Find them, keep them

Why greater education and outreach is critical to more effective clinical research. Interview with CISCRP's co-founder Ken Getz.

The Center for Information and Study on Clinical Research Participation (CISCRP) was founded in 2003 with the core aim of raising awareness of the clinical trials process, and the important role that process plays in advancing human health. By educating patients, the public, medical and research professionals, the media and policymakers about clinical research and facilitating more effective collaboration among all members of the clinical research enterprise, the non-profit organization is helping the industry to readdress a balance that had led to some serious problems.

NGP Editor Alice Sharp caught up with CISCRP’s co-founder and Board Chair, Ken Getz, to find out why greater education and outreach is so critical in enabling more effective clinical research.

NGP. I read that 87 percent of physicians are not involved in clinical trials – mostly as a result of the time commitment involved. Is this the case and how is the industry trying to address the problem?

KG. Our own analysis shows that the percentage of board certified physicians taking part in clinical trials is even lower, at somewhere nearer six percent – 94 percent of board certified physicians don’t get involved. From experience, we have found this is less due to time commitments and more because they lack context. Physicians typically don’t have much exposure to or knowledge about the clinical research process and the important role that it could play in administering healthcare to their own patients. Physicians are bombarded with so much information from so many sources today, and as they have no real prior exposure to clinical research, it ends up on the backburner.

We also know from surveys we have conducted of the public that while physicians are still the most trusted sources of health-related information, the referral rate by physicians of their patients into clinical trials is very low. In the US, we found that less than half of all board-certified physicians had referred a patient within the past year, the average referral for that group being a single patient each year. Considering that a typical physician in the US will see between 3000-4000 patients each year, this referral rate is shockingly low.

NGP. So how can that be changed – what incentive does the physician have to get involved in the process?

KG. The primary incentive for most physicians should be simply that they care about their patients’ health and want to explore every option available for them. There are cases, particularly for those patients who have exhausted other treatment options, for which a clinical trial should be an important consideration. Patients expect their physician to keep them abreast of every option.

What we’ve learned from much of our research is that many physicians don’t refer patients because they neither have the time nor know where to look to properly evaluate the available information on clinical trials. They don’t feel able to make real sense of it and to make a recommendation to their patients that they can feel confident in. So it’s really an issue of accessibility and early education. We need to teach physicians and healthcare professionals about the processes involved in clinical research and how they can find out more.

NGP. And is this something that is happening?

In general, the industry has so far done a really poor job in engaging the physician community when it comes to clinical research. Typically, the industry has relied on its sales force, professional conferences and continuing medical education as the primary means to reach physicians. Unfortunately, however, the industry has focused on these channels to talk primarily about drugs that are already on the market. Most physicians have limited or no exposure to clinical research specifically, except perhaps for what they read in the drug’s package insert, the Physicians Desk Reference or other prescribing manuals. Typically this is at a point when they are ready to prescribe a drug and want to understand the mechanism of action and the side effect profile.

CISCRP is trying to be far more proactive and has, over the last 18 months, given lectures at medical schools, sent out leaflets and brochures to physicians’ practices, and run public service announcements that are designed to raise interest and awareness in clinical research and the vital role it plays in advancing public health. While we’re just getting started, last year alone we gave presentations to students at more than a dozen medical schools. We hope that reaching them at such an informative stage will have a big impact.

NGP. I understand this kind of outreach is also important in addressing the shortage in volunteers. Is this true and just how big is the problem today?

KG. We definitely feel that education and outreach will have a direct impact on participation in clinical trials. In fact, it has already been shown in a wide variety of case studies, particularly those studies involving very targeted communities, that outreach can have a huge impact.

One thing to note is that we need to be more careful about our articulation of the problem. I often hear people talk of a shortage in volunteers when technically there is no such shortage. The statistics on the demographics and the numbers of people who are potentially eligible to take part in clinical trials show that there are plenty, but sadly only about 5-6 percent of the eligible population ever take part in a clinical trial in the US and in Western Europe.

The problem in the industry is that we have not yet found an effective way to connect with the public to engage them as a partner in this process, and there are many ways in which we can do this better. I would go so far as to say we are facing an international crisis in terms of the levels of awareness and appreciation of clinical research and its importance in advancing public health. The lack of awareness that exists today has led to a complete detachment of the public and patient communities from the clinical research enterprise.

Let me illustrate the point with an example. If of three friends one was to announce that they have just given blood, the other two would think it was wonderful. If the second then said that they have decided to donate an organ, his friends would find it inspiring. However, if the third friend then responded by announcing that they have volunteered for a clinical trial, the likely reaction from the rest of the group will be one of disbelief, even disapproval. The point being that a very different philosophy exists, even though each of the three people is contributing something important to the advancement of another person’s or the public’s health.

What we are trying to achieve at CISCRP is a change in the mindset of the public and patient community. That has to begin with efforts to provide education and outreach by all research sponsors, be they government agencies or by industry. Transparency will play an important part but it only gets us so far. After all, you can have all the information in the world, but if people don’t understand why that information is important it will only have marginal impact.

NGP. The other big problem, of course, is holding on to participants once you have them. I read that one in four volunteers drops out of a clinical study – what are the main reasons behind this statistic and how can participants be retained more effectively?

KG. In fact, this rate is even after we have already adjusted for adverse event fallout. It is higher still for the longer, more costly phase three clinical trials, when close to one third of all enrolled or randomized volunteers will drop out. The reasons for this relate largely to the high demands of the typical protocol and the inconvenience of participation today.

There’s no doubt that retention is a huge issue and a very expensive and time-consuming problem for the sponsor. At CISCRP, we believe this issue has to be addressed on a certain level through education and outreach. It’s not enough to find more volunteers by engaging a larger number of investigative sites. There’s a fundamental problem here, which relates to a failure to engage the volunteer. We have to help the volunteer better understand the research process and the importance of complying with the protocol. We believe that a better educated volunteer will be more likely to remain in a study than one that really knows nothing about clinical research.

There’s actually also another issue that is less discussed, and that’s the fall-off of volunteers post-trial. Even after volunteers have completed a study we lose over 80 percent of them with no follow-up, which is a terribly sad statistic. Once a participant has gone through the profound experience of being in a trial they become a kind of ambassador for us, as they now understand the process and the level of professionalism and integrity that exists. These are potentially valuable partners who could spread the word, raise awareness and help in the process of education and outreach. However, the majority of all volunteers say that once they have completed their participation, there is no communication or connection sustained with the research center. To not go back to those people and let them know why their participation mattered, what it enabled or what resulted from it is a huge failure to convey recognition and appreciation.

NGP. It now takes nearly twice the length of time to develop a new drug than it did 30 years ago. What part have clinical trials played in this slowdown and how is the industry addressing the need to speed up this phase?

There are so many places where the drug development process is inefficient and patient recruitment and retention is clearly one of the major causes of delay. In fact, we know from interviews with investigative sites that during the actual conduct of the study, patient recruitment is the largest cause of delays today. You’ve no doubt seen the statistic that in an estimated 90 percent of clinical trials, the trial period has to be extended by an average of six weeks. There are two root causes for this – it is not only that sites have difficulties in finding subjects, but also that today’s protocol designs are too onerous and complex. In addition, there is currently a lot of variability in the way that investigative sites go about finding and recruiting subjects.

These are all key areas that should be addressed by both sponsors and investigative sites. Sadly, the sponsor has typically addressed this problem by shifting responsibility onto the investigative site. As protocols have become more complex and ambitious over the years, these sites have had to shoulder an increasingly heavy burden, while at the same time, public trust in the pharmaceutical industry has eroded.

We see huge opportunities for sponsors to help make recruitment and retention easier. This can, in part, be achieved through the use of certain new technologies, such as ePro technologies, like patient diaries, interactive voice response and a range of convenience technologies to enable the patient to more easily participate in the study. However, these will only have a minimal impact. What both government and industry research sponsors really need to do is band together to find ways to deliver broad education that will improve the understanding and image of clinical research and its importance. Once the volunteer feels like a valued partner in this process, efforts to improve the convenience of participation will finally pay off.

This is next generation stuff. It will take an open-minded approach that runs counter to the mentality of a typical research sponsor today, which is focused on maintaining profit margins and delivering an immediate return on investment. What we are talking about here requires a long-term investment – it will have a huge return in the future, but that will certainly not be measurable in the first year. When it comes to focusing on raising public pride and appreciation in clinical trial participation it is going to take many years of effort just to undo the damage that has been caused by our failure not to do so in the past.