What Are Clinical Trials?
Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people. Often, a clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Other aims of clinical research include:
- Testing ways to diagnose a disease early, sometimes before there are symptoms
- Finding approaches to prevent a health problem, including in people who are healthy but at increased risk of developing a disease
- Improving quality of life for people living with a life-threatening disease or chronic health problem
- Studying the role of caregivers or support groups
In a study published on September 3, 2025 entitled Nonregistration, Discontinuation, and Nonpublication of Randomized Trials A Systematic Review, researchers sought to investigate the percentage of randomized clinical trials (RCTs) that are unregistered, prematurely discontinued, or unpublished.
The researchers reviewed 347 RCTs receiving ethical approval in 2016 in the UK, Switzerland, Germany, and Canada and found that 5.8% were unregistered, 31.1% were discontinued (predominately because of poor recruitment), and 20.5% did not make results available. Industry-sponsored RCTs performed better than non–industry-sponsored RCTs in making trial results available (often through trial registries) and industry-sponsored RCTs were less likely to be discontinued due to poor recruitment.
So, what is the significance of these findings? The researchers stated: “Randomized clinical trials (RCTs) are critical for evaluating clinical interventions, and nonpublication of RCT findings may compromise the available evidence by distorting the apparent safety and efficacy data of interventions … Findings from this systematic review indicated that nonregistration, premature discontinuation due to poor recruitment, and nonpublication of RCT results remained major challenges, especially for non–industry-sponsored trials. To mitigate these challenges, requirements enforced by funders and ethics committees also taking into account legal obligations should be considered and empirically evaluated.”
The study concluded: “Inadequate trial registration (ie, nonregistration and retrospective registration), premature discontinuation due to poor recruitment, and nonpublication of RCT results remain major challenges in clinical research. The results of our systematic review indicated that industry-sponsored trials performed better in these aspects, whereas non–industry-sponsored trials showed a greater need for improvement. We recommend that granting agencies mandate completion of a successful (internal) pilot trial before funding full definitive trials and require investigators to publish their findings publicly as a condition of funding. When it comes to sharing trial results in registries, it is important to assess the feasibility for non–industry-sponsored trials, particularly given the often high administrative burden on investigators. More pragmatic solutions—such as linking registry entries directly to journal publications—may offer a viable alternative that should be considered by responsible stakeholders.”
If you or a loved one may have been harmed as a result of a clinical trial in the United States, you should promptly find a medical malpractice lawyer in your state who may investigate your clinical trial malpractice claim for you and represent you or your loved one in a clinical trial malpractice case, if appropriate.
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