Patients today want greater access to and control of their healthcare data than ever before. They also require the ability to share it with whomever they believe will provide them with tools for better health. Historically, there’s been a reluctance on the part of pharma companies and other healthcare providers to share patient data due to fear of transgressing privacy laws and potentially losing a competitive edge.
In this post, we explore the increasing demand from patients for greater ownership of their data and how this impacts the running of clinical trials.
Patient Wish Lists
Any non-blinded data should be made available to patients from the screening process throughout the trial and after completion of the study. This is what proper patient engagement looks like, explains Dr. Andreas Koester, vice president and global head of Janssen Clinical Innovation.
Not only does this approach result in more engaged patients, but it’s the right thing to do in clinical research, he adds. The feedback from patients has been clear: The data is from their bodies and they have the right to access it in a format that is easy to understand. Adopting this approach, Koester says, ensures patients become true partners rather than just participants in clinical research.
Give Patients What They Want
One of the main reasons patients take part in trials is for access to their data. In fact, it is even more important to them than access to free healthcare, writes Ken Getz, founder and chair of CISCRP. However, what actually happens most often is patients learn about study outcomes through general announcements from sponsors or in the news. They end up feeling let down and disregarded.
Change is taking place, though. In addition to some pharmaceutical and biotechnology companies delivering trial results in easy-to-understand language, they are aiming to provide patients with personalized findings. In the future, Getz says, patients will be able to attach clinical trial data to their EHRs so they can easily share that information with treatment providers.
Data Sharing as a Catalyst for Change
Granting patients, researchers and sponsor companies access to data can lead to innovation. More data increases the chances of medical breakthroughs, writes Dr. Ulo Palm, head of global drug development operations at Allergan. It’s no wonder patients are pushing for this to happen.
Palm explains that patient advocates in disease areas without effective treatment options, such as Parkinson’s, are pressing for data to be shared among industry players. They want to be able to dictate where their data ends up to help speed development of and access to treatment.
Examples of Data Sharing Initiatives
Palm lists a number of projects that have arisen because of patient demand for change, in addition to. These include:
- The Cancer Moonshot Initiative was launched by former Vice President Joe Biden to improve data sharing and to break down silos preventing the exchange of information.
- The International Committee of Medical Journal Editors now requires researchers to share deidentified patient data for publication in medical journals.
- The Accelerating Medicines Partnership is a collection of pharma companies committed to sharing data about diseases such as Alzheimer’s, Type 2 diabetes, rheumatoid arthritis and lupus.
- The Placebo and Standard of Care Data Sharing Initiative focuses on reusing data from historical studies.
The FDA now also has clearer guidelines for sharing clinical trial data on the ClinicalTrials.gov database.
The Impact of Patients’ Access to Data on Trials
Data subject rights include the right to access, correction, restriction and objections, along with the right to be forgotten. Rights include prior consent, explanations in plain language and notification of any data breaches.
Because of the explicit requirements of patient consent and the necessity of this data for scientific research, clinical trial data occupies a special category, explains Greg Gogates at CRF Health. This means that after patients have consented to their data being collected — and knowing the reasons why — they no longer have the right to erasure or portability. This is because the data cannot be removed from the dataset without impacting trial statistics.
However, subjects can leave a trial to prevent any further data being collected. Ensuring people know their data rights has become a priority, as seen in recent regulations such as GDPR.
Clinical trial data occupies a unique category, but Gogates says this just means sponsors and trial staff must be transparent and accountable as to how they use the data, who processes it, and where it is transferred and shared.
The Tricky Question of Data Ownership
Ownership of medical data is not straightforward. It could lie with a patient’s physician, medical institution or even a third party, says Raj Sharma, CEO of information platform Health Wizz. The result is that data may not be regarded as the patient's property. There is a problem with this idea especially as the industry moves towards more patient-centric approaches to research.
Data comes from patients, so why shouldn’t they own it? Different states have laws as to who owns medical records; however, Sharma notes that only New Hampshire outlines in explicit detail that patients own their health data. Under federal law (as well as the laws of most other states), once patient data is captured and documented in written or electronic form, the owners of the media on which the data is stored become the legal custodians that record. Of course, they are required by law to act responsibly when handling the data.
Sharma says this means patients own the information stored in health records — but the records themselves are owned by their healthcare provider.
Despite this, it’s becoming easier for patients to access and control their information and to become more engaged with their own healthcare and treatment. Sharma argues that the time will come when patients will be able to treat their data as an asset to be sold or donated for clinical research.
Moving From Data Ownership to Data Access
Patient data held by CROs and pharma sponsors gives those entities a competitive advantage, so there is a reluctance to share it. The technology exists for it to be shared but attitudes persist in prohibiting this from happening, says Lisa Henderson at Applied Clinical Trials.
This lack of transparency and access also places a burden on clinical investigators, who often have to answer the same questionnaires and submit the same forms many times. It’s also a sore point for patients. Henderson refers to cancer survivor T.J. Sharpe’s tweet to a #Bridging2018 panel discussion about the need for data integration in clinical trials to be EDC-agnostic and created open source principles.
“Need to move away from data ownership and to data access” re: #patient data @ #Bridging2018 #EHR panel. HUGE concept. “This data may be important enough to save your life”. Yet EHRs, trial sponsors still believe the data “belongs” to them. Are. You. Listening #JudyFaulkner??
— TeamTJ (@TeamTJSharpe) April 4, 2018
Ask and Patients Will Give You Data
Patients struggling with diseases and seeking treatment often form supportive communities to help others going through similar experiences. It’s not hard to believe then that patients want to be data-sharing partners, Aetna CEO Mark Bertolini says. Especially if pharma companies and other relevant parties can demonstrate how cooperation delivers benefits to patients.
By making data easier for patients to access and understand, they will be more inclined to share it with healthcare providers, Bertolini suggests.
Data Privacy Concerns
While some may believe in the altruism of patients sharing their data, the reality is that many want to know they have control over how that data is shared. This is why discussions of data sharing always raise concerns about privacy and security. It’s also why those handling the data need to ensure high levels of security, writes Andrew Burrows at KNect365 Life Sciences.
These standards should be more stringent than HIPAA requirements and grant patients the right not to share their personal data. A more pressing a concern, he says, is to ensure data does not fall into the hands of competitors or criminals which may then be used to thwart healthcare outcomes.
Indeed, this is why the FDA has often limited the release of data as large sponsors are worried about competitors acting on the data by improving their market offering.
Many tout the efficacy of the blockchain of keeping data safe and data transactions transparent. This is why the technology is being used to manage personal health records, says Pradeep Sreekanthan at healthcare blockchain consortium Embleema. It is patient-driven and HIPAA-compliant and relies on the smart contract platform, Ethereum.
The platform enables patients to gather their data from multiple sources, and own and share their data with healthcare stakeholders. It also allows patients to receive payment for participation in clinical research, without the need for third parties to be intermediaries.
As the clinical trial industry strides towards a more patient-centric model, it will have to take note of the importance patients attach to their data. Whether this requires pharma companies to relinquish control over data and third party providers to enable better collation and potentially monetization of data remains to be seen.
What must happen, of course, is that patients feel that their data is secure and respected and accessible to them to make the best healthcare choices they can.
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