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International Clinical Trials

Relationship Advice


Despite the best intentions, the relationship between sponsor and service provider can be tested severely. Consultant John Faulkes considers the strains and stresses encountered by pharma and CROs, and offers some helpful hints for keeping the relationship on track


Doctor Michael Fisher, VP of Clinical Operations, walks by Tom’s office door and sees him with his head in his hands. Tom is a Clinical Project Manager and is currently in charge of two Phase 3 trials. Mike is the one person he hoped he wouldn’t see today. “Tom, where are we? You said you’d check on it?” Tom explains that the trials are at least one month behind schedule. “Time to get a bit tougher with them, wouldn’t you say?” Fisher says on his way out, with a notaltogether friendly smile.

Eight months ago, it all seemed so optimistic. A deal was signed with a well-respected CRO, ABQtrials; Tom and the Outsourcing Manager were impressed by their bid defence presentation and especially by their project manager, Jane. The launch was good, the project plans and expected deliverables were fully agreed. How could this great start have gone wrong? Jane has been replaced. The new PM is OK but not as switched-on as Jane. Also, Tom’s getting messages from around the company – as well as Mike – that CRO staff seem to be working too slowly and without much drive, just when everything is most urgent.

What would you do, if you were Tom? Or more importantly as a reader of this scenario, what could you do ahead of time to stop this sort of thing happening? It’s clear that Mike, and many sponsor-side senior executives, would be clear about where the problem lies: the CRO has signed the deal, they’re being paid, and now they’re not delivering. Tom should monitor them much more closely, ask them urgently to explain what they are doing day-to-day, and urge them to accelerate in each area of detail.



PROBLEMS WITH THE NATURAL RESPONSE

Having had such experiences before, many companies would set out to micro-manage in this way, and it’s a natural response. But if they heard the story from the CRO side, they may pause for thought. Many CROs that are trying to win big contracts may ‘oversell’ their capabilities to deliver. Talented staff are in demand with their competitors who are hunting the biggest strategic deals. What Tom may fi nd out if he asks (but they may not volunteer this) is that ABQTrials’ staff are not motivated by the deal their commercial team have negotiated. Micro-management might make things even worse.

What I am suggesting may feel ‘unnatural’ and have the appearance of being a leap into the dark: focus on building trust, high levels of engagement into the team of players on both sides, and use techniques for motivating everybody that have been around for decades.

TO TRUST OR NOT TO TRUST?

I have met many people in pharma companies who have said that you can’t trust people outside of the company. But building trust is a very good idea, just so long as we remember a few things. Sponsors can’t delegate away oversight, which is a regulatory requirement, but they can stop supervising detailed aspects of peoples’ day jobs, which they can do perfectly well themselves, and invest them with some proper responsibility. Trust is more than a ‘nice to have’ which develops over time; it can be built more quickly than you’d think, really help to tap into the motivation of people and eventually produce great results (see Covey’s formula for the effect of trust)



LEVERAGE WITHIN THE PROJECT TEAM

We can’t generate extra resources by magic. What we can do is encourage everyone to work as hard as possible, in a focused manner, to provide us with the highest level of support.

Encouraging this type of attitude is supposed to be the responsibility of the sponsor’s and the CRO’s managerial structures. They take charge of individuals’ performance management and development. But we leave it to these managers at our peril, as their performance focus may well miss some of the key motivating factors.

What do you think of the senior management in your company? Odds on you don’t hero-worship them. It is not uncommon for people to be highly enthusiastic about their professional work, closely bonded with colleagues in the same functional area, but unappreciative of senior executives’ leadership. Some human resources experts say that organisation membership typically produces commitment (a feeling of duty to work in return for pay) rather than engagement (a sharing in enthusiasm for business goals and a drive to achieve them). The good part though, is that the latter is within the remit of the ‘horizontal’ project team structure that manages operations day-to-day (see Figure 1). For over 30 years, organisations’ basic leadership training courses have introduced motivational theories and models that still have huge relevance today. We can infer a similar message from two of the oldest – Abraham Maslow’s ‘Hierarchy of Needs’ and Frederick Herzberg’s ‘Motivation- Hygiene’ theory – financially-based attempts to motivate, such as increased fees and bonuses, or threatened removal of them, while being important to businesses as a whole, provide only limited motivation for individuals.



In fact, validated research by US economists showed that there are three things that really do produce worker engagement: autonomy – self direction is good; mastery – people love to do what they are good at, and can get better at; plus purpose – people benefit by being connected to an overall, longer term goal.

THE CHICKEN OR THE EGG – WHICH COMES FIRST?

In one episode of Star Trek: The Next Generation, First Officer Riker attempts to explain to the android Data that “with trust, there is always the possibility of betrayal.” “So, it is better never to trust?” replies Data. “But without it, there is no friendship, no bonding” says Riker. “So, you take a risk?” Data queries, furrowing his brows, but just beginning to learn. “Every time,” Riker affirms.

It can be difficult to make a case to operate in this way, particularly with regards to giving autonomy and increased responsibilities to CROs. The all-pervasive ‘but just in case...’ from a senior manager can so easily demand the sort of micromanagement that our industry is well known for (see Figure 3). However, the signs are that two industry trends are pushing this way of operating on to the meeting table.

Top management in medium-sized pharma companies are leading the exploration of new models. Several companies are looking at the fi nancial benefi ts of smaller internal teams, where the CRO is involved at a very early stage writing trial protocols. The values of trust and motivation are being expressed by CEOs and clinical directors alike. Secondly, the CROs themselves are becoming ever more persuasive and powerful. Several have expressed the view that they can take the lead in all aspects of the relationship management with a sponsor, leaving the pharma company just to get on with the science and other functional aspects.



WHAT CAN BE DONE RIGHT NOW?

Whatever culture you fi nd yourself in, if you are an outsourcing manager or clinical executive, like poor Tom in the opening section of this article, there are some really helpful things you can do. Discuss the goals in depth, not just the CRO deliverables; try to make everyone understand the sponsor’s business objectives. What are the various commercial and healthcare drivers for a new drug? What is particularly important out there in the key opinion leader community? If possible, get your top scientists to come and talk.

Plan a regime of communication, covering who alerts who, when certain events happen, and so on. Let the CRO drive some of the communication. Why not let them prepare agendas for meetings in advance?

Complete a thorough stakeholder analysis together. Sure, there are diffi cult characters in your senior team, but treat them like customers. Help people to understand what the position is, what their personality is, how best to infl uence them, and so on.



Complete a risk assessment, together. Don’t forget you can use this as a powerful infl uencing tactic. Not only can you fl ag up what horrible losses might occur, but you can also have a plan in place. Risk assessment is of course a standard part of managing studies, it’s just that it’s often not done very well. Somehow, you have to get the more junior people in the extended team involved and coming up with possible suggestions for what might go wrong. It’s these guys that will give you the real value.

Talk about the relationship. What hasn’t worked well, why, and what are you going to do about it? Assess the health of the relationship. It’s a great idea to get an outside pair of eyes to observe your team in action, and/or you can use an online assessment.

CONCLUSION

Hopefully, if we went back to one of Tom’s extended team meetings in a few years’ time, we would see a changed landscape. There would be no painstaking review of detailed site data, or line-by-line checking of SOPs. It would focus on only two or three points. Risk – reviewing the rolling risk register; major decisions – what the team needed to do to infl uence the sponsor senior team to keep the project evolving; and learning – how are things going, and can we continue to get better. And hopefully this will still leave time for coffee, and a nice lunch!

References

1. www.wimp.com/surprisingmotivation
2. Covey SMR, The Speed of Trust, Simon & Schuster, 2006

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John Faulkes began his career as a scientist in the pharmaceutical industry. He then moved into HR as an L&D business partner, before working as a consultant specialising in cross-functional collaboration and project leadership. John helps companies to develop ways to work in effective business relationships, coaches teams and team leaders. He also has designed an innovative online relationship health assessment tool that helps teams to review progress and make continuous improvements. Email: john.faulkes@ppmld.com
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