The first thing we do, let’s kill all the lawyers. – Wm. Shakespeare, Henry VI, Part 2, c. 1591

…And the procurement officers and outsourcing managers, while we’re at it. – Clinical Research Executive (Anon.), c. 2012

Professionalizing the contracting process in clinical development has gone astray. What was once meant to add a little bit of needed legal-oriented skill to project management has become a self-perpetuating web of complexity.

Here’s a true story: we were interviewing various managers of a sponsor’s clinical research department, exploring their skills at outsourcing. The departmental lawyer, the procurement officer, and the strategic outsourcing officer each said that s/he was the only one who was protecting the company from financial ruin, compliance risk and regulatory sanction. Not a single clinical person had the arrogance to assert such importance to the clinical research success. How did we get here? When and why did clinical trial expertise get so buried under layers of bureaucracy of our own making?

Every sponsor I visit has such a story. These days the stories are told as muted rumblings: monitors who report investigators furious at the site contracts sent by the sponsor’s legal department, trial schedules with built-in 3-6 month delays to allow for “CRO contract negotiations”, trial managers throwing up their hands at having to use the same CRO that failed them last time because “procurement likes them better.” Sometimes the storytellers don’t even sound like they are complaining – is this a sign of healthy acceptance, a sign of despair, or is it that no one remembers when life was easier?

When Bad Things Happen to Good Ideas

The overlapping sponsor roles of contracting/legal/procurement/strategic outsourcing all grew out of the rapid growth of CRO usage starting over ten years ago. This trend, combined with increased trial complexity, regulatory scrutiny and budget pressures, led first to a professionalization of Clinical Operations, which took responsibilities away from medical leadership, mostly appropriately. Clinical Operations diversified and specialized rapidly, and soon it was felt that study managers had too much learn, to much to be expert in, too much to handle – again, probably appropriately. One of the identified specialties was how to contract with the proliferating third parties.

But somewhere along the way, those who were supposed to advise study managers in contracting, and advise the enterprise in broad-based improvements such as standard contract terms and volume discounts, became in charge of these key elements of trial conduct. Indeed, at some companies they have become virtually in charge of the trials themselves, as a side-effect of negotiating with those who now actually do the trials (the CROs and sites, instead of in-house staff).

For instance, some companies report the procurement people now have more to say about which sites should be used than the clinical staff. While I am the first to criticize clinical managers for continuing to use under-performing sites because they want to use key researchers or long-time friends, it is no better to have procurement staff decide which sites to use on the basis of ease of negotiation or compatible liability clauses. One group should be advising the other, while the other actually decides. Now let’s see, should that be the outsourcing department or the medical director?

Professional procurement was intended to improve Clinical Operations management skills. But lawyers don’t manage trials and they don’t improve CRO relationships, although they can make them worse. The inappropriate empowerment of legal-oriented staff has introduced consistent and costly program delays; their issues can be an enormous time sink. Even the value of standardization is diluted by a level of inflexibility that is now getting worse and worse in sponsor contracting. And make no mistake: poor contracting experiences lead to poor vendor/site performance. This is strongly aggravated by the now common gamesmanship of sponsors delaying payments: poor payment performance starts site performance on a downward spiral. What was supposed to help is now aggravating and delaying the work. And the work, lest we forget, is drug development, not shiny and polished contracts. It is about good conduct practice, not good contract practice. It is, in fact, about people, not bid grids and invoice templates.

There is an assumption that contracting staff are better, indeed necessary, to create good arrangements with CROs. The thinking is that research doctors are not good managers, that individual project managers will only serve their self interest and not the company’s, and that the art of contracting is so arcane as to be unteachable. I think this assumption is abetted by both parties: study managers are happy to have one less thing to do and procurement staff want to perpetuate an aura of indispensability, as anyone does. But regardless of whether these are accurate assumptions, what was the purpose of this assumption? What was the problem we were trying to solve, and did we solve it, or did we solve something and create another problem? The solution has grown out of proportion to the problem.

Going back to our earlier example, one of the assertions of procurement indispensability is risk aversion – that we have professionalized risk management in these staff and so that is where protection lies. Generally speaking, risk aversion in this particular area of research is overkill. Site and CRO performance is not dictated by contract terms, but rather only by the skill with which Clinical Operations managers (people, not paper) learn how to monitor, measure, communicate and hold accountable their service providers. Contracting per se does not lower risk, people do. I remember long ago, my first corporate lawyer wisely advised me that if I ever actually needed to use one of his contracts to confront a business problem, I had already lost half the battle.

When Good Things Happen to Bad Ideas

Here’s a way to change the suboptimal status quo for the better. We need to vastly reduce the procurement/contracting/outsourcing infrastructure created in clinical research and instead rely on a handful of expert advisors who work with those who should be in charge: the clinical research managers. In this advisory role, procurement and legal experts can advise on the topics of good contracting, standardized terms, possible volume discounts, metrics and penalties. This advisory role, instead of a controlling role, is where the legal profession was always meant to be. It will keep us focused on executing clinical trials instead of executing lawyers, as Shakespeare would have it, while improving the relationships among the essential parties in conducting clinical research.