Suppose you developed a drug or medical device. It may have worked on a disease or illness you’re targeting. However, the ones who tested your drug were mostly mice and rabbits. While they may have similar physiology as humans, they’re still not humans. Because of that, nobody will try out your drug; and most definitely, the government will consider producing that drug for human consumption illegal.
You need to test your drug or medical device on humans to overcome that dilemma. And the only way you can do that is through clinical trials.
Before you can even start a trial, you need to design it first. You must set and control variables like how many participants, the duration of the trial, the dosage amount, and so forth. Depending on your design, the trial may go well, get your drug or device approved, and prevent any medical incidents during the trial.
If you’re having trouble thinking about how you can design an effective trial, you may want to continue reading.
Aim For A Simpler Scope
Aim to make the trial answer one simple question. Stay away from big-picture problems. By default, the big question is, ‘Will your drug work on humans?’ To work on that problem, dissect it into smaller portions and be precise with your goal. Instead of answering if your drug works on humans, try answering the question, ‘Will your drug work on older patients with X condition?’
Making things simpler can easily get you through complicated clinical trial regulations. And if you do, you may get approved faster by the Food and Drug Administration (FDA) once you send your data to them. And you want to make sure that your data and trial pass CDISC differences and standards.
Minimize The Amount Of Work And Responsibilities Required From Everyone
Making things simpler and easier for patients, stakeholders, investigators, and sponsors can make your clinical trial effective. It also raises the chances of recruiting the best people for their specified roles.
Aside from that, reducing or minimizing the amount of work, particularly for patients, reduces errors in the trial and may keep things much safer for them. After all, it’s difficult to guarantee the complete safety of patients if they’ve undergone intense medical processes like penis lengthening surgery. Also, prioritize activities that’d only help get the answers or data for your trial.
Don’t Forget Your Goal When Designing The Four Phases
Clinical trials have four phases (five if you include Phase 0). Remember that each phase's conditions greatly affect your clinical trial result. You must succeed in one phase to proceed to the next one. Remember that the rate of proceeding to the next phase lowers every phase.
Here’s a brief overview of the rate of proceeding to the next phase according to the FDA:
- 70% of trials proceed to Phase II
- 33% of trials proceed to Phase III
- 25–30% of trials proceed to Phase IV
You need to focus on your goal to raise your chances of making it to Phase IV or the post-marketing surveillance trial.
Plan Your Budget And Resource Allocation Well
Clinical trials can be resource-intensive. And it’s often you’ll get funding from a sponsor or stakeholders. If you can present your budget or allocate your resources properly while planning your trial, sponsors or stakeholders may not approve your funding request.
Be sure to be systematic and set milestones. And in every milestone you reach, review your budget and find ways how you can measure the performance of your trial. If you can’t, your trial may be bound to fail.
Critique Your Design
Usually, you can do this by performing a SWOT analysis (strengths, weaknesses, opportunities, threats). A lot of things can go wrong during a clinical trial. Some of the common causes of failures are inefficient assessment methods and schedules, poor study design, improper trial dosages, and wrong efficacy markers and metrics.
By being critical of your clinical trial design, you should identify whether your trial will encounter those concerns. Is the project manager you’ll choose skilled enough to handle the trial? Is your team capable? Are the protocols too complex for your trial? Do your drug and methods ethical? Can you guarantee that you’ll be able to collect high-quality data?
These are just a few things you can do to design an effective clinical trial. Remember, years of research are at stake at your trial. You might have been researching this drug or medical device throughout your life, and the last thing you may want to happen is to lose all of it because it failed in the phases or has been disapproved by the FDA.