Skip to content
Zanteris - Logo
  • Home
  • Company
    • Our Values
    • Our Approach
    • Areas of expertise
    • About us
    • Resources
  • Solutions
    • Clinical Operations Consulting
    • Clinical Project Management Resources
    • Human Efficiency Consulting
    • Strategic Partnerships
  • Insights
  • Contact
Menu
  • Home
  • Company
    • Our Values
    • Our Approach
    • Areas of expertise
    • About us
    • Resources
  • Solutions
    • Clinical Operations Consulting
    • Clinical Project Management Resources
    • Human Efficiency Consulting
    • Strategic Partnerships
  • Insights
  • Contact
August 4, 2022

Factors in Clinical Trial Failures

90% of Clinical Trials fail. Even after all the investment in time and resources, only 1 out of 10 clinical projects passes testing and regulatory approval. According to Dr. Duxin Sun, a professor of Pharmaceutical Sciences at the University of Michigan, developing one successful drug through clinical projects takes around 10 to 15 years and $1 billion to complete.

Clinical Operations may fail due to drug performance, clinical operations management, or legalities. Failure may emerge from avoidable mistakes like poor planning and management and misunderstanding biological processes or drug development. However, some culprits for the failure of clinical projects may arise from unpreventable events.

As stated in a review written by David. B. Fogel, “Factors Associated With Clinical Trials That Fail and Opportunities for Improving The Likelihood of Success: A Review” (2018), there are many chances that failures can arise from clinical trials for new drugs or new medical devices. Failures in such trials can come from lack of efficacy, lack of funding, safety issues, and even nonobservance of FDA regulations or government policies.

Efficacy

Most clinical trials fail because of the inability to exhibit efficacy. According to Fogel (2018), the reasons why potentially efficient drugs fail in a clinical operation can be pointed out as flawed study design, inappropriate statistical endpoint, or underwhelming clinical trial in terms of sample size. Unfortunately, these shortcomings can only be seen later in the clinical projects; Phase 3 to be exact.

In a paper published by Thomas Hwang, Daniel Carpenter, & Julie Lauffenburger, “Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results” (2016), phase 3 in trials can provide the highest percentage of success in experimental treatment. However, even though remarkable investments on the side of participants, researchers, and sponsors have taken place, many experimental treatments still fail at this point.

Hwang, et. al (2016), also added that drugs in their development stages are on their superlatives. However, in these phases, breakthroughs are rare. However, as also stated in the aforementioned paper, drugs that didn’t show signs of efficacy can still be significant for future purposes and evaluation.

Safety

17% of failures in Phase 3 of clinical projects are linked to safety. Although safety is of the utmost importance in a trial not only for the researchers but also for the participants as well, failures in safety are still apparent, especially in clinical studies that have bigger sample sizes or populations. Hwang, et. al (2016) states that safety issues can only be evident in Phase 3 or even in Phase 4 of a clinical trial.

Sometimes, drugs can even be withdrawn even after Phase 4 or the “post-market” stage. This system endorsed by the FDA is called “Pharmacovigilance”. Patients or consumers are encouraged to report any adverse or side effects they are experiencing to collect data and decide whether drugs that are fresh from the clinical trials should be withdrawn from the public or not.

According to Mark Crowther, in his published article “Phase 4 Research: What Happens When The Rubber Meets The Road” (2013), states that phase 4 is required to examine a drug’s performance overtime to anticipate any toxicity or any abnormal events that didn’t take place in previous phases. Furthermore, he added that “Pharmacovigilance” or post-market surveillance remains an integral tool to detect infrequent toxicity. As an additional explanation, he added that the reason Pharmacovigilance is important is that detecting all clinically relevant side effects in sufficient sample size is unfeasible.

Crowther (2013) also gave examples of drugs that were withdrawn from the public due to toxicity detected via Pharmacovigilance. One is Cevastatin, a cholesterol-lowering agent, that was pulled out from the public due to fatalities. Failures in safety can still provide the public information as to what drugs should be avoided and be reported to the FDA.

Organizational Issues

Inexperienced and unmotivated staff are two components of a disastrous clinical operations department. According to Artem Andrianov Ph. D, in his published article “7 Reasons Why Clinical Trials Fail”, he said that the top 2 contributors to organizational failure in clinical projects are unskilled clinical project managers and unproductive clinical operations management.

Clinical Project Managers

Clinical project managers are expected to be experienced, excellent, and expert clinical staff. The problem arises when the clinical project manager has little to no experience. This problem can be possible if a former associate fresh from a clinical project manager training or a newly moved up CRA (Clinical Research Associate) is being placed to take the role of a Clinical Operations Manager. The promotion isn’t the problem, but because of the evident lack of experience, a new CPM or a Biotech can set unrealistic timelines, discord between stakeholders and the staff in decision-making, and unproductive group due to lack of managerial experience.

Negligence of Legalities

According to Chris Plaford, in his published article “Why Do Most Clinical Trials Fail?” (2015), one frequent problem why there is a delay or failure in clinical operations management is the inability to prepare and complete the required criteria set by the FDA. Companies or Clinical organizations that don’t prioritize completing such requisites imposed by the FDA can jeopardize their chances for approval or can face complete rejection of the drug itself.

Funding

Hwang et. al (2016), said that many trials are underfunded. Because of this unfortunate state, many trials may not have the ability to generate beneficial outcomes. 22% of the failures in phase 3 of clinical operations are related to cost issues. The cost of bringing a drug to a market varies. However, some Clinical Operations reported that they have spent $2.5 billion to complete the whole testing with desired accuracy, efficacy, and results. This could mean that underfunded clinical projects can only produce underwhelming, insignificant, and inaccurate results concerning predetermined levels from the planning phase.

Conclusion

Anything can go wrong, but that doesn’t mean success is impossible. This also applies to Clinical Trials and Clinical Operations Management. Nothing can ever go 100% according to the plan, but with clinical operations consulting, clinical operations solutions, and clinical operations expertise, the odds will be in the researcher's favor.

References:

https://theconversation.com/90-of-drugs-fail-clinical-trials-heres-one-way-researchers-can-select-better-drug-candidates-174152
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2565686
https://ashpublications.org/hematology/article/2013/1/15/20867/Phase-4-research-what-happens-when-the-rubber
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479
https://www.clinicalleader.com/doc/why-do-most-clinical-trials-fail-0001
https://cyntegrity.com/7-reasons-clinical-trials-fail
https://www.nuventra.com/resources/blog/why-do-clinical-trials-fail/

Featured Insights

Loading...
1202491940197073.gOUSATFDelIUtv00a9tS_height640
May 25, 2022

Factors To Consider In Making a Clinical Research

Clinical Research is being done to extrapolate, explain, and explore various medical concerns through data and experimentation. Basically, the objective...
READ MORE
1202491940197071.pJ88VakUjZQWAZsXpAJl_height640
May 25, 2022

Keys To Success With Clinical Trials

Clinical Trials is a specialized area of study that faces an ever-changing environment. The shifts in this field are happening...
READ MORE
1202491940197069.2ayavKakJhUoeVrFuELP_height640
May 25, 2022

The Challenges of Clinical Research

Working in a Clinical Project is challenging but rewarding. It also requires the support of many different stakeholders. These include...
READ MORE

What It’s Like Working With Us

… a good sense of what it takes to successfully navigate challenging clinical trials to achieve success on behalf of his customers. In particular, his data and information expertise gave him the ability to mentor, support and coach teams towards a more data driven approach to strategy and outcomes. …

Senior Vice President

Clinical Informatics US
CRO Company

  • Privacy policy
  • Cookie policy
  • Legal notice
  • General terms
  • Terms of use
  • Privacy policy
  • Cookie policy
  • Legal notice
  • General terms
  • Terms of use
©2022 Zanteris – All Rights Reserved
  • Privacy policy
  • Cookie policy
  • Legal notice
  • General terms
  • Terms of use
  • Privacy policy
  • Cookie policy
  • Legal notice
  • General terms
  • Terms of use
Scroll Up

We are using cookies to give you the best experience on our website.

You can find out more about which cookies we are using or switch them off in settings.

Zanteris - favicon
Powered by  GDPR Cookie Compliance
Privacy Overview

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Cookies strictly necessary

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms.    You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

If you set your browser to block or alert you about these cookies, but some parts of the site will not then work.

3rd Party Cookies

This website uses Google analytics cookies to store unique user data in order to get detailed data over how users use and navigate on the website.

We also use social media buttons on our site which allow you to share content and interact with your social network on platforms like Linkeldin and Twitter. These social media platforms may set their own cookies on your device. We do not control the settings of these cookies so we suggest you check the social media website for more information about their cookies and how to manage them.

If you'd like us to improve our website, please keep this cookie activated.

Please activate the "cookies strictly necessary"; so, we can record your choice!