During our January webinar, Site Empowerment – Envisioning New and More Effective Ways to Work with Sponsors and CROs, we had several questions related to the use of standard site profiles. Here, we list your questions along with a more comprehensive response to address all of them.
Q: It looks like the #1 area that sites think they can have the biggest impact is sending standard site profiles. I don’t have experience with this so can you elaborate more on exactly how sites are doing this.
Q: You mentioned the Transcelerate Biopharma standard profile – I’m not familiar with Transcelerate so can you elaborate on who they are and their form?
Q: How are the site profiles being accepted by sponsors? I am finding that even the Transcelerate forms are having to be completed over and over. And a related question: We’ve tried providing our profile but sponsors are not usually happy with it and want THEIR form completed. Or they state in their feasibility questionnaires that, unless we respond a certain way, our forms can’t be accepted. How do we best handle this?
A: First, let’s start with the basics. A site profile is typically a document that describes all of the basics about a site: years of experience, type of studies conducted, infrastructure (staffing, facilities, equipment), IRB/ERC process, training, FDA inspection experience and results, enrollment performance metrics and so forth that help establish the site’s basic qualifications and capabilities for conducting clinical trials. This may include a “meet the staff” section with a snapshot of the staff’s experience (photos, experience, interests), which provides the sponsor/CRO with a sense of the staff resources prior to reviewing detailed CVs. The profile is sometimes supplemented with a video or website “virtual” tour of the facilities (e.g., patient rooms, drug storage facilities, document storage and monitoring facilities, etc.). Sites use this for marketing purposes to showcase their experience, and it’s increasingly being used to replace the need for sites to complete redundant information for each sponsor on more traditional feasibility questionnaires.
Towards that end, Transcelerate Biopharma has been one of the industry initiatives spearheading solutions to drive more efficient clinical research conduct. This is in collaboration with some 20 biopharmaceutical companies that are designing and advocating different initiatives to reduce the redundant work that sites have to go through for each sponsor. One specific initiative has been to create a standard Site Profile Form.
A core idea behind the Transcelerate initiatives is to get agreement and buy-in from sponsor organizations to adopt their recommendations, so that ultimately there is greater standardization across the industry on some of these operational activities (among others) that contribute to a lot of waste, inefficiency and frustration for sites. Transcelerate was launched in September 2012 and has around 20 participating organizations.
In theory, if sites use the Transcelerate Site Profile Form, it should be universally accepted by the member companies, thereby eliminating the need for sites to complete basic information over and over when being considered for a trial. This is complemented by other initiatives focused on mutual recognition of standard GCP training, plus the development of a common investigator database/portal that will contact this standard information about sites, all of which will be accessible to the member companies. That said, some of the concepts are still relatively new and not all biopharma companies and CROs are members of Transcelerate, so it will take time for their recommendations to become more widespread and common practice.
Regardless of whether a site uses the Transcelerate Site Profile Form or their own form/virtual tour, the idea is to convey site experiences and capabilities only once and avoid the redundant efforts. This enables sites to focus the time they spend during the feasibility stages on more value added activities, like conducting more robust enrollment validation efforts that truly drive study success.
As the industry shifts from traditional practices, the challenge is that not all sponsors or CROs have bought into this process or have a mechanism to incorporate the sites’ forms into their internal site databases or study-specific feasibility analysis forms. While one of the webinar participants noted, “Some sponsors have been great in accepting our site profile and willing to put it into their format for us — great customer service,” this is still the exception rather than the rule.
Like all of the site empowerment techniques, a lot of this comes down to relationship building and management. If a site has a good relationship with the sponsor/CRO, often a phone call to the Director of Clinical Operations or Study Manager can help explain the rationale for why the site is sending the standard profile information, and help them understand that allowing the site to focus their precious resources and time on more critical activities helps both parties. In my experience, management within the organizations completely understand and agree with the need to eliminate inefficiencies, although they may be bound by existing SOPs. That said, they may be able to short-circuit things, and at the very least, the more they hear from sites about this issue, the more empowered they are to drive change within their organizations. As more sponsors and CROs recognize the value of this approach, and as more sites advocate for this process, I anticipate that this will become a common practice. In the interim, both parties need to be patient with the transition, which in some cases may still necessitate completion of redundant forms.