Data collection methods vary between different hospitals. Some clinical trials teams seem to be very efficient in data collection while others struggle. Because data collection is a difficult task this is not related to quality of work of the team but more to the methods that they use. Also some clinical trials teams are very experience and they have well-established routine and support from their quality assurance members.
In reality data collection is one of the most time-consuming parts of clinical research. Missing data result in data queries, which the team has to resolve. If we are talking for one patient, this could be an easy task but usually clinical trials teams work on lots of studies and they have lots of patients.
What are the consequences of missing data for the clinical trials team?
- The nurse or study coordinator has to contact the patients again and again to ask for missing information. This could upset the patients and leave them with feeling that there is no coordination in the team. Some patients may even decide to withdraw form the study if they think they are disturbed too often with questions.
- The team has to deal with numerous data related queries, which takes lots of time.
- Constantly missing information could raise concerns about quality of work of the team.
What could be done to improve data collection and avoid clinical trials teams constantly chasing data?
- Use worksheets provided for the study – Majority of the clinical trials have developed worksheets, which clearly list what is required at each visit. Some clinical trials teams are very good in using these worksheets to avoid missing data.
Challenges: Some regulatory agencies do not accept worksheets as source data and the team needs to document all the information again in patients` files, which leads to duplication of work.
- Develop checklists – Some teams have support from their quality assurance group and have their own checklist with required data collection for each visit. The checklist is used as guide and the actual data is documented in the source notes, which allows avoiding duplication. Challenge: A team member has to review the protocol and develop really detailed checklist, which is accurate to avoid confusions.
- Radiology worksheets – Some studies that require regular radiology assessments struggle with inconsistent data. One of the easiest solutions to this issue is to develop radiology worksheet that will capture all assessed lesions and will help radiology team to assess the same lesions at each procedure. Challenge: Clinical trial team has to provide the radiologist who is performing the assessment with the updated worksheet for each patient before the assessment to avoid confusions.
- Develop patients’ questionnaires for medical history, adverse events and concomitant medications – This could be very helpful in collecting such information, which is easily missed. Challenge: Some patients may not be in a position to complete the information due to their health condition.
General advice is clinical trials teams to be more proactive and find the best for them method to collect data. Developing checklists and worksheets may take some time but it will safe time late on when the clinical trial is running and there are lots of patients.
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 15 Dec 2014