Lost To Follow-up
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In the
clinical research Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. The ...
trial industry, lost to follow-up refers to
patient A patient is any recipient of health care services that are performed by Health professional, healthcare professionals. The patient is most often Disease, ill or Major trauma, injured and in need of therapy, treatment by a physician, nurse, op ...
s who at one point in time were actively participating in a clinical research trial, but have become lost (either by error in a computer tracking system or by being unreachable) at the point of follow-up in the trial. These patients can become lost for many reasons. Without properly informing the investigator associated with the clinical trial, they may have opted to withdraw from the clinical trial, moved away from the particular study site during the clinical trial, become ill and unable to communicate, are missing or are
deceased Death is the end of life; the Irreversible process, irreversible cessation of all biological process, biological functions that sustain a living organism. Death eventually and inevitably occurs in all organisms. The remains of a former o ...
. __TOC__


Adverse effects

Patients who become lost to follow-up during a clinical research trial result in many negative effects on the outcome of the trial and on the
pharmaceutical company The pharmaceutical industry is a Medicine, medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or Self-medicate, self-administered b ...
sponsoring the clinical research trial. Patients who are lost-to-follow-up lead to incomplete study results, which in turn can put a
bias Bias is a disproportionate weight ''in favor of'' or ''against'' an idea or thing, usually in a way that is inaccurate, closed-minded, prejudicial, or unfair. Biases can be innate or learned. People may develop biases for or against an individ ...
on the result of the study as well as a bias on the investigational study
medication Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmaco ...
. A lack of complete results leads to intensified
FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
scrutiny of the particular study drug, as well as the pharmaceutical company sponsoring the clinical research study. Biased study outcomes also lead to issues of
HIPAA The Health Insurance Portability and Accountability Act of 1996 (HIPAA or the Kennedy– Kassebaum Act) is a United States Act of Congress enacted by the 104th United States Congress and signed into law by President Bill Clinton on August 21, ...
standards and compliance. Aside from partial study data and regulatory issues, patients that are not retained due to being lost-to-follow-up can lead to problems with the progression of any clinical research study. Low rates of retention and high rates of patients lost-to-follow-up have many side-effects, including longer clinical research trial periods and more monetary expenditures because extra resources may need to be dedicated to the recruitment efforts.


Solutions

There are no standards or guidelines that express the process or methods that can be used to attempt to reach patients who have become lost to follow-up. Institutions such as the FDA have taken action over the recovery of or communication with patients lost-to-follow-up. Section 4.3.4 of the ICH E-6 Good Clinical Practice: Consolidated Guidance reads
"Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights."


References

{{Reflist Clinical research