Top Site Complaints: Budgets, Communication, And Technology
By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
Technology firm Greenphire conducts an annual survey to determine the trending issues that matter most to global clinical sites. Last year the company asked me if there was a question that I would like to see included in their survey. It has been a few years since I attended my last SCRS Summit, which is generally where I get to hear feedback from sites about clinical trials and everything they would like to see improved. After giving it some thought, I requested that Greenphire ask its survey takers to respond to the following question: If there was one thing you would like sponsor companies to do for you, that most are not currently doing, what would it be?
The question clearly struck a chord with individuals completing the survey. Although it was not a question where respondents could simply check a box, many of the 500 site representatives took the time to provide thoughtful responses to the question. Those responses seemed to fall into three broad categories: budgets, communication, and technology.
Contracts And Budgets
The majority of comments received in response to the question focused on the issue of budgets and payments. When it comes to study budgets, simplification seems to be the main result sites are hoping to achieve. Several respondents noted the entire budgeting and invoicing process needs to be simplified.
Understanding how sponsor companies produce their budget estimations were a concern to some respondents. “Provide more analytical information on how (sponsors) arrive at their budget estimation,” noted one person. “They often claim that their estimation is fair market value, but their estimation is completely wrong. Furthermore, they request detailed explanations on each increase in the budget but are unwilling to provide the reasoning behind their calculations. This makes our work harder and more time consuming than it could be if sponsors/CRO's provided more analytical info from the first contact with our site.”
Another responder recommended that sponsors provide current contracts and budgets directly to the CRO, noting sites should not have to provide the information since they are not the company that contracted with the service provider. When the CRO requires contract or budget information, they should go to their client, the sponsor. CROs should not be asking sites for that information.
Site costs are going up, due to inflation, the great resignation, demand for trial services, and other factors. Sponsors need to be aware of those cost increases to properly budget for them. One survey responder noted sponsors should help sites anticipate budgetary changes that may result from rising prices, but this puts sponsors in a bit of a catch-22, since a sponsor’s insights into rising site costs will generally come from information received from the sites themselves.
Finally, sponsors should provide realistic start up goals and open communication regarding budgeting and negotiations. According to one respondent, they should also provide all necessary start up documents in one batch upfront. This will keep sites from having to request this information when needed.
Fix Site Payments
When I attended my first SCRS Global Site Solutions Summit about 6 years ago, payments were the biggest complaint I heard about over the three-day event. Site personnel I spoke to were not happy about the timeliness of payments and how those payments were made. Sites were often left waiting far too long for a payment to arrive, and when it finally did, it often contained no supporting information that would allow site personnel to tie it back to a specific trial or trial activity. In the 2021 SCRS Site Landscape survey, sites re-confirmed the preference for frequent payments, and while improvements have been made, Greenphire data validates that sites feel that the most important activity a sponsor/CRO can do to foster enhanced relationships with them in 2022 is to “streamline site payments and invoicing.”
“Take ownership of site payments and take the lead,” noted one respondent in the United Kingdom who seemed to be exasperated by the effort needing to be put forth.
Others requested more timely payments with supporting documents. 82% of sites in the Greenphire survey agreed that delays in site payments from study sponsors has a negative impact on their business operations. “Provide prompt payments along with payment summary information,” said another. “Sponsors send payments that are difficult to tie to a study when you have 10 ongoing studies with the same sponsor. Sites require detailed payment summaries for every payment made.”
The payment summary information is not just an issue with checks received in the mail. One respondent noted their site received a fair number of electronic transfers that were also unaccompanied by any notation stating what the payment was for. Detailed statements that accompany payments should, at a minimum, include the protocol number, subject number, and visit number.
A few respondents also requested sponsors eliminate holdback, or at the very least reduce it to less than 5%. Some would also like to see pharma companies limit invoicing. This could be accomplished by paying promptly based on data entry or activities performed. “Budgeting and contracting are difficult for site finance teams,” said one individual. “Payments need to be more automatic for all clinical procedures. There needs to be an easy and clear way of paying sites.” It’s clear that sites desire more automation and standardization as it relates to being paid for study activity, instead of traditional manual methods.
Focus on Patients
Sites have always prioritized a positive patient experience, but especially post-pandemic, these services are critical. Some sponsors are more efficient than others at providing patient reimbursement and travel support. And sites could also be helped by sponsors increasing stipends when inflation is causing gas prices and other transportation fees to increase.
Finding ways to relieve the burden on patients, so sites don’t have to, was an issue noted by several respondents. Patient reimbursement also came up in several comments, with a few individuals noting reimbursement or a travel allowance should be provided for all patients in a manner that would not require sites to invest time and effort on it. “Put the patient first for everything,” said one. “Make it easy for them to participate – getting involved with a clinical trial should not be a burden for patients.”
Offering patients the opportunity to take advantage of home visits and implementing tools enabling sites to reach patients in homeless populations were also suggested.
“I would like sponsors to ask sites about their preferences as part of the site feasibility process,” noted one respondent. “Feasibility tends to be very one sided, where drug developers decide if they want to work with us. The process does not give sites much input on what trials we would be much more efficient in conducting.”
Provide Better Communication
On the topic of communication, sites would welcome more direct conversations with sponsor companies. That communication is especially important when an issue arises and the CRO is non-responsive. “We need to be heard,” said one respondent. “That would be the best thing ever for sites.”
Site liaisons, provided by sponsor companies, could also improve communications, help sites expedite an issue, and get problems resolved. However, site burden will not be reduced if there is unnecessary or duplicate communication, such as sending requested information to a CRO multiple times. Other activities that can unnecessarily increase the work of sites is frequent check-ins even though screening logs have been sent and changing CRAs multiple times during a study.
Ease Technology Challenges
Technology use is clearly an issue for sites, as demonstrated by the number of survey responses mentioning tech-related challenges. For the most part, sites seem to want sponsors to understand the time and effort it takes to implement new technology tools, and to do what can be done to minimize the challenges that arise. For example, one respondent mentioned the number of websites that must be used for a trial.
“I am working on three studies that each have nine sites I am required to use. Nine sites mean nine log ins and nine passwords.” Technology certainly plays a critical role to conduct clinical trials, but these challenges indicate an increased need for integration across platforms.
Another respondent asks sponsors to be aware of the additional time and effort required to perform activities not related to working with patients, such as waiting an hour for a password to be reset or dealing with electronic gadgets that are not functioning properly.
“Understand that your study is not the only one we are working on. Respect our experience and try to focus less on things that are totally irrelevant,” said another.