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Krista Armstrong explains the CRO's evolving role within clinical trials.
A clinical drug trial is nearing the start of enrollment when the sponsor gets a call from the CRO’s project manager. Notwithstanding the sponsor’s very aggressive start-up requirements, the PM recommends a protocol amendment that tightens the patient eligibility criteria-a change that would lengthen the enrollment process but yield a trial that’s more efficient and cost-effective in the long term.
The drug under study is everything to the sponsor, a small biotech company, and to its small group of investors. And while it’s this young company’s first clinical trial, the CRO has performed four studies in the same indication in the past two years.
Recognizing that there’s no substitute for experience, the sponsor wisely takes the PM’s advice.
There are lots of reasons sponsors rely on contract research organizations to perform clinical trials. These projects can be extremely complicated, and just managing the data can be an overwhelming prospect, especially for a small company without the robust tools and processes a CRO can offer. But the most compelling reason may be the partnership that results when the sponsor-CRO relationship evolves to its fullest potential.
Partners, not vendors
Service providers of all kinds like to talk about how they are more to their customers than mere vendors, casting themselves instead as full-fledged partners. And there may be no better example of that distinction than the complex interplay between sponsor and CRO. Clinical trials are hardly commodity products, after all. The work is highly collaborative, in contrast to the transactional exchanges that typically characterize contractor relationships.
Small biotechs and specialty pharma companies in particular need help with planning, protocol writing, budgeting, capitalization, regulatory filings, and numerous other aspects of the drug development process. Such strategic partnerships are rooted in constant and candid dialogue, the type of intense interaction that enables the CRO to:
Know the players. The CRO must really get to know the sponsor’s team: who needs lots of backup, who just wants the facts, and who is the strongest influencer. This insight leads to more precisely tailored and targeted service.
Communicate exhaustively. Suppose the sponsor assumes, incorrectly, that the CRO knows about a site contract it signed in Germany and one it declined in South Korea-and meanwhile, the CRO doesn’t know about a startup issue related to the central laboratory that may affect when enrollment can start. These things happen and are generally unforeseen and unavoidable. Regular contact between the CRO and sponsor can minimize the impact of such occurrences, which can be embarrassing at best and devastating at worst.
Staff appropriately. CROs must staff to meet their margins and may have alternate plans for a project team when the current assignment ends. To ensure that the team is available for a large planned project, the CRO needs to understand the sponsor’s roadmap.
Speak up. The CRO project manager must be comfortable with phrases like, “I’d approach that differently” and, “Have you considered …?” The sponsor is paying for expertise and collaboration, not live in an echo chamber of agreement when the team can provide advantageous alternatives.
Let’s get comfortable
You’re going to spend a lot of time with your CRO, so it really helps to work with people you feel comfortable with. And you need professionals who will handle your compound as if your livelihood depended on it. So here are some questions you should ask potential teammates:
· What is your expertise in my therapeutic area and disease indication?
· Have you worked in the countries where the trial may be conducted? What is your experience with those countries’ regulatory guidelines, ethical standards, and import-export regulations?
· Do you have experience with the nuances of rare and complex indications?
· Have you dealt with sites that have never participated in industry-sponsored research? Have you successfully conducted training at such sites?
· Do you have the background and self-assurance to work with key opinion leaders, investigators, and large academic institutions without feeling intimidated?
· Have the people who would staff your trial worked together before? Do they augment your internal team’s potential deficiencies?
Attitude is just as important as qualifications. The CRO and the individual team members need to understand that the project is not just about data management or writing queries or monitoring outcomes, but about the success of the sponsor’s organization, about people’s jobs, and about whether a potential treatment moves to the next phase of development.
Skin in the game
An effective partnership also involves risk-sharing. When sponsor and CRO pursue common goals, following a timeline and plan that was developed mutually, risk-sharing can be highly beneficial. If the CRO isn’t hitting its targets, the sponsor isn’t paying for failure-but if the CRO delivers ahead of schedule, the sponsor may be able to submit its dossier earlier, financially benefitting both parties.
Risk-sharing agreements between sponsors and CROs are becoming increasingly common, and it’s a constructive trend in an industry ruled by project deadlines and rising costs. These arrangements focus both parties early on the elements most important to ensuring a successful trial and motivate the CRO team to perform-drawing, again, on the spirit of partnership.
Having participated in a lot of these, we like to avoid the term “risk” in describing what are more accurately opportunity-sharing arrangements. Risk implies penalty, but in truth, the last thing sponsors would want is to exact fines when their research partners fail. These agreements instead should emphasize incentives for compliant or superior performance-payments the sponsors make gratefully as their projects proceed on or ahead of schedule.
The best sponsor-CRO relationship is a fully functioning partnership, not a transactional vendor or employer-employee affiliation. Every aspect and every interaction should be designed with that goal in mind, and the arrangement will thrive on the strength of continuous and candid dialogue. Such an enterprise produces superior results without disruptive and costly surprises, helping advance the development of life-changing therapeutic advances.
Krista Armstrong, Senior VP, Clinical Development Services & Global Head of Neuroscience, Premier Research