Gender equity relies on health equity
By Sanskriti (“Sans”) Thakur, CGO. As we celebrate Women’s History Month this March, the world takes a moment to recognise women’s accomplishments, while also highlighting the inequity that remains. When it comes to women’s health, those inequities are stark. And a contributing factor is the lack of women in clinical trials. When population representation falls short, medicines are less safe and effective. Measures such as the US Congress’s proposed DIVERSE Trials Act are helping drive equitable representation, but that’s just the beginning.
Population Representation: Everyone Must Play a Part
By Hady Khoury, Chief Development Officer, Medable. The life sciences industry has been talking about improving diversity in clinical trials for years. Historically, this talk has amounted to a lot of hot air. But the situation is urgent: while racial and ethnic minorities comprise nearly 40% of the US population, they only account for 2% to 16% of clinical trial participation. Within oncology, Black Americans constitute around 22% of cancer cases, but less than 5% of trial enrollees. This isn’t just a US issue; globally, 76% of patients enrolled in oncology trials are white. And this challenge exists within a research landscape where nearly 80% of trials fall short of enrollment targets to begin with.
ACRP: Unique Considerations for Patient Retention in Decentralized Clinical Trials
By Ingrid Oakley-Girvan, PhD, SVP, Value and Strategy. As decentralized clinical trials (DCTs) become more prevalent, particularly in the wake of the pandemic, their lower burden approach can make participation more attractive for some. Yet the vexing issue of retaining participants throughout the course of a trial will continue to be problematic without a thoughtful approach to keep them engaged. A three-phase model of engagement, based on proven science and intelligently informed by utilizing data, can make important inroads into solving this long-standing challenge.
ACRP: With a Reinvigorated Focus on Vaccine Research, Why Are We Still Using Dated Approaches?
By Musaddiq Khan, VP DCT Solutions. The pace of development for new medicines has traditionally been slow and burdened with lengthy enrollment, conduct, and analysis timelines. However, COVID-19 was a catalyst to adopt novel approaches to drug development that have harnessed technology to create new, accelerated processes for conducting clinical trials. Technology-enabled hybrid and decentralized clinical trials (DCTs) are now moving from the periphery into starring roles across many areas of research—with a notable exception.
The Powerful Impact of Caregivers on Clinical Trials
By Ingrid Oakley-Girvan, PhD, SVP, Value and Strategy. Caregivers are essential partners in health care. Due to their direct, ongoing engagement with patients’ care, caregivers can often provide early insight into “simmering” symptoms the patient may be experiencing, as well as identify and report physical function when patients are at home, instead of waiting until they have a clinic visit. These observations and reports help clinicians and clinical investigators improve the view of their patients’ experiences and might even be predictive of adverse events.
Global Forum: A Tale of Two DCTs: Lived Experiences of Both Patient and Caregiver
By Jena Daniels, VP Patient Success. The global virtual clinical trials market is now worth $8 billion, according to Medi-Tech Insights, and is growing at a clip of more than 10% annually. It’s not surprising: Virtual or decentralized clinical trials (DCTs) got their kickstart during the pandemic and have gone mainstream. Are the benefits they promised being realized?
Progressing BYOD Adoption
By Flo Mowlem, PhD, Senior Director, eCOA Science & Solutions. It’s time to stop asking ‘if’ clinical trials should employ bring-your-own device (BYOD) strategies to collect electronic patient-reported outcome (ePRO) data, and instead develop considered approaches to ‘how’ we do it. This is not to say that BYOD will always be suitable for every given context; rather, let’s stop getting caught up in concerns around whether regulators will accept such data and instead focus on optimizing implementation.
Clinical Lab: Proof Positive: Decentralized Trials Drive Value
By Ingrid Oakley-Girvan, SVP, Value and Strategy. The cost of drug development is high and increasing—Tufts Center for the Study of Drug Development (CSDD) estimates the total capitalized cost for an approved new compound at $2.6 billion USD1—and the process is lengthy. These factors prolong and limit access to new therapeutics to treat patients. One study found that for every $1 billion USD spent on research and development, the number of new drugs approved has decreased by 50 percent every nine years since 1950.2