Why Do Clinical Trials Fail?

If you're in the wellness industry, here’s a sobering statistic: 90% of clinical trials fail! This high failure rate can be discouraging for companies looking to bring new products to market.

But why do so many clinical trials fail, and what can you do to increase your chances of success? This article explores why clinical trials fail and discusses strategies for running successful Wellness clinical trials using wearable technology.

Key Takeaways

• Clinical trials often fail due to lack of efficacy, safety concerns, poor study design, and challenges in patient recruitment and retention. 

• Misidentification of biomarkers and endpoints also contributes to the high failure rate, especially in wellness products.

• Wearable technology can revolutionize clinical trials by providing continuous, real-time data on participant health and behavior, thus improving data accuracy.

Why Do Clinical Trials Fail?

Clinical trials can fail for various reasons, and here are some of the most common:

Lack of Efficacy

One of the primary reasons clinical trials fail is that the intervention does not demonstrate a significant therapeutic effect in humans. While a drug or intervention may show promise in preclinical studies, it may not translate to meaningful benefits in human subjects. 

This can be due to biological differences between animals and humans or because the preclinical models do not accurately reflect the state of human disease.

Safety Concerns

Another major cause of clinical trial failure is unacceptable toxicity or side effects that outweigh the potential benefits of the treatment. 

Safety issues may not become apparent until larger human trials are conducted and can range from mild adverse events to severe or life-threatening reactions. Careful monitoring and reporting of safety data is critical throughout the clinical trial process.

Poor Study Design

Flaws in study design can also lead to clinical trial failure. Inadequate sample sizes, incorrect endpoints, or improper patient selection can all contribute to inconclusive or misleading results. 

Designing a rigorous, well-controlled study that is adequately powered to detect meaningful effects requires careful planning and expertise.

Patient Recruitment and Retention Issues

Challenges in enrolling and retaining enough participants can also derail clinical trials. Recruitment can be difficult if the eligibility criteria are too narrow or the study demands are too burdensome for patients. 

Retaining participants throughout a lengthy trial can also be challenging, particularly if the study protocol is complex or the interventions are not well-tolerated.

Biomarker and Endpoint Misidentification

Relying on biomarkers or endpoints that do not accurately predict therapeutic response can also lead to clinical trial failure. 

Biomarkers are measurable indicators of biological processes or pharmacological responses, while endpoints are the specific outcomes a trial is designed to assess. 

Choosing the wrong biomarkers or endpoints can make a trial fail to demonstrate efficacy, even if the intervention is actually effective.

What Percentage of Clinical Trials Fail?

The vast majority of clinical trials do not get FDA approval. As noted earlier, a staggering 90% of drugs that enter clinical trials fail to reach the market. 

This high failure rate can be broken down by phase:

• Phase 1 trials have a 33% failure rate. These early-stage trials assess safety and dosing in a small group of healthy volunteers.

• Phase 2 trials, which evaluate efficacy and side effects in a larger patient population, have an even higher failure rate of 60%.

• Phase 3 trials, the final stage before seeking FDA approval, still have a 40% failure rate despite the intervention having passed the earlier phases.

These numbers underscore the immense challenges in bringing a new drug or intervention to market. Even after years of preclinical research and development, most candidate interventions will not prove safe and effective in human trials.

These statistics can be daunting for Wellness brands looking to validate their products through clinical research. However, there are strategies you can employ to increase your chances of success and avoid common pitfalls.

How Can Wearables Improve the Success of Wellness Clinical Trials?

Wearable technology can revolutionize the way wellness clinical trials are conducted. By leveraging continuous, real-world data collection, wearables can provide a more comprehensive and accurate picture of participant health and behavior.

One key benefit of using wearables in clinical trials is the ability to monitor participants 24/7 in their natural environment. Unlike traditional methods that rely on periodic clinic visits or self-reported data, wearables capture objective, real-time data on a range of relevant metrics, such as activity levels, sleep patterns, heart rate variability, and more. 

This continuous monitoring allows researchers to understand how interventions impact participants' daily lives and long-term health outcomes.

Wearables can also improve patient compliance and engagement throughout the clinical trial process. Many devices offer features like reminders and notifications that can help participants stay on track with study protocols, such as taking medications or completing assessments. 

By providing participants real-time feedback and insights into their health data, wearables foster a sense of ownership and motivation to adhere to the study requirements.

Perhaps most importantly, wearables collect more accurate and objective endpoints in wellness trials. Rather than relying solely on subjective measures like participant surveys or diaries, researchers can use quantitative data from wearables to assess key outcomes and other relevant biomarkers. 

This data-driven approach helps to reduce bias, increase statistical power, and ultimately lead to more reliable and meaningful study results.

Overall, incorporating wearables into wellness clinical trials provides numerous advantages over traditional methods. As this technology continues to advance, wearables are likely to become an increasingly essential tool in the clinical trial toolkit.

5 Strategies for Running Successful Wellness Clinical Trials with Wearables

Using wearables in clinical trials for wellness products can improve data quality, participant engagement, and study outcomes. 

Here are five key strategies to ensure your wearable-based trial is a success:

1. Select Wearables Validated for Your Endpoint

When choosing a device for a clinical trial, look for wearables that have been validated for the specific endpoints you plan to measure. 

For example, if your study focuses on sleep quality, select a device with proven accuracy in measuring sleep metrics like duration, efficiency, and stages. Validated wearables provide reliable and meaningful data, increasing the chances of detecting treatment effects.

2. Develop Clear Data Collection and Analysis Plans

Before launching a trial, establish detailed protocols for data collection and analysis using wearables. Determine the specific metrics you will collect, the frequency of data uploads, and how you will handle missing or anomalous data points. 

Create a statistical analysis plan that outlines the methods you will use to assess treatment effects and account for potential confounders. Well-defined data management practices ensure the integrity and interpretability of data from wearables.

3. Provide Participant Training and Support

Proper participant onboarding and support are vital to the success of wearable-based trials. Train participants on how to use their devices, including charging, syncing, and troubleshooting common issues. 

Provide clear instructions on when and how to wear the devices and emphasize the importance of consistent use throughout the study period. Offer ongoing technical support to help participants resolve any problems that arise. Empowering participants to use their wearables correctly can improve data quality and reduce study attrition.

4. Monitor Data Quality and Participant Compliance in Real-Time

One of the advantages of using wearables in clinical trials is the ability to monitor data quality and participant compliance in real-time. Review incoming data regularly to identify any issues with device malfunctions, data gaps, or inconsistent wear patterns. 

Use automated alerts to flag potential problems and prompt timely interventions. Provide participants with regular feedback on their compliance and data quality to reinforce good habits and address any concerns. 

Real-time monitoring allows you to catch and correct issues early, preventing data loss and ensuring a more complete and accurate dataset.

5. Consider Combining Wearable Data with Other Measures for Comprehensive Insights

While wearables provide valuable objective data, they may not capture all relevant participant health and behavior aspects. 

So, to understand treatment effects better, wearable data should be combined with other measures like patient-reported outcomes, clinical assessments, or biomarker analyses.

Integrating multiple data sources provides a more holistic view of participant experiences and helps to corroborate findings from wearable data. Triangulating data from different sources also increases the robustness and credibility of the study results.

Are Wearables the Key to Reducing Clinical Trial Failure Rates?

Wearable technology has generated considerable excitement in the clinical research community because of its potential to improve data quality, participant engagement, and study outcomes. 

However, wearables are not a panacea for all the challenges that lead to clinical trial failure.

Incorporating wearables into a study design requires careful planning and execution. You need to select validated devices for your specific endpoints, develop clear data collection and analysis protocols, and provide adequate participant training and support. 

Real-time monitoring of data quality and compliance is also necessary to ensure the integrity of your results.

Even with the best wearable technology, clinical trials can still fail if the fundamental elements of study design are flawed. Inadequate sample sizes, inappropriate endpoints, or poor patient selection can undermine the ability to detect meaningful treatment effects, regardless of the data collection methods used.

That said, wearables provide valuable insights that inform better trial designs and decision-making. The data captured by these devices can help you refine inclusion/exclusion criteria, optimize dosing and intervention strategies, and identify potential safety issues early. 

Ultimately, the key to reducing clinical trial failure rates encompasses rigorous study designs, diligent execution, and strategic use of innovative technologies like wearables. 

When applied thoughtfully and in the context of sound scientific principles, wearables can significantly enhance the efficiency, accuracy, and patient-centricity of wellness clinical trials.

At Reputable Health, we understand the complexities of running successful wellness trials and how a study can supercharge your marketing strategy. 

Contact us today to learn how we can support your trial.