Patients commit to clinical trials for multiple reasons. However, a prevalent cause is to further medical science — they want to know that their participation has been valuable. Clinical trial data sharing is an important means of showing patients this value but it remains a complicated issue in clinical research. We explore how data sharing can be improved and the role that medical affairs (MA) teams play in making these changes.
The Current Reality of Data Sharing
In January 2019, several leading medical journals agreed that, henceforth, authors must inform them of how they intend to share de-identified data from individual clinical trial patients. Study authors should also reveal their data sharing plans in a public registry such as ClinicalTrials.gov.
This is a significant shift from past practices, according to Rebecca Li, Ph.D., executive director of Vivli, an independent nonprofit organization that has developed a global data-sharing and analytics platform. Under the new policy, researchers are forced to consider how they plan to share data even before the trial begins, she adds.
It’s also a welcome shift. In research published at Data Dryad, only 25 percent of large pharma companies met the data sharing requirements set out by researchers. Jennifer Miller, Joseph S. Ross, Marc Wilenzick and Michelle M. Mello say that levels of data sharing were assessed according to data available at ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms such as the Yale Open Data Access Project and Clinical Study Data Request, and information from pharma companies themselves.
The main reason for not meeting data sharing requirements was that few companies shared results by the specified deadline. When given feedback on their performance, however, most companies improved their data sharing score.
This is good news for all stakeholders, but particularly for patients. Kate Yglesias Houghton, a young adult patient advocate, says it’s vital that patients are informed of trial results. Yet in her experience, this practice remains uncommon. “I’ve never seen the results of any clinical trial in which I’ve participated,” she reports.
The Good Pharma Scorecard
The clinical research community is duty bound to make trial data available. Patients want this to happen because it’s good for science, argue Yale School of Medicine assistant professor Jennifer E. Miller, Ph.D., and Amy Price, Ph.D., patient editor at The BMJ.
Data sharing also assists in public health benefits through independent re-analysis of data, the pair explains. This is why researchers from Yale University, Stanford University and Bioethics International, supported by Arnold Ventures, created the Good Pharma Scorecard (GPS).
The scorecard defines good data sharing practices and compares pharma companies’ data-sharing practices. It provides an annual ranking of new FDA-approved drugs as well as how the drug sponsors have performed in terms of ethics, transparency and data sharing.
Miller and Price say the GPS has had positive results, with many pharmaceutical companies improving their scores within 30 days of receiving them. Beth Snyder Bulik at FiercePharma writes that 95 percent of patient trials now provide public results within six months of FDA approval.
Barriers and Opportunities to Sharing Trial Data
Patient confidentiality is one of the most important concerns when making trial data available. When patients give consent to participate in research, they agree to share data with defined recipients only, explain Susannah Condie and Professor Gareth Griffiths at CRUK Southampton Clinical Trials Unit in the UK.
So data has to be fully anonymized before sharing it with any party that is not a defined recipient.
Anonymizing data is costly, Condie and Griffiths write, and determining which party should bear the cost can become confusing. However, they say that the Clinical Study Data Request (CSDR) — a consortium of sponsors — is a useful mechanism through which to share trial data.
Using the CSDR allows researchers and sponsors to agree to data sharing details as well as set limits on the data’s use.
Beyond patient confidentiality, there are also concerns about market competition, legal contracts and misuse of data, notes Neil Dymond-Green at UK Data Service.
Still, opportunities that arise from data sharing are plentiful too. For instance, data sharing could improve health outcomes through validated research, build on previous research for further discoveries, avoid data duplication and enhance data transparency.
Sharing Individual-Level Patient Data
Individual-participant data (IPD) could lead to better understanding of clinical evidence and greater transparency. The result would likely be more confidence in the clinical trial community, researchers at the National Academy of Medicine say.
Sharing IPD transforms raw data into aggregated data to enable statistical analyses; however, barriers to successful IPD sharing are cause for concern. These range from issues over consent, anonymization of data and the resources needed to enable IPD and metadata compiling. Researchers also say the heterogeneity of data repositories is a problem.
Quality data repositories can be highly effective for sharing IPD. Rita Banzi, clinical research design and management consultant, is a corresponding author for an article published in Trials. In an assessment of 25 available repositories, the team of researchers found an “extremely heterogeneous” offering that had been developed by a range of stakeholders including funders, infrastructures, universities and editors.
The quality and relevance of repositories also depended on their maturity, dataset preparation, contractual agreements, metadata and identifiers. A more robust and formalized system is needed, the researchers conclude.
Paying Patients For Their Data
Patients can now earn money for their data. A next generation legal technology company Hu-manity.co, for instance, reimburses patients and gives them rights to recourse should their data be used against their permission. Sarah Neville, global pharmaceuticals editor at the Financial Times, writes that human data ethicist Richie Etwaru — founder and CEO of Hu-manity.co — offers patients legal title over their data, much in the same way homeowners have title to their property.
Hu-manity.co uses blockchain technology to buy and control patient data. It has 16,000 patients from 70 countries signed up to it and has grabbed the interest of large pharma companies. Patients win, of course, but Etwaru says pharma does too as companies gain access to richer data and better relationships with patients — plus they won’t break any privacy laws.
Blockchain technology is also an effective means to safeguard patient data and improve the quality of that data. The result is greater protection not only of patients’ data but their health, as data is more robust, accurate and unchangeable, explains Uli Brödl, VP of medical and regulatory affairs at Boehringer Ingelheim.
Improving Communication Channels
As we’ve documented before, MA teams are tasked with educating relevant stakeholders and communicating vital information with them. Patients, key among these stakeholders, need to be kept in the loop.
So the work being done by pharma company Janssen is promising. It has launched the Global Trial Community (GTC) to create a dialogue between patients and sponsors before, during and after the trial. Tammy Guld, Janssen clinical innovation, global team lead, says that the GTC enables pharma companies to travel along the patient journey with the patients.
Guld adds this is how the relationship should be; after all, patients want access to what belongs to them: data. The GTC allows for more efficient communications and data sharing.
Creating Layperson Trial Summaries for Patients
Rather than simply sharing medical results, MA teams have the opportunity to communicate information to patients in a meaningful, relevant and accessible manner. That’s what the team at Ipsen has done, tailoring their messaging in the form of a layperson summary.
The Clarinet Trial — a study of somatuline autogel (lanreotide autogel) in non-functioning neuroendocrine tumours of the pancreas, intestines or unknown origin — was the company’s first layperson clinical trial summary.
The company says the goal of a layperson summary is to make data more transparent and accessible to patients and their caregivers.
Patients in trials are the key audience of layperson summaries. But MA teams should write them for any member of the public that wants to know more about clinical trials. The typical audience member will not have high health literacy levels, so simple and clear language is essential, explains Amber Barnes, Ph.D., senior director, head of global medical writing at biopharmaceutical company UCB.
MA teams should aim to inform and explain so patients feel that data is transparent and accessible. Lay summaries are not required by regulatory agencies but some pharma companies are choosing to do so anyway. They wish to move beyond regulatory requirements to provide a more patient-centric trial experience, and show the value to the public of clinical research.
Some ways that pharma MA teams are sharing this data include releasing datasets on portals and registering results on sites such as clinicaltrials.gov.
Sponsors sharing data from clinical trials is becoming more common. Yet barriers persist. Medical affairs teams are uniquely placed to open up channels between pharma and stakeholders, particularly patients. By seizing the opportunities of data sharing, MA teams can make the clinical research process more transparent and accessible to healthcare practitioners, the general public and, most of all, patients.