Importance is a perception issue. Perceptions can drive actions. Work to create and maintain positive perceptions and people will alter how they approach a situation or a task.
The two clinical trial perceptions relating to Importance are:
1. the site must believe the study is important, and 2. the site must feel important.
In investigator and site motivation, importance is often overlooked, but if you want to be the sponsor of choice, take steps to show the sites they’re important. Take steps to show the sites the study is important.
If a molecule or project is deemed important, the site may allocate more resources to it. Documents will get turned around quicker; phone calls returned faster; meetings scheduled sooner. The study quickly becomes a high priority.
The story matters. Every sponsor and/or molecule has a story. If the sponsor articulates a compelling story, clinical trial sites will want to be part of that project and perform well. As a CRO, if the sponsor hasn’t presented a good story, efforts should be made to construct and tell the story.
What are things that set a study up to be perceived as important?
- Novel molecule that has an interesting mechanism of action.
- Sponsor is a valued partner to the site. Yes – relationships are important in clinical research.
- There is a direct connection with the sponsor. If the CRO puts up a wall and doesn’t permit the site and sponsor to correspond, that study immediately becomes less important. If the sponsor valued the relationship with the site, there would be a connection.
- For small companies, the story of the journey of the company and/or its key people can help create the importance narrative.
- A sponsor’s commitment to a therapeutic area. If the sponsor has more than one compound in development in a therapeutic area or is planning multiple studies, that matters to sites and elevates the status of the single study. Sites like to know that the sponsor is in it for the long haul and that there will be future studies.
The most important group in clinical trials is the participants. Hands down, no question. They’re without a doubt at the top of the list. However, sites should be the second most important group.
Sponsors and CROs must demonstrate to sites that they are important and critical to the success of the study. Steps to take that matter to sites:
- Have direct contact from the sponsor
- Involvement (see previous article)
- A reasonable budget. When a budget is deemed “low” by a site, the importance level drops because the site feels their time is not valued by the sponsor.
- Design a study that is site centric. As the protocol is written and vendors selected, take careful consideration and get input on how the various components will affect the site. Things that make a clinical trial not site-centric are:
- Lots of portals for the site to accessSpurious data queries – the “are you sure? queries”Generally, the more footnotes there are below the protocol table of procedures, the less site-centric the study is (and greater chance for error)
- The larger the number of vendors used; the less site centric the study becomes
If a molecule is deemed as “important” by the investigator but the protocol design is flawed, the importance of the project drops.
The Importance aspect of Investigator and site motivation can be the most challenging one to get right but can’t be set aside as a lower priority.
Despite being the last “I” in this article series, Importance should be the first thing that sponsors start working on as they plan the study. Every study has a “story”, but most sponsors are not generally good at developing it and articulating it. The typical path in engaging sites in the clinical trial process does not support good story telling:
The receipt of a cold, legalese email with a draft CDA is typically most site’s first introduction to a potential clinical trial. The CDA is finalized, executed and the site is most often provided a short synopsis or a few basic details on a study along with the feasibility questionnaire that is lengthy, redundant and takes considerable time to complete. Is that a process that sounds engaging; that tells a good story about the study so that the investigator is thinking “I want to participate in this study above all others”?
Remember, Investigator motivation in a clinical trial directly drives enrollment. Sponsors should want that motivation to be as high as possible. What could be done differently to generate excitement about your study?
What if a sponsor approached the feasibility stage of a study with an effort to generate excitement about the project? What might that look like?
Let’s say that I work for a biotech company that is very progressive and innovative. I’ve been hired as their VP of Enrollment, a role that is dedicated to all the factors that affect enrollment in clinical trials. My team reviews all aspects of a clinical trial that might impact enrollment and provides guidance to the development and ops teams. Protocol design, vendor selection, site engagement, recruitment planning, country and site selection are all reviewed with an enrollment lens. Part of our job is to build and tell the story to engage our sites and vendors in the trial. We start constructing the narrative with the story that was told to senior management to obtain funding for the study. That must have been a compelling story after all since it was able to secure a significant investment.
That story is reviewed and modified with the site perspective in mind. What about the story of the company, the people, the molecule, the indication are going to resonate with sites? Perhaps the mechanism of action is novel or how it was discovered is compelling. That information is packaged and prepared to share. Presentations, videos, and materials are prepared that all tell the story of the molecule and the company. Before the broader site feasibility begins, the team starts engaging key sites (not necessarily KOLs, but experienced sites with a history of high performance in the indication). We get CDAs in place and start sharing the story and collecting feedback. We tell the story of our company’s commitment to this therapeutic area and share about our engagement with patient advocacy groups and associations. We articulate through calls, meetings and online presentations why we’re so excited about this study and the molecule.
We set up paid advisory boards with those investigators and their key coordinators to help us with the operational design of the protocol and collect advice on vendors we are considering. Separate advisory boards are conducted with patients who represent the individuals who may be candidates for the project. A select group of investigators and coordinators attend those meetings as well.
As we plan for the second part of the feasibility assessment, we prepare a list of potential sites. We specifically construct the list to have both experienced sites and some new sites. Our team knows that often the new sites can contribute significantly to enrollment. We have a team prepared to assist the newer sites and support them through the study.
The materials prepared for the feasibility assessment include an introductory video and presentation slides along with the protocol if it’s ready to be shared. [*Note: There is no mention of a “protocol synopsis” here. A traditional protocol synopsis is of little value. Re-packaging study information in other materials that provide answers to the questions sites actually want to know is of much greater value].
Has your company ever completed the exercise of asking: “What information does a site need from us to properly assess if a study is a good fit for them?”. Perhaps now is a good time to do that.
The feasibility questionnaire has been narrowed down to just the key questions we absolutely need the sites to answer. To save them time, the questionnaires are pre-completed with the information we have on file for the known sites.
The sites are given two weeks to complete the questionnaire and an offer is given to schedule a meeting to answer any questions the site might have.
Following the receipt of the completed feasibility questionnaires, a thank you email is sent to each site that indicates when the selection decisions will be made and informs them that they’ll hear back either way.
During the decision process, some sites are contacted with follow-up questions for clarification. A preliminary list is determined with back-ups identified and pre-study visits are scheduled. At the pre-study visit, the story is again articulated in a creative format and the site is thanked for taking the time to conduct the visit.
Selection notices are sent, with personalized letters attached from the trial medical director addressed to the individuals at the site that have participated in the process so far. Instead of just assuming the site will proceed, a request is made to confirm that they accept and can move forward. As a sponsor, I understand that time passes between the site completing the FQ and being selected. During that time, the site may have accepted a competing study, and my feasibility planning must account for that possibility.
Non-selections notices go out as well, providing a reason that the site wasn’t selected. These are also accompanied by a letter from the medical director along with a request to keep the site information on file in case we need additional sites in the future.
Once the site confirms participation, a welcome notice is sent from the key sponsor and CRO team members highlighting the excitement of having the site as a partner in the study.
This approach to site communication as a valued partner of an important project should continue through the various stages of the clinical trial.
The following are things to consider throughout the study that dramatically impact whether the site views the study as important and feels like they’re an important partner.
- Low ball budgets that don’t reflect site effort.
- Staff time wasted
- Spurious queries
- Vendor problems or dealing with their IT support
- Constant requests for updates, phone calls or meetings
- Added requirements after study start
- Delays in payments – there is maybe nothing that makes you feel like you’re insignificant like facing delays in getting paid for the work you’ve already completed.
- Drug or lab supply issues
As a general approach, think of experiences that you’ve had that made you feel valued and appreciated and replicate that experience for sites.
Spend the time and resources to tell a compelling story of the study and treat sites like they’re important and they will in turn value your study and enrollment will benefit.
Reflecting back on this series, there are several key points to highlight:
- Investigator / site motivation and momentum in enrollment in the clinical trial are directly linked. It’s critical to successful enrollment to keep motivation high and quickly address anything that might affect momentum in the trial
- Impediments directly decrease motivation so have a plan in place to detect and minimize impediments throughout the study
- Irritations might seem like a silly thing to affect momentum in a clinical trial, but if left unaddressed, they can build and cause sites to quietly quit
- Involvement of the sites is increasingly important. Don’t wait and involve them last and still expect smooth sailing for your study.
- Importance is a two faceted concept. For a study to achieve high priority by the site the study must be deemed important by the site and the site must feel that the sponsor believes they’re important .
This is the last in the series of articles on Investigator motivation in clinical trials, but it’s not the end. Keep the discussion going and subscribe to get notified of future articles.
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