It’s time to roll up our collective sleeves and address the tangible “blocks” obstructing a truly effective patient-centric approach in clinical trials, says Amanda Wright, Co-Founder and Chief Development Officer at Javara, a pioneering Integrated Research Organization.
“These obstacles are often unrecognized as obstacles” ranging from policies at sites and with sponsors, regulatory constraints, and even outmoded definitions, Wright says. “If we are serious about changing perceptions and ensuring the optimum patient experience, we have to address these barriers.”
For example, on the regulatory front, if a patient is compensated more than $600 per calendar year for a clinical trial, the income is taxable, Wright notes. It’s a financial hit some don’t anticipate, and many might find to be a deterrent or disincentive.
Another example: the definition of sites and the acceptance of so-called satellite sites. As Wright points out, some sponsors won’t allow the use of the “hub and spoke” concept to expand physician and patient reach. If two important goals are to widen the patient net and improve the patient experience, it stands to reason that sites should offer as many locations as feasible.
Wright also calls on sites and sponsors, and everyone in the clinical trial ecosystem, to take an introspective look at processes such as contracting or patient communications. Why? It is vital to ensure such efforts are enabling clinical trial information access and ultimately participation, rather than delaying or discouraging such consideration.
“As we strive to improve not only our rates of participation but also inclusivity of underrepresented populations, these seemingly small decisions can have unintended consequences,” Wright says. Such consequences lead to continued distrust or unrealized opportunities as a result of awareness gaps, she notes.
Wright says that the industry has a tremendous responsibility to address what she views to be a public health crisis–the gap between the number of participants needed and actual participants in trials–but it requires all stakeholders to assess and act.
“Continual reflection and evaluation are key to ensuring that we aren’t inadvertently hindering participation or making the patient experience more difficult,” Wright says.
Author: Michael Causey