ClinicalTrials.gov (2024)

FAQs

Why do 90% of clinical trials fail? ›

“Most drugs will fail in a Phase 2b trial because of lack of efficacy, and part of it is because maybe we didn't choose the right target for the disease, or perhaps we didn't have the right biomarker [measureable substance] to be able to determine whether the drug worked, or maybe we didn't select the right patients.”

Difficulty enrolling patients in a clinical trial can result in costly delays or even termination of the trial. In fact, nearly 80 percent of all trials fail to meet their original enrollment deadline¹ and 55 percent of trials are terminated for failure to achieve full enrollment.

Sometimes these failures are unavoidable, but most of the time they arise due to poor planning or a misunderstanding of key biological and/or drug development principles.

For example, Phase 1 trials offer the highest payments (around $2,000 on average), but this is because the treatments being studied are less well-understood. Phase IV trials, in comparison, offer the lowest average compensation (around $400).

Since 2014, there have been more than 150 deaths related to clinical trial treatments. Should that be a concern for the industry?

Why does 90% of clinical drug development fail? Only 1 out of 10 drug candidates successfully passes clinical trial testing and regulatory approval.

Some trials only include people in a certain age group, or of one sex, or at a particular stage of their illness. The exclusion criteria state who cannot take part in the trial. For example, people who are already taking particular medicines may be excluded as these may affect the trial treatment.

Researchers must be meticulous if they want a shot at receiving approval. Phase III trials can be one of the most time-consuming phases. The longer the trial lasts, the more money it costs, making Phase III one of the most expensive in the clinical trial process.

Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III.

Patient Dropout in Clinical Trials: Implications and Challenges. According to the National Center for Biotechnology Information, around 30% of participants ultimately drop out of trials, which can be costly and result in serious implications for research outcomes.

Are clinical trials a bad idea? ›

Clinical trials do come with some risks. Most clinical trials pose the risk of minor discomfort, which often lasts only a short time. However, some study participants experience complications that require medical attention.

Cancer treatments have the highest clinical trial volume

Treatments for cancer have the highest number of clinical trials by therapeutic area – 15.4% of all trials analyzed.

Depending on the study's complexity and duration, participants can earn a substantial amount of money. This can be particularly appealing if you're looking to supplement your income or save for a specific goal. Clinical research studies often involve drugs and devices that aren't yet available to the public.

You may feel more control by taking a more active role in your health care. You'll likely see your cancer care team more often so that they can monitor your disease and check for side effects of the new treatment. Some study sponsors may pay for part or all your medical care and other expenses during the trial.

How clinical trials pay for travel. Some clinical trials will offer compensation to participants for their travel expenses. Often, this will be in the form of a stipend intended to cover transportation expenses such as gas or mass transit fairs, and certain trials may even cover the cost of air travel.

It takes 10 to 15 years and around US$1 billion to develop one successful drug. Despite these significant investments in time and money, 90% of drug candidates in clinical trials fail.

Clinical trials can save lives and provide new ways to treat disease. The industry estimates that 85% of all clinical trials face delays due to patient enrollment.

The most common factor associated with drug failure in phase 3 clinical trials is the lack of evidence to support efficacy. This evidence is used to support the claim that the drug performs well with the intended effect, and will benefit the individual.

According to the National Center for Biotechnology Information, around 30% of participants ultimately drop out of trials, which can be costly and result in serious implications for research outcomes.