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.
The value of Biobanks is not simply measured by the number of samples held in inventory, but how those samples can be optimised for use in investigative scientific research. Unless the samples held in the Biobank provide significant value in research then valuable time, money and resources can be wasted in storing and preserving unusable samples.
The role of Biobanks is becoming integral to providing researchers with high-quality samples that can be used in scientific research. With the emergence of precision medicine; providing accurate, detailed clinical information against each sample, including demographic data, lifestyle information, diagnosis and treatment history, 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
Challenges of combining clinical and sample data
Rising to the challenge of combining all this data into one centralised location can raise several complex questions including:
- 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 to begin – the steps to implementing a single clinical and sample system
- 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.
- 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.
- 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 it is stored, 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?
Software Solutions for Clinical and Sample Data Management
Traditional Sample Tracking and Laboratory Information Management systems 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.
There are Laboratory Sample Management Software systems that have been offering this advanced capability for over 15 years, including Achiever Medical by Interactive Software Limited. This product’s unique data encryption capabilities have enabled Patient Identifiable Information (PII) and sample data to be stored in one central application, whilst protecting this sensitive information from unauthorised access either from within the system or via its SQL database. The solution has been rolled out across multiple departments in numerous organisations with diverse business and data requirements, helping meet compliance requirements including the Human Tissue Act (HTA), through comprehensive consent and auditing tools. The product’s public-facing portal allows external researchers to search for and request samples within the Biobank using a combination of sample and clinical data criteria. Prospective sample requests can also be made allowing the Biobank to identify potential new opportunities.
If you are looking to integrate clinical and sample management data in your Biobank or across your labs and need some help – contact our team to discuss your requirements or arrange a demonstration.