Why Clinical Trials Fail and How to Overcome Such Risks

Over the years, the success rate of the clinical trial has baffled the healthcare market. After all, biotech companies and pharmaceuticals invest a substantial amount of time, resources, and money into clinical trials. 

In fact, according to recent studies, the cost of clinical trials can cost up to an average of $41,117 per patient and $3,562 per patient visit. Considering that standard clinical trials can require up to several hundred participants, the overall total cost can amount to a staggering figure.

However, even after investing such amount of money into clinical trials, the final results are not always promising. In fact, as per the latest statistics posted by MIT Sloan School of Management, the success rate of clinical trials is just about 14%.  

An in-depth analysis of the study revealed that the Possibility of Success (aka POS) for new drugs from phase I to phase IV.  

POS for new drugs entering the phase I was about 13.8% (~14%).

POS from phase I to Phase II clinical trial was 66.4%.

POS from phase II to Phase III was 58.8%.

Finally, the POS from phase III to Phase IV (getting the final approval) was 59%.

So, what does this mean?

Simply put, even if your drug manages to get past phase III of the clinical trial, there is still a hefty 30% chance of failure.

So, why do clinical trials fail, and what can you do to minimize the risk involved in such procedures?

Reasons your clinical trials fail.

It is difficult to zero in on the actual root of failure in the case of clinical trials. The reason greatly differs from one organization to another. Some of these failure-causing variables may be unavoidable. But, in most cases, the problem can be traced down to simply misunderstanding the concept of how to go about designing an efficient clinical trial model.

To begin with, your clinical trial may fail due to the difference in how humans and animals respond to the drug, especially during the initial stages. 

Other reasons may include

  • Limited knowledge about the targeted disease (aka, orphan diseases). Often, when you’re developing an orphan drug, the scarcity of information, can play a massive role in causing the ultimate failure. In fact, studies show that the POS for orphan drug trials is just over 6%.
  • Using under-qualified staff to manage and operate the clinical trial is another common cause of failure. Unqualified (in-house) staffs with their poor knowledge and limited in-field experience can greatly diminish the outcome of your clinical trial.  
  • Implementing a complex and inefficient clinical trial design protocol. Usually, when you design a clinical trial model, it is best to stick with the basic protocol. This makes it easier and also more convenient for both the patient and the investigator’s end to conduct such trials with ease.

What can you do to minimize the risk involved in clinical trials?

The short answer?

Outsource your clinical trials to a professional CRO company.

Top-tier agents like Novotech CRO have established themselves as one of the leading companies that can help streamline the entire process and ensure a better success rate.

How do they do that?

Years and years of experience and comprehensive market-relevant knowledge.   

Simply put, with professional CRO companies, the possibility of error is extremely narrow.

However, if you want to proceed with a more conventional approach, here are some things you can do.

  • Implement a simple clinical trial protocol to preserve the interest of the participating parties.

According to a recent study, the complexity of design protocol is one of the leading challenges in patient recruitment with a sizeable 38%. Besides, 46.6% of people also believe that developing a simple recruitment strategy prior to the study can boost clinical trials’ overall efficiency. 

  • Keep the stakeholders informed about your drug development decisions and spread awareness about your clinical trials.

Most organizations make the crucial mistake of sidelining patients and investigators about the study progress. However, recent studies suggest that 63% of people believe spreading positive awareness about the trial boosts patient recruitment by a significant degree.

  • Set appropriate efficacy endpoints.

Setting a clear and appropriate efficacy endpoint is clinical trial 101. An ideal efficacy endpoint is one that helps you determine if the clinical trial being studied is beneficial. Besides, efficacy endpoints can also include analyzing the improvement in the quality of life, symptoms, relief, and safety of the drug, etc.

About RJ Frometa

Head Honcho, Editor in Chief and writer here on VENTS. I don't like walking on the beach, but I love playing the guitar and geeking out about music. I am also a movie maniac and 6 hours sleeper.

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