Data collection is a big part of clinical trials and often clinical trials teams find it overwhelming because they feel they don`t have enough time for their patients because of data collection. Although this is a valid point, it is important that that physicians and nurses working on clinical trial understand the rational behind data collection.
Why data collection is vital for all clinical trials?
- Proper data collection allows better analysis of the data for new medications. It empowers regulatory agencies to make the right decision when approving new medications and to assess risk/benefits ratio.
- It also provides serous scientific and clinical evidences, which could be used to make the right decision for future patients` treatment. Based on the data physicians across the world will select the best treatment for their patients.
- Data allows sponsors to evaluate their product and look for improvements and new therapies.
Clinical trials teams need to understand that the data collected by them could affect the future of the medications and the patients who need these medications. This is why it is important that all required procedures and assessments are done as per study protocol.
What are the big challenges with data collection in clinical trials?
- Overcomplicated protocols – Often clinical trials protocols could be too complicated and serous challenge for proper data collection. Physicians and nurses find it difficult to follow them, which could result in missed assessments.
- Patients do not complete questionnaires and follow treatment guidance – Very often patients do not pay much attention to quality of life questionnaires, don`t report adverse events and concomitant medications or miss appointments. There are various reasons for this but the result is the same: inconsistent data.
- Hospital resource issues – Clinical trials teams are often under resourced and sick leave or annual leave of a team member could result in missing data.
- Factors out of the control of clinical trials teams – It is quite common that patient will withdraw consent, move house, change health care provider, switch to a new treatment, etc.
What could be done to improve clinical trials data collection?
- Usage of supporting materials – Almost all sponsors provide supporting materials for patients to help them stick to the treatment requirements. However, in most of the cases clinical trials teams fail to provide them to the patients.
- Protocols supporting materials – There are simplified diagrams and flowcharts for most of the clinical trails but often the teams do not use them or are not aware that they exist.
- Back-up team – It will be beneficial for clinical trials teams to have back-up team members who will be able to cover sick leave or annual leave. Back-up team members could benefit for supporting materials to assure that all assessments were done as per protocol.
- Educate your patients – It is important that patients understand the importance of data collection and they are willing to comply with the protocol.
There is no simple solution to data collection issues but there is a way for improvement.
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 18 Oct 2014