Glossary of Terms

Trial Conclusion

Most clinical trials proceed as designed from beginning to end, even when they don’t show the results the researchers hope for or expect. Completion of the study allows the scientific community to have conclusive results upon which to base their understanding and design future studies.

Sometimes clinical trials fail despite the best efforts of everyone involved. Clinical trial failures are categorized as either a project failure or a research failure.

The most common reason for clinical trial failure is an inability to prove that a new treatment is effective. The reasons for not being able to demonstrate treatment effectiveness may include:

  • The new therapy shows little or none of its disease-fighting effects researchers anticipated.
  • The treatment may be effective, but:
    • Researchers lack the tools or the data to show this effectiveness.
    • The effectiveness of the therapy is smaller than anticipated and therefore not captured by the tool selected.
    • The trial did not have enough volunteer participation.

Although not as frequent as failing to show efficacy, clinical trial sometimes fail due to safety issues or a lack of funding.

Usually, volunteer participants can’t continue the treatment if the study fails. However, some exceptions can be made which depend on the treatment’s sponsor. The sponsor will consider several factors to decide whether or not to allow continued access to the treatment tested in the clinical trial, including:

  1. The new treatment shows a clear benefit for the individual taking it.
  2. The trial failure was due to efficacy or finances — NOT safety.
  3. The disease being treated is life-threatening.
  4. No alternative treatments are available.

If these conditions are met, and the sponsor is able to keep providing the treatment, the participant may be allowed to continue the new therapy. These exceptions fall under the compassionate use or expanded access programs allowed by regulatory bodies for unapproved therapies.

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