The transformative value of collaboration between pharmaceutical companies that are developing drugs and devices, and the people living with illnesses is widely recognised within the healthcare industry. Clinical trial teams and patient volunteers have expressed the benefits of serious interchange, including sharing patient experience. Widely accepted and supported in an increasing number of pharmaceutical companies, such as Lilly, Sanofi and Novartis, the partnership that embodies ‘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 health authorities.

Historically, clinical trial teams did not engage directly with patients. In 2014, a Novartis internal patient engagement survey that aimed to gauge a trial team’s involvement with patients returned many responses of ‘we can’t’. Just a few years later, trial teams and patients around the world are interacting frequently to work towards solutions in drug development.

Promoting engagement

At the same time, companies, patient advocates and organisations are working together on how to engage compliantly, effectively and ethically while respecting the patient’s perspective. Many stakeholders who are new to this kind of interaction find that unintended outcomes arise that may revolve around patient health information, so creating guardrails that protect patient details and minimise risk, while maximising the benefit for all parties, is a critical consideration.

Pharma companies and patient organisations have created diverse, imaginative ways of working together. Global patient organisations, including advocacy groups and patient networks such as the Parkinson’s Foundation, the National Health Council and European Patients’ Academy (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 easily with clinical teams and provide significant contributions.

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.

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, making it all the more important to reach a delicate balance.

Identifiable data

Maintaining anonymity for clinical trial participants is also key when conducting qualitative or quantitative feedback surveys during a trial, in order to determine the burden of a trial and how satisfactory it is through using electronic data collection tools.

Also, ensuring that patient engagement activity facilitators and pharma attendees are well trained on adverse event reporting is crucial to ensure timely communication with health authorities.

Data privacy laws outline protected patient data, such as what patient information may be collected and how the information is to be stored are clearly stated in many countries. Laws vary internationally, creating challenges for global teams. The EU-US and Swiss-US Privacy Shield frameworks also provide guidelines for proper data storage, access and transfer.

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

Pharmaceutical companies may set up contractual confidentiality agreements, collect information through a third party or use a ‘masked’ methodology to collect patient and caregiver insights, where the individual’s identity is not revealed. Explicit consent agreements can minimise risks in most instances; however, identifying information is disclosed to a wider audience as companies develop deeper, sustained relationships with patients, who participate in video interviews, steering committees, campus events and health authority meetings. It is, therefore, critical to ensure that recognisable patient-partner information is only shared by team members that need access to it.

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

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

Safeguarding information

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

Patient and caregiver partners sign consent forms or 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. Here, the patient’s perspective can impact many parts of a clinical trial, scientifically and operationally. However, trial teams don’t always anticipate the ways in which they will incorporate the patient’s perspective once a project has been initiated.

Contracts, confidentiality agreements and consent forms that are given to patients need to be clear, transparent and provide examples of how their information will be used, as well as its global reach and the types of roles the information might be shared with. Patient interview data gathered for a protocol insight, for example, may be shown to trial investigators to improve patient experience at a site.

While insights can provide great value for sponsors and investigative sites, patients may not completely understand how their feedback has been shared and used. In cases where a new form of use was not anticipated in the contract and significantly differs from the consent given, clinical teams consider whether gaining reconsent is necessary. But ethically obtaining this permission is a challenge.

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

Videos can be especially challenging, depending on the specific 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 widely viewed within the business.

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 realising 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 programmes, the impact is multiplied. Protecting the data, keeping it within the company and avoiding stalling or making paternalistic assumptions can be challenging.

An environment of trust and transparency that encourages long-term relationships between specialised drug development teams, patients and their representatives is 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, pharma companies must have their best interest in mind and put the right processes in place to 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 companies?

As an industry, what guardrails and best practices can we put in place so patients are never negatively impacted from their cooperation? It’s critical to get patients, advocates, organisations, sponsors, third-party partners and other entities to share their perspectives and experiences in a safe environment, in order to address this issue, which seems to be running under the radar. A few specific actions that can be employed, including:

  • choosing patient data privacy as the central topic of a patient conference, with free access for all patient and patient advocacy attendees, so we can hear a wide range of perspectives
  • providing open meetings, forums, blogs and social media arenas that encourage all stakeholders to openly discuss perspectives, case studies, challenges and potential solutions that can help drive further discussion
  • encouraging patient-centred organisations, cooperatives like the Clinical Trials Transformation Initiative, DrugDev and businesses, such as HealthiVibe, PatientsLikeMe and Inspire, to formulate and publish useful guiding principles
  • getting regulators to develop ‘patient voice guidance’, which is similar to social media guidance, that outlines best practices for patient protections
  • creating a pharma cross-industry steering committee of protection experts, including representatives from legal, privacy, compliance and regulatory areas.