Review: How to improve data collection in clinical trials

Review: How to improve data collection in clinical trials

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. (Updated on 15 Dec 2015: Please note that not all regulatory agencies approve sponsor provided worksheet.)
  • 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.
Published on 15 December 2014
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe
Review: How clinical trials teams can help to avoid missing data?

Review: How clinical trials teams can help to avoid missing data?

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.
Published on 
25 August 2014
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe.
Review: Clinical trials – How to simplify vendor manuals?

Review: Clinical trials – How to simplify vendor manuals?

 

Few years ago a nurse working on clinical trial contacted me to ask about simple instruction on how to send X-ray images to external vendor. I sent her e-mail with 5-step instruction and attached the form she needs to complete. She rang me few minutes later and said, “This is brilliant! But if it is so simple why there is a 40 page manual for this?” This is indeed a valid question.
There are lots of different manuals in clinical trials and all of them are quite extensive and detailed. Vendors always try to include as much as possible information and cover all possible questions but the result is a huge manual that clinical trials teams do not have time to read.
What are the common problems with manuals?
  • Vendor training provided is too long and with too many details and clinical trials teams do not remember all requirements.
  • When the study is initially set up there was not enough training provided during the site initiation visit.
  • Vendor support team is not providing adequate guidance on specific questions and often refers clinical trials teams to the manual provided.
  • During the initial set up clinical trials teams have to go through hundreds of pages to find out how to ship lab samples, register patients in IVRS, enter data, send images, etc. This is very time-consuming process.
  • When a team member is not at work or has left, the new team member has to spend the same amount of time to go through all manuals to identify what is required.
What can be done to safe time for clinical trials teams?
1. Ask the vendor support team to provide simple step-by-step instruction for the procedure. This is their process so they should be able to explain what is required.
2. Keep simple instructions in a study specific folder on your server so your colleagues could find it easily if needed.
3. Once you have gone through the process create a simple procedure that could be used by the whole team.
4. Ask your administrative support to help create a simple procedure.
5. Communicate the procedure to your colleagues.
6. Check if there is a simple way of doing things – is it possible to send the required information online which will be easier and faster?
7. Do not forget to add any specific tips or requirements.
Published on 
12 July 2014
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe.
Review: How to manage adverse events documentation in clinical trials?

Review: How to manage adverse events documentation in clinical trials?

 

Adverse events are one of the critical aspects in clinical trials. Proper collection of potential adverse events will allow adequate safety information on the future drug label and also allow the regulatory agency to assess drug safety in comparison to current standard of care medications. Majority of the clinical trials require all adverse events reported by the patient to be documented and reported to the sponsor. Often clinical trials teams are struggling to collect all that information due to varies reasons – patient forgot to mention it or did not realize it is important, adverse event was reported to GP or another physician, etc.
In order to collect all adverse events information it is important that patients understand how critical is this for their own safety and medication profile. It is also important that all health care providers, which the patient is visiting, are aware that the patient is participating in clinical trial.
What can be done to improve safety reporting process?

1. Educate your patients – Explain to your patients during the consent process the importance of reporting adverse events. Encourage the patient to contact the clinical trial team if there are concerns that the patient may forget to report the adverse event during the next visit.
2. Inform GP and other health care professionals who are looking after the patient – Make sure they know that the patient is part of a clinical trial and they are aware of possible side effects. You can easily do this by providing them with list of common adverse events, especially for product that is not on the market yet and there is limited information.
3. Ask someone from study team to follow up with the patient – Some clinical trials have a big treatment window and patients may not come to the hospital frequently. By the time they come to the hospital for their visit, they may forget the adverse events that have had. You can ask a nurse or someone from the study team to contact the patient and check if there are any adverse events.
4. Inform the relatives – It is beneficial to inform patient family about the importance of reporting adverse events. Sometimes relatives could be better source of information.
Preparing a list of common adverse events could be very beneficial for the study team and will allow them to keep track on possible complications. Also this will help physicians to properly evaluate the causality of the adverse event.
Published on 
13 May 2014
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe.
Review: How to identify patients for clinical trials?

Review: How to identify patients for clinical trials?

 

Although the process of identifying patients looks quite straight forward, often it is not. Some hospitals use their electronic medical records (EMRs), while others – paper medical records. The process is very specific for the particular clinical trials and depends on the eligibility criteria. However, there are hospitals that recruit lots of patients, while others have very high drop out rate (patients not completing the clinical trial).
How some hospitals are able to find patients who complete the clinical trial while others are not?
Lots of physicians and nurses are too eager to get as many patients as possible on the clinical trial in order to meet their recruitment target and guarantee that many of their patients will benefit from the new treatment. But often the fact that the patient meets the eligibility criteria and could be enrolled does not mean that patient has to be included in the clinical trial.
If the patients will not be able to complete the clinical trial, they may not be suitable for the clinical trial at all. A good analogy will be to prescribe medications to a patient, knowing that the patient will never take them. This is a waste of time and resources and the patient does not benefit from such treatment. If the patient included in the clinical trial is not able to complete it, then the patient does not benefit from the alternative treatment.
Dropouts and noncompliance affects significantly clinical trials results because they can cause bias. Missing data has direct impact on drug safety profile; prevent regulatory agency of proper evaluation of the medication and could put at risk future patients.
Main points to consider when identifying patients for clinical trials:
• Is your patient in a proper emotional state to start a new treatment? – If your patient is not ready to start a new therapy or you know it is unlikely to complete the treatment, this may not be the best patient to offer the clinical trial.
• Is your patient immobile or need assistance? – When you plan to recruit a patient who is immobile or needs assistance, you have to assure that your patient has all the required support to attend the visits.
• Does your patient live far away from the hospital? – If your patient lives far away from your hospital, you need to make sure your patient feels confortable with all required visits for the clinical trial.
• Does your patient have compliance issues? – If your patient has problems to stick to current treatment, it is very likely to have the same problem during the clinical trial. Before enrolling such patients, make sure they understand that it is important to take their medications.
• Is your patient likely to have a major surgery in near future? – If your patient has planned major surgery, it is very likely that will not be able to complete the treatment. You may consider other options with your patient.
• Does your patient plan to travel abroad on a holiday or move to a different country? – Make sure the patient will be available during the clinical trial. This may sound irrelevant but there are lots of cases patients going abroad for months.
• Is your patient moving house? – Check if your patient has plans to move to a new place. It could be far from your hospital and your patient may not be able to travel anymore.
• Is the family of the patient supportive? – It is common that the family of the patient may get involved and convince the patient not to participate. You need to discuss the clinical trial with the relatives as well if this is the case.
Before enrolling patients in clinical trials always consider if they will benefit from the new treatment and will be able to complete the study.
Published on 
1 April 2014
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe.