Guest Commentary: Changes of Scope—The Clinical Study Budget Secret
Pharmaceutical, biotech and medical device companies want to conduct faster, safer, less expensive clinical studies.
But as the industry continues to innovate and adopt new technologies, one of the most expensive, time-intensive and potentially frustrating components of clinical study management remains unchanged: the change of scope. It’s the issue nobody likes to discuss. Changes of scope affect both sponsors and CROs because they change the process. The CRO with an unrealistic budget wants to deliver the study properly but is tied to the terms of the contract. The sponsor wonders if it’s worth the time, money and piles of paperwork required for even a small change. Both sides can collaborate to create comprehensive RFPs that limit—and even avoid—changes of scope by taking potential changes into account upfront and adopting a flexible billing model to accommodate changes and meet the sponsor’s needs. Here are three steps sponsors can take to create an RFP that decreases changes of scope: First, get the most thorough proposal. The amount of time and care invested in compiling an RFP is directly related to the number of changes sponsors will experience. Sponsors can avoid changes by developing a comprehensive RFP template and sticking with it. Otherwise there will be a change in scope in the middle of the study. If sponsors consider every potential activity associated with a study they will get proposals that capture every possible contingency. Review past studies to prepare a new RFP. Ask the CROs what happens if they add more sites, more patients, more meetings or monitoring visits, extend the timelines, etc. An RFP template can be a simple word file in a table format with some of the following items:
- Estimated startup time – anything less than three months is not feasible, although CROs will work with shorter startup times if they are compensated for the extra resources and time.
- Date of first and last patient screened and enrolled – If the sponsor needs the CRO to estimate this, they should be clear about when they want to screen the first patient.
- A checklist of responsibilities – This should include the sponsor, CRO and other vendors. Most CROs can provide a complete checklist of study responsibilities if the sponsor is not sure what is normally included. It should be detailed enough to budget the study but easy to follow.
- Challenges – The RFP should include any challenges to help the CRO project enrollment and budget. The sponsor should not assume that the CRO will know all the challenges. The sponsor is an expert on the product and usually knows something the CRO doesn’t.
Second, ask the CRO to assign someone with clinical training and expertise to review and respond to the RFP, rather than a business development person. It’s a sponsor’s best chance for a comprehensive proposal because clinical professionals take into consideration all the contingencies that might come up during a study.
Third, don’t assume that the lowest bid is the least expensive bid, or that the highest bid is the most comprehensive and will not have changes in scope. Sponsors get something different from every CRO. Budget should not be the deciding factor. But whatever bid sponsors choose, they should get the guarantees in writing.
Don’t accept a bid without considering every possible aspect, or both sponsor and CRO will be constrained by an unrealistic contract. During the proposal review process, ask as many questions as possible to be clear about upfront and hidden costs. Be certain the proposal includes a thorough budget. Sponsors need to know how many people will be assigned to their study and their areas of expertise. Two important questions to ask:
1) If you have enrollment difficulties, what is the monthly cost to maintain the study beyond the timelines? An experienced CRO should be able to give the sponsor a concrete answer and number.
2) Where does your study rank on the scale of the CRO’s ongoing studies? The sponsor might not get a direct answer but should be able to determine priority by the staff assigned to the project.
Finally, sponsors should demand a certain level of work product from each CRO team member. Get a clear understanding in writing of each person’s role and how much of their time will be dedicated to your study.
A thorough RFP process with clear expectations from the sponsor and a CRO willing to adapt and be flexible can reduce or even eliminate changes of scope and let both parties focus on the end result: delivering quality data to clients.
DSP Clinical Research is a CRO specializing in small to mid-size pharmaceutical, biotechnology and device companies.