Developing solid, reliable and lasting relationships between sponsors/CROs and trial sites is essential not only for the positive outcome of a particular trial, but for long-term trend analyses too. However, many past relationships between the two parties could be described as imbalanced with sponsors using their partners once and never again.
What is needed instead is open communication, mutual respect and a fair amount of autonomy handed from sponsors to trial site staff. By doing so, trials will run more efficiently and patients will be better engaged. This post will explore how best to build positive relationships.
Pharma companies and CROs need to ditch the “build-and-break mentality” and adopt an approach of longer-term commitment, Paul Evans, corporate VP, global site solutions at PAREXEL, says.
Rather than use a site once and be done with it, sponsors should foster long-term agreements by choosing the best site for their needs and committing to the partnership. Over time, both parties will begin to trust the other’s processes and goals, ultimately resulting in a better patient experience.
Evans says the current model is as unwieldy as if a large business used a different vendor from which to buy paper clips each time its stock needed replenishing. Yet many sponsors act this way when it comes to choosing sites, and of course clinical trials are far more complex than buying paper clips. Still, the time and effort necessary to find a reliable site to partner with over time is seldom made.
By adopting this strategy of site alliance, both parties would benefit, seeing better recruitment figures and faster start-up times. An additional advantage, Evans explains, is that sponsors will be better equipped to monitor and identify longer-term trends within studies, which in turn will improve future trials.
Long-term relationships that thrive, as any expert on relationships will tell you, needs open communication that is clear and responsive. The same is true for trial sponsors and site staff.
Prioritizing high-quality communication allows both parties to list their goals and desired outcomes. They can then work together to ensure they are in alignment, Kristina Lopienski at Forte Research explains. This will result in more efficient trials and better budgeting.
Communication will also mean sponsors and CROs make the process of working with them simpler, Jeffrey Zucker, VP clinical operations at Worldwide Clinical Trials, explains. Site staff will know what is expected of them but also be able to seek the necessary support and input from sponsors and CROs to ensure more successful trials.
Zucker says that most sites want to be more involved with the whole study process and have keen insights into operational efficiencies, protocol, start up, patient recruitment and retention as well as data quality.
“Ultimately, a collaborative design process will benefit all involved and result in more positive study outcomes,” Zucker suggests.
Greater collaboration requires a checklist of practices in place to facilitate this. Among these are:
Indeed, it could well be worth appointing a clinical trial liaison, senior clinical research associate Robert Dannfeld writes at Applied Clinical Trials. He explains a contact person is needed to answer questions and provide solutions as difficulties arise during clinical studies, which occur during any research project.
The liaison’s role of providing open and transparent communication with site personnel and research teams isn’t easy, however. “The required competences of this person include analytical skills, strategic thinking, communication techniques, relationship management, as well as a well-founded understanding for the work of investigational teams,” Dannfeld writes.
The clinical trial liaison can also help with determining that the best trial site is selected. This decision is largely based on whether the site has experience in the indication or condition under investigation, Dannfeld says. The site will need to know, for example, what participation means to patients in terms of procedures and have plans in place for motivating patients to adhere to the program. It will also of course need to have the infrastructure necessary for the study.
Increasing collaboration also means seeking greater equality in the relationship. Investigative staff at a trial site have important decisions to make each day the trial is underway. So it makes sense to grant them the necessary autonomy to do their jobs well, clinical trials project manager Nadia M. Bracken at GCP Cafe, a community for clinical research professionals, says.
This greater empowerment encourages and allows site staff work harder and more efficiently, and also puts them in a better dynamic in relation to sponsors and CROs.
Bracken also suggests that the reverse feasibility questionnaire can be used as more than a one-sided transaction. After completing it, the study staff should be able to determine if the study’s designs and site selection fit well.
Questions to ask should include:
Clinical Performance Partners president Beth Harper highlights the importance of the reverse feasibility questionnaire, adding that site staff should also ask sponsors exactly what they need to make the trial a success. Questions surrounding “non-negotiable contract language” should be addressed as well as those pertaining to budget and data capture.
The questionnaire, Harper explains, helps sponsors and site staff understand what is essential for the trial’s overall success as well as completion of their individual tasks.
Additionally, site staff should provide or sponsors should seek information about the site’s start-up processes and timeframes, staff certifications that prove training and GCP compliance, and site protocol.
Using technology to streamline the flow of data and documents makes for more efficient trials, Beenu Kapoor, senior director at Cognizant Business Consulting, writes. And choosing a platform that enables these capabilities will cut out a lot of wasted time spent on repetitive or manual tasks.
Additionally, a “centralized access point to clinical trial information” means fewer trial site visits and shared access by all parties to important data. These factors will help sponsor staff and site staff work more efficiently and accurately.
Another useful means of accessing reliable trial sites is through initiatives such as F1RST Up from Frenova Renal Research. After rigorous testing and reviews, clinical trial sites (dedicated in this case to renal research) are invited to join the alliance, Kurt Mussina and Christina Kahn explain.
The assessment of sites includes their experience, size of patient populations, efficiency of their systems and processes, their enrollment targets and previous audits.
The advantages for sponsors accessing sites through the alliance are many. One is that it accelerates trial site start-up by eliminating time spent hammering out trial agreement terms. Evidence shows that time is reduced on average by more than two weeks: from 41 days with non-alliance sites to 25 with F1RST Up members.
The practice of central IRBs (research ethics committees), which can approve multiple sites in the same protocol, has proven to save as much as half of the industry average time from site selection to first patient enrollment.
As with any contractual relationship, it’s wise to discuss in plain language exactly what is required of each party and the ramifications for non-fulfilment.
Getting all the finer details nailed down and agreed to will yield positive results later on in the relationship, clinical research consultant John Carlos Diaz writes. Both parties should know the ins and outs of the contract and how people are accountable, and all the responsibilities of each team’s staff should be written out in detail and circulated among staff.
Sponsors and site staff will need to work together to ensure the separate parts unify to form a team mentality, Diaz says. That way, everyone will be working to the same realistic timelines and seek the same milestones. Built into this is agreeing to what is needed versus what is wanted.
Obviously, the former takes priority. While this process can be tedious, it is vital and should be undertaken to eliminate wasted time and resources.
There’s no rule book for better communication between sponsors and trial site staff, however, open dialogue is vital. Defining what is expected of each party and aligning outcomes at the outset will lead to more accurate and efficient trials.
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