By Lisa Marsh MA, BSN, RN, CCRP, Research Nurse Supervisor, Department of Infectious Diseases, University of Texas MD Anderson Cancer Center
Q: What empowerment best practices or techniques does your site apply to ensure mutual alignment between your site and sponsors/CROs?
A: We do a number of things.
1. Require that sponsors provide a direct contact person for every aspect of a clinical trial for all studies.
This includes a contact for the budget, contract and protocol. We will work with a CRO, but have found that when clarification is needed, it is best when handled directly with the sponsor.
2. Establish communication expectations up-front.
A very important proactive measure is to state what you expect in regards to communication and turnaround time for responses. Larger pharmaceutical companies and CROs tend to take longer to respond for various reasons. I would expect to hear from either the sponsor or CRO for urgent matters within 24 hours.
3. Know what sponsors expect in regards to data entry.
Sponsors typically expect sites to enter data within 5 days, but sometimes we can’t if we don’t know what specifically needs to be entered or how to enter the data correctly. So, another proactive measure is to ask for the EDC guidelines prior to negotiating your budget to know what is expected per visit. This should also allow for the least amount of auto-generated queries when entering data. Recently, we were blindsided when we looked into the EDC system of one of our studies and realized that if you answered a question a certain way, it triggered 18 additional pages. The EDC guide was not provided or helpful.
4. Budget according to our needs.
In the previous example, the study required at least 2 full-time data entry people to enter all the information the sponsor wanted in their required time frame. Sponsors want you to enroll, and to do so quickly. They also want you to enter data with the quickest turnaround time from a visit, and we need to know up-front what that will entail. Then, we can budget accordingly before we start.
5. Ask sponsors what triggers payment.
Are you paid when monitors have source data verified (SDV’d) the data, or once the visit had been verified as having occurred? We have had both options trigger payment. It is ideal to have payment triggered at the point of a visit occurring (i.e. you enter a date into the EDC that you saw the patient), as it can take a while for monitors to verify the data and delay the payment by months.
6. Proactively ask about payment for prescreening.
We spend hours every week looking for potential patients to approach, and we aren’t typically paid for this time. I don’t see why a site can’t be paid for this activity, as the sponsor routinely wants a weekly spreadsheet of screened patients, in addition to why you didn’t approach a patient and enroll them. Recently, a sponsor that we worked with at an investigator meeting asked that sites enter all of our prescreened patients into the EDC, and the very first question from all the sites was, “Are we paid for this?” In this particular instance, the answer was “yes.” It never hurts to ask, and often we as sites just don’t respond to our sponsor’s request for this info, or we don’t complete their spreadsheets and send a quick email stating, “We screened 3 patients they didn’t meet X, Y, Z criteria.” When we can, we leverage our effort and ask for this up-front as a per-patient screened cost. It won’t be a substantial cost – I’d think $20-$25 per patient screened is reasonable.
Q: What are the biggest barriers you are encountering when implementing these techniques?
A: First, getting responses in a timely manner –because CROs have to mitigate with sponsors prior to responding to a site. That is why it is always best to speak directly to the sponsor when you can. I find meeting your sponsor contacts at investigator meetings helps.
In addition, many times they have yet to complete their EDC guides, and so we have made it a rule to not start a budget or contract until we see it up-front. You need to know what to expect and how much help you’ll need to enter data. More importantly, often your payment is tied to data entry. Without the right assistance to enter data, there will be a delay in payment for all the work you are doing. It is not the site’s responsibility to ensure monitors SDV data in a timely manner. That’s why we ask that the confirmation of a visit occurring trigger payment, and not the verification of the data being entered. This should be seen as a reward for a site to maintain data entry timelines and to be paid on time for entering that data.
Remember, you always have the right to negotiate, especially if you have a known history of meeting your data deadlines.
Q: How have you worked through these to accomplish everyone’s goals?
A: We’re a large enough site that we can say “no” to sponsors who aren’t willing to work with our terms. I know other sites need to have a certain amount of studies to pay their staff, but because we budget well, we can enroll 20 patients and employ several staff to work on that one study. This should translate for sites of all sizes – from small private research organizations to large academic institutions. Sponsors often choose a site because of answers on the feasibility questionnaire. If you can promise at least a third of the total recruitment goal for the entire study, they will make the budget reflect that. Often times, we have a good existing relationship with a sponsor, and they are more willing to work with sites that have a proven track record with them. Never over-promise and undersell your site.
Most sites aren’t paid up-front for their work (such is the case with NIH grant funded research). If know you will need a data entry person but don’t have the funding, initially ask that the sponsor to consider contracting data entry people to assist you with data entry, or it will delay continued enrollment. That way, they control when and how to pay for someone to assist you with the backlog of data entry, without having to pay you up-front for something they aren’t sure they’ll get a return on. This can be a viable option, though not ideal, as there may be a delay in finding a suitable contractor and getting them all the access they need to complete data entry.
Q: How many sponsors/CROs are you having success with these practices?
A: We have 100% success rate with these practices and our sponsors, but that’s because we are selective in who we work with. Consider choosing a sponsor based on their willingness to assist you when it comes to that time, which will most likely be when you have around 10-20 patients enrolled and no data entered. If you plan on being a high enroller, they should be willing to assist you with data entry. Sponsors seek us out because of our access to a specific patient population and the nature of our work, which is unique. That is not something I can say happens across the board, so smaller private organizations will have to sell themselves up-front with the feasibility questionnaire.
Q: Are you starting to see an impact?
A: As a site, we have seen an impact when it comes to CROs. I would say they are learning that in some situations it’s probably best that the site work directly with the sponsor. They may be told all sites are to receive the same budget and think they can’t negotiate, but each site is different and so there is always room for negotiations. I think sponsors are always willing to do what needs to be done for their highest enrolling sites and for sites with a proven track record of entering data in a timely manner (within reason). Of course, it depends on the sponsor. Larger ones that choose to work with hundreds of sites as opposed to a few sites may be difficult to work with, and so we end up invoicing a lot. For smaller sponsors, this is not an issue and we often work directly with their upper management. I prefer working with smaller companies, but the larger ones reimburse more. It’s not bad to have a good mix of both.
This post is part of the site empowerment campaign. To learn more about site empowerment techniques, you can find all of the articles here.