According to the latest estimates from the World Health Organization, there are over 19 million cancer patients worldwide. Oncology treatments help save millions of those patients’ lives every year. But how could accelerating the approval process affect their lives? What are the ramifications? Let’s find out together.

Understanding the significance

In a previous article, we discussed how bureaucratic procedures in the European Medicines Agency (EMA) delay patient access to life-saving cancer treatments when compared to its American counterpart, the Food and Drug Administration (FDA). In case you missed it, the EMA took around 240 more days than the FDA to make cancer treatments available to patients. In the same article, we mentioned that “When we talk about cancer, every day matters!”. But how?    

Many studies have discussed the reverberations that delays in cancer treatment have on the death rate. In a systematic review and meta-analysis published in the British Medical Journal (BMJ), researchers found that a one-month delay in cancer treatment translates into a potential 10% increase in the risk of death! This means that delays have devastating effects on patients who have cancer.  

It’s not only months or days that matter, but also seconds. Research indicates that a 12-second delay in the journey from drug discovery to approval could lead to one life-year loss (the time lost due to disease)! To put things into perspective, a study that assessed the impact of EMA delays on approving only two cancer treatments on the number of life years lost in Europe found that the delay experienced by bureaucratic EMA procedures resulted in a potential loss of over 30,000 life years. As humans, we understand that the consequences extend beyond the numbers. Those years lost are taken away from a family member, a friend, a co-worker, or someone we know.

It’s important to note here that it is not only European patients who experience delays in accessing life-saving cancer treatments. Similar results were obtained when assessing delays in accessing oncology treatments across Canada, Australia, and other regions. Another important thing to note is that even though the FDA is relatively faster when compared to some other regulatory authorities, there is still a delay in patient access to life-saving oncology treatments.

How Narrativa is helping

Narrativa utilizes a suite of generative artificial intelligence and other tools to assist medical writing teams in drafting the initial version of patient narratives and other parts of the clinical study report (CSR) in a matter of a few minutes. This is important because, as we discussed in a previous article, the finalized version of a CSR could take up to 200 days from drafting to delivery! When our solutions were utilized, our clients reported that their medical writing teams had more time to attend to more critical, high-value projects.

In addition to the above, Narrativa has other solutions that support companies in introducing their life-saving oncology treatments to patients. One of these solutions is the automated creation of Tables, Listings, and Figures (TLFs). This solution cuts the time to create TLFs from weeks to minutes. Another tool that offers significant value to regulatory professionals is our anonymization and redaction solution, which can scan thousands of pages within a few minutes to protect the privacy of trial participants.  

When combined, our solutions help pharmaceutical and biotech companies overcome barriers that delay patient access to treatment and dilute the negative effects resulting from bureaucratic procedures encountered with regulatory authorities.

About Narrativa

Narrativa is an internationally recognized generative AI content company that believes people and artificial intelligence are better together. Through its proprietary content automation platform, teams of all types and sizes are empowered to build and deploy smart composition, business intelligence reporting, and process optimization content solutions for internal and external audiences alike. 

Its tech stack, consisting of data extraction, data analysis, natural language processing (NLP), and natural language generation (NLG) tools, all seamlessly work together to produce content quickly and at scale. In this way, Narrativa supports the growth of businesses across a variety of industries, while also saving them both time and money. Accelerate the potential with Narrativa.

Contact us to learn more about our solutions!