What Do You Find Most Exciting About Clinical Research?
A Guest Post, By Stacey Carmody, CCRP
Someone recently posed the question: “What do you find most exciting about clinical research?” I find that it is hard to answer this is in just a few words. If I was to sum it up, I would say, “making a difference.” The role of clinical research is an awesome responsibility when you think about it. It determines which new drugs get approved that will enhance, or perhaps even save people’s lives. I find it exciting and humbling to be part of that. It is a great thrill to work with a drug that I later see gain FDA approval- to see it go from a number to a brand name. It’s kind of like knowing an unknown actor who finally becomes a star.
Another exciting aspect about clinical research is that it is never static. It always changes. There are always new treatments to study, and improvements to be made on the treatments we already have. Just when you think you have seen the best drug in its field, another one comes along that has promise to be better. Research never stops.
I also find it exciting when I have opportunities to connect with others who work in the profession. Logistically, research coordinators are often isolated in their private practices or hospital departments where there aren’t too many other coordinators around. Meetings and conferences have given opportunity for interaction, and the rise of social media have been especially beneficial.
I keep these thoughts in mind if I find myself aggravated- and anyone who works in this field can tell you that there will be times when you want to tear your hair out! In the worst times, you have to deal the demands of the study sponsors, the requests of the IRB, unpleasant monitor visits, noncompliant patients, stressed out Principal Investigators and so forth. There is also the strain of meeting enrollment demands, as in many cases, payment amounts to center depend on the amount of subjects enrolled in a clinical trial. Often, the existence of the research staff’s jobs depend on the amount of subjects enrolled. As unpleasant a thought that might be, it is a hard truth that clinical research is also a business and a competitive one at that, so there is a sense of urgency to enroll when you can. My former principal investigator was found of saying, “We’ve got to strike while the iron is hot!” The sponsor also has the pressure of deadlines to meet- which in turn is transferred to the participating center.
But all of this is quickly fades when I think about the main benefactors to research: the patients. Things happen when patients sign up for a clinical trial and come in for their visits. You get to know their personalities, their hopes, their fears. A relationship is formed. You find yourself rooting for them, hoping that the study drug will enhance their lives. Nothing gets more exciting than telling a study patient that the drug worked and that they are cured. To witness the looks of relief, the smiles, the tears of joy- is priceless. And it reminds me why I do what I do.
I got asked a great question by a viewer who is considering to participate in a clinical trial. He asked me what phase of trial would be best for him. For those that want to learn more about the various phases of clinical trials, I recently wrote about it here.
My answer is addressed in the video, but basically if a clinical trial gets to Phase 3, it is often called a pivotal trial. These studies usually recruit a large number of study participants, usually between 500 and 2500 total participants. The dose and the majority of side effects are believed to have been determined by this point, so the main objective is to determine whether the drug works in comparison to a placebo (sugar pill). Safety and side effects are still closely observed as well. These studies usually occur in outpatient settings and involve many study visits (between 10-30 at times). If the drug proves to have efficacy (does it actually work?) over placebo, or a comparable drug that is already approved and on the market, the drug company will file an NDA (New Drug Application) for FDA review. The FDA may take as long as 1 year to make a decision on whether the drug will be approved, or whether even more trials are needed to determine safety or efficacy. At this point, labeling issues (what information appears on the bottle, and what the drug company can claim regarding the drug) are addressed.
So as I’ve been searching for good clinical trial, study participant focused websites over the years, you can say that I’ve been easily disappointed. I even tried to search for good content for Investigators and study coordinators but had trouble finding very many sources. This is one of the biggest reasons why I even created this website. This being said, ClinicalResearch.com , the study information website aimed first at study participants, is indeed a step in the right direction. What’s even more impressive is that the website is owned and operated by Quintiles, which in my opinion, is easily the industry leading CRO both in terms of market share and staying ahead of the curve. The website is not without it’s flaws, but it shows that even the CRO’s in our slow to adapt industry, are catching on to the idea of marketing your business around content. In this video I share ways in which the website could be even better, and what I like about it so far. If anyone from Quintiles is reading this, I’d love to work with you guys on this project or just sit down and talk about some good ideas! By the way, if you’d like to follow Quintiles on Twitter, here is the link.
Today we got asked an interesting question from a viewer who wanted to know if it is ok to bring a family member or loved one with you to a clinical trial visit. Don (video feed missing) and Dan discuss this very common question in regards to clinical trials. This is an especially common question during a clinical trial screening visit, and it may often help someone be more comfortable when it comes to going over the Informed Consent form. Let us know what you think!
In today’s video, we get into the topic of why a big misconception in regards to clinical trials is that people who join them are nothing but guinea pigs. We hope to be able to dispel this myth by providing examples of safeguards in place that are set up in order to protect all clinical trial study volunteers. We also list reasons and examples of why some people may think that people who join clinical trials are guinea pigs, but we also provide some fact to argue against this statement as well.
In today’s interview we were joined once again by our guest guru, and whistle blower extraordinaire, Sara Siegler. It was brought to our attention a few weeks ago, thanks to our Twitter pal Adam, that there is an oncologist who has apparently found a loophole in the clinical trial approval process and has been able to charge his study participants hundreds of thousands of dollars for the privilege of participating in one of his self-funded trials. This is a very controversial topic that we have uncovered here and we will be sure to bring you further news as this breaking story develops. The bottom line is this: be very wary of any clinical trials that charge you money to join. As we stated in the video, most clinical trials foot the major costs for any clinical trial participation.
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