Joseph Tauber, M.D. – Making Ophthalmology Trials More Efficient
Joseph Tauber, M.D., just joined Lexitas Pharma Services as Executive Director of Medical and Clinical Sciences. We sat down with him to discuss his role, his vision and how to tackle the challenges that are unique to ophthalmology clinical trials.
Welcome to Lexitas, Joe. You have an extensive career as an ophthalmology researcher and expert, with three decades of clinical experience and participation in more than 150 trials! What are some of the highlights that stand out to you?
I’ve been doing clinical research in the Kansas City area since 1989, mostly in ocular surface disease but also corneal transplantation, uveitis, and ocular immunology. But I really take pride in having been being involved to some extent or another in the studies leading to FDA approval of all five dry eye medicines that are available to patients today.
That work translates into useful experience because I’ve seen studies that have led to successful approval, as well as many studies that have failed to achieve positive results. It gives me a certain insight into whether a study might have a structural flaw. It informs me in creating efficient, well-designed studies that are more likely to succeed.
Can you elaborate a bit further?
Many studies collect a lot of unnecessary data. That leads to inefficiency for study coordinators and it leads to investigator fatigue. The quality of the data is not as good, and sponsors are paying for work that doesn’t lead to any useful results. So, I hope to leverage my experience in designing efficient studies that focus on collecting the data that matters.
Describe your role at Lexitas?
I’ll be responsible for medical monitoring for both anterior and retinal studies. And I’ll also be involved in working with sponsors on protocol development, selection and optimization of study metrics, as well as working with the Lexitas Reading Center to make grading of ocular surface staining more reliable and reproducible. Coming to Lexitas with the investigator background and the practical experience from so many studies provides an opportunity to really elevate the investigator perspective to the CRO level. It’s quite exciting.
Why did you choose to come to Lexitas?
I’ve known Lexitas for many years, all the way back to its inception. I know how strong the organization is, certainly in terms of knowledge and expertise, but also in its honesty and transparency. I was eager to work with Lexitas even in the early years and it’s been a real pleasure watching the organization grow over time into what I consider to be one of the premier ophthalmology product development organizations.
I feel that being here, I’ll be able to help drive more systematic change in protocol design and study conduct, so that we can have faster enrollment with happier investigators. I think my hands-on experience allows me to do that. I bring real world knowledge of the roadblocks that hamper subject enrollment, that create challenges for research coordinators, and I hope to translate that understanding into protocols that meet sponsor needs more efficiently.
What are some of the key challenges that you see out there and how can they be addressed?
There are lots of challenges to be addressed. There is a real staffing problem at the investigator and site level. The relatively low number of well-trained coordinators nationwide is problematic because many appropriate patients don’t get enrolled into trials. It’s a lost opportunity for both the site and for the sponsor.
It’s also important to bring new investigators to the world of clinical trials because they don’t have the infrastructure or experience, and are hesitant to add clinical research to their practices. Part of the solution here is to reduce the burden on the site by bringing more responsibility in-house to the CRO. For example, we can be far more efficient with the use of technology to help us move away from paper case reports. That is an obvious, low-hanging fruit to becoming more efficient.
What advice do you have for a sponsor who is looking to work with a product development partner?
Experience matters a lot. You want to partner with an experienced ophthalmology product development organization. Ophthalmology is unique among the various specialties. In fact, it was the first subspecialty out there. The type of data that is collected in these studies is unique to ophthalmology. Oncology, urology, cardiac studies – they may collect data, but eyes are eyes. It’s just a different world and you need specific expertise here that doesn’t translate from doing other specialties. So, if a CRO hasn’t worked with eye studies, they shouldn’t say they know how to do eye studies.
Second, it is critical to be able to identify appropriate sites. Sponsors need to work with someone who has extensive relationships with ophthalmology researchers, and that will help you select the right site for the right study. You need to work with investigators who collect the right data, who enroll the most patients with fewest screen failures. That’s what an experienced partner can deliver to you.
And finally, do you have any interests or hobbies?
I’ve recently become a first-time grandfather and I’m absolutely loving it. They truly are the reward for being a parent all those years. I’m also a great Kansas City Chiefs fan and I’ve certainly been enjoying the wild success we’ve had in recent years. During playoff season, there is a good chance you will find me wearing a Chiefs jersey. And finally, I’m both a bourbon and coffee aficionado. For some years, I’ve led local groups that have similar interests and we meet every weekend, discussing a very wide range of topics.
That’s fantastic. I look forward to having a round with you some time. Thank you very much for your time.
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