What are the Challenges and Opportunities facing Clinical Trial Research?

Every year, tens of thousands of clinical trials are initiated globally, important research studies that evaluate new medicines, treatments, and their effects on human health.  Accel Research Sites, a multi-therapeutic network of clinical research sites, has completed more than 1,000 clinical trials for industry sponsors since its founding in 1998. It operates in several locations across the southeast United States and can conduct phase one, two, three, and four studies.

In this article, Dr. Bruce Rankin, Medical Director at Accel Clinical Research’s DeLand, Florida Site, talks about the challenges facing clinical trials, the future of clinical trial research in a post-pandemic era, and what's so special about Accel Research Sites.

We're multidisciplinary, so we do a vast amount of different trials for multiple medical indications. We are able to work on many different types such as cardiovascular, rheumatology, dermatology, and neurology.

We also do early phase development. We're able to take care of and work on phase one through to phase four clinical development for medical compounds, devices, and vaccines. Accel Sites can work on all stages of development.

With multiple locations and expertise, you can work on several trials simultaneously.

Yes, we have multiple sites. I'm talking to you from our phase one unit here in DeLand, Florida, but we have other sites with other condition specialists. For example, specialists in Alzheimer's, GI (gastrointestinal), dermatology, pediatrics, and gynecologists. 

From your experience, what would you say are the biggest challenges facing clinical trials?

There are several, including the time that goes into making sure the investigational product is well tested before starting in humans and then just running the trials.

Obviously, you have to have the participants, and then there is the protocol development, which is obviously something that can affect the trial. So those are the main challenges: the protocol development, the IP (investigational product) development, and then getting participants that meet specific criteria to come in and enroll in the trials.

Which one is open to the most improvement?

The challenges that can delay or affect progress are trial specific. In some trials, the protocols are so prohibitory. Sometimes there's an issue with the investigational product, which causes delays, and they have to alter the formulation. Then there times when it is tough to get people to come in and get involved with the trials. 

Here at Accel, we have a very big marketing group, so we're able to do a lot through social media and advertisements to inform people about the trials we are doing. 

Successful recruitment and retention of participants have long been among the most challenging aspects of conducting clinical trials. What can be done to get more people into trials and reduce any subsequent dropout rate?

I think it's just about raising public awareness and informing people that new developments and new treatments for disease are achieved through the trial process. I think the COVID vaccine trials have done a lot to start that process. More people are coming in now that previously never knew about or understood clinical trials. They want to do something to try and help with this COVID illness. So, this is kind of unique, seeing people come in during the middle of a pandemic saying they want to do something. I think raising public awareness of how trials are done, the stringent safety measures we follow, and the amount of oversight there is would be helpful.

Clinical trial participants are probably going to be followed much closer than they would be routinely through their general medical care. That's because we look for signals of safety issues constantly to make sure what we're working on is safe and effective.

You’re overseeing research of both the Pfizer and Moderna vaccines at Accel Research Sites in DeLand, do you think the pandemic served as a recruitment tool to get people into trials?

Yes, without a doubt. We've all been affected by the pandemic. We've all had to do things and change our normal activities and behaviors, and there's a lot of motivation to get life back to a closer model of what we had before. So, awareness of what needs to be done and the hopefulness of a treatment for COVID and vaccine development is very much on everyone's mind right now. 

How will the seemingly warp-speed development of COVID vaccines affect the future of clinical trials?

A lot of barriers to faster production is the interaction between the sponsors and the regulatory bodies, putting all that together, and working with the clinical trial research sites. I think many of the barriers that have been there before have been lowered or changed because we can move at a faster pace, especially in the middle of a pandemic. 

I think all groups, sites, sponsors, and regulatory bodies have made adaptations that haven't reduced safety during this process. We haven't skipped any steps; we've just collaborated better to make things move faster. Everyone has moved at a faster rate in cooperation with one another to get where we are today. That is probably going to change our industry.

I mean, so many industries have been affected by COVID and will probably come out with some differences relative to how they were before the pandemic. I don't think that is going to be any different for clinical trials. 

I think we will see a different process, maybe a more streamlined process, after we are finished with COVID. We are going to find out through efficiencies that we can work just as effectively as we worked before. Maybe there will be a lot fewer hurdles or barriers to get things through. I expect our industry is going to be more efficient because of how we've had to do processes and what we've learned from working on COVID vaccines and treatments. 

It is working smarter without cutting corners.

New cooperation between groups has made everybody more effective and made things quicker. We've kind of reinvented the process without cutting any corners or changing any of the critical endpoints needed for safety and efficacy. Obviously, those are the two big things where there can be no shortcuts.

Clinical trials still have to run a certain amount of time so that we can get to our analysis and our endpoint data. So, there are certain things where time cannot be reduced, but there are other processes involved in getting studies up and running where you can shorten their times without cutting into the safety or efficacy of the actual trial.

Healthy volunteers have a lot of choices when looking to participate in clinical trials. How should they decide? What criteria should they be weighing up?

It depends. When we do phase one studies, there is always a group of volunteers looking for those types of trials. Some you may consider as professional clinical trial subjects who keep themselves healthy and look for trials. A lot of times, they are guided by how long confinement will be. At Accel Research Sites, we have people here for 7 to 14 days for some of our phase one trials. Obviously, the longer the confinement, the higher the stipend. Their decisions may also be driven by the type of trial and, to some degree, the compensation for time and travel.

We also have groups with certain disease conditions, and participants want to try advanced treatments for those specific diseases. I see both types of groups of people who take part in our trials.

What's been the most fascinating trial you have been involved with or come across?

The Alzheimer's trials I'm working on right now are very fascinating. We're trying to detect early cases of early-onset Alzheimer's to see if we can delay the onset and make a difference in disease progression. Instead of trying to slow it down with current treatments, this is trying to prevent progression. 

I think working on other vaccines such as the shingles vaccine was fascinating because of how well it worked. This vaccine actually helped with the dose development of other vaccines.

Another one was a Parkinson's trial we did recently. During phase one, we brought people in for 30 days and saw very remarkable improvements in their condition while the subjects were here. For example, someone who was pretty young and in their forties was able to start drawing and writing and doing their artwork again while they were on the trial.  This is something they hadn't been able to do for years.

These kinds of developments really inspire us, doing work that is going to affect many people and help all of us when we get new medications and treatments out to pharmacies.

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