Few industries are more regulated than the medical industry, and for good reason. The last thing any medical professional wants is to make your health worse. DeNova Research of Chicago has led dozens of clinical research projects to completion, making new treatments and products available to millions. It’s all thanks to our clinical researchers.
Have you ever wondered what a clinical researcher does, or are you interested in becoming one yourself? We’ll go over the various stages of a clinical trial and the critical jobs that researchers perform along the way.
What Does a Clinical Researcher Do: 6 Crucial Tasks
1. Design the Clinical Trial
Even though there is a standard protocol for how clinical trials are to be conducted, each trial has unique characteristics and special considerations. The lead researcher or head of a research team will need to design the parameters of the trial and determine who can participate in it.
One of the most important parts of any trial is determining the study groups. The most common method is to use a parallel-group design, where all of the participants are randomly placed into two groups, one for placebo and one for the actual treatment. The researchers also need to decide if the study should be blind or even double-blind, where not even the researchers know who is in which group.
If the goal of the trial is to demonstrate the safety of a new drug or product, then the design will need to be approved by the FDA in order for the trial to commence. Researchers provide justifications and requisite paperwork to satisfy the FDA’s demands.
2. Select Participants for Study
One of the hardest parts of a clinical researcher’s job is to find people willing to participate in a trial. Many people are reluctant due to fears or simply because it may be inconvenient to participate. Even if people are willing, they might not be suitable for the trial.
For instance, imagine you were going to conduct a trial on a new contraceptive for women. Naturally, you wouldn’t include males in your study, but you would also have to consider the ages and health of the women you incorporate into the trial. Many willing people may not be eligible because of prior conditions or contraindications with the medicine you wish to test.
Researchers work tirelessly to recruit enough people and keep them coming back to complete the study. This calls for charisma and good people skills. A clinical researcher is much more than just a scientist in a lab coat.
3. Record Data
The bulk of the work that researchers perform involves collecting data from the participants. Every time a participant returns to the research site, researchers record vital information about the patient and record their progress. This data will determine how successful the treatment is and whether it’s fit for another round of trials.
The most committed researchers will accommodate participants’ odd schedules, make numerous phone calls, and send dozens of emails. If too many patients drop out of the trial, it means thousands of dollars and hundreds of hours have been wasted. Nothing deflates a researcher more than a lost trial.
4. Follow Up With Participants
Even after the trial period ends, researchers still have work to do. They need to evaluate if there have been any long-term side effects of the product. In addition, they also need to see if the patient’s condition has regressed since they stopped taking the trial medication.
Follow-up visits allow researchers to complete their trial and gather more crucial information. Once again, interpersonal skills become a must as researchers need this vital information to conclude their work.
5. Publishing Results
A good clinical researcher is both a mathematician and a strong writer. Most of us as students were probably only good at one of those two subjects. But researchers have to combine these skills to take the data from a trial and turn it into a publishable study.
After crunching the numbers, researchers analyze their findings and determine if their trial was successful or not. The FDA requires a new medication or product to be at least 50% as effective as what is already on the market, so researchers must also compare their results to other published studies.
Once the text has been finalized it can be sent to medical journals for publication and turn into authorities for government review.
6. Peer Review
Another important job for researchers is peer review. Studies are more credible when they have been reviewed by an independent researcher who did not participate in the trial. In fact, California actually requires that all medical publications be peer-reviewed.
Some researchers may even perform validation studies where they attempt to replicate the results of a trial on their own. These studies can strengthen original findings or reveal new information that may have been missed by the original research team.
The Value of Researchers
Modern medicine and advancements in medical technology would not be possible without the support of dedicated researchers. Our research projects are led by our two board-certified plastic surgeons who, both individually and collaboratively, have published dozens of studies.
If you need a research team to help you with your next trial, are considering participating in a trial, or want to pursue a career in clinical research, contact DeNova Research of Chicago today to schedule a meeting.
