As healthcare digitizes everything from insurance claims to clinical decisions, some functions remain frustratingly analog, old school, and inefficient.
One such function is the distribution of human biospecimens necessary for medical research. Specimens are essential in providing much of the data that researchers examine, EHRs capture, and scientific databases aggregate. Unfortunately, the distribution of specimens and their data to researchers is woefully outdated and inefficient. Frankly, it can be a drag on medical progress.
The specimen procurement ordeal
It often takes a research organization many weeks or months to gather an adequate supply of biospecimens to conduct a typical R&D project, and even longer for complex projects. The upfront work entails myriad phone and emails messages back and forth between researchers and potential specimen providers – such as clinical labs, pathology labs, health care systems – just to identify those organizations that are willing to make their specimens available for research. Once identified, staffers at these specimen-providing organizations must then attempt to find specimens that meet the researchers’ needs or identify patients that might be willing to donate a sample. Too often, the parties can’t find enough specimens or patients for the study, which then starts the process over again as researchers loosen their criteria in order to meet their quantity requirements. Finally, the organizations must come under contract with each other before any specimens can be distributed, adding further delays to the process.
This process is frustrating, costly, and time-consuming, and the projects sometimes end up being untenable. In one survey, four out of five researchers told the National Cancer Institute that they’ve limited the scope of their work because of their inability to obtain sufficient numbers of specific, high-quality specimens. We did an informal survey of our own last year and found this is still the case.
The need for specimen procurement is only rising in this era of precision medicine, which often increases the demand for specimens with ever-more-specific criteria. Generic specimens no longer suffice. Rather than 50 samples of breast cancer tumor tissue, for example, a researcher may need 50 samples of tumor tissue from patients with stage 2, triple-negative breast cancer, refractory to a particular treatment. Even when such specimens are available, it takes a lot of time and money to track which suppliers have responded to specimen requests, who can provide the needed samples, how many, when, and for how much.
Once specimens are confirmed to be available, more red tape unfurls contract negotiation (if not already done), compliance audits, ordering, project training, collection tracking, and management, and extensive busy work on the part of both the specimen supplier and researcher.
In the end, the answer is an online marketplace
The solution is simple: This whole process from availability query through payment has got to work more like booking travel online. Unfortunately, biospecimen procurement is a little more complex. There are a lot of moving parts.
Here’s what needs to happen:
1. Catalog biospecimen data – Not every specimen collected for medical research is carefully stored, cataloged, and searchable. It should be. When researchers inquire about the availability of certain specimens, many biorepositories are unable to easily say yes, no, or how many they have. Moreover, there’s no standard way to manage specimen data for those who choose to. In a 2018 biobank survey, we found that only 40% of respondents were using laboratory information systems (LIMS) or laboratory information systems (LIS) to curate patient and specimen data. The majority of respondents in the study stated that their biobanks were using Microsoft Excel spreadsheets, Microsoft Access, relational databases (SQL), other ad hoc systems to curate their patient and specimen data – or no system at all.
2. Harmonize specimen data. Searchability requires data harmonization, and specimen holders need to speak the same language. More than two-thirds of survey respondents reported that they used internally defined standards for data harmonization across their collections. Only 14% of biobanks reported operating with externally defined biorepository standards such as Minimum Information About Biobank Data Sharing (MIABIS) or Ontology for BIoBanking (OBIB). Furthermore, 16% reported using no standards at all for their biorepository data.
3. Link EHRs to specimens. This step will attach to each specimen a wealth of valuable patient data, including their demographics, conditions, treatments, test results, outcomes, etc. The more information a specimen carries the more valuable it is for research. And the easier it is to pinpoint in a search. Every specimen, without exception, should be de-identified to protect patient privacy.
4. Make these inventories searchable. Nearly 3 in 4 of the participating biobanks (73%) in the survey lacked an online system for even their own researchers to search their catalog for the cases and specimens that could meet researcher needs. Once biorepositories are searchable, they should generally be open to credentialed external researchers. Only 44% of biobanks in the survey released specimens to external researchers from for-profit organizations (e.g., pharma and biotech companies) with whom they were not actively collaborating.
5. Bring researchers and specimen suppliers together in one place. Just as travel websites bring travelers together with airlines and hotels, life sciences R&D needs a platform to bring researchers and specimen suppliers together in one place. In the ideal world, all participants in this vast specimen-procurement process should be able to easily connect their enterprise systems – including laboratory information management systems and electronic medical record systems on one side – with procurement systems on the other. It should be a seamless process from inquiry to invoice.
6. Automate contracts and compliance. As part of this aggregation, the platform should simplify contracting and compliance. Researchers and suppliers should be able to easily enter into standard contracts and be confident the platform handles all pertinent ethical details, including IRB and patient-consent terms, such as allowable specimen uses.
7. Forecast demand. Using data on specimen searches, orders, and industry activity, the platform should be designed to provide insights into specimen demand and how it’s changing over time, enabling suppliers to focus on collecting those specimens that researchers really need.
These steps are logical and quite achievable. They should be familiar to anyone who’s made online purchases. What’s needed most is for the healthcare provider community to embrace safe and secure data sharing. That begins with a full understanding of how valuable a human biospecimen really is. Medical progress can’t wait.
About Jill Mullan, Chief Operating Officer, iSpecimen
Jill is responsible for ensuring operational excellence throughout the company. In this position, she oversees iSpecimen’s supply partner programs and operations, human resources, marketing, corporate communications, and corporate strategy. She is also responsible for ensuring regulatory compliance, privacy and security across the company’s operations.
Jill has over 25 years of experience in operational management, strategy, and marketing. Before joining iSpecimen, Jill ran a consulting business to help companies develop business and product strategies, raise funds, create brands, and launch new products. Prior to that, Jill was on the founding team and Director of Marketing at Storigen Systems, where she built and ran the company’s marketing organization, developed the company’s brand identity, and launched several successful products. She was also the Director of Product Marketing and Management at Avid Technology, managing the P&L for Avid’s $400M editing product line.
