Clinical trials are important part of drug development process because they provide safety and efficacy information for the tested medications. They also provide more treatment options for the patients, especially for disease areas where the treatment alternatives are very limited.

Clinical trials are very complex due to the extensive regulatory requirements. However, one of the biggest challenges is recruitment. According to some statistics 80% of the trials fail to meet recruitment targets. 

But what is preventing the physicians and their teams to meet the recruitment?

There are lots of factors affecting the recruitment, for instance not enough experience of the team in taking informed consent, overestimation of patient population that will meet the protocol criteria, poor communication between different departments involved, etc., but still the main challenge remains – lack of resources.

  • Majority of the teams have only 1 physician and 1 research nurse. 
  • Majority of the physicians have to work on clinical trials on top of their normal workload in the hospital. Some of them work in more than 1 hospital and are involved in academic work as well.
  • Majority of the nurses work part time and are not available during the whole week. Some of them work full time and clinical trails activities are addition to their workload in the hospital. Nursing team often have to cover lots of trial – for example, a cardiology team in UK has been working on 20 different trials.
  • Pharmacy team is often limited to 2 people, pharmacist and pharmacy technician. They are not able to cover weekends or out side of working hours. For example, a pharmacy team in London is covering over 100 clinical trials.
  • Radiology teams have waiting lists of patients who are on standard of care and they struggle with the workload and extra documents requirements for clinical trials patients. Often radiologist work on rotation in different hospitals.

What could be done to support clinical trials teams?

In the current economic climate it will be unrealistic to expect that these resource issues will be easily resolved by hiring more staff. So the question remains – what can we do to help all people working on clinical trials and looking after their patients at the same time? Some of the suggestions are:

  • Reconsider the administrative support – try to allocate as much as possible administrative tasks to administrators and allow clinical teams to have more time for their patients.
  • Back-up and additional support – make sure clinical teams have backup in case someone is on annual leave, in a different hospital or in a clinic.
  • Improve communication – establish a data base with contacts so clinical teams will know how to get in touch with their colleagues from other departments who also work on clinical trials.
  • Knowledge sharing meetings – organize knowledge sharing meetings between the clinical trials team within the hospital. 
  • Clear standard operation procedures – create clear SOPs for all clinical research teams that will guide them how to deal with emergency situations and who is the best person to contact.
  • As a nurse recently mentioned “no need to invent the wheel” – support open communication and interactions between the clinical teams in the hospital. Encourage support and referrals between the different clinical teams. 
  • Provide tools that will help the teams to keep on top of study requirements and recruitment.

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 Feb 2014