Clinical Researcher—March 2020 (Volume 34, Issue 3)

SITE STRATEGIES

Diane Carozza

The last thing an overburdened investigator site needs is for a sponsor to insist upon the use of yet another potentially pricey, isolated, and complicated technology solution to facilitate the conduct of (possibly) just one new study.

However, that’s what’s happening every day at sites around the world.

Consider the following:

On average, the typical investigator site is working with 12 different systems to collect clinical research data;
Fewer than 10% of sites believe that technology solutions provided by sponsors and clinical research organizations (CROs) do a good job of meeting their operational needs;
Most sites feel strongly that there are too many usernames and passwords that they must manage.{1}

The problem isn’t really the technology itself; it’s the way sponsors and CROs expect sites to use it.

Deployed appropriately, technology allows sites, sponsors, and CROs to streamline processes, reduce costs, and deliver therapies to market sooner. It augments the site/sponsor relationship. It keeps the people-processes-technology triad in harmony.

Too often, technology becomes the primary focus; what should be a high-touch/high-tech relationship becomes a low-touch/high-tech one. This interferes with the important work of scientists, clinicians, and others involved in a clinical trial.

It is of little surprise that sites are exasperated. We hear the same complaints wherever we go. They fall into one of two categories:

The hassle of too much technology and too much red tape.
The lack of time to talk to the sponsor or CRO representative, in person, about scientific concerns.

Sponsors and CROs are also frustrated. In fact, 30-40% of sponsors and CROs report being somewhat or completely unsatisfied with their site initiation processes.{2}

The solution is to rebalance the people-processes-technology triad. That starts with minimizing the technology burden, especially as it relates to study implementation.

Technology: Getting it Right

So how do we reduce the site burden related to technology implementation? What would make it less cumbersome?

The answer is consistency. Sponsors who use the same technologies across all programs and studies allow sites to become trained in and familiar with them.

Sponsors who do this need to train sites only once, regardless of how many studies they work on. Instead of forcing sites to learn a whole new technology tool at each engagement, smart sponsors are moving to this streamlined approach, capturing data and using it for all studies moving forward, whenever possible.

This allows training certifications, data, contact information and site-attribute information to be used multiple times in future studies. This makes sense in an array of training areas, including:

Good Clinical Practice
Electronic data capture
Safety systems
Feasibility and study start-up systems

The same logic applies to data collection: The site needs to be able to provide contact information, attribute information, etc. only once. At the same time, sponsors can provide an easier way to manage multiple usernames and passwords. Minimize the points of entry and you maximize site efficiency.

All these efforts to streamline technology and training pay off in another area: more meaningful encounters.

People: Make Face Time Count

Sites frequently tell us they don’t have meaningful face-to-face conversations with CROs and/or sponsors. Even when they do meet in person, the time is often squandered on logistical issues related to the technology or redundant training. That leaves little time to talk about what really matters—the science, the patients, and the trial.

Using consistent technologies allows sponsors and CROs to spend critical onsite time with investigators and coordinators discussing, among other things, the scientific details of the study, potential recruitment challenges, and strategies for patient support.

It’s all about the relationship. When the technology serves the relationship, rather than undermining it, everyone benefits.

Processes: Consider the Big Picture

To reduce the technology burden and create the opportunity for meaningful interactions, sponsors need to invest time at the beginning. Start asking questions like, “How can I frame this question so I need to ask it only once?” and “How can I offer this training one time and have it applied to future studies?”

When we talk about the site/sponsor relationship, we’re talking about something that should be a long-term relationship across studies, indications, and programs. Investigators are the critical business partners to sponsors. The goal in any site identification/site selection effort is to find highly motivated and highly qualified sites, engage them, and retain them as long-standing partners in the development of a sponsor’s research program.

For too long, sponsors and CROs have taken a piecemeal approach to site selection and startup. Sponsors pour resources into getting one particular investigator at one particular site up and running on one particular study. They train that site on the technology. And for the next study? They go to a different site and start all over again.

It’s simply not logical. We know that site startup takes 10 weeks longer at new sites than at repeat or familiar ones.{2} Study site selection is an important aspect of the clinical trial process, and study centers with a track record of successful performance are historically more likely to meet enrollment targets.

Overall, research suggests that if an investigator performs well on a trial, he or she will likely do so again on another study of similar indication and phase.{3,4}

Taking a Portfolio Approach

When you find highly qualified sites and get them engaged on that first study, that’s the beginning—just the beginning. You want to retain them for the long haul so you can build that relationship. They need to feel supported by the infrastructure of the sponsor organization, not just in the technical communication pathway that’s established through the technologies being used in the trial.

The smart approach is to engage with a site that’s interested in working with you on an entire program, not just a single trial. Sites and sponsors alike benefit from such consistency. Sponsors develop relationships with sites they know and can rely on. Sites know these sponsors will treat them well, pay on time, and reduce the overall site burden.

Keep sites engaged by streamlining the technology and taking a high-touch, as well as a high-tech, approach. Give equal weight to people, processes, and technology.

References

CenterWatch Monthly (May 2016).
Tufts Center for the Study of Drug Development. 2018. Impact Report 20(2).
Fogel DB. 2018. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Contemp Clin Trials Commun 11:156–64. doi:10.1016/j.conctc.2018.08.001
Getz KA. 2015. Characterizing the real cost of site regulatory compliance. Appl Clin Trials 24(6). appliedclinicaltrialsonline.com/characterizing-real-cost-site-regulatory-compliance