In the

clinical research Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatm ...

trial industry, loss to follow-up refers to

patient A patient is any recipient of health care services that are performed by healthcare professionals. The patient is most often ill or injured and in need of treatment by a physician, nurse, optometrist, dentist, veterinarian, or other health c ...

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 irreversible cessation of all biological functions that sustain an organism. For organisms with a brain, death can also be defined as the irreversible cessation of functioning of the whole brain, including brainstem, and brain ...

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 discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate sympto ...

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 closed-minded, prejudicial, or unfair. Biases can be innate or learned. People may develop biases for or against an individual, a group, ...

on the result of the study as well as a bias on the investigational study

medication A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and re ...

. 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, 1 ...

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 patient’s 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