dry eye in patients undergoing cataract surgery in a real-world setting is significantly higher than was thought at the time of the study, Trattler said.

“It’s an impactful study, one we were a part of, and it’s these types of studies that can help us improve care for our patients,” he said.

Khanani agreed that it can be a rewarding experience. Being part of a large-scale trial, seeing the product or therapy receive approval from the FDA and then going on to positively affect patients’ lives is “just a huge satisfaction for me.” – by Robert Linnehan

Disclosures: Price reports he is a consultant for STAAR Surgical, Alcon, RxSight and Calhoun Vision. Durrie, Khanani, Thompson and Trattler report no relevant financial disclosures.

Click here to read the Point/Counter "What common mistakes might a practice owner make when starting to host clinical trials?"

 

Hosting clinical trials has benefits, such as allowing physicians to offer cutting-edge technologies and therapies to their patients and increasing practice marketing opportunities and revenue, but the amount of time and manpower involved, as well as the arduous process of achieving all necessary certifications, can be underestimated.

Participating in clinical trials can give a practice a unique dynamic it otherwise would not have the opportunity to enjoy, OSN Refractive Surgery Board Member Vance M. Thompson, MD, said.

Thompson’s practice, Vance Thompson Vision, has a separate research team with 10 full-time employees dedicated to clinical research.

Arshad M. Khanani, MD, MA
A practice usually needs to be established for several years before having the necessary patient numbers to successfully host clinical trials, according to Arshad M. Khanani, MD, MA.

Source: Arshad M. Khanani, MD, MA

“It brings a neat dynamic to practice as far as the excitement of helping to innovate the future and trying to figure out the technology and drugs of the future for your patients,” Thompson said.

By participating in clinical trials, physicians can research specific areas to benefit their patients, but there are no guarantees of outcomes, Thompson said.

According to ClinicalTrials.gov, every clinical study is led by a principal investigator, often a medical doctor, and conducted by research teams consisting of physicians, nurses and other health care professionals. The studies are typically sponsored or funded by pharmaceutical companies, voluntary groups, academic medical centers or other organizations. Federal agencies such as the U.S. Department of Defense or the National Institutes of Health also sponsor clinical research.

Access to new technologies

Sierra Eye Associates, the practice of Healio/OSN Board Member Arshad M. Khanani, MD, MA, has been hosting clinical trials for the past 7 years.

“I participate in clinical research due to my passion for advancing science and to offer patients cutting-edge treatment options. A common misconception is that clinical trials are an easy way to benefit financially, but there is a lot of work and dedication involved. This work is in addition to the current day-to-day clinic obligations. A lot of time and commitment is required to recruit patients for research, managing the clinical trials department, signing off on lab and safety reports, and other tasks,” he said.

If building a revenue base is the main goal for entering clinical research, physicians may find it is easier to increase their number of surgeries or see more patients rather than engage in clinical studies, OSN Cornea/External Disease Board Member Francis W. Price Jr., MD, said.

PAGE BREAK

Price’s practice, Price Vision Group, has a separate research foundation, the Cornea Research Foundation of America, and participates in about 12 clinical trials a year.

Francis W. Price Jr., MD
Francis W. Price Jr.

These trials require intensive work with extreme dedication to organization and proper documentation to be successful. Often, clinics barely make a profit by hosting trials after the necessary manhours and resources are accounted for, he said.

However, if a product or therapy from a study is approved and becomes a popular treatment, the marketing opportunities for a practice that hosted the successful study can be a big benefit, Price said.

Price Vision Group is one of several clinics participating in STAAR Surgical’s multicenter investigational study of the EVO/EVO+ Visian ICL. The first patient in the study was enrolled at Price Vision Group.

“That’s a great marketing opportunity for us. We’re able to do some really cool things for our patients with the EVO lens. That’s very exciting. It’s been proven around the world, so we have a great shot of that working in this country,” Price said.

Adding workload to a clinic

Clinical trials add chair time for employees outside of normal day-to-day business. Participation requires extra time and effort from physicians, staff and technicians for a treatment or device that may not provide efficacious outcomes after years of testing, Price said.

“You can’t hurry these things when you’re trying to help define the future of a treatment or technology. It needs to be proven safe and efficacious, and for the FDA to do that, you have to put in the time and do it right,” he said.

Not all new developments and clinical trials lead to success. Physicians need to be ready for the mental aspect of enrolling participants into a trial along with the possibility of the product or drug not working as well as expected, OSN Refractive Surgery Editor Emeritus Daniel S. Durrie, MD, of Durrie Vision, said.

Durrie Vision has a separate research group, Durrie Vision Research, which has hosted clinical trials for more than two decades.

“Maybe the market moved on, and then you have a group of patients who have a product that is in their eye, and it doesn’t have a great reputation. What then? All of this needs to be thought of ahead of time before you agree to do any clinical research,” he said.

Hosting clinical trials takes focus, dedication and a high attention to detail, but for physicians who want to make a difference in the field or stay on the cutting edge of technology and innovation, it can be rewarding, OSN Technology Section Editor William B. Trattler, MD, of the Center for Excellence in Eye Care, said.

PAGE BREAK

The Center for Excellence in Eye Care participates in about two to four clinical trials each year, Trattler said.

Applying for trials

William B. Trattler, MD
William B. Trattler

The most important factor when beginning to apply for clinical trials is to have a large patient base in the area that will be studied to ensure trial enrollment is successful, Trattler said.

“Participation in a clinical trial requires that you enroll patients that fit into the study inclusion and exclusion criteria. If you do not have patients that meet the criteria, you will not be able to enroll patients. It is important to understand the study protocols and understand who good candidates are for the study. If you are able to identify candidates that meet the criteria for the study, you can begin recruitment,” he said.

Not having a robust patient base is a common mistake for a physician to make when entering the clinical research field. A practice usually needs to be established for several years before having the necessary numbers to successfully host clinical trials, Khanani said.

Sierra Eye Associates had to build its referral base and patient pool for 3 years before it was attractive to companies to host clinical research, he said.

“If you don’t have a busy clinic, you’re not going to be able to run these trials because companies are looking for very specific populations of patients. You need the numbers,” Khanani said.

Importance of research coordinators

When the numbers and referrals are solid, clinics should hire or appoint a trusted, organized employee to serve as a research coordinator. Research coordinators deal with regulatory and protocol-specific paperwork involved with hosting clinical trials, Khanani said.

A research coordinator will handle the management and documentation of the trial, including submitting institutional review board applications and FDA investigator forms and procuring curricula vitae for the principal investigator and subinvestigators, he said.

“The first step is to have a great coordinator. You can train your own from your clinic or hire someone with experience. Because they’re so in demand, I’ve trained all my coordinators internally. Look for someone who is organized, maybe a certified technician, someone who is meticulous about paperwork,” he said.

Daniel S. Durrie, MD
Daniel S. Durrie

Khanani said he interviews coordinator candidates within his clinic, gauges their experience and interest, and makes his decision. Each research coordinator is then instructed to attend a specialized course to learn how the FDA works, how to host clinical trials, how to complete the necessary paperwork and how to apply for clinical trials. This ensures the clinic has a qualified person to organize and help run the research trials.

PAGE BREAK

The research coordinator ensures each team member has appropriate certification, keeps track of investigational products, schedules protocol training and monitors visits with the trial sponsor.

When the necessary paperwork has been filed, practices need to be sure they are equipped to handle a clinical trial. They need laboratory certification from their state to draw blood during the trials, proper site operating procedure certification and certified visual acuity examiners and photographers on staff, Khanani said.

A practice may need dedicated 20-foot research lanes at its facilities and a dedicated secure room for research equipment. Many studies require a full 20-foot lane to evaluate vision, which many clinics have shortened to make their facility more space efficient, Thompson said.

“Some studies will allow for these shortened lanes, but many really want the full 20-foot lanes. Many facilities don’t have these,” he said.

Having dedicated space to store study documents and paperwork, with additional fire protection, is also a requirement. It is the clinic’s responsibility to properly store all of these documents for a predefined amount of time. This is necessary in case the FDA decides to audit the facility or the clinical trial, Thompson said.

These are all added expenses, not even counting the potential of bringing in personnel to handle the additional day-to-day work involved with the trial. Practices also may need to invest in equipment necessary for certain types of trials, which can include a freezer, a centrifuge, an electrocardiogram machine, a locked refrigerator with an alarmed thermometer, a certified procedure room for blood draws and other pieces of equipment, Khanani said.

Breaking into clinical trials

Procuring a trial can be more difficult than initially thought. If owners do not know how to apply for trials or apply for ones that may not be a good fit for the practice, it will not matter if they have the necessary equipment, certifications or a large patient pool, Durrie said.

Companies tend to trust their trials to practices and physicians they have worked with before and have given them good compliance with the study protocol. Practice owners with no experience in hosting trials need to directly approach companies and pitch their services, he said.

“We’ve done a couple hundred clinical trials at Durrie Vision; companies know we can do this well. If you’re new to clinical research, you need to get some training. You need to participate in other trials, and you have to justify your worth,” Durrie said.

Owners should keep an eye out for potential well-fitting studies on websites such as ClinicalTrials.gov, but they should also take the extra step of applying to or reaching out directly to a company sponsoring a trial.

PAGE BREAK

An established practice with a history of successful clinical research will have one to two studies pitched to them a month, but practices just starting out will receive fewer opportunities, Trattler said.

“If your center enrolls well, follows the protocol and focuses on the completeness of the paperwork, the word will get out, and companies will be knocking on your door. Take advantage of any relationships you may have with companies big and small to possibly be included in future trials,” he said.

Vance M. Thompson
Vance M. Thompson

Selecting the ideal trial

According to the FDA, practices should be prepared for a pre-study visit by a clinical research associate as part of the qualification process. The clinical research associate will evaluate the facility itself, the proper certification of its employees and the potential of its population available for the trial.

Practice owners need to carefully evaluate trials before applying to host. When first starting out, it may be easier to take on a post-approval phase 4 study, which tends to be less rigorous. Practices also have an easier time completing phase 4 studies without hiring new personnel to complete the research, Price said.

Phase 4 trials typically are post-FDA approval marketing studies conducted to provide additional information about possible drug or therapy risks, benefits and best uses.

“There will be roles for practices starting out that are disciplined to do these phase 4 studies and follow protocols. You have to have staff and resources set aside to do this, but it can be a good place to start. Post-approval studies are becoming more popular, so there will definitely be opportunities for these in the future,” Price said.

Any clinical study, regardless of phase, can be an expensive proposition for practices. It is essential for physicians to have strong contract negotiators when study contracts are negotiated, Thompson said.

Whoever is negotiating the contract should be able to understand the value of investigator, coordinator and technician testing time when negotiating, as well as the necessary costs for required equipment, what supplies the company provides vs. what the practice provides and what is covered by insurance, he said.

“Our research lead is very good at contract negotiations and represents our center very well,” he said.

Advertising costs to enroll participants for a trial may also not be covered by the sponsoring company, Thompson said. Without doing quality contract negotiations, practices may lose out on potential profit from hosting the research.

“In the end, though, people may think they make lots of money from clinical trials. But really, it can be an added overhead expense if you’re not careful. Companies are very fair with how they reimburse, but you really want it to pay for itself or have a nice, slight profit,” he said.

PAGE BREAK

Just as important as evaluating the study, physicians need to evaluate the company sponsoring the trial. Companies such as Allergan, Bausch + Lomb or Novartis — larger companies with solid backgrounds — will likely never be a problem to work with, Durrie said.

But if a physician decides to host a trial for a smaller company with an innovative idea, there is the risk of the company declaring bankruptcy or deciding to not take the product to market during the ongoing trial, he said.

Even if the company cannot make payments to the practice as legally agreed upon, the practice still has an obligation to finish the trial.

“It has happened before. If a center makes an obligation to a patient, they need to see them through the clinical trial. You need to evaluate the companies you’re working with to make sure they have the staying power and the resources necessary to do the clinical trial. That’s on you,” Durrie said.

More than a financial benefit

Through it all, the valuation of hosting clinical research is not purely financial. Trattler said just being part of a study that helps advance the field can be the most rewarding aspect.

One of the most significant studies his clinic hosted was a decade ago and led to the publication of the Prospective Health Assessment of Cataract Patients’ Ocular Surface study in Clinical Ophthalmology in 2017.

The study, sponsored by Allergan, concluded the incidence of dry eye in patients undergoing cataract surgery in a real-world setting is significantly higher than was thought at the time of the study, Trattler said.

“It’s an impactful study, one we were a part of, and it’s these types of studies that can help us improve care for our patients,” he said.

Khanani agreed that it can be a rewarding experience. Being part of a large-scale trial, seeing the product or therapy receive approval from the FDA and then going on to positively affect patients’ lives is “just a huge satisfaction for me.” – by Robert Linnehan

Disclosures: Price reports he is a consultant for STAAR Surgical, Alcon, RxSight and Calhoun Vision. Durrie, Khanani, Thompson and Trattler report no relevant financial disclosures.

Click here to read the Point/Counter "What common mistakes might a practice owner make when starting to host clinical trials?"