Alzheimer's disease (AD) remains one of the most challenging diseases to treat medically, and it impacts millions of people. Although AD primarily directly impairs cognitive function, it also impacts the emotional well-being of both the patients and their loved ones. Clinical trials offer hope for many people by testing potential treatments. But what happens when these trials come to an end?
Standard Endings of Clinical Trials
Ideally, the clinical trial will run for the intended length of the study, and participants will know well in advance when that end will come. There will be a plan in place for the next steps of the study, depending on what phase it is in. Upon the completion of a clinical trial, several steps take place:
Continued Care
Once a clinical trial ends, participants remain an integral part of a worldwide volunteer community committed to medical progress. As a participant, your health journey may continue beyond the study's conclusion. Your healthcare providers and care team will consult with you to explore options for continued care. This could involve joining the next phase of the study or determining the best course of action for your individual health needs. Your ongoing contribution and participation are invaluable in the collective quest to address critical health questions and develop new medical treatments.
Data Analysis
Researchers meticulously review and analyze all collected data to determine the result of the treatment and if it should move forward. Even if the study was not successful in its initial objective, there is still learning to be done from the data about why it was not successful and how the research can move forward.
Publication
The findings, whether positive or negative, are usually published in scientific journals. This transparency ensures that the entire medical community benefits from the research.
Further Trials
In phase 1 and 2 clinical trials, drugs frequently go through further testing, even after the original trial ends, to ensure further safety and effectiveness.
FDA Approval and Go-To-Market
After phase 3 clinical trials, if the results are promising, they are submitted to the Food and Drug Administration (FDA) for approval. If the FDA decides to approve the treatment, the treatment is released to the public. There are often aftermarket studies that continue to monitor the treatment for long-term safety and effectiveness.
When Clinical Trials End Early
Trials may terminate early due to a variety of reasons, including insufficient funding, enrollment challenges, unforeseen safety issues, or lack of promising results. The Institutional Review Board (IRB) and the research team will make the decision necessary to prioritize the safety and well-being of the participants. Participants will be informed promptly about the cessation of the trial and the subsequent steps. While they might not always reap the anticipated benefits from the experimental treatment, follow-up care is often available, and alternate treatments might be suggested.
Learning The Results
All participants have a right to know the outcome of the trial, but it can sometimes take several weeks, months, or even years for a trial to be completed. Talking directly to the research team is the most effective way to learn the results of the study. Should direct contact with the research team become challenging, results can often be found in clinical trial registries or through the National Institutes of Health (NIH).
Coping and Seeking Support
Participation in a clinical trial is both hopeful and exciting, particularly with the potential for groundbreaking discoveries. Naturally, early termination or a failed study can lead to disappointment and uncertainty. Regardless of the trial outcome, remember that every contribution furthers Alzheimer's research. During such times, it's beneficial to lean on family, friends, or support groups. Discussing feelings with healthcare professionals can also offer comfort, as they can guide you toward additional resources or alternate treatment paths.
Your Role in Alzheimer's Research
Active participation is the foundation of successful Alzheimer's clinical trials. Those interested can consult their primary healthcare providers, reach out to ATRI, or search for ongoing trials in their area. Together we can move toward a world without Alzheimer's disease.
