As pharma’s use of CROs continues to grow, so does the talk about outsourcing models. Today, one of the most popular models seems to be highly integrated strategic partnerships. Unfortunately, that model does not work for every company. Partnering agreements often seem to be built on a broad and sustainable pipeline, but for small- and mid-sized companies, that pipeline often does not exist.
“Being in a small company means that when it comes to outsourcing, I am left with the transactional model,” says Craig Coffman, executive director of clinical operations and outsourcing for Nektar Therapeutics. “This often has me wondering how disadvantaged I am being forced to use this model.”
But Coffman also believes that working for a small company has also made him incredibly resourceful. He often has to handle complex situations with limited resources. His situation has also convinced him and his team that they could find a way to improve the transactional model. Speed is always of paramount importance in clinical trials, and he notes getting that first patient in (FPI) as quickly as possible is necessary to keep the timeline on track. With that in mind, he searched for a way to get studies started as quickly as possible while minimizing the cost and maintaining high-quality standards.
“It’s difficult having to deal with quality, time, and budget constraints,” says Coffman. “Those are three attributes that always have to be considered simultaneously, and this is the case regardless of what outsourcing model you opt to use. It’s a very challenging triangle that companies have to deal with.”
Are RFIs Even Necessary?
When Coffman started looking into how to make the transactional model work, he first threw out some old paradigms that he didn’t think were necessary. The first was the traditional request for information (RFI). Coffman dislikes RFIs and sees no value in them.
“RFIs contain volumes of information that is probably outdated the day I receive it,” he says. “Generally, RFIs go into a drawer or electronic file, and I do not look at them again. I have also found they generally have no bearing on who I would talk to within the company.”
But if you are a small company that has no time for RFIs and you also find no value in them, what do you do when it comes time to select a vendor?
In a recent example, there was a need for a Phase 3 trial dealing with pain, and Coffman was aware of several CROs that had experience performing pain trials. He brought together an internal team made up of personnel from clinical development, development operations, data management, safety, and additional departments to sit down and discuss the factors important to them in a CRO. They also discussed criteria that would help them in the CRO selection process. The team selected six CROs that it felt had the necessary experience in pain management to conduct the study. Coffman decided the first step should be to set up a strategy call with each potential CRO to pare down the list of potential CRO partners.
Plan The First CRO Call
To prepare the CROs for the call, Coffman provided each one with the protocol, timeline, and other specific instructions. Those instructions consisted of things like the required number of sites and patients and the deadline by which Nektar needed to have the last patient in. The purpose was to ensure the CRO understood his needs up front, so there would be no confusion over what was expected.
To further eliminate any confusion, Coffman also conducted a pre-call with the business development contact at each CRO. The purpose was to discuss what would be expected during the strategy call. He requested that each CRO have someone on the other end of the phone who could discuss the company’s level of experience in the therapeutic area as well as their understanding of the study objectives. He also requested that each one have someone available to articulate the ability of the CRO to execute the study on behalf of Nektar. Coffman felt the pre-call would ensure each company was prepared for the strategy call and could answer any questions from his team.
For the actual strategy call, each CRO was allotted one hour in which to provide the requested information. Each one also provided a PowerPoint presentation for the call. Coffman asked that the presentations contain 10 slides or less.
“If they went over 10 slides I cut them off,” he says. “I wasn’t trying to make this difficult on the CROs, but we didn’t want this to be a long, drawn-out call. We wanted to quickly and easily understand their capabilities, determine how they would conduct the trial, and help us determine if they would be able to partner with us to operationalize the trial and collect the data we needed for submission.”
Coffman had his team ready for those calls, and he notes team members are not afraid to jump in with questions. Many of those questions were tough, complicated, and well thought out. Although none were intended to be tricky, Coffman states they were intended to quickly establish the level of expertise of the CRO on the other end of the phone.
After completing all of the strategy calls, the team got together again to discuss the CRO candidates and select those that best articulated how they could bring their experience to conduct the trial on their behalf. He acknowledges this may not have been the easiest way to conduct the search, but in this instance the model met his needs.
Getting Off To A Quick Start
Next began the arduous task of getting through the RFP and bid defense process for the remaining pool of candidates. When the CRO selection was complete, the original challenge still remained: How to get to FPI as quickly as possible. Being in a smaller company again meant he would have to find ways to adapt his approach. One critical key to his success that he adopted in consultation with his colleagues is the study initiation meeting, from which the statement of work is developed.
“We get everyone together at this meeting,” says Coffman. “The meeting includes all of the leads at the CRO, CRAs, project managers, regulatory teams, recruitment, clinical operations, data management, clinical development, and outsourcing. A recent study initiation meeting had over 35 people in one room discussing the trial. I remember at least one that included over 50 people.”
According to Coffman, everyone walked through the entire protocol, examining data points and looking at every aspect of the trial through the eyes of the site as well as the patient. Then they identified all of the key interdependencies between departments and vendors. Everyone’s roles and responsibilities were discussed, and one-on-one conversations were not allowed.
“Everyone had an equal seat at the table, and everyone was in the same room at the same time, listening to the same discussions,” notes Coffman. “We were able to establish critical timelines and what each party needed to get that first patient in. When we walked out of that meeting, everyone had a good understanding of how we were going to execute the study. Without that meeting, we could not have gotten it done. More importantly, because we got everyone on board early to discuss the trial, we had minimal changes in scope.”
Invest Now For Success Later
If there is one thing Coffman has learned from this process, it’s that it pays to make needed investments upfront. Although the CRO selection process and study initiation meetings required an investment of both time and money (bringing 50 people together in one room is not a cheap date), he believes those investments will lead to successful studies down the road.
“Invest early and you’ll find the payback to be tremendous,” says Coffman. “From the outset, your study will be on track for enrollment, and you’ll find you have highly satisfied sites. If you don’t invest in the process, the consequences can be devastating to your study timeline. Establish the plan early, communicate it, and always be as transparent as you can possibly be. I have always believed in giving everyone as much information as possible so they can be as invested in the process as we are.”
Although Nektar is able to make the transactional selection model work, Coffman notes there is a downside to the model that he does have to overcome: There is no appreciable accumulation of intellectual capital. In other words, when moving from one transactional relationship to the next, anything a CRO might learn in one trial is not transitioned to the CRO selected for a subsequent trial.
Coffman laments that he always seems to have different pressures, timelines, and individuals involved in each study. That makes it seem like you are starting from scratch each time you begin a trial. With the current model he has in place, he has been able to consistently use the same thorough selection process. Following the model has also resulted in initiating several successful trials for Nektar.
“My job involves selecting and contracting with vendors,” he says. “Whether you are working with a strategic partner or a transactional service provider, the process comes down to the same basic things. You have to do your homework, select the right company, communicate your goals, and provide proper oversight. For me, using this transactional model has become as simple as shampoo, rinse, and repeat. Doing the right things, and doing them over and over again, helps ensure we always get the right vendor to meet the needs we have.”