Proper Feasibility Planning Is Critical For Clinical Trial Success
By Ed Miseta, Chief Editor, Clinical Leader
“Right now, the key to proper feasibility planning is data,” says Paul Evans, VP of feasibility and enrollment solutions for PAREXEL. “Years ago, feasibility planning generally involved asking key opinion leaders what they thought about your protocol and how well it would run in a certain country. Questionnaires would then be sent to hundreds of sites requesting their input. It’s what I would call a crowdsourcing approach, and we now know we have to do better than that.”
That old approach to feasibility planning might involve asking sites how many patients they could recruit over a 12-month period, tabulating the responses, and taking the mean of the responses. But even once you had the answer, you had no way of knowing if it was the right one. There would also be questions around how the sites produced their answers, and whether there was any scientific evidence to back it up.
Today, with mountains of data everywhere, that type of approach is no longer necessary. With more patients and data to draw on, as well as more data on countries and prior clinical trials, better and more informed decisions can be made. Unfortunately, just because we have the data doesn’t mean we will always know what to do with it. This is where feasibility enters the picture.
“It is vital that we look at all of this data and figure out what we can do with it,” says Evans. “In the past, too much of what we have done as an industry is to sit around a table listening to people say, ‘Well, in my opinion,’ or, ‘in my experience.’ There is nothing wrong with listening to the opinion of experts, but we now have the ability to validate those experiences and perceptions. Data is not perfect and often incomplete, but when used with other available tools, it can better provide the answers we need.”
Feasibility Helps Understand Risks
A sponsor company preparing to start a clinical trial will always be in a situation where they want to know more, and will accept the fact that there is a gap between what they want to know and what they actually know. That knowledge becomes a part of the risk assessment. In the opinion of Evans, that is what feasibility is ultimately doing – combining and analyzing all of the available data into a comprehensive risk assessment.
“If you do the job properly, feasibility should direct you where to go and how to do it,” he says. “It helps you to understand what risk exists, and what will be your overall chance of success. This will change how we do our jobs, and it will be driven by the evolution of “big data” of which electronic patient health records is an example. We see this happening rather quickly in America, but we see it happening in Europe and China as well.”
But there remains one final piece that must be put in place: patients. We now have access to a lot of patient data, and are better able to identify the best candidates for trials. But getting patients to actually sign up for trials is still a challenge. Assessing patient willingness as well as eligibility in the feasibility process is now much more practical through social media and digital listening, and it adds the patient voice to the process. Sponsors and CROs struggle with the fact that there are few, dedicated, clinical research sites. The sites themselves are also busy with their clinical workload, making it difficult for sponsors and CROs to help them do the things they need to do. Evans believes the industry must get to the point where it is better able to assist sites in engaging patients around a clinical trial, rather than simply expecting the sites to do it all themselves.
The Recruitment Challenge
For various reasons, patient recruitment remains a challenge for most sites. “History has taught us that a site might have access to a large population of patients, but those patients do not always move out of the database and into a clinical trial,” notes Evans. “Sponsors and CROs need to be more supportive of the whole process. Sites need help managing the practical realities of the day-to-day business. That's really where things often fall down, and the end result is few recruits and under-performing sites.”
Evans is quick to point out that the problem is not that the wrong sites are being selected. It's that the sites didn't have the needed support to help them through their toughest hurdles, one of which is recruitment. Technology that is now available from sponsors and CROs can certainly help sites to be more effective.
Sponsors and CROs should attempt to build better relationships with sites to help in the process, and try to do a better job of selecting those sites that seem to have a higher probability of becoming a long term partner. Unfortunately, the structure of the U.S. healthcare market may also be holding back the recruitment process.
The healthcare system in the U.S. functions much differently than those in other countries. Many countries in Europe and Asia have state-funded healthcare systems, which is not the case in the U.S. In the states, if a patient is referred from one physician to another, there can be a loss of revenue to the referring physician.
“In many countries like the U.K. for example, a general practitioner is paid because a patient is on his list,” says Evans. “If I never go to see him, it doesn’t matter. He still gets paid and does not have the added burden of having to see me. If he sends me to a physician that's doing a clinical trial, he does not lose me from his practice.”
In the U.S., the potential loss of revenue could discourage a physician from sending a patient to participate in a clinical trial. Unfortunately the knowledge that could be transferred to clinical trial could be far more valuable than the financial incentive to the referring physician. That is a barrier that must be overcome if we are to get to the point where physicians can truly help with the recruitment process.
Finally, while investigators are important, Evans recommends we not forget about the site coordinators. “Site support tools should focus on coordinators rather than investigators,” he says. “We have always understood how important the coordinators are in successful, clinical trials. Ignoring their needs would be a tremendous mistake.”
In Part 2 of this article, Evans will examine what sponsors and CROs can do to better engage patients and physicians, and build better relationships with clinical research sites.