Sponsors and CROs would agree more work needs to be done to better plan and design clinical trials. Taking a more proactive approach will produce better trial results by having the right countries and patients involved from the start. Paul Evans, VP of Feasibility and Enrollment Solutions for PAREXEL, believes better planning will happen only once we get more patients and physicians involved in trials, and that will require changing the relationship that currently exists between pharma/CROs and the clinical sites.
A classic problem in clinical research has been patient awareness. That is one reason why the industry has turned to advertising to get the message about trials out to the patients. Although there are many types of advertising available, Evans believes it is still a blunt instrument. Online methodologies now present more sophisticated ways of reaching patients, and there are probably more databases today than the industry can tap into. But that does not mean we are doing a better job of increasing awareness.
Unfortunately, part of the problem has to do with physicians. Many do not have the time they would like to discuss trials with patients, and there is still the issue of not enough physicians getting engaged in clinical trials. Because of the manner in which pharma and CROs interact with sites, the problem is compounded. Fixing all three relationships will be vital to conducting better trials.
Are Patients Better Informed?
Getting more patients involved in trials is instrumental to improving the clinical trial process. But with all of the additional information now available to patients, including the advent of social media and more activist patient groups, Evans questions whether patients are actually any better informed than they used to be.
Patient information sheets are one example. The sheets have gotten much more complex, sometimes reaching twenty pages or more. Even if the patient signs the form, Evans wonders whether we can be confident they bothered to read it, or are aware of any of the information contained in it. You could argue the patient has been given too much information, and perhaps does not know what to conclude.
A physician might go to a patient and say, "I've got bad news for you. I am unable to do anymore for you. Your cancer has reached a stage where I have nothing additional to offer, but I know of a clinical trial that might be able to help you."
"That patient likely did not even hear the words clinical trial," says Evans. "All many of them will hear is the traumatic news about their health. In that situation, all they want to do is go home and discuss their situation with family members. That is not a situation in which you can expect them to read a 20-page consent form." To assist with this problem PAREXEL has developed an online tool that explains the clinical trial process and the details of the study in a far more compelling video format. It also allows friends and extended family to be a part of the process.
Get Physicians Involved
Getting patient consent is just one piece of the problem. Another is getting physicians involved. There have been a lot of discussions of late about whether incentives are necessary to generate greater interest in trials by doctors. Most physicians have never done a clinical trial, and never will. For the ones that do participate, 55 percent will never do more than one.
"Oftentimes, the connection between the patient and the clinical research site is at the nurse level, not the doctor level," notes Evans. "Unfortunately, neither the doctors nor the nurses are often aware of what is going on with clinical trials. They don't know how the process works and certainly don't know what is going on with other physicians."
While incentives might help, Evans believes education will be more vital to getting physicians involved. Physicians will be more likely to get involved once they better understand the process and what is required of them. Unfortunately, they are also extremely busy. PAREXEL has been experimenting with new ways of getting information to potential Investigators making use of animation and videos to communicate the benefits of clinical trials to their patients in a more compelling way. Physicians are also some of the best networked people on the planet, if we could only get them involved and use technology and social media to tap into those networks.
Better Align With Sites
If sponsors and CROs could better align themselves with sites, that might also help in the recruitment process. In that regard, site alliances are a key factor. Evans believes that, as an industry, pharma has not done a very good job of managing these relationships.
"As an industry, we seem to always complain that sites don't deliver," says Evans. "But if you step back and look at how pharma and CROs typically engage with sites, you'll see it is very much a build-and-break mentality," he says. "It's all tactical. If a large business was buying paper clips and went to a different vendor every time that would obviously not be a good model. But in the clinical space that is often how we manage sites. Consider how important physicians or research sites are to sponsors and CROs, and the model makes even less sense. There seems to be no long-term commitment."
Furthermore, efforts to improve site performance are generally done around a single trial. Evans questions the logic of investing in improvements to an investigator's study if there is a high likelihood they will never do another. This is not a recipe for success, and is why he feels developing long-term, strategic relationships are the right solution. By identifying the right sites to work with, sponsors and CROs can then identify longer-term trends that will result in continuous improvement from one study to the next.
Although the selection of sites is based on detailed analysis, the softer relationship issues are equally important in the decision. As is the case in any type of relationship, Evans believes making sure there is good alignment from the partners in terms of what they are prepared to put into the relationship and what they hope to get out of it is critical to assessing the likelihood of success.
Put An End To One-And-Done
Getting past the one-and-done problem will improve this process, but we first need to identify the reasons behind it. Evans believes he has identified a couple. The first is that overseeing a clinical trial is not easy, and over the last ten years has gotten increasingly complicated. Protocols now have more procedures and inclusion/exclusion criteria in them, which have resulted in more demands on investigators and patients. Although clinical trials are getting more difficult to perform, investigators are not finding out until they perform the first one. By the end of the study, they realize the effort was not worth the compensation, and decide to not do others. "They don't realize the knowledge they have gained will mean less effort required in future trials," says Evans.
Second, Evans doesn't feel investigators involved in their first trial have the needed support structures in place. For example, during that initial trial, a physician may not have a study coordinator nor the dedicated space required. Both resources are needed to handle all of the paperwork and supplies required for the trial. Physicians will become aware of the need after the first trial, but that does not help if they opt to never do a second one. Having a better relationship with physicians and educating them up front will help alleviate this problem.
Finally, Evans believes identifying sites which are more likely to participate in more than one study is important when performing the site evaluation. While this is a difficult task, he notes there are soft issues that can be examined for clues. Does the investigator display a level of commitment? How high is the motivation level? Does the site seem willing to be helped? Do they seem to be willing to work in partnership with a pharma company or CRO?
PAREXEL put a Site Alliance network with a dedicated team in place two years ago, and Evans is already seeing results. "We are seeing faster start-up times and higher recruitment rates and that is as a result of the positive changes the sites are making with our help," he adds.