Although the process of identifying patients looks quite straight forward, often it is not. Some hospitals use their electronic medical records (EMRs), while others – paper medical records. The process is very specific for the particular clinical trials and depends on the eligibility criteria. However, there are hospitals that recruit lots of patients, while others have very high drop out rate (patients not completing the clinical trial). 

How some hospitals are able to find patients who complete the clinical trial while others are not?

Lots of physicians and nurses are too eager to get as many patients as possible on the clinical trial in order to meet their recruitment target and guarantee that many of their patients will benefit from the new treatment.  But often the fact that the patient meets the eligibility criteria and could be enrolled does not mean that patient has to be included in the clinical trial. 

If the patients will not be able to complete the clinical trial, they may not be suitable for the clinical trial at all. A good analogy will be to prescribe medications to a patient, knowing that the patient will never take them. This is a waste of time and resources and the patient does not benefit from such treatment. If the patient included in the clinical trial is not able to complete it, then the patient does not benefit from the alternative treatment. 

Dropouts and noncompliance affects significantly clinical trials results because they can cause bias. Missing data has direct impact on drug safety profile; prevent regulatory agency of proper evaluation of the medication and could put at risk future patients.

Main points to consider when identifying patients for clinical trials:

  • Is your patient in a proper emotional state to start a new treatment? – If your patient is not ready to start a new therapy or you know it is unlikely to complete the treatment, this may not be the best patient to offer the clinical trial.
  • Is your patient immobile or need assistance? – When you plan to recruit a patient who is immobile or needs assistance, you have to assure that your patient has all the required support to attend the visits.
  • Does your patient live far away from the hospital? – If your patient lives far away from your hospital, you need to make sure your patient feels confortable with all required visits for the clinical trial.
  • Does your patient have compliance issues? – If your patient has problems to stick to current treatment, it is very likely to have the same problem during the clinical trial. Before enrolling such patients, make sure they understand that it is important to take their medications.
  • Is your patient likely to have a major surgery in near future? – If your patient has planned major surgery, it is very likely that will not be able to complete the treatment. You may consider other options with your patient.
  • Does your patient plan to travel abroad on a holiday or move to a different country? – Make sure the patient will be available during the clinical trial. This may sound irrelevant but there are lots of cases patients going abroad for months.
  • Is your patient moving house? – Check if your patient has plans to move to a new place. It could be far from your hospital and your patient may not be able to travel anymore.
  • Is the family of the patient supportive? – It is common that the family of the patient may get involved and convince the patient not to participate. You need to discuss the clinical trial with the relatives as well if this is the case.

Before enrolling patients in clinical trials always consider if they will benefit from the new treatment and will be able to complete the study.

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Originally published on 1 Apr 2014