Mark Summers, WCG president of patient engagement and founder/CEO of WCG ThreeWire, and Molly Hair, ThreeWire director of site engagement and management, provide their take on subjects ranging from forecasting study enrollment to ensuring reasonable return on investment.
Question: What is the best way to realistically forecast new study enrollment?
Summers: The way to realistically forecast is to literally develop a flowchart, beginning with study candidate identification and following that all the way through to scheduling the initial office visit, attending office visits, all of the sites’ screening processes. And then when you get into the processes that have to happen at the site, mapping out who’s going to do each of those steps and how much time that’s going to take. Because identifying patient candidates is often easier than solving the problem of a site’s bandwidth.
Hair: Sites really do need to be honest with themselves about what competition is at their site — not just competition for the patient, but the competition for their team’s time and competition against maybe less obvious sources, like standard of care.
Question: What are the best methods to advertise to or recruit patients located in rural areas?
Summers: The first thing I would say is, unless you have a patient population where the patients are going to predominate in rural areas, then don’t pick sites in rural areas because recruiting in a rural area is very difficult. So this is really more a question the answer to which entails going upstream into the site selection process. If you have to choose patients in rural areas, conduct a very careful site selection process. You should be picking sites that have patients in their database or have ready access to patients without advertising for the study.
You have a very sparsely distributed patient population. Media costs are going to be amortized over those patients and it’s going to be very expensive. If you do have to advertise, then local advertising is going to be the way to go. Meaning, local newspapers or small town newspapers. Interestingly, the page-per-page readership of small town newspapers tends to be a lot higher than it is in big cities.
Hair: There needs to be a reason that you go to a rural site, and there may be very logical ones depending on what your protocol is. What I would recommend to the sponsor or CRO, in order to set the site up for success, is that they engage in discussing recruitment earlier on in the process and maybe interact with the recruitment vendor or other places where they can consult with some expertise about recruitment earlier in the process because the information that they get about the strategy may better equip the sponsor for adjusting the timeline for recruitment and enrollment, give them a more realistic notion of when the timelines can be achieved within a rural setting.
Question: Clinical trial agreement contracts play a huge role in patient recruitment. Which is better: a cost-reimbursable or fixed-price model?
Summers: From our perspective, the cost-reimbursable model is better than the fixed-price model that may be great for a CRO or sponsor, may be great for the internal budgeting process. But the economic equation has to work for sites. So if it turns out that that fixed-price model is going to become detrimental to the site — either in terms of the site incurring costs that they had not forecasted when they contracted for the study or perhaps putting that study at a disadvantage from a reimbursement standpoint compared to other studies that the site is engaged in — I think cost reimbursable is virtually always a better way to go.
Question: Does your approach include recruitment at any cost? Where are the limitations of that approach?
Summers: Well, the short answer is no. It’s not recruitment at any cost, it’s recruitment at a cost that represents an ROI that is acceptable to the sponsor or CRO, whoever’s paying for recruitment. And so the limitations are really going to be set by that ROI. And that’s going to depend on each individual study. It’s possible to calculate the value of each enrolled patient. There’s a simple spreadsheet tool we’ve developed to do that. And then you can build a recruitment funnel and enrollment funnel and evaluate the cost and compare the cost of enrolling each patient against the value of that enrolled patient and determine return on investment. We try to do that up front.
Some projects we have a cost per enrolled patient of $4,000 or $5,000, and that’s acceptable. For some, it’s $25,000 or $30,000, and that can be acceptable. But if it should be $5,000 or $6,000, that’s not acceptable. So no, it’s not recruitment at any cost. That has to be reasonable and it has to make sense and represent that reasonable return.