“Whenever we say we’re doing the best we can, it means something has gone wrong”

How often do you hear, from someone who has just failed you, that “we’re doing the best we can”? It is the universal response of auto repair shops, phone companies, catalog merchants, hospital nurses – just about anyone who has not delivered the service you expected. Instead of an apology, or a promise to improve, we are meant to believe we are getting the best there is. It is a universal and automatic expression, and also almost certainly a lie. The worst of it is, those who say it probably believe it.

A Story

Here’s a true story. I was supposed to receive a time critical, very important package one morning from Fedex. Ten-thirty AM came and went, and no package. I found the tracking number and going online, I instantly found out that the package would be on time! Except that it wasn’t. So I picked up my phone and called Fedex, seeking a human rather than a database explanation. After the usual keypad entries and insipid hold music, and various transfers, I found myself speaking to a very kind and enthusiastic representative who told me there had been strong storms in the Midwest the night before, most packages were delayed, and delivery could not be estimated. When I pointed out that their website said it was “on time”, she had no explanation other than, “we’re doing the best we can”.

Really? Was Fedex that day actually doing the best they could? Employing one of the most sophisticated worldwide tracking and communication systems in commercial use, could they not have done something other than post out-of-date, incorrect information? Could they have added a message alerting users to expect delays? Could they have had a recording on their customer service line? Could they have promised delivery within one additional day, rather than not having any prediction at all? Could they have looked at a weather forecast the day before? Could they have offered a partial refund? I’m sure you can think of many more things Fedex could have done, and then ask yourself, did they do the best they could?

Best of What?

I worry that this phrase is not just an expression, a habit of speech, or even just a feeble attempt at placating customers. I think it is a reflection of two key aspects of our daily work:

1) we’re always told how good we’re doing and how hard we’re trying; and therefore

2) we settle for the status quo, believing that since we work long hours, we must be doing the best we can.

What this means for clinical research is very important: we ignore the opportunities, and avoid the cost and time, for improving how we work – and how our suppliers work – because it is daunting to think of changing it. It is so much easier to think we’re doing as well as we can.

Let’s review a few of the opportunities for improvement in front of us:

§ A large majority of our trials are behind their enrollment targets.

§ Clinical staff change study protocols repeatedly, even after study start.

§ Ethics committees’ reviews routinely cause months of startup delay.

§ A new study team rarely has the information to learn operational improvement from past study teams, nor do they seek this information.

§ Service providers routinely charge substantial amounts in change orders, in part because of misguided contractual terms insisted on by sponsors.

§ Joint steering committees between sponsor and service provider are neither truly “joint” nor “steering” anything.

§ EDC, ePRO, eTMFs and all the other “e’s” are surrounded with paper, negating their cost savings.

§ A focus on quality and oversight has turned into an endless loop of mistrustful triple-checking.

§ Outsourcing requires more in-house management resources than insourcing did.

And so on.

Clearly, in this 21st century world of clinical research, we are not doing the best we can. And yet, do we move through our days thinking about all the stupid things we do, or instead are we thinking about how we should stop and fix the stupid things we do? And let’s not shy away from an important new reality in clinical research: it is even harder to stop doing stupid things when we are paying outsiders to do them, at our direction!

Building the Airplane in the Sky, and Other Moronic Metaphors

The typical, and possibly most potent, argument for saying we are doing our best (insert shrug here), is that we can’t stop the pace of clinical research to fix it. Pick one:

§ We are building our airplane in the sky.

§ We are trying to change the tire on a speeding car.

§ We are trying to work on a speeding train.

True enough. But here we have once again a case of the pharmaceutical industry somehow thinking they invented business adversity (regulations, the unpredictability of research, recouping capital-intensive development, requiring a highly skilled workforce) and no one has ever faced such novel problems. Which is very silly. Think of the number of enormous (and ultimately successful) transformations the automobile industry has undergone in every aspect of their business, while they still built and sold cars. Think about journalism, entertainment, the computer industry. They’ve all had planes in the sky and trains on the track, but learned (eventually and sometimes painfully) how to change and execute at the same time.

Biopharma desperately needs to recognize when it is not doing the best it can, and figure out how to improve its operations other than mergers or outsourcing. Society needs our best; it is critically important that we find it.

It is a perverse use of the language that whenever we use this phrase, we’re doing the best we can, that it always means something has gone wrong. Our “best” is apparently never enough. When we’ve done something great, why don’t we ever stand up and say, truthfully: “we’re doing the best we can”? Shouldn’t that be the better — and only — time to say it, rather than mumbling it as an excuse for shortcomings? Let’s hope that someday, your organization, and even all of clinical research, can say this proudly.

“Consequences are good for us – they are the guides to behavior and decision-making.”

We are not hearing the truth. And we are not in danger of the consequences of the truth. This is not only a poor standard for human interaction. It is directly responsible for inefficiency and perpetuation of substandard performance in clinical development.

How many of us have dutifully filled out “RACI” charts, documenting who is responsible and accountable for various tasks or projects in the clinical development process? Having completed these charts, what happens next? Is our behavior, or the behavior of colleagues, materially changed? What level of concern do we carry when we have been assigned accountability? What are the consequences to us personally for not being successful in a task we are accountable for? Or for that matter, what are the consequences for succeeding in a task we are accountable for? I suggest that in most biopharmaceutical companies, where the projects are so large and interdepartmentally dependent, there are essentially no consequences of our actions, good or bad, in any manner that significantly guides behavior. In fact, what does guide our behavior, in a damaging way, is this fact that there are no consequences one way or another.

Developmental Immunity

What happens if we fail at our work? If we don’t lock a database on time, we miss a monitoring visit, we let our CRO go over budget, we obstruct process improvement, or – universally – we miss our enrollment dates? Do we lose our job? Our rank? Our stock options? Do we even lose our credibility? It is not at all clear that anything adverse occurs. In a very few urgent, high-stakes circumstances, the consequences may indeed be onerous. But mostly we live on, more or less unsanctioned, for as long as we care to hold on to our jobs.

What happens if we do a great job? If we bring a project in on time or under budget, keep the CRO from changing project managers, enthusiastically contribute to process improvement, write reports with no corrections needed, or – amazingly – meet the enrollment targets? Do we get promoted, get a raise, get more stock options? We hope our credibility improves. In the rare entrepreneurial biopharma environment, there may be a financial benefit. But in an environment where pay raise percentages are severely limited by policy, where cost-cutting is shrinking supervisor discretion, and where special recognition is culturally disapproved, the good news will go unrecognized. Mostly we live on, more or less unrewarded, for as long as we care to hold on to our jobs.

We do a better job raising our children than managing our companies. Good parents teach their children the consequences of their behavior, either overtly or subtly, every day. Morality, socialization, even just getting through the day, would not be possible without the concept of actions and consequences. Indeed, we probably learn more about life from the application of consequences than we do from the classroom. In the absence of consequences, we get widespread mediocrity.

In all of these ways, consequences are good for us – they are the guides to behavior and decision-making. Economic markets are ruthless appliers of consequence. If nobody needs or wants our new drug, no one will pay for it. If we can’t hire people because our salaries are too low, we can’t get out work done. If we consistently mistreat our CRO with unreasonable demands or poor communication, they will give us inattentive service in return. These are the consequences that teach us how to succeed as people and businesses. So why don’t they apply internally?

Risk, Rewards, Fear, Teams, Truth

There are at least five consequences of the lack of consequences:

· The absence of truth

· Irrational fear of truth-telling, and consequences

· Dilution of the value of rewards

· Hiding individual accountability behind teams

· An unhealthy absence of risk.

What does truth have to do with this? Telling the truth should have consequences – good ones. Too often we are afraid of bad consequences, and so routinely withhold the truth, thus depriving us of the good consequences of the truth as well. For instance, if we are afraid to say that a manager is not performing well, then all sorts of bad things happen: that manager does not learn she needs to improve, her staff continues to suffer, the work continues to suffer, improvement is blocked, staff cynicism grows. But most supervisors are more afraid of telling someone they need to improve or else. It’s the “or else” – the consequences – that must be at the heart of the performance feedback. Otherwise we’re back to stagnating in mediocrity.

There is good reason to think that this situation will get worse over time. It has been widely observed that we are raising a generation (at least in the US) without consequences – where everyone gets a trophy in every competition, and it is culturally incorrect to admonish poor performance. Presumably there will be a rude awakening – in college, or on the job. But what if corporate environments imitate the youth culture as this generation becomes the management layer?

Perhaps the best cover given to poor performance in most clinical development groups is the reliance on teams. I’ve written this before and it can’t be said enough: teams cannot be held accountable for anything. Only individuals can. While I suppose it is possible to demote or fire a team, it is highly unlikely. Team accountability makes the application of consequences almost impossible. You can give everyone a t-shirt if the team succeeds; can you take the shirt off their back when they miss the deadline?

A powerful fairytale for our fearful, politically-correct corporate cultures is the Emperor’s New Clothes. Clinical development groups are filled with courtiers afraid to point out that the manager next door, or their team leader, is naked. Trying to articulate and enforce consequences is risky. What if staff get offended and leave? What if they resent one person being rewarded but not them? Will you keep your job if you reveal the emperor has no clothes? Will you open your company to lawsuits if you tell an employee the truth about their poor performance?

We have to create clinical research environments where it is safe to be a truth-teller about process performance, or we will never improve our productivity. We have to know there will be consequences, fairly and quickly applied, for all of our actions. Truth, and consequences. In the fairytale, it is the little boy who has the courage to tell the truth. We need him now, at a company near you.

“What are we in clinical development going to do to contribute to therapeutic innovation?”

At a recent holiday party, one of my neighbors said to me, “YOU are in clinical trials – why do they take so long and cost so much? What’s up with that?” After I explained that I wasn’t personally responsible for the state of drug development, I gave my standard answer (concern for safety, regulatory requirements, minimum drug exposure periods, hypotheses complexity, etc.), but I thought about the question later. With all the advances in science in the past twenty years, what have been the advances in how we prove drugs are safe and effective?

A simplistic overview over the past decades would conclude that there really have only been two big ideas in clinical development in this period: enabling technology, and outsourcing. Basically, EDC (electronic data capture) got rid of the paper and CROs got rid of the people. Of course, more than that has happened, as we will discuss below, but regardless, what have the results been? Fewer people, fewer companies, fewer drugs. While we are ultimately dependent on breakthrough science, what are we in clinical development doing to contribute to therapeutic innovation?

Information Technology Leads the Way

Information technology has generated considerable innovation, time saving, and enhanced analysis over the last fifteen years. EDC has been transformative, the very definition of “enabling” technology. EDC has made adaptive trial design possible, even though the concept was around for decades. EDC has altered the relationship between sponsor, sites and monitors fundamentally. It has enabled a series of related technologies to blossom (electronic patient-reported outcomes, interactive response technology for patient randomization and drug supply management) and made other technologies infinitely more practical and useful (data warehouses, clinical trial management systems, etc.).

ePRO has given us data direct from the patient which can be relied upon for accuracy and timeliness – a dramatic change. Improved adverse event systems that have enabled rapid and comprehensive regulatory filings have eliminated much burdensome hand work and improved analysis for signal detection. The electronic submission of a panoply of regulatory documents – most importantly NDAs/BLAs – has progressed a great deal from the CANDAs of twenty years ago. Sponsors now understand how to apply technology to the fundamentals of trial documents, in an electronic trial master file. Data warehousing is replacing clinical data management systems and helping sponsors grapple with the flood of new data types (images, samples, genomics data, lab data) which go well beyond simply replacing the paper case report form.

Strategy Innovation Lags Behind

But what can we say about innovation in the strategy for and process of clinical development in recent years? In particular, what can we say the industry has achieved other than exploiting technology and outsourcing the heavy lifting?

There has been no lack of concern. For years, industry meetings (and private executive discussions) have focused on critical issues such as reducing the “white space” on the timelines between one trial and another, one program and another. We have focused on the continuing, nearly unchanged dilemma of slow patient enrollment times. We have struggled with resourcing trial tasks through the peaks and valleys of clinical development pipelines. We have despaired at the continuing dilemma of study protocols taking too long to develop and changing too often once they are finally finished. But most of all we have been under constant pressure to work faster and cheaper without compromising scientific or ethical integrity.

So what have we done in response? There is not much to highlight. Investigative sites have improved their trial competency and the efficiency of their operations. We have traveled to many new corners of the world looking for trial subjects, hoping this will accelerate enrollment completion. Study designs have evolved usefully, not just toward adaptive designs, but with an eye to combining Phases, using branching protocols, and exploring secondary study endpoints as a means to do better, faster science. The “virtualization” of study teams (again enabled by today’s technology) has tried to overcome geographic barriers to hiring and assembling the best talent to manage and execute trials.

We have played endlessly with organization charts, chasing the ever-elusive answer to the question of which comes first – functional discipline, operational process, or therapeutic specialty? Having tried every possible combination with equivocal results, we should not expect an answer to that one soon.

Most noticeably, we have tried probably every possible staff resourcing strategy under the sun: outsourcing, in-sourcing, off-shoring, in-shoring, functional service providers, full study outsourcing, complete outsourcing, contract employees, and more. In the end, what we as an industry have developed as a process innovation is the concept that any and every piece of the clinical development process can be done by someone else. We haven’t innovated how the outsider does it, just the fact that an outsider is the one who does it. There is no question that outsourcing has been a huge business success – the CRO market is estimated to exceed $20 billion in annual revenues. But is it more than a shell game, moving resources using the same mediocre processes from the sponsor to the outside?

Where Will the New Ideas Come From?

Let me be clear that clinical development runs much better today than twenty years ago. We not only have technology to thank for this, but the creativity of innumerable specialists within and outside sponsor companies and CROs who have tackled specific niche problems of clinical research and improved them. We can fully expect that these incremental improvements will continue. But what will emerge as the “next big idea?”

Undoubtedly there will continue to be technology-based improvements. Perhaps putting the power of unlimited computing literally in the hands of everyone, everywhere, can be harnessed for a leap forward in the research process. Globalization (of sites, patients and scientists) will become more and more prevalent and could be more powerful than software. There are so many questions, we can hope that some of them will lead to exciting answers: How will the industry adapt to governmental and public backlash on profits? Will personalized medicine offer more than new justifications for very high prices? How will investigative sites, and more specifically, patients/trial subjects, be changed by the breadth of instantly accessible information (regardless of accuracy or relevance)? Will global economics permanently change the dynamics of the industry, governments, insurers and patients?

Meanwhile…

As we start a new year, with the challenges in clinical development only getting more difficult, what answer do we have besides getting someone else to do the work? Do we await the next technology revolution and hope those in another industry show us the way once again? Almost all change comes either as a reaction to adverse circumstances, or through the disciplined cultivation of “eureka” moments. The adverse circumstances are here now; eureka we will have to wait for. In the meantime, are we working at our tasks as efficiently as we possibly can? Certainly not. Maybe the idea, for now, is an old one: work harder at working smarter.

©Waife & Associates, Inc., 2012

When one party provides services to another party, he is called a “service provider.” It is the oldest, most widespread relationship in human history. It must work! And it does, in every industry and in every culture.

It is almost inescapable today that CROs and biopharma study sponsors refer to each other as “partners.” New contracts for long-term or multi-program work assigned to CROs apparently are not exciting enough for what they are — long-term relationships based on significant awards of work — and need to be termed “partnerships.” The semantics are obviously important for all sorts of reasons, having almost nothing to do with the achievement of efficient clinical research. The partnership concept is also seriously misleading and sometimes dysfunctional. I suggest the heresy that there is nothing to be gained by characterizing service providers as partners. Indeed, using language accurately and managing accordingly can lead to better performance.

Everyone who provides a service these days wants to position themselves as your partner. Your dentist is your “oral health partner.” Your car mechanic is your “automotive mobility partner.” Really? The Oxford Dictionaries define a partner as “a person who takes part in an undertaking with another or others, especially in a business or company with shared risks and profits.” Does your dentist share the risk of toothache if she does not completely clean out your cavity? Does your auto mechanic share the risk of being stranded at night if he does not securely reattach a wire? Or stated positively, does your dentist feel the relief in her mouth when your abscessed tooth is pulled? Does your mechanic get to drive your car after he’s fixed it?

These are not silly analogies. Except in the rarest of circumstances, no matter how often the term “partner” is misused, a CRO is, like a dentist or car mechanic, simply providing a service to the sponsor. A sponsor and a CRO both may benefit from a successful study or both be harmed by an unsuccessful study, but they do not share risks and profits in kind nor in degree. Relatively speaking, the CRO’s risk is low and its modest profit is predictable and near-term. In contrast, the sponsor’s risk is high and so are its potential long-term profits.

When one party provides services to another party, he is called a “service provider.” It is the oldest, most widespread relationship in human history. It must work! And it does, in every industry and in every culture. Somewhere along the way, the relationship in which a CRO is a service provider and a study sponsor is a customer has become passé, frowned upon, and almost shameful. There is nothing wrong with this kind of relationship! In a properly defined customer/provider relationship, the roles and responsibilities are clear, the risks are articulated and objectively managed, the tasks, costs and profits are short-term and straightforward, and both sides care just enough to ensure a successful result. If not, the relationship is broken and a new one is formed, quickly and with much less angst than in a divorce of partners.

Let’s look at three substantial reasons CROs and sponsors are not partners: profit, risk and care.

Profit

If you and I were partners in a lemonade stand and the price of sugar went up 20%, we would sit down and discuss what to do: Should we raise the price? Switch to a corn syrup sweetener? Make lemonade that is less sweet? We would both care about our product’s taste, market success, and cost to produce, because it is “our” business. But if it were my lemonade business and all you do is mix the ingredients, or sit by the road after school and sell the lemonade, what do you care about the price of sugar? How does it affect your ability to stir, or shout to passing cars? It doesn’t, and it shouldn’t.

Indeed, there is hardly any overlap between the business of a biopharma and the business of a CRO. The CRO performs functions parallel to and derived from what biopharmas do, but the businesses are completely different. The core financial drivers of the two entities are profoundly different; the owners therefore have profoundly different interests and concerns.

A drug in development represents a decade’s investment that is unlikely to, but might, lead to a brief but enormous profit. A staged succession of successful development projects can produce some continuity of business over time and has created some of the largest corporations in the world. Investors judge biopharmas based on current revenue and profits, of course, but also on the likelihood that their science and investments could produce a series of low-probability successes.

In contrast, CROs live on numerous, relatively short-term projects from multiple customers, with relatively low but predictable margins. With enough customers and staged projects, CROs can grow steadily with relatively stable profitability. Investors pay more attention to the current financial results of CROs because they are more predictive of future results (squishy backlogs and multi-year “partnerships” with sponsors notwithstanding). There are no blockbuster drugs in the future of any CROs. On the other hand, the failure of a study or the loss of a customer is bad news, though probably not catastrophic.

These fundamental differences in the business models of biopharmas and CROs drive fundamental differences in their attitudes toward a given study. It is impossible to align the goals of two such different organizations in an effective partnership. On the other hand, the customer/service partner relationship is designed to handle such differences. You pay your dentist for competent work. You pay your car mechanic for competent work. It’s a bit of an oversimplification, but why not just pay your CRO for competent work without all the “partnership” trappings? Look at any recent press release announcing a new sponsor-CRO partnership. Every single service or advantage listed as part of the partnership can be purchased individually, or in any combination, from that CRO by any sponsor at any time without a partnership agreement.

Risk

It should be obvious to even the most ardent proponents of “partnership” labeling that sponsors and service providers do not share the same risks. Do both parties have “risk”? Sure, but the nature of the risks is quite different, and they are certainly greater for the sponsor. To suggest otherwise is misleading.

The service provider’s risk in non-performance is mostly one of tarnished reputation. While news of non-performance spreads quickly in our intimate industry, such news is far from rare and the responsibility for failure is usually obscure. Theoretically, a service provider could be investigated by regulatory authorities, but the number of such incidents is very small. A greater risk for service providers is not being paid, although sponsors are notoriously loathe to pursue any sort of penalties for their service provider’s non- performance. If there is a sanction, it would most likely be loss of additional work. But anyone familiar with CRO contracting knows that sponsors routinely continue to give work to service providers who have failed them in the past.

Compare this level of risk to that of the sponsors. A poorly conducted trial risks regulatory rejection, late market entry (which could significantly reduce lifetime revenues), patient safety, and the return on millions of dollars of investment. It threatens international reputation, rapport with the medical community, and employee morale. At best, it means delay, re-work, higher costs, or even repeating the trial. Clearly, the sponsor has much more to lose.

Care

Considering the above differences, it simply cannot be said that the service provider cares as much about the performance of a clinical trial as the sponsor. This is not to say that service provider personnel are not professional and do not take pride in their work — surely most of them do. Neither are all sponsor personnel undyingly committed. But, no matter how professional your dentist, it’s not her tooth; it’s yours. Your mechanic is not repairing his car; it’s yours.

The practical result of this gulf in caring is potential (not universal) problems, such as CROs assigning junior people to a project that is mission-critical for the sponsor, or a slow response to a data quality issue or protocol revision, or tolerance of process inefficiencies that the sponsor would deem unacceptable (if it knew about it).

At the most fundamental level, it is impossible for organizations with such different interests to be “partners.” But can they play a critical role in each others’ success for high mutual benefit? Of course.

Improving the Service Provider/Customer Dynamic

The practical way to ensure that the relationship of service provider and customer will work effectively is for the customer to actively manage three basic dimensions: cost, risk and care.

Cost Management

Effective cost management begins with clarity on both sides of the relationship. Many sponsors, even those with years of outsourcing experience, put out RFPs to CROs that are too vague, too open-ended, and with insufficient detail, especially for contingencies. CROs are equally guilty of responding in kind, including vague assurances for specific contingencies. CROs so love the partnership concept because they can use it as a license to issue change orders without restraint, and change orders are where the profit is. If a sponsor complains about excessive change orders, the CRO that has a major multi-year “partnership” agreement with that sponsor is very likely to assert that this is what partnership means — in return for dedicated staffing, guaranteed capacity, and such, the service provider needs to be able to make up for the unexpected (a given in clinical research) with a steady flow of change orders. Since it is a “partnership,” both parties are “in it together.” The CRO can submit change orders with confidence because both parties “share” in the successes and failures of the partnership.

Eventually, however, the sponsor may realize that the partnership is not working as expected and be brave enough to upset the partnership status quo, a rare event in today’s outsourcing environment. Clarity of expected costs and responsibilities, honest expectations of a trial’s changeability, analysis and prevention of change orders, and a steady eye on integrated cost reporting will help both parties plan their timelines and resources better in a healthy service provider/customer relationship.

Risk Management

The first step in proper service provider/sponsor risk management is to recognize the imbalance of risks and start to manage the project accordingly. Accept that the two parties are not partners sharing equivalent risk. Risk management is best addressed through clear project accountability, which means placing project control in the hands of the party with the most risk (the sponsor), and detailing what the service provider will be accountable for, within the limits of their responsibilities. This means dropping the fashion of both parties having equal voices in a Joint Operating Committee (JOC), which suffer from the failings of all committees and also the ambiguity of who’s in charge.

The parties should agree upfront on a clear procedure for replacing CRO personnel who are not performing adequately. This procedure must spell out how such replacements will be made quickly, rather than allowing the CRO to stall for time, which the trial cannot afford. The parties should also agree on what trial performance metrics are important and how often they should be reported, with what explanations. For instance, EDC tools can tell the sponsor if, when and how often CRO personnel are “in” the sponsor’s data, which is one indicator of whether the CRO is actively performing the necessary work. Good CROs embrace such reporting as an opportunity to prove the quality of their service and other competitive advantages.

Caring

Eliminating the partnership myth will help the sponsor understand the inherent limits on how much a service provider will care about what is really important to the customer. It will also help the service provider understand why the sponsor needs to be in charge, no offense intended. The parties can then act and communicate honestly according to their natural, differing priorities. The things each party cares about will not be the same, nor do they need to be. The motivation for performance, not a shared reason for it, is important part.

Conclusion

Both sponsors and service providers have different, but powerful reasons to see the sponsor’s development succeed. No sponsor today is likely to return to a time when it did all clinical development work itself. While shared objectives are essential to successful clinical study execution, pushing the “partnership” myth has been useful for CRO marketing but has done no favors to clinical trial execution and customer management.

The criticism of a pay-for-service relationship in favor of something somehow more lofty is misplaced and misleading. The oldest form of relationships may be the better way to develop new medical therapies.

“If only we were as adaptable as viruses. Our clinical research processes unfortunately evolve at a much slower rate.”

Flu virus evolves continuously, so much so that a new vaccine is needed every year. It’s the fast replication of virus generations that produces such rapid mutations. Typical viruses change so rapidly, through natural selection, they are able to respond quickly to new environmental conditions. If only we were as adaptable as viruses. Our clinical research processes unfortunately evolve at a much slower rate; clinical research can often take a decade or more to make much less dramatic “genomic” changes. Can we learn as fast as natural selection?

Excuses

I can hear the objections to this comparison already: biology is “objective,” process is “soft.” The excuses we have for the slow pace of change are many:

Regulatory requirements. Biopharma quickly takes refuge in the argument that the reason why things don’t change is because we are a regulated industry. This is rarely relevant to process discussions. There are actually surprisingly few regulations on clinical research process (for instance, nowhere do the regulations say we must perform 100% SDV), and on more than one occasion (I can think of at least three in the past decade), FDA has actually led the industry by issuing guidances describing processes more advanced than industry was initially willing to accept.

It’s not broken so why fix it? This is a typical reaction among those working in a long-lived, experienced and successful (i.e., drugs approved) development organization. But it is broken, and if you look, you will see the facts to prove it. You will find inefficient policies, overlapping responsibilities, unexploited technologies, and political speed bumps slowing your processes.

The “not broken” argument is used a lot when considering ePRO, for instance: “well, I know the paper data is probably bogus but it’s the standard of approval.” Well, no, not anymore, but how long does it take for that fact to filter through research departments who are still rejecting ePRO because it costs too much? That in itself is misleading: what costs “too much”? Don’t they really mean that they didn’t adequately budget for the cost of reliable data?

We don’t have enough evidence yet to justify the upheaval of change. This is false rigor and laziness. When management resists change for a lack of “data,” ask them where is the data to justify current processes? Try taking a zero-sum approach to how you work, and see what proportion of your current processes would survive the analysis.

It’s an unfair comparison – viruses are much simpler organisms than human. – Ah, now we are on to something. If only we could examine human behavior the way we can a genome.

A Method

Actually, we do have a method for accelerating human evolution – it’s called learning. And in the jargon of process improvement, we call it “Lessons Learned”. Many biopharmas would point out that they do Lessons Learned exercises routinely. So the questions are how do we do them, what do we do with them, and where can we see the impact?

One concern is that Lessons Learned exercises have become perfunctory and disrespected. Is the lesson from the “Lunch ‘n’ Learn” session in the cafeteria excreted later in the day? Is the Lessons Learned binder carefully shelved, accumulating dust like autumn leaves? Are those who run these sessions prepared to make them productive? We are neither born teachers nor born learners.

Is the whole Lessons Learned concept thought of as a training function (and therefore underfunded and mostly ignored)? At best it is probably a Clinical Operations function, so the lessons do not permeate medical, biometrics and planning departments. More importantly, where are the lessons coming from? That is, do we have the skills or training to analyze properly the experience before us, and derive the lessons needing to be learned?

Information technology is an important tool ready to help us learn – data on clinical research performance has never been so plentiful or accessible. But no company does a comprehensive job of mining that data for the most relevant process indicators, and no technology vendor does as well as it should in providing easy tools for analysis.

If we’ve outsourced research operations, do we think we can outsource learning too? Are those we have outsourced to learning from their experiences? Must we pay them to learn, otherwise they will have no incentive to improve?

We can and must do much more to learn from our past work. First, learning needs to be incorporated as an expectation and requirement of all functions, and not shuffled off to some ancillary group. I am amazed, for instance, when study teams are not held accountable to document the good and the bad of their experiences. Who were the high performing investigators? What approach worked best in getting drug supply produced on time? Which data manager should be promoted because she was so effective? And I am equally amazed when functional specialties do not take the time to assess their effectiveness, to learn from each other, to routinely identify means of self-improvement.

Be Afraid, Be Very Afraid

The best source of lessons learned is in the head of our experienced staff, and here is where we should be very concerned. At the moment when we most need to learn from past experience, that experience is walking out (or being shown) the door. As we send staff to CROs or retirement or forced career changes, we are losing the chance to capture and define and articulate the lessons they could be teaching us.

We have to care much more about learning. As always that starts with upper management. It continues by allocating money and time. And it is capped by a willingness to learn (change) and a method for applying lessons quickly.

George Santayana famously said, “those who cannot remember the past are condemned to repeat it.” That was more than a hundred years ago. And here we are decades later with that lesson still unlearned. Our industry cannot afford to wait that long to apply the many lessons available at our fingertips. We may not be able to match the adaptation rate of viruses, but we will fall victim to the disease of ignorance unless we organize the learning from our experience.

©Waife & Associates, Inc., 2011