How to Make a Medicine

A dcotor in a research lab

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In a drug’s journey from ideation to pharmacy shelves, there’s a mind-boggling amount of logistics behind the scenes. Trials alone can take up to six years. Along the way, developers, government agencies and universities need reliable data from controlled studies of real people. In order to make that happen, they look to contract research organizations (CRO) that handle the research piece of the puzzle, usually outsourcing trials on a contract basis.

To better understand the integral role of clinical trials in developing new therapies and devices, we talked with a CRO founder Nancy Snowden of NCGS in Charleston.
A medical research team in the lab
What inspired you to begin your own CRO?

Previously, I was an oncology transplant and critical care nurse and managed an oncology unit. I then transitioned into running clinical trials on an institutional basis. During that time, I impressed an investigator while giving a talk at the National Cancer Institute, and he offered me a job. The reason I moved into research from treating patients as an oncology nurse is because of the particularly difficult arena I was in because of the emotional toll it takes on you. However, it was meaningful to me to work on changing health care for the future, so I established my research company, NCGS, Inc.

How closely does your CRO work with other organizations in the drug approval process?

NCGS works collaboratively with drug or biological companies developing new therapies or working with device companies developing new implantable devices like pacemakers. We work with diagnostic companies, the government and the university research system as well. These are collaborative partnerships. We are basically high-level consultants; we have nurses, doctors, scientists, data managers, mathematicians and biostatisticians, and we function as an extension of the drug company. They develop the idea and we are basically the cavalry.

What are the most common types of trials you conduct?

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Oncology, transplant medicine, hematology and the areas that deal with side effects and subsequent medical issues. We got involved with infections, AIDS and sepsis as well.

How long does it usually take to conduct a trial, and what factors most affect timing?

The size and duration of the trial has to do with what phase you’re in. Diagnostic trials can be done in six months, whereas a therapeutic trial (to develop a treatment) has to go through three different phases to be approved for a drug therapy. Phase one looks at the safety parameters and the activity of the compound, which involves maybe 20 participants at one or two sites and can take anywhere from six to 12 months from start to finish. Phase two trials can be two years. Phase three can be three years or longer. Obviously, if you’re working in something like oncology with cancer patients, it will take longer because you are monitoring them over the course of their treatment and until their disease progresses/spreads. To take a drug to market can take up to 12 years overall.

As for size, the size of the trial has to do with what you’re trying to prove. The newer the therapy, the smaller the size, because you’re trying to determine if your drug works and is safe, but there is little to compare it against. If it’s a common therapy already with good treatment results and a good safety profile, then the trial size will be bigger because there is more to compare your new drug with and it has to be more efficacious and safer than what is already available.

How do people usually find your company and become a part of your clinical trials?

Sponsors find us based on our reputation and expertise in the therapeutic area under development. Sometimes our sites recommend us to sponsor companies. We also pursue new clients at scientific meetings our clients are attending and some conferences where I may be presenting. We work with investigators who have the patients already or have a specialty that we can together recruit patients for. So we find investigators who have a very qualified facility and everything you need. If it’s a cutting-edge drug, you are going to need cutting-edge technology. Once you find those sites, you qualify them: Do they have the right credentials? No findings from any regulatory agency? Adequate staff? Then you work with them on the plan to enroll subjects. What you need is a homogeneous group of patients who got their treatment exactly the same way. You have to make certain that all of this is done under the proper safety regimen. It is safety first in this industry: “Do no harm.”

What do you see as the main risks and benefits of being a participant in clinical trials?

The risk of a new compound is that the profile drug hasn’t been followed as long as something that’s been on the market. But you have to weigh the risk with the benefits. If I have cancer, and there’s not as much known about this but I’ve already failed two other compounds, then that risk makes sense to me. It’s the risk-benefit ratio. Only the individual in that position can really assess what the risk-benefit is. Of course, a physician would absolutely be involved. Nobody can be involved with a trial without proper informed consent, where you tell them all of the risks, all of the benefits and everything you know about the compound to date. Then it is for them to decide.

From your own perspective and experience — what is the biggest challenge with clinical trials?

As with any job, it’s quality of work and collaborative commitment to our collective team. The team includes the site team, sponsor team and the individual patient. Our staff and the nurse or coordinator at the site assigned to the study have to be fully committed to understand. If there are deficits, even though they’ve gone through all the necessary education, they have to be retrained and monitored until you get the quality required. That human factor is the greatest challenge, because it is elemental. If you do not put every piece of that puzzle together in a quality fashion, then the end result or “picture/profile” of this drug is not going to be complete or of high quality. The most challenging factor is the human factor.

By Enid Brenize

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