Data collection is vital part of all clinical trials. Missing data could cause results bias and incomplete safety profile, mislead the regulatory authorities, which approve the medication on the market and put patients at risk. Still this is the most common issue in all clinical trials.
There are different reasons that could affect data collection in clinical trials. Usually there is no simple explanation why there is missing data but there are some considerations that could be taken into account.
What could affect data collection in clinical trials?
- Study design – often clinical trials have very complex protocol design that could cause confusion in clinical trials team and patients.
- Too many procedures that do not contribute directly to the clinical trial endpoints – it is common issue that clinical trials can have lots of additional procedures and tests that could burden clinical trials teams and patients.
- Patients’ selection process – some clinical trial teams have problems identifying the right patients for the study and have high dropout rates. Often this is result of their enthusiasm to recruit as many as possible patients for the clinical trial and give more patients access to new treatment.
- Resource issues – often changes in clinical trials teams could result in missing data during the handover process to new team members.
- Missing follow up visits and long-term outcome – there are clinical trials teams and patients who fail to understand the importance of long-term follow up requirements and data collection.
Reducing the amount of missing data for clinical trials requires joint efforts of clinical trials teams, regulatory agencies and sponsors. Often clinical trials teams have limited impact on study design and required procedures and tests but in reality their input is very important for the successful completion of the clinical trials.
What could clinical trials teams do to avoid missing data in clinical trials?
- Feedback your concerns – it is important clinical trials teams to feedback their concerns regarding study design and required procedures as early as possible to help sponsors and regulatory agencies identify potential issues. Standard of care varies between different countries and clinical trials teams are the ones who best understand the health care system and have practical experience.
- Careful selection of patients for the clinical trial – if the team has any concerns that the patient will not be able to complete the study, it is in patient interest to discuss alternatives that will be better for the patient.
- Make sure the team is aware of the critical procedures for the clinical trial – provide training and support to new team members to avoid missed procedures.
- Make sure the team understands the importance of follow up visits – often clinical trials teams pay little attention to follow up visits for patients who are not on treatment. This is due to 2 main reasons – clinical trials teams try to focus their attention to patients who are on treatment and they fail to understand the importance of follow up data collection. Long-term follow up data is very important for drug safety profile and clinical trials teams have to attempt to collect this data. It is important that this requirement is discussed with the patients at the very beginning of the clinical trial and they are aware of the importance.
It will be unrealistic to expect that missing data issue will be resolved, however it is critical that all parties involved make attempt to reduce it as much as possible.
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 25 Aug 2014