The number one reason for a failed project
pharmafile | August 16, 2012 | Feature | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | Communication, Failed project, Les Rose, clinical trials
There was once a company that had an amusing form of words for admonishing people. It went something like this: “As you know, the procedure for X is…” The sub-text was: “As you don’t know because (a) the procedure didn’t exist in written form, and (b) nobody had even said it out loud.
That was about 30 years ago, so one might look condescendingly upon our poor ancestors who struggled without email and the web.
Driving the information superhighway
Hands up everyone who thinks communication is light years better now. Not many, eh? This suggests that good communication is more dependent on people than it is on technology. In reality, there’s an argument that we suffer information overload, and that we are in serious danger of missing the important things because of it.
Thus far, I have been thinking in general terms, and readers from any professional field will recognise the picture I am painting. So let’s focus on pharmaceutical R&D, and in particular clinical development where (with a nod to ‘Bladerunner’) “I have seen starships burn”.
A risky business
Events over recent years, such as late-phase product failures, show graphically how risky drug development is. It is so risky, that around 80% of drugs launched don’t recover their R&D costs. One of the reasons is not poor product performance in the clinic, but simply arriving too late to the market.
The received wisdom these days is that if you are later than one-third into an established class, you have no chance of getting your money back, no matter how good the product is. So we are looking at operational risk as well as technical risk. To me, a late project is a failed project, and it can be late for many reasons that could have been avoided.
Over nearly 40 years in pharma, I can say that a very large proportion of errors leading to project failure are rooted in people not knowing what they should know, because somebody has forgotten to tell them. This is more of a problem than people being told the wrong things, although that happens a lot as well.
As ever, the solution lies at the top, with senior management needing to set the standard for good communication. The problem is, they are usually the worst offenders.
“But I didn’t know he did that!”
One of the most basic questions in projects (or in organisations) is ‘Who does what?’ In one company, I repeatedly asked for an organogram of departments and functions, and it took four whole years for it to appear.
Well of course, that’s about a typical cycle of staff turnover, but that’s no excuse for not doing it – it’s a living document. The same ‘who does what’ question applies to projects, and of course at that level it’s far easier to answer.
Too often I see people running project plans that are little more than an expensive way of drawing bar charts. Set up properly, a project plan deals with all the relationships, accountabilities, and responsibilities that define collaborative working.
The great negotiator
I am now challenging what has become the accepted dichotomy between ‘hard’ and ‘soft’ skills’ in project management. The former are taken to include planning, progress control, reporting, and delivery, while the latter define what is required to get people to do what you want. In reality the division is artificial, because the project plan is the result of all the persuasive negotiation that the good project manager is employed to do.
Each piece of work has its own deliverable, somebody doing the work, somebody responsible for getting it done (they might not be the same), and somebody checking the quality of the deliverable. All these names are attached to the task because their owners have agreed to what they are doing, and when they will do it. They have also agreed to report progress back to the project manager.
Communication breakdown
Do drug development projects work like this in most companies? I know they do in some, and I know they don’t in quite a lot. Communication failures come in many forms. I find it helpful to divide them into categories of time and space. One of the biggest problems over time is the transfer of projects from team to team as the drug goes through development.
One client of mine had frequent delays at the transition from pre-clinical to Phase I studies. This required a lot of probing questions, until it emerged that the Phase I team simply doubted the data that were being offered by their pre-clinical colleagues.
Etiquette precluded direct challenges to the authors of the data package, so the Phase I people tried to pull it apart to find out where the problems were. Of course, they were not the right people to do that. The solution was to get the teams together, to encourage openness, and in particular to involve the Phase I team in the run-up to the transfer, so that they were comfortable with the process before it happened.
What if…?
Even what appear to be simple operational problems over time can be very damaging. Everyone needs to ask themselves the question: “What happens if I fall under a bus?” How will the business or project carry on without me?
It surprises me that, in this field in which regulation and documentation seem to increase exponentially, people can leave a company without leaving behind records that will enable someone else to grab the baton.
I have to put top management in the firing line again; is it not their responsibility to ensure business continuity? The space issues typically fall into vertical and horizontal groups.
Vertically, there is the problem of line management, such as the dilution of a message as it goes up the hierarchy. This is particularly a problem in large organisations; the need for remedial action may be very obvious at the clinical trial level, and needs higher management approval, but that approval is held up because the approver doesn’t understand the need.
A solution to this involves the communication of possible future needs of the project – in other words, a risk management plan. That way, risk mitigation can be approved in advance so that the project manager can implement it without having to ascend Mount Olympus to talk to the gods.
Chinese walls
Horizontal communication issues are often seen in the multidisciplinary world of drug development. Every clinical trial involves a wide range of specialisms, grouped into functional departments. Of course, no project is going to involve everyone in a department. People are assigned to projects as required, so they end up with two managers (at least) – their line manager and the project manager.
This should not be a problem if the project plan has defined responsibilities clearly, but what if it didn’t? Let me give you a financial example.
One department insisted on managing contractors who were assigned to a clinical trial managed by another department. Thus, the contractor’s invoices bypassed the project manager, even though he was the key person to approve the expense. So the project manager didn’t know that bills were coming in, and being signed off, when they should have been checked against progress of the project. Budget control was then compromised.
A voracious appetite for information
This is just one small aspect of the need for a continuous feed of information to the project manager, and out to the team members. I believe that no news is rarely good news.
If you are not hearing anything from a team member, it could mean there is something they don’t want to tell you. It could mean they are overloaded because senior line management has assigned them to other work without telling you.
It could even mean they are dead (that happened to three of my clients). Yes, it’s hard work, but the project manager has to be badgering people nearly every day to stay in control.
In reality it need not be so hard, as we have excellent IT tools now that can do the repeated nudging for you. However, useful as the computer is, it can’t do the thinking for you (not yet anyway). I have never spent time better than on planning, and in particular on planning deliverables. By defining at the outset the concrete items that the study will produce, it becomes clear what is to be communicated, by whom, and when.
This approach homes in on the key information needed, and mitigates against dilution of messages by irrelevant data.
You can control email!
I am not going to tackle email overload head-on, partly because that’s a feature of modern business that isn’t particularly a problem of drug development. I will say though that I prefer to have too much information than too little. If it gets too much, I can always tell people to back off. But think about this; if you are swamped by emails and can’t get on top of them, could it be that you are not delegating effectively?
Perhaps people have to pester you for decisions that they could make themselves. Is your management structure too flat? Your email volume could be a useful barometer of how well you are managing your people.
Les Rose is a freelance clinical scientist, specialising in project management consulting. www.pharmavision-consulting.co.uk
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