My Trials and Tribulations

Last updated July 17, 2023

My name is Nurse D and I have administered 16 clinical trials. This is the story of one of my trials.

As administrator of a clinical medical trial, my story is about doing some meticulous planning as well as being scrutinized by intense oversight. With the goal of a relentless pursuit of scientific truth. The following narrative is an example of how I navigate through such a complex process:

A blank slate and an idea.

My journey towards truth begins with a lightning bolt - a scientific question or some sort of medical need that we believe a new novel compound could address. I have meetings with researchers, clinicians and regulatory agency experts in order to brainstorm and to draft the protocol. This isn't all about just what we want to test, but it's also about how we'll test it using scrupulous methods and safety protocols.

I think to myself, will we do randomized double-blind study? Yes of course this is the standard that we tried to live up to. How many participants do we need to achieve statistical significance? What are goals and endpoints? These decisions are part of the crucial decision process and I spend days and sometimes weeks refining and then redefining this blueprint for our trial. I ensure that every detail from participant selection, to data collection methods is scrutinized and then justified./p>

When we finally get to go ahead.

With our protocol all tuned up and polished, I go ahead and move to secure regulatory approval. This is probably one of the more important steps in the process. I file for an investigational new drug IND application with bodies like the FDA. This process involves compiling a dossier of our testing protocol. It also includes pre-clinical data and any other previous human trial data that we've been able to source. It becomes a back and forth process as we receive inquiries and respond to them. We amend documents and make changes as necessary. Then we wait for approval, and this process is nerve-wracking. Without the approval, we won't be able to proceed, and all of our work will be for nothing. Meanwhile, I'm already planning ahead doing tasks such as selecting trial sites and setting up the Data Safety Monitoring Board (DSMB) to independently oversee and check all of our protocols that ensure participant safety.

Setting up the site and training our staff.

Making a choice of where we'll conduct the trial isn't about just one thing. It is about geography. It's about finding a staff that has the expertise and knowledge to accomplish our protocol and finding a facility that is available, affordable, and has all of the lab gear that we will need. I make personal visits to potential sites, assess them, take notes, and train the local teams on our precise protocol. My goal here is to ensure that everyone understands what our study's objectives are, what our procedures will be, and the ethical implications of the research we will be conducting. It is absolutely vital that consent processes are handled with total care which will help to ensure that participants are fully briefed and informed in order to make an uncoerced and willing decision to join us.

Finding the right participants.

The recruitment process of the trial is another integral part. Recruitment is where theory meets reality and I choose to devise strategies to attract participants, whether through advertising in print or on the Web. I use physicians that are working in the field to make referrals. I also can find helpful registries of patients who use other drugs or who have had certain treatments. I use these databases as a starting point, but also reach out to the general community for more participants. Oftentimes, the numbers don't add up as we require because the inclusion criteria are so stringent. Many people will apply who eventually get disqualified for one reason or another. I will end up spending hours refining our approach to finding candidates and sometimes expanding our search and loosening our requirements in order to get the number of participants higher within certain ethical guidelines.

Once the participants have all been identified and are all enrolled in the study, we may begin the real work. I do oversee the administration of the drug or placebo. I am involved in managing data collection and supervising all of my staff that they are collecting data in the most meticulous way and that we adhere to our protocol. Since it's a double-blind study, maintaining that the blind (the protocol and the placebo) are separate is an art form. I spend many hours monitoring for side effects and I use the data to prepare for DSMB meetings, which helps to ensure that all of the safety data that we collect is meticulously reviewed. If we find any red flags, we might need to pause the study or completely rework it in order to satisfy the DSMB. This is part of modern research, but it becomes a headache for researchers who are looking for new treatments

And with the advent of more digital tools, data collection is augmented by our software. Data management is an ongoing task. I will be working with data managers and tech gurus to input, verify and analyze every bit as we comb the data, looking for trends or anomalies. Interim analysis and preliminary data might reveal that we're following the guidelines and staying on track or if there is some sort of a need for an adjustment. This phase of data collection is about balancing. Our goal is to pursue new knowledge, yet underscore that participant safety is paramount.

Navigating through turbulent waters.

A clinical medical trial is never without a hurdle of some sort. There's always the possibility that participants will drop out so it is important to make sure that participants are selected in a way that informs them of the rigors of participating in a trial such as ours. There are also unexpected adverse events sometimes due to drug interactions or unforeseen medical emergencies. Sometimes, it's something simple like a logistical issue or not being able to find the right staff. Or maybe our lab has some sort of natural disaster that confounds our study. Anything can happen because this is the real world and discovering breakthroughs using the scientific method is a rigorous pursuit. I constantly find myself problem solving through the trial phase whether it's revising recruitment tactics for next time, intensifying safety monitoring as we find issues, or dealing with regulatory queries and paying attention to changes in the regulatory framework.

When you begin a trial you imagine the day that it ends as a beautiful ceremony, but sometimes that is not the case. Closing a trial is as important as starting a trial, so I make sure that all participants are safely transitioned through the study as they make their way back to regular life. Sometimes patients are guided back into regular care or they flow into the next treatment protocol if our data finds that our treatment is useful. Finalizing data and preparing for analysis and scrutiny is an effort that requires immense work. We compile the study and create a report which scrutinizes every piece of data that we've collected. This report will be the legacy of the study. The document that could become published and push our drug towards being approved for public use.

But when the trial that we've been conducting officially ends, my analytical work really just begins. I coordinate long-term follow-ups, manage the archival of the data we collected and prepare for potential positive publication. Every research trial that I've been involved in has taught me something new about drug development, about participant care, and the troubles of trial management. I continue to reflect on things that we attempted that worked and places where we failed. Also, I understand how we can improve future studies by incorporating what we've learned. As I look back on the trial that has concluded, I realize it's not just about producing a drug or mitigating pain and suffering. It's also about the lives that we touch in the pursuit of medical breakthroughs and it's about a scientific community that we are all a part of. Each clinical trial is a chapter in the book of medicine. Being a practitioner in this role caused me a great sense of pride.

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