How Can You Increase Transparency with Patients?

In the healthcare industry, patient data is not often made readily available to the public. However, in response to growing pressure from patients, physicians and healthcare advocates, research data is becoming increasingly less private. Moving patient data into the public sphere may increase transparency, but it also presents many difficulties for life science companies. 

What is Patient Centricity?

Life science companies should ideally consider how much information they are giving to patients participating in their clinical studies. One of the measures of patient centricity is the Good Pharma Scorecard. Administered by Bioethics International, pharma companies are ranked based on whether they disclose research data adequately. This ranking system is effectively used as a tool to measure patient centricity, and to signal how often certain companies are sharing their data with patients. One of the concerns that companies run into while trying to achieve patient centricity is successfully balancing transparency with privacy and innovation. There is a delicate balance to be met between all three, and companies sometimes run the risk of being too transparent, and end up violating privacy laws. This remains one of the primary issues for companies looking to share their data with the public.

What to Disclose

Companies will generally disclose their Phase 2 and Phase 3 trial results to the general public, however, this may not be sufficient in light of recent changes to the General Data Protection Regulation (GDPR) or Policy 70 by the EMA. GDPR, the European privacy law, requires companies to process data requests from patients, consider how data will be transferred across borders, and gives patients the right to erase their data, among other things. This may impact how U.S. healthcare providers are treating E.U. patients–particularly now that consent forms and increased data sharing are mandatory. 

When considering what data must be disclosed in clinical trials, companies should also consider the implications of the Declaration of Helsinki. This declaration states that all researchers, sponsors, editors and publishers have ethical obligations concerning the publication of their research results. Further, researchers must make their research on human subjects publically available, and are held accountable for the completeness and accuracy of their reports. The declaration also says that all parties must follow accepted guidelines for ethical reporting, and make all results–whether positive, negative or inconclusive–publically available. This very clearly supports the idea of patient centricity, and the need for patients to receive information about their trial results.

Results of Transparency

While patient transparency seems like a worthwhile undertaking, there are certain issues which companies may run into when releasing patient data. If pharmaceutical companies release all of their research data, for instance, what happens when they start using each other’s data? This poses a problem for companies looking to protect their business intelligence, and maintain their edge over competitors. On the other hand, disclosing research data may be valuable for groups such as healthcare providers, publishers, researchers and venture capitalists. Venture capitalists, for instance, might wish to see research results before investing in companies–giving more transparent companies an economic benefit.


As companies move toward increasing their overall data transparency, there are many privacy regulations that they should keep in mind. It is worthwhile for companies to consult with a legal expert to ensure that they are following new GDPR documentation, as well as pre-existing HIPAA regulations, and are staying fully compliant.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Play or on Soundcloud.