Clinical trials can fail for a number of reasons, with the most obvious due to unforeseen toxicity. According to recent research, as many as 90% of drugs that undergo clinical testing and development never reach FDA approval and commercialization (Plaford, 2015). As drug development results in hundreds of thousands, or even over millions of dollars, many researchers are making sincere efforts in comprehending the often preventable causes as to why clinical trials. There are several reasons as to why clinical trials fail more often than not, primarily due to impediments that are largely unrelated to the mechanism or efficacy of a drug.
There are several factors that can ruin a drug’s opportunity for approval at any stage in their development. For example, there are often complications associated with the basic pharmacology, or even confusions that arise prior to the trial when corresponding with the FDA, thus placing a trial at severe risk (Buonansegna et al, 2014). Additionally, once a drug reaches the later phases of research, further impediments can result by way of not meeting specific targets via cost overruns, miscommunication with the FDA, or lack of management. For example, sometimes discrepancies can arise throughout a clinical trial that go undetected by the researchers, only to be found out later by the FDA investigator following submission, which leads to a failed clinical trial (Corman & Davidson, 2007).
Another reason clinical trials fail often is a result of being unable to meet the fixed criteria, stipulations, and timelines that are set forth by the FDA. All too often, companies may accidently forget or neglect at least one of the responses or feedback given by the FDA (Rickels & Robinson, 2007). For example, the FDA requires that toxicology screenings be performed on more than one animal species. Or, they may require that a drug undergo synthesis and evaluation by way of techniques that are utilized for commercial purposes. Pharmaceutical companies that progress to the stage of clinical development without completing these, or other mandates, can thus hinder their chances for further development and approval later in the clinical development, or may even have the drug rejected entirely (Chow & Liu, 2013). Companies can effectively avoid these losses if they invest the proper amount of time and resources to guarantee their drug development success, as well as review all of the FDA requirements and strategize how to address each regulation requirement (Plaford, 2015).
Several other procedural setbacks can greatly hinder the chances of a successful drug trial. Common examples include: misinterpreting a drug’s safety profile by not completely addressing all the possible adverse effects with the FDA, failure to properly comprehend the FDA feedback, and lack of proof in regards to concept data (Schueler, 2014). One key finding in research has concluding that many clinical development trials are often hindered by their failure to address the particular timing of FDA reviews (Chow & Liu, 2013). For example, the Toxicology, Chemistry, Pharmacology, and Manufacturing and Controls require review periods that may take various spans of time to reach completion. Researchers and companies that fail to allocate the proper amount of time for these particular reviews, as a result, may be setback in their own timelines, thus resulting in significant delays. Thus, proper planning with appropriate allocated time could prevent these costly delays (Plaford, 2015).
Risks can arise at any stage of a clinical trial; however, the delays result in hefty costs, or having to repeat the studies as drugs continue to progress through the process. Thus, planning and taking the necessary steps to both recognize and address any risks early on in a trial is essential. However, many researchers and pharmaceutical companies fail to monitor their trials for these particular risks, and only notice issues later when it is impossible to correct the issue without incurring a steep expense (Rickels & Robinson, 2007). While may companies may waver in ending trials hastily, considering that many impediments may lead to either non-approval or possible delay, much research has been conducted confirming that companies who effectively plan and take the necessary steps to identify and address risks and problems in advance have a much higher success rate with their clinical trials (Buonansegna et al, 2014). Thus, following a successful clinical trial, the drugs can then finally reach the market. Finding flaws early on in the development of a drug can hence permit companies to take the crucial steps to either diminish or even remove risks, and also make informed choices as to whether the trial should proceed or not.
In addition, poor study design and too complex protocols can effectively halt the success of a clinical trial. As far as poor study design, researchers often select the wrong patients for which the drug may not work for (“Why,” 2015). Additionally, selecting an incorrect dosage, such as too strong or too weak, can also lead to the inefficacy of a trial. Data sources exist to aid sponsors and researchers in ensuring that the correct types of patients are being recruited for the trial, as well as the correct locations in which the chances for success can be augmented. Complex protocols can also impede upon a successful clinical trial. For example, a clinical trial may include too many, unnecessary questions in just one trial, which can lead to contradictory findings and inaccurate data (“Why,” 2015). The protocols that are more likely to encounter success are those that are simple and straightforward.
In summary, there are a multitude of reasons as to why clinical trials can fail, in addition to toxicity. Not thoroughly researching the FDA guidelines and reviews, not effectively planning for risks or complications, poor study design, and over complex protocols can all deter the success of a clinical trial. To avoid this, companies must measure development protocols against the same standards of which the drugs will be evaluated and reviewed, thus enabling companies to plan for and address risks appropriately.