As the new quest for individualized cures progresses and patients increasingly constitute an “N of 1,” it’s becoming apparent that precision research will be essential to achieving the promise of precision medicine.
Consider the specimens biomedical researchers need. From pre-clinical research through clinical trials, scientists need increasingly specific human biospecimens and corresponding data on which to execute their studies. Unfortunately, such precise procurement has long proved difficult, requiring researchers to cobble together specimen collections from different labs, hospitals and biobanks across the world.
Specimen providers in turn have been forced to manually pore through medical records to find patients and specimens of interest. This approach has been laborious, time-consuming and costly while typically failing to provide the right number, types or quality of specimens researchers need from the patients they want.
If science hopes to answer to the questions precision medicine poses, such as how disease presents itself in unique subsections of the population, then we must make it easier for researchers to obtain highly specific biospecimens.
In fact, researchers should be able to obtain specimens with the same ease that internet users enjoy to find rare books, travel deals or late-night rides home. They should be able to filter specimen requests by such fine variables as:
• age
• gender
• medical conditions
• treatment history
• outcomes
• even molecular or genetic characterizations.
But how can this be accomplished?
By doing for researchers what e-commerce has done for consumers: bring specimens, specimen providers and researchers together – online – and eliminate unnecessary friction in their transactions.
A central searchable, online biospecimen marketplace pairing a wide array of specimens with the universe of researchers who need them would be a game-changer. It could use technology to manage detailed data about 1) specimens already available for research (such as specimens banked in biorepositories), and 2) patients willing to provide specimens for research.
This single view into available biospecimen supply would make it much easier for researchers anywhere to quickly find the specimens they need from anywhere in the world to drive their studies. An online biospecimen marketplace would also help healthcare organizations that have collected samples to fulfill their research mission by more easily connecting them to researchers who need their samples and patient access. Fortunately, companies are hard at work developing solutions like this.
Moreover, the industry is ripe with similar opportunities to meet unmet health care and research needs using technology. For example, startups are using the internet to enroll patients willing to participate in research and then sending test kits or clinicians directly to their homes to collect samples when they meet research inclusion criteria. All this activity signals a promising shift toward nimbler and more efficient approaches to science, medicine and health care delivery.
A closer look at the need
The progress in information technology parallels that of precision medicine: A flurry of large, small, public and private precision medicine initiatives has begun to deliver results. Patients right now receive targeted and customized solutions in immunotherapy and regenerative medicine.1 As a result of the increased research opportunities, human biofluids, solid tissue, and cells, along with associated patient- and specimen-level data, are in greater demand than ever.
Yet we obviously have a long way to go. Even simple specimen requests have proven difficult – 81 percent of cancer researchers reported limiting the scope of their work due to the shortage of biospecimens back in 20072. Progress threatens to take longer than it should.
Ripe for marketplace benefits
The good news: Clinical sites dispersed throughout the world – including hospitals, labs, biobanks, and blood centers – are home to a wealth of patients, specimens, and data that researchers would love to access.
Although many of these clinical sites have built state-of-the-art biorepositories, these organizations often lack the time and resources to market and distribute their specimens. They also carry the burden of prep work: investigating and extracting medical data to find the right sets of patients and specimens to satisfy researcher requests.
So by default, billions of specimens pass through the healthcare system each year yet end up thrown away or banked indefinitely. Science could put these specimens to better use in research, but hospitals and other organizations often lack the reach to make this happen. And unfortunately, patients miss opportunities to participate in research that may benefit them, their family members, and other patients like themselves.
A cloud-based marketplace is the logical solution to close this frustrating specimen gap. By Connecting providers and researchers, scientists will more easily obtain the specimens they need from the precise patient cohorts required to drive their research. As with any marketplace, both sides will benefit: Clinical sites gain a new revenue stream while contributing significantly to biomedical discovery.
The opportunity for hospitals
Hospitals in particular are well-positioned to contribute to and benefit from their daily flows of patients, specimens, and data across clinical labs, pathology labs and biorepositories. A specimen marketplace gives hospitals a meaningful opportunity to repurpose clinical discards, collect specimens specifically for research, fulfill patient wishes, and at the same time create a new revenue stream to be put back in to operations.
Contributing to research matters deeply to hospitals and other clinical organizations that may be seeking grants, accreditation, or public relations gains. Participation in research could even improve satisfaction of patients, including potential “donors” who correctly assume their specimens are languishing unused today.
Surveys show that patients are eager to contribute to research, whether through the de-identified clinical remnants that are no longer needed for their care or through actively giving samples for research purposes. One study showed 83 percent of Americans are willing to donate their de-identified clinical discards and nearly 70 percent are willing to give an extra tube of blood.3
How it works
An online biospecimen marketplace must first capture and catalog data about available specimens and patients. The technology must also interface seamlessly with IT infrastructure at participating clinical sites to collect data from electronic medical records (EMRs), laboratory information systems, data warehouses, biorepository management systems, and other clinical sources.
This data is de-identified, harmonized and organized by a standard lexicon that allows it to be easily searched across participating clinical sites.
Researchers looking for specimens use an online portal to enter their inclusion and exclusion criteria, starting with a real-time scan of all available cases for specimen and patient matches. When matches are made, researchers can then review the details of each case and select the ones of interest. The participating clinical sites are alerted to collect and pick specimens from the selected cases. Data required to annotate the specimens are automatically retrieved and de-identified before being sent along to the researcher with the shipment of the associated specimens.
Providing this data improves returns on the heavy investments hospitals and medical centers have made in EMR adoption4. With four of every five non-federal acute care hospitals invested in at least a basic EMR system , most healthcare systems are candidates for participation in a marketplace.
Regulatory compliance
There are two ways to obtain patient specimens – either use remnant clinical samples that were originally collected for patient testing purposes, or collect specimens from patients specifically for research purposes.
Under current law, specifically the Department of Health & Human Services’ “Common Rule,” leftover clinical samples may be used for research when no longer needed for patient care without securing patient consent, as long as the physical sample and any associated data sets are de-identified.
Specimens collected specifically for research use, however, fall under a class of studies known as “human subjects research,” which generally requires institutional review board (IRB) oversight and patient consent for use in research.
Conveniently, information technology can also drive consent management. Organizations are increasingly moving from paper-based consent forms and to electronic consent solutions. This change dovetails with the need to ensure that specimens enter research programs only when processes comply with patient, institutional and federal regulations.
As users of healthcare data, biospecimen marketplaces must also comply with privacy and security rules, specifically HIPAA. HIPAA regulations cover how data must be de-identified in order to maintain patient privacy, including the removal of 18 identifiers from healthcare datasets.
HIPAA also specifies administrative, physical, and technical safeguards to reduce the chance that electronic health data is breached. Operators of a technology-driven biospecimen marketplace must be especially careful to protect the identity of participating patients in accordance with these rules.
The Precision Medicine Mission
The goal of precision medicine is to discover targeted treatments for people based upon their unique, specific makeup. But precision medicine will only be successful if precision research – studying many to discover care solutions for one – is first realized.
To meet this need, a technology-driven marketplace will connect clinical sites that have access to patients and samples to researchers who need them. Hospitals are both critical contributors and beneficiaries of this new research paradigm, and they can be at the center of an expansive, federated network of providers and researchers.
With hospitals leading the way, and online specimen marketplaces supporting them, the precision medicine reality will begin to approach the vision.
1 http://learn.genetics.utah.edu/content/precision/action/
2 “The Cancer Human Biobank (caHUB): Advancing the Vision of Personalized Medicine” by Carolyn C. Compton, M.D., Ph.D., Director, Office of Biorepositories and Biospecimen Research, National Cancer Institute, presented at 2nd Annual Biospecimen Research Symposium, March 17, 2009
http://biospecimens.cancer.gov/meeting/brnsymposium/2009/docs/t/Compton%20CC.pdf
3 “Patient Attitudes on the Use of Clinical Biospecimens for Medical Research - An independent, US-based population survey”, commissioned by iSpecimen Inc. and conducted by independent research firm Lab42, December 2015. www.ispecimen.com/blog/whitepapers/attitudes
4 http://dashboard.healthit.gov/quickstats/pages/FIG-Hospital-EHR-Adoption.php
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