The process of achieving a particular goal is lengthy and complicated. Delivering Clinical Operations is no exception to this principle. Aside from requiring clinical operations expertise such as clinical operations management, clinical trials also need financial support, patient participation, technological knowledge, and regulatory clearances to function and succeed. These components are as vital as they are challenging. That is why failure to comply with these needs can ultimately result in the collapse of the whole study.
To work with limited resources is difficult. It is like going to a grocery store to buy everything essential. Except that you don’t have enough means to purchase everything necessary. So, to make ends meet, you have to make decisions on what goes into your shopping cart and what goes out of your shopping list. In clinical operations, a lack of budget can result in many things: low productivity, inefficacy, and overall study performance.
According to Dr. Duxin Sun, a professor in Pharmaceutical Sciences at the University of Michigan, running a clinical operation requires more or less $1 billion and 10 to 15 years to succeed. This poses a challenge to clinical operations management as acquiring this gigantic amount of money requires obtaining large sponsorships. If a clinical project fails to do so, it could lead to underwhelming, insignificant, and inaccurate results due to cut losses.
As stated by Thomas Hwang, Daniel Carpenter, & Julie Lauffenburger, in “Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results” (2016), 22% of failed studies are due to lack of funding. Underfunded trials may not only miss the chance to generate relevant or even usable outcomes but also may affect the required patient enrollment to show statistical relevance at a predetermined degree of efficacy.
According to a paper published by the US Institute of Medicine “Challenges in Clinical Research” (2010), if patient recruitment is disrupted, clinical operations deliverables are delayed. The slowing down of enrollment can cause the study months or even years to just complete the required number of patients needed for the study.
As also mentioned in the article published by BiopharmaDive in 2019, recruitment has been a running challenge for delivering clinical operations. As for the numbers, 85% of all clinical trials fail to enroll enough patients. 80% are delayed due to recruitment challenges. The Director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, believes that one contributing factor to recruitment challenges is its location. She said that sites for clinical trials are usually selected based on the location of the investigators rather than the patients.
As reported by Eian Kantor in the article” 5 common Clinical Trial Patient Recruitment Challenges and Solutions” (2022), patient sites play a big role in the recruitment of participants in any given study. According to the article, 11% of clinical trial sites fail to enroll even a single patient. Furthermore, challenges in recruitment can be seen in patient databases. Some contact information for potential participants might be outdated. In addition, patients that show interest in participating might lose it due to a lack of interaction and follow-up.
Social and Clinical Value
There is risk in every experiment. But in order to expose a subject to it, the risk must be first justified. Any discovery or results by the society or the scientific community must be shared and gain a significant amount of importance to allow the public to question the inconveniences and outcomes for the common good.
In simple definition, technology is the application of scientific knowledge for the betterment of human life. Essentially, the definition could also translate to the goal of clinical trials. That is why clinical operations incorporate new technologies to produce faster, reliable, and accurate results. New technology can boost the productivity and efficiency of the clinical operations. However, a problem arises when new technologies are not user-friendly.
As mentioned by Marc Leighton in an article on the AppliedClinicalTrialsOnline (2022), one of the challenges that the clinical operations departments face is the duration of the implementation and adoption of new tech. Around 30% of Clinical Research Associates (CRAs) find it difficult to quickly be comfortable in using new technology. Around 60%, on the other hand, suffer from a decrease in efficiency when doing their daily task due to lack of training on how to operate such new tech.
Supposedly, incorporating new technology in delivering clinical operations is to help physicians and researchers alike to ease their workload and stress. It is counterintuitive if applying such devices cause more delay and fatigue that might affect the operation’s performance. Some clinical operation departments are not willing to use new technology because of additional stress. As what Leighton reported, more than 50% of investigators said that they wouldn’t go for their second trial due to pressure and tension.
As what Jacob Vazquez reported on the p360.com website article “4 Challenges With Managing Clinical Trials and How Technology Can Help” (2019), about 43% of pharmaceutical executives say that regulatory approval delays is the common challenge they face. Furthermore, if data isn’t managed and stored correctly, it can lead to a regulatory disaster. More than 30% of clinical operations funding goes to keeping the clinical operations management in compliance with regulatory bodies. The globalization of clinical trials increased the complexities of getting approval from regulatory institutions. That is why standardized record-keeping and tracking all information is as important as it is challenging for clinical operations management.
Keeping track of patient retention, clinical trial protocol, or even adverse events in any phases of the trial requires active data analysis. Updating and integrating data quickly is a problem to many clinical operations for site directors usually rely on manual spreadsheet methods. This gives emphasis that automating reports using software can be very helpful in making standardized reports. Also, such software can provide ease of access to different clinical operations department.
The goal of any clinical trials, in essence, is to make human life safer and better. But in order to achieve such noble and great feats, researchers and physicians alike will inevitably encounter challenges along the way. But no matter how challenging and stressful trials can be, there will always be institutions and technologies available to help the researchers along the way.