There’s a lot of talk about patient centricity in the clinical trial arena these days, and for good reason — hearing the voice of patient and incorporating patient perspectives into trial design can pay huge dividends for all stakeholders involved. But what does it mean to be patient centric, practically speaking? What tactics are leading pharma companies employing to make centricity a reality in their trials?
How many of the clinical trials that your company has conducted have met the initial recruitment timelines? How often have you seen recruitment issues increase costs or cause delays in your company’s operational objectives? Nearly 80 percent of clinical trials experience delays or even early termination due to recruitment issues.1 These delays not only negatively affect the sponsor company but also keep patients from getting potentially life-saving treatments in a timely manner (if at all).
Consumers today are asked to make increasingly complex decisions around their healthcare. They have access to so much information, yet the level of detail and potential for confusion is only increasing. At the same time, social media has fundamentally changed the way people gather information and relate to each other.
Back translation is a powerful tool for ensuring that a clinical trial document has been accurately translated without loss of meaning; however, it is not the right QA tool for every project. The alternative is quality assessment performed by a professional translator, which will not be dealt with in this article but is important to mention as an option.
With all of the focus on patient centricity and patient-centered clinical trials, it’s easy for the focus on investigative sites to be lost. Prior to the patient-centricity movement, at least for a time, site engagement was the concept du jour in the industry with conferences, articles, and surveys exploring and expounding on the importance of enhancing site relationships. And while some still believe that “patient centricity starts and ends with the investigative site,”1 it seems that the needs of the sites only get cursory attention these days. Not to detract from the importance of patient centricity, but without engaged and efficiently operating sites, many of the patient-centric initiatives will fall short of expectations. As someone who obsesses about root cause analyses, I have naturally been thinking about the primary root causes for why we seem to have lost focus and interest in the sites and what we can do about it.
Though the statement “we live in a global world” typically refers to healthcare and the environment, it truly applies to science, which spans country borders and languages. This is why the 2016 decision by the British electorate to leave the European Union (EU) was so significant for the international scientific community. Brexit doesn’t just apply to the U.K. and Europe; it needs to be considered for all international communities, including the clinical research industry.
Since the late nineteenth century, it has been well-known that individuals can vary widely in their responses to the same medication. Yet, accurately predicting and addressing the effects of that variability during drug development has continued to bedevil researchers, drug sponsors, and regulators.
Imagine for a moment you are your favorite superhero, charged with the task of saving the whole world from villains such as the Joker, Lex Luthor, Doctor Doom, and the Green Goblin. You would not be very effective — or much of a superhero, for that matter — if you only took one of them out while letting the others roam free. In the same way, as an industry, we cannot effectively tackle the issue of delays in the execution of Clinical Trial Agreements (CTAs) by only addressing one or two of the “villains” contributing to this industrywide problem.
Located between the United States and Central America, Mexico’s geography and Spanish language put it in an ideal position to act as a gateway to Latin American pharmaceutical markets. With an estimated size of $10 billion in 2016, the country’s pharmaceutical market ranked twelfth globally, lagging behind only Brazil as the second biggest market in Latin America. Mexico has a stable economy, and although it is classified as upper-middle income, it also offers lower costs than other countries.
Sponsors, CROs, and investigative sites are often faced with two key challenges when planning and managing clinical trials: getting patients recruited and determining how much to spend to find and enroll them. With the explosion of e-recruitment tactics (e.g., social media and digital advertising) and e-recruitment service providers over the past five years or so, there seems to be an industry-wide perception that the cost to enroll patients should be dramatically reduced compared with the use of more traditional advertising and awareness tactics.
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