3 Common Myths Related To Global Patient Recruitment

By Ed Miseta, Chief Editor, Clinical Leader

Dan McDonald has been around global trials for more than 14 years, spending considerable time traveling internationally and working for US and Asian based clinical research organizations. In his current role as director of business development for DAC Patient Recruitment Services, he works with biopharmaceutical companies to develop and execute customized strategies for their site selection and patient recruitment and retention programs. When it comes to global patient recruitment, he also hears many myths repeated time and again regarding global trials. Presenting at the 2014 Global Clinical Trials conference in Boston, McDonald sought to put an end to several of those myths.  

McDonald opened his talk with some stage setting: “The challenges facing biopharmaceutical companies in the process of bringing their new compounds from bench to bedside are vast and well documented.  The resulting seismic shift from a well-known domestic drug development policy to a global one – with MANY variables - has kept clinical operations personnel up nights trying to navigate – figuratively and literally.”

“The change the industry has faced in a relatively short time period – maybe 15 years – has been unprecedented. That change has certainly presented land mines to navigate, but it is also uncovering goldmines for the industry. There is a larger and more diverse pool of patients available to volunteer for studies and ensure genetic diversification in studies. There is a broader base of medical expertise to leverage in using physicians across the world. Last but certainly not least, conduct of trials in other countries opens up the opportunity to then market the product in those countries in future years.

It has also created a lot of hype and certainly plenty of myths.”

Myth #1: When Going Global, Recruitment Plans Are Not Needed

One widely circulating myth states that if going to countries with high disease prevalence, enrollment need not be a concern. While many in the clinical recruitment business believe this to be true, the facts do not support the myth. McDonald notes the following:

- Every country requires a different approach.

- Logistically speaking, global studies will always present more of a challenge to recruiters.

- Regulatory approval timelines will often delay FPI dates.

- The FDA will regulate the amount of data from particular countries.

- And consent often involves buy-in from multiple individuals.

McDonald also notes that despite claims from local CROs, the BRIC countries (Brazil, Russia, India, and China) are not always the answer. “When operating in these countries, religious, cultural, and socio-economic conditions, as well as languages spoken and communication channels, can make trials difficult,” he says. “Additionally, ethics committee structure and approval timelines can be a challenge. Long story short, if you do not have a recruitment plan in place, your trial may be in trouble before it even starts.”

Myth #2: Regulators And Ethics Committees In Many Ex-US Countries Don't Allow Patient Recruitment

The facts here are pretty clear. First, most countries have not regulated patient recruitment. DAC, for example, has yet to have a patient recruitment strategy rejected by local ethics committees. "Often, it is not regulatory obstacles, but cultural ones, that make a particular initiative inappropriate for a country," he says. "In addition, when planning patient recruitment programs, we put a heavy emphasis on adoption rates. Meaning, do the sites actually use the patient recruitment materials, tools and resources provided. I have seen local CRAs reject a strategy that local sites embrace. To help overcome this problem, DAC has developed a matrix with adoption rates and effectiveness data for different strategies in different countries."

Myth #3: Use The Same Feasibility Approach Everywhere

Many believe that if the PI is English speaking, companies can just keep using the same feasibility template. This myth has been around for some time, but McDonald notes the facts show a grassroots approach may be necessary in certain countries. On the positive side, a growing number of data driven resources are available. "To help manage this, we recommend on-site visits and in-person sponsor visits, which provide many benefits,” he says. “Also be sure to determine availability of onsite CRC and be sure to consider accessibility."

McDonald also recommends that you consider the catchment area around the site, referral patterns, and of course location. PI's in tier 2 and 3 cities often enroll better. He also finds it helpful to consider critical site support personnel availability, and to be sensitive to regional compensation differences. "Don't forget about back-up sites," he adds. "They should be included in your plan as well as your regulatory application. It is always a good idea to apply for more patients than are actually needed." 

Finally, McDonald always recommends taking a proactive approach to recruitment planning. The rescue of a study that does not have a recruitment plan in place can cost a company millions. With a proactive plan in place, the savings for a company can be as high as 160 to 280%. “Proactive planning just makes sense,” he says. “When you look at the cost of a clinical trial today, companies can no longer afford to not make proactive recruitment a part of their planning process.”