According to some statistics approximately 20% of the hospitals participating in clinical trials in US and Western Europe fail to recruit any patients. This may not sound as a significant number but in reality setting up clinical trials at hospitals, which are not able to recruit costs millions to the pharma industry. But pharmaceutical companies are not the only ones that lose in such cases. Hospitals also lose from clinical trials that fail to recruit because they have invested lots of time and resources in set up process and pre-screening activities. Their patients do not benefit from clinical trials that are not applicable for their conditions.
Why is this happening?
Part of the response to this question is some of the myths among physicians involved in clinical trials.
1. Only top specialists can conduct clinical trials.
Majority of the young physicians are under the impression that only leading consultants can run trials and they do not even try to get involved. In reality there are lots of young physicians who have interest in research and if they have the proper support, they will be able to bring new therapies to the patients.
2. I have to promise to recruit lots of patients; otherwise my hospital will not be selected for the study.
Unfortunately this could be quite damaging for the reputation of a new physician who starts in clinical trials. Promising high recruitment without the ability to deliver is causing frustration to sponsors. Sponsors are not aware with your patients’ population and they expect the physician to give them insight on the situation and help them identify what recruitment to expect. Always try to be realistic about recruitment figures. If the physicians often give promises to recruit lots of patients and consistently do not meet the target, they risk not to be selected for any clinical trials in the future.
3. Sponsor expects me to recruit 10 patients, so I have to agree with this; otherwise my hospital will not be selected.
Sponsors always have some targets in advance, however they expect the physician to give them realistic figures on how many patients could be potentially suitable for the clinical trial. Based on the provided figures, sponsors adjust their country targets and plan the whole study ahead. Giving them what you think they want to hear will affect not just the timeline of the clinical trial, but also the timeline of the product that will be released on the market.
4. I have to participate in the clinical trial even if I know I won`t be able to recruit any patients, because otherwise I will jeopardize my relationship with the sponsor.
Promising to recruit patients and not been able to do so could be much more damaging to the physician reputation. Sponsors do not need hospitals that are not able to recruit because this costs them lots of money and resources. They would prefer to have few hospitals that will recruit instead of thousands not recruiting hospitals.
5. I know that we do not have patients for the clinical trial but I prefer to keep the trial open at my hospital; otherwise I can jeopardize my relationship with the sponsor.
Unfortunately this is very common issue and often physicians do not realize that this strategy costs lots of time, money and resources not only to the sponsor but also to the hospital. If the team is not able to identify suitable patients for the trial in 4 months, it is highly unlikely they will be able to do so in the next 2 years. Instead of keeping not recruiting trials, make an attempt to analyze the situation and provide honest feedback to the sponsor. Focus your time, energy and resources on clinical trials that will be beneficial to your patients.
6. All clinical trials are beneficial for the patients and hospital. They are great source of funding.
If the hospital dose not have the patient population required for the clinical trial, the study will not be beneficial for your patients and your hospital. Clinical team will invest time and resources with minimal patient benefit and financial return.
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 Mar 2014