The transformative value of collaboration between pharmaceutical companies developing drugs and devices and the people living with health challenges is widely recognized within the health care industry. Clinical trial teams and patient volunteers have expressed the benefits of serious interchange that includes sharing the patient experience. Widely accepted and supported in an increasing number of pharmaceutical companies such as Lilly, Sanofi and Novartis, the partnership embodied in the terms “patient engagement” and “patient centricity” has moved from a novel concept to one that is expected by clinical trial teams and patients as well as by health authorities.

Historically, clinical trial teams did not engage directly with patients. A 2014 Novartis internal patient engagement survey to gauge trial team involvement with patients returned many responses: “we can’t.” Now, just a few years later, trial teams and patients around the world are interacting frequently to partner toward solutions in drug development. At the same time, companies, patient advocates and organizations are working together on how to engage compliantly, effectively, ethically and respecting the patient perspective. Many stakeholders, new to this kind of interaction, are finding there can be unintended outcomes that may revolve around patient health information. Therefore, creating guardrails that protect patient information and minimize risk, while maximizing the benefit for all parties, is a critical consideration.

Providing the Context

Pharma companies and patient organizations have created diverse, imaginative ways of working together. Patient organizations globally, including advocacy groups and patient networks, such as the Parkinson’s Disease Foundation, the Lupus Foundation, the National Health Council and EUPATI have outlined best practices on how to integrate the patient voice into the drug development process. They have trained hundreds of patients, participants and caregivers on the clinical trial process so they are equipped to partner more easily with clinical teams and provide significant contributions.

Understanding the Challenges

As companies begin to develop “rules of the road” for interactions with patient volunteers, it is important to consider a range of potential challenges and solutions. In some areas of engagement it is easier to outline standard practice since there are logical continuations from current health authority guidelines. For instance:

1) Sponsors must ensure that the patient interaction is non-promotional when working on a trial design that uses an approved drug. This is often managed by not disclosing the medication’s name during the patient engagement interaction. Patients and families, on the other hand, are highly interested in the drug’s name so they can track its progress to approval. A delicate balance that needs to be navigated and appreciated.

2) Maintaining anonymity of clinical trial participants when conducting qualitative or quantitative feedback surveys during a trial to determine burden of the trial and trial satisfaction through use of electronic data collection tools.

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3) Ensuring that patient engagement activity facilitators and pharma attendees are trained on adverse event reporting is crucial to the timely reporting to the health authorities.

4) Data privacy laws outline protected patient data. What patient information may be collected and how the information is to be stored are clearly outlined in many countries. Laws vary between countries and regions, creating challenges for global teams. The EU-US Privacy Shield regulations also provide guidelines for proper data storage, access and transfer.

New patient information issues have arisen as partnerships and teams become more sophisticated and develop new expectations and applications for the information gained.

Engaging with Patients and Volunteers

Pharmaceutical companies may set up contracts and confidentiality agreements, collect information through a third party and/or use a “masked” methodology to collect patient and caregiver insights where the individual is not revealed. Explicit consent agreements can minimize risks in most instances. However, as companies and patients develop deeper, sustained relationships and patients participate in video interviews, steering committees, campus events, and health authority meetings, the patient identifying information is disclosed to a wider audience.

Ensuring identifiable patient partner information is only shared by team members that need access is critical.

Identifying Patient Risks

A search of literature databases and the internet reveals little emphasis or research on the potential risks for the patients who share their personal information during a patient engagement activity or relationship with a pharmaceutical company.

We live in an era of open, public lives on social media such as Facebook, Twitter etc. Identifiable patient information can be found on health authority websites, patient advocacy sites and in public patient communities. In our daily lives we hear frequently about data breaches, misuse of information for personal or nefarious gain and even unintentional revelations have the potential to harm or embarrass an individual. This exposure can also create stereotypes that could potentially create negative perceptions around an entire patient population.

Investment in processes to decrease patient risk and protect patient information so it does not become public or get misused is the next step.


Patient and caregiver partners sign consents, confidentiality agreements and may receive a stipend for their participation. The information they share with clinical teams is highly valued and integrated into plans and discussions. As trial teams learn from patients, they apply the information into the drug development planning and the patient perspective can impact many parts of a clinical trial – scientific as well as operational. Trial teams don’t always anticipate the ways they will incorporate the patient perspective when a project is initiated.

Contracts, confidentiality agreements and consents with patients need to be clear, transparent and provide examples of the ways their information will be used, the types of roles the information might be shared with as well as its global reach. For example, patient interview data gathered for a protocol insight might later be shown to trial investigators to improve the patient experience at the site.

Data Security

While the patient insights can show great value to the sponsor and investigative sites, patients may not completely understand how their feedback has been shared and utilized. In cases where the new use was not anticipated in the contract and significantly different from the consent, clinical teams have considered whether a re-consent might be necessary. How to ethically obtain this consent is a challenge.

Ensuring data is collected in a thoughtful, vetted procedure by trained staff who understand the risks to patients, is critical. Collecting and posting the data on a secure, validated system with limited access will prevent the misuse of the information. Ensuring companies are able to share information as widely as possible to maximize its impact while having strong safeguards in place to ensure patient protection, is a question we as an industry need to examine and discuss further.

Videos can be especially challenging depending on the country. A participant’s expressions and body language bring enormous value to the discussion and at the same time participants are clearly identifiable. It is the pharma company’s responsibility to ensure patients understand how the images maybe used and how widely viewed within the company.

A Call to Action

Patients and their caregivers may be vulnerable partners as a result of their need for solutions to incurable, deadly and/or painful diseases. They may openly share personal information without fully realizing the uses and potential consequences.

Trial teams may also not fully understand the sensitivity of data from people that are not in clinical studies. When patient and caregiver interviews can be shared across multiple teams and programs impact is multiplied. How to keep the data protected and internal to the company and yet avoid paralysis or paternalistic assumptions can be challenging.


An environment of trust and transparency that encourages long term relationships between drug development teams, patients and patient representatives are the goal. In a world where a Twitter storm or any social media outlet can create highly visible, emotionally charged conversations and painful, unplanned publicity or financial impacts, it is vital to protect patient and caregiver volunteers and put their interests first. It is our ethical responsibility to spend time considering potential risks and vulnerabilities for volunteers. To remain a trusted partner, we must have their best interest at top of mind and build the right processes that prevent unintended harmful outcomes.

How can we do a better job?

Do we fully understand the short and long term risks for the patients and caregivers who are partnering with pharma?

What guardrails and best practices can we put in place, as an industry so patients are never negatively impacted from their partnership? It’s critical to get patients, advocates, patient organizations, sponsors, third party partners, etc, sharing their perspectives and experiences in a safe environment so we can address this topic that seems to be running under the radar. A few specific actions that can be employed include:

  • Choose Patient Data Privacy as the central topic of a patient conference with free access for all patient and patient advocacy attendees, so we can better hear a wide range of perspectives
  • Provide open meetings, forums, blogs, and social media arenas that encourage all stakeholders to openly discuss perspectives, case studies, challenges, and potential solutions can help drive further discussion
  • Encourage patient-centered organizations, cooperatives like CTTI and DrugDev and businesses, such as HealthiVibe, PatientsLikeMe and Inspire to formulate and publish guiding principles
  • Encourage regulators to develop a “Patient Voice Guidance” (similar to the Social Media Guidance) that outlines best practices for patient protections
  • Create a pharma cross-industry steering committee of protection experts (representaitves from legal, privacy, compliance, regulatory)

Prior to writing this article, I wasn’t sure if my concerns were warranted, so I asked two patients. They confirmed that it is. So let’s talk about it!

Patients and their families deserve it.


Therese Johnsen

Clinical Trial Intelligence Manager



*The author wishes to thank Jack Whelan, Jan Geissler, David Palacios, Lani Hashimoto and Abbe Steel for the critical review of this article.