President and Founder of DSP Clinical Research discusses challenges in infertility research and where the industry is headed
Until about 15 years ago, research in infertility had been largely stagnate. Standard of care was accepted, and minimal effort was being made to further advance treatment or add new options to the market. As more and more women delayed pregnancy, a greater need for studying and combatting infertility arose. Significant progress has been made in recent years. Darlene Panzitta, the President and Founder of DSP Clinical Research, provides insight into in the challenges of coordinating studies in infertility based on her more than 25 years in the clinical research industry.
What led DSP to specialize in fertility/infertility research?
DSP started as a women’s health CRO working on hormone therapy birth control pills. After working in the women’s health space for 4-5 years, a client hired us to conduct work in infertility. There weren’t many others supporting this area of research because fertility wasn’t a big focus for pharma at the time. As a company, it made sense for us to specialize in this area. We had a base of knowledge from working in women’s health and were able to provide greater value to Sponsors by building special relationships and developing expertise in the space. Research began to expand as more women were delaying pregnancy. Doctors were looking for alternatives to natural pregnancy, to support older women looking to become pregnant as well as younger women who wanted to wait.
What are some of the most common challenges that arise when conducting trials in fertility/infertility?
Getting women to participate. When you say investigational and baby together, there is a fear that something will happen with the baby. Being able to communicate the risk-benefit and making the incentive clear is the biggest challenge.
Also, the workload associated with a clinical trial poses a lot of challenges for participating sites. Creating a strong CRO-site relationship and understanding the workload at the clinic is imperative to overcoming challenges that may arise when conducting trials. Infertility clinics are very busy and usually running at maximum capacity. When a clinic takes on a trial, they will likely need an employee dedicated to managing that trial full-time. A lot of clinics don’t want to take that on, especially when they could manage patients similarly without involving them in a trial.
We help to mitigate this concern by making study protocols as close to the standard of care as we can. This helps minimize the burden at the site level. We feel it is also important to educate Sponsors about the impact on the clinics so that they understand the commitment being made.
How does your experience change the way you approach new trials?
Often, the first thing that a Sponsor is going to do when they have a new asset is go to a doctor for clinical trial design support. However, the doctor may not fully understand the operational challenges of a clinical trial. When designing a study, we must consider what is being done at several sites, not just one. The standard of care also varies from state to state and country to country. So do regulatory requirements. You need to be aware of these differences so that your patient recruitment plans, procedures and endpoints are taking these variations into account.
Because we work with a number of clinics regularly, we have a better sense of how differently they operate. We can proactively address these challenges in our plans and study designs. Our site relationships and our deep understanding of differences between sites give us an advantage.
Looking at current research, are there any areas you feel are most promising?
The use of apps to collect patient data is promising because of the feasibility of downloading an app rather than having a patient carry an extra electronic device.
Also, site staff are often pulling data from Electronic Medical Records (EMR) and manually inputting it into the Electronic Data Capture (EDC). If we can identify more cost-effective options to automatically pull data from the EMR to the EDC, it would save sites a lot of time. Site staff wouldn’t have to handwrite medical charts or pull from printouts, and the volume of the data available would be far more significant.
What is your vision or hope for fertility and infertility patient care?
My hope is that we can increase the pregnancy rate. Instead of women having a 30 to 60 percent chance of getting pregnant and carrying a pregnancy to term the first time, they have an 80 to 90 percent chance. With all the genetic testing, improved embryo quality, available monitoring, and other advancements that are being made, I don’t think we are far from this.
What is the most rewarding part of what you do?
We get to know our clients personally and provide them with specialized direction. We reduce the distance between ourselves and the Sponsor, enabling us to give more than what is expected from a CRO.
In 2019, DSP Clinical Research and Health Decisions entered a partnership to support Sponsors conducting clinical trials in fertility/infertility. Learn more about their partnership here.