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Addressing Common Challenges in Clinical Trial Labeling

June 3, 2021

The demand for new pharmaceuticals has never been higher. J.P. Morgan research reveals that the U.S. Food and Drug Administration (FDA) approved an average of 20 to 25 new drugs per year over the past 20 years. But during the last five years or so, the FDA's annual drug approval rate has hovered between 40 and 50.

That stark increase isn't necessarily surprising. As America's population grows older, we're constantly coming up with new ways to safeguard public health. While not every single pharmaceutical developed is done so with the intent of extending a patient's lifespan, many of the products we're now seeing on the market are aimed at improving overall quality of life -- and ensuring that life lasts as long as possible. Whether it's a breakthrough treatment for cancer or a highly effective vaccine for COVID-19, we're seeing the real-life effects of drug development on a near-constant basis.

Of course, developing new medications and treatment methods will typically involve clinical trials and studies. Clinical research plays an essential role in evaluating potential interventions for medical or health-related applications. In many cases, clinical trials will reveal whether a treatment can be considered safe and effective, especially in comparison with any other existing treatment methods.

Without a doubt, clinical trials play an integral role in maintaining or improving public health. That said, clinical research does come with its fair share of challenges. This is particularly true in regard to clinical trial labeling and packaging. Let's take a closer look at some of the challenges you may face with your clinical trial label design -- and why you should evaluate pharmaceutical labeling companies by their ability to effectively address these challenges.

Changing Timelines

An obstacle frequently faced by clinical trial teams is the amount of time given to prepare for and execute the phased trial. In many cases, preparatory periods may be quite short or may even change rapidly with very little notice. Although clinical trial timelines have actually increased during the last few years, this can also present complications for smaller drug companies. What's more, review and approval periods may be much faster than the trial duration, which can lead to complications or even dissolution of public trust.

Because clinical trial timelines can change quickly and without ample warning, this can make it more difficult for researchers to obtain the pharmaceutical labels they need to complete crucial research and testing. In order to meet the needs of your clinical trial, you'll want to work with pharmaceutical labeling companies that can offer a quick turnaround of the high-quality products you expect.

Last-Minute Changes in Trial Protocol

It's not just the trial timelines that can evolve at the drop of a hat. Clinical trial protocols can also change without much notice. This might involve anything from new storage conditions for treatments to the addition of new testing locations on an international level. In many cases, it may also involve changes to the treatment dosage, dispensation instructions, or expiration date.

Understandably, last-minute changes like these can render your existing clinical trial labeling practically useless. As a result, you may have to amend those labels or create entirely new label designs for accuracy and compliance. Because adaptive trials are now becoming more common, the demand for adaptive labeling (or for pharmaceutical labeling companies that can implement changes quickly) has increased. While you may not be able to prevent those last-minute changes in trial protocol, you can prepare for this possibility by ensuring your pharmaceutical label design can be easily amended as needed.

Demand For Multilingual Translations

Clinical trials are often conducted on an international basis; testing may even occur simultaneously in different countries. This presents a distinct obstacle for many clinical trial teams, as it means their labels need to address the needs of multinational users while adhering to local regulations.

Pharmaceutical labeling companies are now realizing that their label designs need to extend beyond the barriers of their home countries. Language management -- including accurate translations, proper formatting, and in-depth inspection -- must be made a priority. Whether you're currently conducting a multinational clinical trial or you have plans to later release a drug or medical treatment in another country, it's imperative that you consider how clinical trial information will be effectively communicated in other languages. Ultimately, this can improve the perception of your pharmaceutical brand or product while safeguarding the health and well-being of anyone involved in a clinical trial.

Risk of Labeling Errors

According to the World Alliance for Patient Safety, annual medication errors cost between $5.8 billion and $27.3 billion worldwide. In the U.S. alone, roughly 7,000 people die each year as a result of inappropriately dispensed drugs. This statistic is already scary enough when it refers to products already released on the market. But during an initial testing phase, the inaccurate dispensation of pharmaceuticals carries even more weight.

It probably goes without saying that labeling mistakes can have major consequences during clinical trials. As a result, you'll want to do everything in your power to eliminate potential labeling errors right away. In order to do that, you can't rely on human sight alone. It's crucial you work with pharmaceutical labeling companies that possess the cutting-edge technology necessary to prevent, identify, and fix even the smallest errors before these labeled products are ever dispensed to trial participants. When you prioritize label defect control, you'll be able to keep patients safe and protect your reputation.

Regulatory Compliance

In addition to error prevention, regulatory compliance will also be at the top of your list of priorities. It's absolutely essential that your clinical trial is conducted in adherence with compliance standards set by applicable government agencies. The U.S. Food and Drug Administration (FDA) and the U.S. Department of Human and Health Services (HHS) are typically responsible for overseeing clinical trials on a national level, while the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) may also play a part.

But in many situations, the regulations established by these agencies won't be the only ones you'll need to consider when designing your labels for clinical trials. If you're performing a multinational study, you'll also need to ensure your labels align with the compliance standards of the pertinent regulatory agencies operating within those specific countries. Keeping up with the latest requirements and ensuring those requirements are translated correctly can present major obstacles for clinical trial teams. Working with pharmaceutical labeling companies with adequate experience in global regulations will safeguard trial participants no matter where they're located. Just as importantly, this will protect your brand and potentially improve your chances of pharmaceutical approval.

Subject Attrition

One clinical trial challenge that's often overlooked is decreasing participant enrollment rates. Because the general public has difficulty trusting in the safety and efficacy of clinical trials, this can create issues for patient recruitment and attrition. Loss of participants throughout a clinical trial can result in major delays and other setbacks.

Although there are many contributing factors that can lead to patient withdrawal from a clinical trial, proper labeling can actually play a role in keeping participants engaged throughout the duration of the study. Ensuring that labels are easy to understand, particularly in regard to medication instructions for use, can help bridge the gap. If your labels force a patient to work too hard to be involved in the study, they won't have many regrets about withdrawing from the trial. You'll want to work with pharmaceutical labeling companies that know how to balance the need for compliance and error reduction with a desire for easy-to-comprehend instructions for safe use.

With all of these challenges in front of you, it's a wonder that drug approval occurs as frequently as it does. But in order for your clinical trial to be successful, you'll need the right labeling and packaging partner. To learn more about how we can help you face those challenges head-on, please contact us today.

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