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Tackling the clinical trials diversity challenge

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Kelly McKee is VP of Decentralized Clinical Trials and Patient Registries at Medidata, a Dassault Systèmes company and provider of clinical trial solutions to the life sciences industry.

Kelly has spent the last 20+ years working to make the clinical trial process more efficient and accessible to patients and caregivers through innovative solutions including decentralised clinical trials and disruptive technology.

Currently, Kelly leads Medidata’s work to advance patient-focused clinical trial solutions, which simplify the clinical trial process for participants, sites and sponsors with a focus on patient and site centricity.

Why has there historically been a lack of diversity in clinical trials?

Historically, clinical trials have recruited predominantly Caucasian participants and do not always accurately represent the patient populations most affected by the disease.

This is largely due to a lack of access to clinical trials, awareness of opportunities and inclusion of representative patients in protocol design and patient outreach.

Too often, underrepresented groups are not aware that clinical trials are an option, cannot take time out of their days to participate or are inadvertently excluded from participating due to specific inclusion and exclusion criteria such as restrictive blood pressure or BMI.

This lack of diversity makes it hard for physicians to evaluate how different populations may react to treatments and may result in minority populations not receiving access to the medications they need.

In order to ensure that effective treatments can get to the patients that need them – regardless of their background  –  clinical trials need to remove the systemic barriers that have traditionally hampered widespread participation.

Why is it important to recruit a diverse pool of participants?

Clinical trials are often designed to be as small as possible to speed research and control cost.

In this smaller study population it’s hard to see a safety or efficacy signal difference between demographic groups and how a particular treatment may affect them if we don’t focus on enrolling diverse groups.

After the drug is commercialised and everyone is taking it, we will find that signal but maybe in a way that unnecessarily exposes people to risk first.

We need to integrate diverse patient populations into every step of the complex clinical trial process so we can achieve clinical trial success and provide patients with the best treatments and care possible.

Additionally, clinical trials represent the future of medicine – it’s simply the right thing to do to make them available to all.

What challenges do recruiters face in recruiting trial participants from non-Caucasian backgrounds and how do you address this?

One of the main challenges to recruiting and enrolling diverse patient populations is a lack of awareness and trust about the clinical trial process among underrepresented communities.

There are understandably many valid concerns about trust and safety among some communities of colour due to how they were historically taken advantage of by the medical community.

Of course this creates an inadvertent cycle where diverse groups are not represented and therefore don’t build awareness and trust.

While changing this perception and breaking the cycle will require time and patience, education and community engagement are key to increasing awareness around the importance of clinical trials and ensuring greater representation.

That’s why at Medidata we work to integrate patients’ concerns, welfare and rights throughout every step of the clinical trial process and provide continuous transparency from start to end.

We partner with a group of diverse patient advocates for our Patient Insights Board so we can create the most patient-friendly and inclusive clinical trial protocol.

Other key components of our Medidata Platform, including myMedidata Registries, our partnership with Circuit Clinical’s Site Network and products like Intelligent Trials, allows us to take a multi-faceted approach to supporting trial diversity by helping patients to participate in studies in a traditional, hybrid and decentralised format and engaging with them pre, during and post-trial for improved communication.

This breaks the transactional experience for patients and engages with patients longitudinally beyond a single clinical trial.

What makes Medidata the best company to address the problem of clinical trials diversity?

Across the board, we’re leading the industry by taking real, actionable steps to increase diverse representation in the clinical trials space.

Our most recent effort to address this industry-wide challenge is the launch of the Medidata Diversity Program.

The Medidata Diversity Program is not just another solution – it’s a new groundbreaking and dynamic approach to enabling greater representation that can be tailored to meet each study’s distinct needs.

From trial design to site selection, decentralisation and patient engagement, this programme uses the cutting-edge technology of our Medidata AI and Medidata Patient Cloud solutions to build equity into every step of the trial strategy.

This includes improving awareness and experiences for patients, streamlining access to trials, enabling decentralisation and supporting the data-driven decision-making needed to execute the modern diversity action plans required for regulatory success.

Are there other companies working in this space? What makes Medidata different?

As a life sciences industry, we all need to come together to improve diverse representation in clinical trials.

What sets Medidata apart in this effort is our commitment to patient centricity and extensive collection of patient-level and historical clinical data.

At Medidata, we build technology for patients, inspired by patients and integrate the patient experience into every aspect of our solutions.

The combination of our mission, experienced team and the industry’s largest data set – consisting of 30,000 trials and 9 million patients – allows us to develop strategic solutions like the Medidata Diversity Program and then assess their effectiveness over time by comparing the demographic makeup of historical and current clinical trials.

Where is the Medidata Diversity Program being utilised today?

The Medidata Diversity Program is not just another solution. It is the industry’s most comprehensive, multi-faceted approach to address diversity challenges in clinical trials.

Every trial is unique and so are the diversity challenges associated with them.

We understand that the solutions must be tailored to fit each study’s distinct needs.

From trial design to site selection, decentralisation and to patient engagement, the Medidata Diversity Program provides a suite of solutions that aims to cultivate diversity and ensure more equitable clinical trials.

A broad range of customers – including biopharmaceutical and medical device companies – are seeing the value in using a unified approach to integrate diversity into their studies.

We look forward to reporting results and customer success stories from the programme over time.

What more should regulators and the clinical trials industry be doing to address the issue?

The U.S. Food and Drug Administration (FDA) and other regulators are putting increasing pressure on sponsors to ensure their clinical trials are diverse and represent the overall patient population.

The newly launched Medidata Diversity Program helps to support sponsors with identifying and addressing their diversity enrollment goals and designing strategic action plans that can support regulatory authorities’ guidelines.

While this is progress, the lack of diversity in clinical trials is not an issue that can be solved by regulatory authorities or sponsors alone. We need to come together to develop and implement effective and tailored solutions that can enact long-term, industry-wide change.

What’s next for Medidata?

At Medidata, we’re committed to improving patients’ experience in the clinical trial process so that we can bring safe and effective treatments to patients sooner.

With our best-in-class technology, extensive experience, and dynamic solutions, we will rewrite the narrative of clinical trials, leaving no one behind.

We are working to improve access, raise awareness and foster inclusion, for the benefit of all people.

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