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  • Adam Della Maggiora

Improve clinical trial recruitment with data privacy innovations



Introduction

Data privacy remains a hot topic in biopharma. It's no longer enough for companies to say "We're HIPAA compliant" or "Our data is secure." Instead, they have to show that their data systems are protecting patient information and helping them achieve their goals. But this isn't always easy—particularly when it comes to clinical trials. If you throw in the concepts of “patient centricity” and “de-centralized trials”, patient control of their data privacy becomes important for improving the time and cost of engaging patients for trials.


Participation rates in clinical trials hover around 10%, and recruiting the right participants is one of the biggest problems sponsors face. The right participants are difficult to identify because they don’t know they are the right participants, even though they may be perfect for your study. And this can be frustrating for sponsors who need more people to enroll so that their trials can progress.


Often, clinical trials include patients with a variety of diseases, ages and demographics. By studying these diverse populations, researchers can understand a drug’s effectiveness in different contexts. The more representative, the participants, are of your target population—the sickest patients who have the most advanced form of your disease—the better.


But what if you want to study populations that don't normally participate in clinical trials? This can be difficult because research is often limited to those who are healthy enough or close enough geographically to take part in studies.


According to Deloitte, the path to resolving the under-representation lies in these three things:



  • Awareness

  • Trust

  • Access


Awareness means reaching patients where they are and speaking a language they understand. Most companies do this well enough through advertising and social media.


Access also means reaching patients where they are. Increasingly, we’re seeing mobile, pop up and home-based trials occur.


Trust has been more elusive to address for clinical trials. Building trust requires an ongoing relationship with a patient before, during and after a trial. It requires educating each patient and providing ongoing value so that when a matching trial becomes available the company has built enough trust with the patient that they are receptive.


Unfortunately, the ecosystem of pharma companies involved in delivering a trial are motivated by getting a trial done and a therapy to market as quickly as possible which excludes the idea of building a relationship with a patient over time.



Building trust involves three principles:

  1. Patient control over their sensitive information for when and how they reveal information about themselves

  2. Education and clarification on trials, procedures, and perceived fears from the patient

  3. Ongoing personalized value that the patient can use to improve their lives, their health, and their outlook.


In this paper, we address building trust around data privacy and will address the other two in later papers.



Patients may not be willing to share information.

Patients may be unwilling to share their data with trial sponsors for legitimate reasons or because of unfounded fears about privacy violations. Some patients may have concerns that their data will be shared with third parties in ways they don't understand or approve of, while others have fears that the information they provide will be used to track them in other settings. These concerns are not always well-founded, but it's important for researchers and sponsors to address them when trying to recruit participants.


Diversity, Equity, and Inclusion (DEI) expands the need for patient-controlled privacy. The FDA and other US agencies published a draft of “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry” in April 2022. The US government are pushing pharma to actively resolve the under-representation of African Americans, LatinX, Native Americans, women, and LGBTQ+ in clinical trials. The European Union, Canada, and other countries are pushing similar DEI initiatives.


With today’s increasingly sophisticated data privacy requirements, companies struggle to balance privacy with the need for informatio


n. Fortunately, regulation leads to innovation. There has to be a better way and a role technology can play to shift the burden, liability, and ease of how a patient securely exchanges their personal information.



Studies reveal that innovative data privacy helps recruitment.

There are a number of reasons why patient data is needed for clinical trials, but one thing is clear: if we don’t collect it, we can’t do the research. So how can we address some of the biggest challenges while keeping patients happy and healthy?


Patients expect that their personal information will be protected when they share it with researchers, as well as physicians, who will use this data to inform treatment decisions. But ensuring that all parties involved in a study have access to this information is vital—after all, patient recruitment is at the heart of clinical trials.


A recent survey by the Alzheimer's Association found that more than 80% of respondents were worried about how their personal information would be used in research and clinical trials. The American Medical Association recently reported that “Nearly 60% of patients surveyed said they worried companies would use health data to discriminate against them or their loved ones…”


With that in mind, The Pew Research Center fo


und the following:

(Source: Pew Research Center)





Despite a global focus on privacy, new approaches must be developed if we want to improve our ability to gather accurate data without compromising privacy or security. It requires re-thinking key aspects of the exchange of sensitive information between patients, providers, and researchers:



  • Enable patients to control what they share or revoke and how they make themselves invisible if they choose. This reduces distrust since the patient no longer has to rely on the organization to follow through with her/his privacy wishes.

  • Elminate the storage of patient’s sensitive information in large databases. The databases become attractive targets for theft and make it attractive to “bend the rules” for well-meaning employees. Instead, enable sensitive information to be stored in a distributed fashion, making it more difficult for theft.

  • Leverage Artifical Intelligence/Machine Learning and recommendation technology to personalize communication and access to trials/treatments/services



Avallano makes it possible.

Avallano set out to solve these three issues fundamentally, looking to the future of privacy that eliminates the need for restrictive government regulation. We built our platform on a private blockchain to ledger and enforce patient-initiated s


ensitive data sharing. Combine that with our patent-pending software that enables individuals to share and revoke sensitive information about themselves from their phones and have complete control on choosing to “make themselves invisible”. This is the future of patient-centric applications that inspire and build trust.


With the Avallano platform, patients control when and what they choose to reveal about themselves when considering participating in a trial. This democratization of anonymity is especially important for under-served communities who demand the power of privacy to avoid stigma and overcome fundamental mistrust for the industry.


For businesses, building apps on the Avallano platform improves the recruitment process by reducing the time and number of people needed to achieve recruitment goals and keeps patients actively engaged before, during, and after participating in trials.


We enable you to overcome the “cold vs. warm” recruitment registry issue, actively engaging patients over time, providing value beyond the trials themselves, and ultimately reducing the cost and time to recruit.


Check us out at avallano.com, or email paul@avallano.com to learn more.



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