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.
- Common Pitfalls: Trials often fail due to lack of efficacy, safety concerns, poor study design, and challenges in patient recruitment.
- Targeting Errors: Misidentification of biomarkers and endpoints contributes to the high failure rate, especially in wellness products.
- Wearable Advantage: Wearable technology can revolutionize clinical trials by providing continuous, real-world data to improve accuracy and engagement.
Why Do Clinical Trials Fail?
Clinical trials can fail for various reasons, ranging from biological differences to logistical hurdles:
Lack of Efficacy
The intervention doesn't demonstrate a significant therapeutic effect in humans, often failing to translate from preclinical promise.
Safety Concerns
Unacceptable toxicity or side effects outweigh the potential benefits, leading to trial halts or rejections.
Poor Study Design
Flaws in study design, such as inadequate sample sizes or improper patient selection, lead to inconclusive results.
Recruitment & Retention
Challenges in enrolling enough participants or burdensome protocols lead to high study attrition.
What Percentage of Clinical Trials Fail?
A staggering 90% of drugs that enter clinical trials fail to reach the market. This rate can be broken down by phase:
Phase 1: 33% Failure
Early-stage trials primarily assessing safety and dosing in small groups of volunteers.
Phase 2: 60% Failure
The highest hurdle, where effectiveness and side effects are evaluated in a larger population.
Phase 3: 40% Failure
The final confirmation stage comparing to standard treatments or placebos.
How Can Wearables Improve Success?
Wearable technology provides a more comprehensive and accurate picture of participant behavior. By leveraging continuous monitoring, researchers understand how interventions impact daily lives beyond periodic clinic assessments.
- 24/7 Real-Time Data: Capture objective, real-time data on sleep, heart rate, and activity levels.
- Higher Compliance: Reminders and notifications foster a sense of ownership, reducing dropouts.
- Objective Endpoints: Use quantitative data from wearables to assess outcomes, reducing bias from self-reporting.
5 Strategies for Successful Wearable Trials
Ensure devices have proven accuracy for your specific endpoints (e.g., medical-grade sleep metrics).
Establish protocols for handling missing data and statistical plans to account for confounders early.
Train participants on charging, syncing, and troubleshooting to ensure consistent data flow.
Use automated alerts to flag data gaps or inconsistent wear patterns for immediate intervention.
Combine wearable data with patient-reported outcomes and clinical assessments.
The Key to Reducing Failure Rates
Wearables are not a panacea, but they inform better trial designs and decision-making. By refining inclusion criteria and intervention strategies based on real-world evidence, researchers significantly improve their odds of success.
At Reputable Health, we understand the complexities of wellness trials and how a study can supercharge your marketing strategy.
Don't let your research become part of the 90%. Contact us today to learn how our wearable-integrated methodology can support your next successful study.