OR WAIT null SECS
A cart with a horse behind it won’t get very far. Likewise, it’s important for sponsors and CROs to agree about protocols, timelines, and budgets before a clinical study begins. Even the most enthusiastic CRO will find it difficult to impossible to meet expectations they had no hand in setting.
Recently, I participated in a lively conference panel discussion on the sponsor-CRO relationship. Reactions from the panelists and the audience were not surprising. All the CROs advocated for being involved in the study prior to the RFP process. They appreciated and valued being brought in while the sponsors reviewed the protocol, visit schedule, timelines, enrollment, sites, etc. because it enabled them to offer an accurate proposal. Sponsors didn’t see much value in involving the CRO until they were at the RFP process and ready to submit RFPs.
But Jonathan Lee, Vice President of Development Operations at the pharmaceutical company Cerexa, Inc., voiced the correct opinion: “It’s essential to engage the CRO as early as possible. We are running a pilot program to learn if hiring a CRO during protocol design would change the outcome, and the results so far are very positive. We seem to be adhering significantly closer to our goals and objectives because we developed the program with the CRO.”
We’re living in a regulatory and economic climate where ownership and accountability are absolutely vital for sponsors to not only stay successful, but also to stay in business. Here are three common-sense benefits of forming an early partnership with the CRO for the simplest to the most complex trial:
1. Better communication and collaboration
2. Expertise in trials and site management
3. Budget management
Better communication and collaboration
It’s essential to the sponsor-CRO relationship to establish trust and buy-in from the beginning. Success is much more likely when both stakeholders build a level of trust and the CRO’s opinions and advice are valued. This level of trust gives CROs ownership and an attitude of accepting responsibility for the study and taking control of how it develops, as well as accountability to accept and answer for every aspect of the study.
Partnerships work best when they are based on cooperation and communication.
Bringing in the CRO early allows sponsors to establish a dialog and partnership that enables both parties to set realistic expectations and decide how to address problems at the beginning. That way, when the rubber meets the road, the kinks are worked out and the cart moves forward smoothly.
For example, the number of sites and patients is a key factor in determining study budgets. Sponsors can get accurate proposals from CROs when they give them the study timelines and how many sites they want to include, and ask for the CRO’s advice on how to structure the study based on this information.
An ongoing communication strategy establishes a strong collaborative environment that gives the CROs the ability to take ownership and accountability with solid decisions and appropriate actions. It enables them to contribute openly and honestly about every component of the clinical trial.
A CRO at the same conference panel discussion said, “I’ve heard horror stories about CROs taking on projects with no input, and then needing to have ‘the conversation’ about having to meet totally unrealistic goals for recruiting. Why can’t the CRO just say these are unrealistic goals during the proposal process? It’s much better to have the hard conversation before the trial starts, to give the CRO the opportunity to say, ‘Sorry, nobody can meet those timelines or recruit that number of sites.’ But by coming together early you’re not having that uncomfortable conversation later in the process.”
Expertise in trial and site management
Opinion leaders can have an important role in clinical trial strategies and site management. But relying on opinion leaders in academic institutions only answers part of the problem. Clinical trial management requires a great deal more expertise than even the most informed opinion.
CROs are experts in study management. They have day-to-day, hands-on knowledge about sites that goes beyond common knowledge, to what will work and what won’t. Because they have ongoing relationships with sites, CROs know which ones consistently deliver on enrollment and quality in the sponsor’s therapeutic area. They know the indication, and can approach the sites in an earlier phase with a fresh set of eyes to evaluate a protocol logistically and see if a study is doable. What worked in 2005 won’t necessarily work in 2011.
The pharmaceutical industry is trending toward outsourcing as more companies trim down clinical operations to save money. US-based Turner Investment Partners cites a Goldman Sachs prediction that the CRO sector, which generated $16.3 billion in 2006, will be worth as much as $29.4 billion by this year. Turner believes that up to 50 percent of pre-clinical and clinical stage drug development projects in the next few years will involve CROs.
As a result, the level of expertise and knowledge about clinical trial management is increasingly going outside the pharmaceutical companies themselves, as CROs take advantage of the shift by hiring talent from downsized sponsor organizations. That’s good news for sponsors, because CROs are becoming increasingly well-staffed with professionals who come directly from the pharmaceutical industry and who know how to run clinical trials the way sponsors want them.
We all can name drugs that didn’t see the light of day, or that were pulled after unsuccessful and extremely expensive trials. CROs can be part of an excellent defense against this situation because they know the territory.
The earlier the CRO is included the earlier they get the ability to prepare for the trial, whether it’s gathering information on the therapy or indication, staffing, or making sure they get the best resources for the job ahead.
Unrealistic budgets can be a thing of the past when the sponsor and the CRO work together to prepare a flexible budget to address potential problems and opportunities.
After a CRO review process, a sponsor hired the only CRO who said they could run the trial within a pre-established budget. “The trouble started almost immediately,” an executive from the sponsor said. “We realized very quickly that our timelines and protocol didn’t allow anywhere near the right amount of flexibility. Now we’ve learned to ask potential CROs how they would work with us to develop a comprehensive budget as part of our evaluation process. It takes more time and effort up front, but it saves us considerable angst in the long run. Nobody likes to go to management to ask them for more money once the trial begins.”
Cerexa’s Jonathan Lee added, “When you include the CRO’s team you can set appropriate expectations about recruiting, timelines, data, schedules, communications, and procedures. Even something as seemingly inconsequential as factoring in attendees on conference calls can make a big difference to the budget over the course of a trial.”
Engaging the CRO in budget discussions also helps sponsors avoid what I call “the dreaded change of scope.” Sponsors and CROs can limit changes by creating a flexible and accurate billing model to accommodate changes.
The CRO’s level of involvement in budget development has a direct impact on the actual budget and timeline. The most effective way sponsors can avoid changes of scope, other budget issues, and missed deadlines is to work with the CRO from the start to create a thorough RFP process with clear expectations from both sides.
At the end of the day, it’s all about delivering quality clinical trial data. Bringing in the right CRO early (and often) is the best way to do it.
Brenda Reese is Vice President of Business Operations at DSP Clinical Research, a CRO specializing in small to mid-size pharmaceutical, biotechnology and device companies. She can be reached at Brenda@dspclinical.com.