When the term ‘Next Generation Biobanking’ was introduced a couple of years ago, it underlined the importance of storing clinical data, such as diagnosis, clinical trial and treatment information alongside sample data.
You measure your Biobank’s value on how you optimise and use your samples in investigative research. Not by counting the number of samples you hold. Storing and maintaining your samples is expensive. And unless the samples you are holding in your Biobank provide significant value in research; you will end up wasting valuable time, money and resources storing and preserving those samples.
Your role as a Biobank is becoming increasingly important to researchers. You need to be visible, accessible and able to provide high-quality samples that they can use in scientific research. With the emergence of precision medicine; your ability to provide accurate, detailed clinical information against each sample, including demographic data, lifestyle information, diagnosis and treatment history is essential. As a result of this, you are able to offer highly specialised biological material that can offer invaluable insight such as helping identifying trends, common risk factors or indicators.
The expectations of researchers have also changed as a result of advances in technology and an increasingly competitive marketplace. Researchers expect to be able to locate and find samples with very specific characteristics and biomarkers – quickly and easily.
“If you have a biobank, and all you know is the diagnosis of the patient and the age of the patient, your options for doing something with that information are very limited,” Dr. Barnholtz-Sloan says. “But, if you also know what treatment the patient received, how long they survived, and/or whether or not they had other diseases, these factors make the biobank data more valuable….” [1]
The challenges of combining clinical and sample data
Although the benefits of holding clinical data alongside sample information are invaluable – it’s not always so easy to do. You may find yourself answering ethical, legal and logistical questions. These can be overcome but it is important to recognise and address them. So, when rising to the challenge of combining all this data into one centralised location you should consider:
- How can you store Patient Identifiable Information (PII) alongside biological sample data that researchers require to carry out their day to day tasks?
- How can you ensure consent is managed appropriately?
- Is it possible to manage different, often complex, Standard Operating Procedures (SOPs) in one system for your teams such as Research and Discovery and Clinical Trials?
- Do you need all the information in one application, or can you get a consolidated view across the different systems?
- How can you improve collaboration across your institute?
- Do you have the infrastructure to manage this?
Where do you even begin?
It is important to remember that there are organisations out there already successfully doing this. Talking to them will help make sure you are prepared. There are also associations including UKCRC and ISBER that can help outline best-practices. Plus, they hold events where you can get advice and discuss your requirements with industry-experts and your peers.
It is also important to make sure that you know exactly what you are trying to achieve and why. So, a review of how you currently work and how you want to work is critical including:
- Understanding your key business objectives and customer requirements is the first part to defining a strategy that ensures you are building up a Biobank of samples that researchers will value.
- Identifying and understanding all your data sources is critical. This includes both data inputs and output and includes knowing:
- All the places you hold data and how you store it, such as spreadsheets or databases
- The accuracy of that data. For example, is it consistently formatted, is it duplicated on other systems and is it audited?
- Are there any mandatory data requirements and are they consistent?
- Can you backfill any gaps in data and if so where can you get this data from and will it be accurate?
- Reviewing and updating your existing Standard Operating Procedures (SOPs) to ensure they meet your strategy, identifying any gaps or new processes as well as reworking or removing any unnecessary overheads.
Software solutions for clinical and sample data management
Traditional Sample Tracking and Laboratory Information Management systems (LIMS) have comprehensive sample and laboratory process management capability. Some of these have recently started to offer functionality to capture additional clinical and patient consent data.
However, our Laboratory Sample Management Software system, Achiever Medical has been offering this advanced capability for over 15 years. Its unique data encryption capabilities allow you to store Patient Identifiable Information (PII) and sample data in one central system while protecting sensitive information from unauthorised access. It does this by encrypting your data in the database. And your data is protected from both users accessing the system and your IT team accessing the back-end database.
We have successfully implemented Achiever Medical in organisations that have teams with very different business and data requirements. It helps you to meet compliance requirements including the Human Tissue Act (HTA), through comprehensive consent and auditing tools.
Plus, Achiever Medical’s public-facing portal also allows external researchers to search for and request samples within your Biobank using a combination of sample and clinical data. Prospective sample requests can also be made allowing your Biobank to identify potential new opportunities.
References:
[1] https://www.genengnews.com/magazine/november-15-2018-vol-38-no-20/the-evolution-of-biobanking/
Further reading:
- ‘Holding patient clinical data in Biobanking software and sample management systems to improve your clinical research results’ – Holding patient clinical data in Biobanking software and sample management systems to improve your clinical research results
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