The priority is to save lives, not be acknowledged.
The coronavirus pandemic changed how clinical researchers view and treat data sharing. Previously it was a challenging proposition, because researchers want to make sure that they receive appropriate acknowledgement for their hard-won data. Now, with millions of lives at stake, the pandemic has prompted an urgent plea for the sharing and mining of existing clinical data and combining our resources. Most scientists now agree that data sharing is a moral obligation to save lives.
Last February, at the start of the pandemic, I wrote about how effectively fighting an epidemic means making urgent and swift changes to policy and infrastructure. In addition to encouraging data sharing, policy makers must change the current rules. One of the best examples of this was the 2003 SARS outbreak, which ushered in new protocols and increased disaster preparedness amongst healthcare leaders. It even changed the way new hospitals are designed and how patients are screened at triage stations.
Despite delayed policy changes, global forces are increasingly acknowledging the positive impacts of data-sharing and making strides to implement collaborative practices into ongoing trials. For example, the World Health Organization's (WHO) Solidarity PLUS trial, which represents the largest global collaboration among WHO Member States, will be sharing anonymized data after the trial completes. Solidarity PLUS is entering its second phase and will be testing four new therapies—artesunate, imatinib and infliximab—in hospitalized patients, to treat COVID-19.
The Solidarity PLUS trial is a global platform study which allows for the assessment of multiple treatments at the same time under a single protocol. By recruiting thousands of patients from all over the world, involving thousands of researchers in over 600 hospitals in 52 countries, this is one real-world example of how post-analysis data-sharing could help accelerate life-saving research.
Yet, this shift towards collaboration does not come without ethical, legal or operational considerations. How we share data and who we share it with is increasingly important—especially as the industry introduces more technologies to streamline data capture.
In the spirit of openness, below are the learnings gathered from working with our customers on 300+ COVID-19 studies in 40 countries across 1,750 hospitals. Below, I’ve outlined some best practices to follow:
6 best practices for successful data sharing in clinical research
Put patients in control
Patients willing to participate in research are the driving force behind every clinical trial. By undergoing the inevitable burden of a clinical trial, they have earned the right to their own data. We should give trial participants the opportunity to own their trial data, and with that, the freedom to share it with other research projects. The only meaningful way to do that is through standardization of data (see next point).
Additionally, one of the few real use-cases of Blockchain-esque technology in clinical trials is to not only provide patients with a privacy preserving method, but also to track how their data has contributed to the global body of research. Wouldn’t it be amazing to be able to see that, as a trial participant, your decade old research data was used in over 15 scientific publications?
Standardization is non-negotiable
Standardizing data means using internationally recognized concepts like SNOMED or LOINC to annotate data, or in the very least, capture data in an agreed-upon data model so data from these projects can be pooled and analyzed in unison. Therefore, data is most valuable when it’s standardized. The goal is to assemble large amounts of accurate and usable data as quickly as possible. Taking a standardized approach should allow clinical data from around the world to be aggregated, which can accelerate the work of researchers, including large-scale clinical trials.
Never compromise privacy
When collecting data from study participants, you must have the appropriate ethical and legal approvals. This means de-identifying the data. You’d be surprised how many COVID-19 data submissions have required major revisions because they contained personal information. Protecting the identity of individuals and healthcare information is a must, and this information needs to be de-identified.
Give credit where credit is due
Scientists and researchers dedicate their lives to furthering our understanding, and justly want credit for their efforts. For most scientists, seeing their name in a prestigious peer-reviewed medical journal is a career highlight and an acknowledgement of the hard work they and their team put in. So, give credit where credit is due. Acknowledge the scientists and researchers who gathered the data. Any paper should acknowledge the people who actually generated the data, if you’re citing that dataset. Encourage data sharing by giving credit where it's due and acknowledging other people’s efforts.
Data-sharing is not done alone
This should come as no surprise. Building and developing partnerships are essential for successful data sharing. A number of partnerships between organizations and companies which would have never happened pre-pandemic were formed, focusing on finding a treatment for COVID-19. Forming a partnership provides not only financial and technical support but brings the parties closer together to facilitate data sharing, collection, and analysis.
Practice what you preach
Data openness cannot happen without transparent communication. As groups and organizations work together to share data, communication and trust is key. Due to the inherent uncertainty of the rapidly changing virus and global situation, tensions are high, and challenges may include breakdown in communication between different organizations. Having a regular meeting, with shared goals and vision will help to facilitate trust between partners and existing networks. There needs to be an alignment towards a shared vision, and honest and open communication is at the core of any successful partnership.
COVID-19 has forced scientists and researchers to change their views on data sharing. Now is the time to continue to advance scientific partnerships and research collaborations and shift the current industry mindset towards a data-sharing culture to maximize our effort to save human lives.
Derk Arts, MD, PhD, is the Founder & CEO of Castor