The coronavirus pandemic has generated never before-seen attention on the process of clinical trial research. However, it’s also creating frustration among people around the world who feel that clinical trials aren’t moving fast enough to uncover the treatments and vaccines needed to stop COVID-19 in its tracks.
Clinical trial research is extremely complex, detail-oriented work that must be performed with the distinct guidelines set by the FDA and other governing bodies. These guidelines make clinical trials meticulous and intricate in order to ensure their reliability and continuity.
Calculating The Total Doses and Overage Needed
Even before a clinical trial begins or volunteers are recruited, a clinical trial research team must obtain the drug or medical device being studied. This isn’t nearly as simple as calling a pharmacy and placing an order. In fact, entire companies exist just to help clinical trial teams calculate the amount of “overage” they need to ensure they never run out of a drug.
Precise Standardization to Eliminate Variability
The FDA regulates the quality of pharmaceutical drugs using a regulatory standard known as Current Good Manufacturing Practice (CGMP). The CGMP system provides for systems “that assure proper design, monitoring, and control of manufacturing processes and facilities,” the FDA explains. “Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring manufacturers of medications to adequately control manufacturing operations.”
However, CGMPs are only minimum requirements. This is a major consideration in clinical trials, since the manufacturer of the drugs being studied must adhere to the precise standardization of CGMP. A manufacturer that fails to follow CGMPs can compromise an entire clinical study. On the other hand, a pharmaceutical manufacturer that takes initiative to implement comprehensive risk management approaches that exceed the CGMP minimum can add integrity and credibility to a research study.
Designing the Trial
Clinical trial design is so complex that it’s a whole field of expertise in itself. Hundreds of questions must be thoroughly answered in order to design a coherent, successful trial:
- What will be measured to test the drug’s efficacy?
- What is the primary endpoint?
- How many doses will be checked?
- What are patient eligibility standards?
- How many arms will be included?
- How many patients are needed for each arm?
- How will patients be recruited?
- Who will collect and examine data?
These are just a few of the endless list of questions that clinical trial study leaders must consider.
Patient recruitment is a difficult process, one that often leads to the demise of otherwise promising trials. If target demographics are unaware of current clinical trials or don’t even realize they have the ability to volunteer, it’s impossible to achieve a sample size large enough for reliable results.
The NIAID itself recruited, dosed, and monitored thousands of patients at dozens of clinical centers across several continents, just to enroll a properly matched set of 286 treatment patients and 286 control patients.
Generating Useful Data
Finally, once all other challenges are overcome, a clinical trial study is expected to generate useful data that allows researchers to draw evidence-based conclusions about the safety and efficacy of a specific drug.
Even the smallest details can influence data, such as a patient eating or not eating before taking his medication, or overwhelmed doctors and nurses struggling to balance clinical trial duties with their day-to-day responsibilities. It’s essential to establish the oversight necessary to obtain viable data and filter out misleading variables.
This is why most drugs require an average of 10 to 12 years from conception to approval and marketing. The clinical trial process is complex, and must be to ensure reliable results.