Professional, personal benefits abound with successful clinical research
I am often asked by other ophthalmologists: “How do I get started working with industry?” My answer is always the same: Start by serving as an investigator in an industry-sponsored clinical trial. That is how I began 42 years ago, and it is still the best pathway for a clinician to initiate collaboration with our industry-based colleagues. Most are aware that I am a strong supporter of the virtuous effects of the so-called innovation cycle, and the innovation cycle in ophthalmology requires the engagement of a practicing ophthalmologist at every stage. A few thoughts on how to initiate engagement with industry as a clinical investigator.
First, build a significant clinical practice with meaningful patient volume in one or more areas of personal interest and expertise. Once you have a critical mass of patients, you can let the company of your choice know you are interested in and available for clinical trial participation. Usually your local company representative can help you gain access, or a colleague ophthalmologist who is already engaged with a company can introduce you. The lowest risk way to start is to plan and complete an FDA phase 4 investigator-initiated clinical trial on a device or drug already FDA approved. Once you gain experience here, if you like it, you can seek to participate in FDA phase 1, 2 and 3 clinical trials.
The first criteria for those charged with evaluating a clinical trial site and investigator clinician for participation in an FDA phase 1, 2 or 3 clinical trial is the clinic’s access to patents and ability to recruit study participants. The typical startup is burning $1 million a month or more when engaged in FDA-monitored clinical trials. A month or more of delay in patient recruitment can be the death knell for a small company, and in the larger company, poor recruitment can mean the loss of a job for the company employee who does not choose investigational sites wisely. So, do not seek or sign up to participate in a clinical trial unless you can recruit the type of patient desired in the study being planned.
A clinical research organization and its employees have long memories of both negative and positive outcomes with a clinical site and individual investigator. Be sure to underpromise and overdeliver in your first clinical trials. In addition, it is important to be passionate about the drug, device or diagnostic you are studying. The clinical trial participant can significantly benefit their patients and practice by bringing a new technology into use at an early date, but participating in and especially leading a clinical trial are a lot of work. It also requires some restructuring of your practice, and a first-class study coordinator, usually an optometrist or certified medical technologist, is required. Study patients must be seen in a timely fashion, paperwork completed perfectly and study patients prioritized.
To enjoy it, it is necessary to love the field represented by the technology. It will be the highly engaged clinical investigator who also gets invited to join a medical advisory board and later participate in training colleagues in the use of a new drug, device or diagnostic once available commercially. This opportunity often leads to invitations to lecture and to teach, both in the United States and globally. The entire cycle of planning a clinical trial, completing it, achieving FDA approval, planning a product launch and supporting the launch with quality education is highly dependent on key opinion leader (KOL) ophthalmologists. The total cycle can last 10 to 15 years-plus and be rewarding and fun at every stage, but only if one truly loves the technology in question. The teaching opportunities may extend worldwide, which can lead to many special experiences, but only if you love the field and are interested in and available to travel.
Once an individual ophthalmologist has participated successfully in the innovation cycle once or twice, they will find themselves in high demand to do so again and again. The benefits are many. It can be financially lucrative, but only when well planned. Every ophthalmologist should know what their time is worth per hour of practice (usually $500 to $1,000 per hour or more), and be sure to replace the lost revenues from reduced clinical practice with fees charged for services provided in a clinical trial. All the companies and their clinical research organizations are quite knowledgeable about typical fees paid and will usually treat you fairly in this area, as they will want you to be happy and work with them again. Still, “fortune favors the prepared mind” (Louis Pasteur), so it behooves you to know what you are worth. Also, know that clinical trials, medical advisory boards and teaching engagements today rarely pay better than clinical practice, so do not engage with the hopes of great financial reward. The primary rewards are intellectual stimulation and knowledge gained, the satisfaction of helping bring a new technology to ophthalmology that truly makes a difference to our patients’ quality of vision and life, and the new friends made during the often 10- to 15-year journey.
For me, the most valuable and enduring benefits have been the life-long relationships created and knowledge gained discussing ophthalmology around the consulting and dinner table with a national and global consortium of extraordinary KOL ophthalmologists. The money generated can replace that lost in clinical practice, and for some be lucrative, but what is priceless are the friendships and amazing knowledge gained sharing time with many truly great minds in ophthalmology.
Disclosure: Lindstrom reports he has consulted widely in ophthalmology and participated in more than 100 clinical trials working with every major strategic and more than 100 startups. Minnesota Eye Consultants and his partners participate in 10 or more clinical trials every year.