A smoother ride to market
pharmafile | October 22, 2003 | Feature | Research and Development | clinical development, patient recruitment
The concepts of the 'business case' and 'performance management' have become popular even outside business circles, but clinical trials for the pharmaceutical industry remains one well-known exception.
Experiences in this field are spread across countless man-years, as drug development organisations (either within pharmaceutical companies or specialised development firms) employ thousands of people dedicated to this particular process.
The clinical trial process is therefore often seen as being fully under control and crystal clear a process which very few people would consider assessing and measuring.
But clinical trials are still part of a business effort and, even in this comprehensive process, there is a need to first predict, then to prove, effectiveness and value-adding opportunity through appropriate metrics. Additionally, to get sponsors for these business initiatives, a key question needs to be raised and answered: "how will this project impact shareholder value, and by when?"
Shareholder value and patient recruitment
In addressing this issue, one immediately relevant area springs to the foreground: patient recruitment. By applying commercial considerations to assessment and measurement of the recruitment process for trials, the inevitable impact will yield benefits for many important processes. Analysing the hit parade of the pains of pharmaceutical companies, executives are confronted with challenges in areas such as:
- The need for internal cost containment: for example, in rising R&D costs.
- External cost pressure: with strong pressure on healthcare costs there is a need to promote value add to which upcoming legislation – intended to speed the flow of generic drugs – raises the question of where to look for future revenue-generating fields.
- Meeting expected revenue growth: in clear contrast with the fact that there are more presenting blockbusters than in the past and analyst expectations of growth rates that will drop from double to single digits.
- The R&D pipeline area: where future pipeline weaknesses and upcoming patent expirations seem to force further mergers and acquisitions.
From an investor's perspective, ventures with pharma companies reliant on trials often appear to be risky. Despite better technologies, costs of product development have increased by 250% during the last ten years. Not to mention the more than ten years and $800 million necessary on average to get a drug to market. Lastly, only 30% of the marketed drugs cover average R&D costs.
According to Datamonitor, revenue production from blockbusters is declining at a pace of 3.8%, while market power for them is expected to increase by only 1.4%. Looking at these figures it seems that blockbusters will decline from the level of importance they have today in pharmaceutical market growth.
Consequently companies have concentrated on maximising revenue potential across the drug's life cycle. They are also trying to explain this situation to their investors, re-educating them about alternatives to blockbuster-based performance valuation.
Personalised medicine
The fact is that sustainable growth requires expansion of patient populations by exact identification of patients benefiting from new therapeutics. At the R&D-level, by addressing personalised genomic-based therapies, a new attractive market is opening. If the promises of the one-time/for-me-only cure are kept, this could greatly compensate for what today's blockbusters are expected to lose.
In combination with lifestyle drugs, personalised medicine represents a lucrative business opportunity due to the expansion of the patient population. Indeed, virtually everybody could become a patient!
However, this poses an even bigger challenge in that both personalised and lifestyle medicines require the exact identification of the patients to be addressed and – more importantly – the patients to be enrolled in clinical trials, because without enough patients for the trials, there is no drug to sell.
Effective patient recruitment then, is a key factor in mitigating delays that hinder progress. In fact, 78% of trials suffer delays and hold back production, making this a clear commercial issue, which should be measured and benchmarked to identify areas of improvement. Delays due to patient availability cause a cascade of subsequent delays that negatively impact the drug submission timeframe. The consequences of this are increased investor concern, as analysts keep a close watch on development pipelines, and losses of up to hundreds of thousands of revenue pounds each day.
On the other side of the scale, effective recruitment helps deliver on promise, generating investor trust and a healthy, competitive revenue stream.
Managing risk and improving performance
Recruiting patients for trials is becoming increasingly difficult for a number of reasons. First, in terms of personalised and lifestyle medicine, patients must be exactly identified – based, for example, on a specific genetic pattern. Second, the FDA has doubled the number of patients needed per study, meaning that 2 million patients will need to be found per year within 5 years, compared with 1 million in 2001. Finally, the number of clinical trials is increasing worldwide by at least 15%, with 1,300 trials expected in 2004 compared to 500 trials in 2000.
Hard to reach patients
This seems a hopeless situation, especially as all these studies must compete for the same, few available patients.
However, only 3% of all potential trial patients are informed about the trial and motivated to participate. The great opportunity here is that 97% of potential trial patients are still out there – waiting for a chance to participate.
The clinical trial value chain can be summarised in 3 main steps:
- The first step defines the medical rules and criteria for the specific trial.
- The second step sets the stage for the different delivering players.
- During the last step, patients and physicians are informed and patient qualification is also done.
As already noted, todays traditional manner of advertising reaches only 3% of potential trial candidates and generates 90% of wasted patient qualification time, because only one out of ten interested patients are qualified.
Evaluating the three main clinical trial steps against commercial principles shows their impact on performance, where the customer is the patient and the product is the trial.
Starting with the trial design phase, commercial thinking demands clear definition of the ideal patient profile, not only from the medical point of view as already mentioned, but also from the patient's environmental point of view.
Demographic information as well as the patient's perceived priorities, and the personal beaviours of the ideal patient, will be key to tailoring trial-related information. Re-writing the unique trial selling points in the patients specific language increases the chances of motivating the right person for the trial.
The two concepts 'ideal patient profile' and 'unique selling points' are basics in the commercial world. The first corresponds to the concept of the ideal customer profile, where as many characteristics as possible describing the target customer are identified on paper. The second corresponds to selling points, describing the unique value delivered from a given product or service when compared strategically with the competition.
To fill the gap between the previous suggestions and day-to-day business, there are several directions through which solutions can be pursued. One strategy entails the integration of external and internal databases, governed, for example, by a Decision Support System through a portal. The mentioned data sources are well known to pharmaceutical companies and normally used in business intelligence departments. Also internal, historical databases are available, though sometimes need to be further screened and integrated.
Adding another strategic layer to this direction 'Intelligent Marketing Agents' can be integrated into the above environment, automatically filtering valuable information from the Internet.
A question raised at this point is: Why can't the doctor or the investigator do this information brokerage work? It can be argued that they will not be willing to invest the time for this task. Moreover, frankly speaking, has your doctor ever asked you about your personal priorities, about your rationale when making decisions, or about your personal needs? This is hardly the case! Many doctors are even reluctant to take the time to precisely explain clinical trial terms and advantages to their patients, in a language they can understand and in a convincing enough manner to facilitate a positive decision.
Returning to the analysis of the first phase (trial design), if the suggested commercial considerations are implemented, the positive impact on trial performance will be visible in these places:
- At physician sites (through more qualified patients in less time and less time for recruiting the necessary number of patients); and
- At monitor sites (through better site qualification and awareness).
The result is an overall decrease in trial administration effort.
A positive impact on performance will therefore also be visible for the patient screening step (the third step of the clinical trial value chain), where improved matching of candidates will result in time savings and a much higher patient qualification ratio, enhancing, as a consequence, overall trial performance.
Doing professional, modern risk management
Considering the second value chain step (site and physician qualification), commercial experiences suggest the constant monitoring of key performance indicators, like recruitment status.
By using early warning systems, the situation can be monitored in an automatic manner and previously defined contingency plans help recover from instances of poor performance before deadlines are reached. In doing so, achievement of trial milestones is safer and risks are mitigated through the application of workflow warning mechanisms within existing drug project management systems.
A further strategic program addresses the application of workflow warning mechanisms within existing project management systems to keep track of status and deadlines. Integration with decision support systems is crucial to take advantage of 'what if' scenario analyses and drive contingency plans when necessary.
To emphasise the importance of recruitment monitoring, another commercial suggestion is the introduction of measurement incentives for the responsible organisation. This can be achieved using something along the lines of a balanced scorecard, or enhancing existing scorecards with timely review of progress in recruitment in terms of number of patients at specific points in time.
Another strategic solution demonstrates the typical implementation of a balanced scorecard, integrated with some of the previously suggested systems to achieve comprehensive trial performance management. So called 'management cockpits' are able to host all the relevant key performance indicators, while configured to deliver the requested granularity of information to serve any management level.
One last suggested action can have major impact not only on recruitment performance, but also on overall pharma sales strategy. The concept of Segmentation of Physicians aims to identify high performers in the focused tasks of delivering patients for trials on-time and in the right numbers.
Personal commitment of doctors in looking for trial patients must be followed by results that are measurable in quality and quantity. If we succeed in identifying high performing physicians, able and willing to deliver on-time and on-expectation, then we can advise our organisation on how to concentrate efforts.
As a result, resources can be re-directed to focus on the committed partners, with better remuneration having the added consequence of even higher performance. The advantages of this solution include: integration with existing internal and external data sources as well as with drug project management systems resulting in globally consistent and not redundant collected data; the automatic consolidation of resulting figures will be directly inserted into quadrants, showing individual performance and supporting the strategic decision making process; and an easier, automatic feeding of the very important Physicians' Database (Physicians DB) will increase information accuracy and leverage decision foundations for future scopes.
Implementation of these suggestions will have a positive impact on achievement of trial milestones, while optimising trial budgets and allowing involved managers to be able to constantly control, measure and demonstrate their success. Critical to this process are the organisational changes involved. Cultural and behavioural moves must be carefully prepared, and sponsored by executives.
Concerning the preparation for change, the good news is that we have methods and tools to enable this process and to do it consequently, but internal executive involvement will still remain key.
By drawing on a firm internal commitment, consistent monitoring and measuring programs and optimising trial patient outreach, significant advances can be made in furthering the success of pharmaceutical players.
Lorenzo Nanetti is a business development manager with BearingPoint's pharmaceuticals segment and Tim Jones is a Consumer Industrial Technology Practice Leader for the company.
For more information please contact Jessie Allen at River Rouge Communications.
Related Content
Recruitment and retention: How can we do better?
In pharma R&D, data is king, but consistent struggles with patient retention is undermining the …
The July/August issue of Pharmafocus is now live!
The new July/August edition of Pharmafocus is now available to read online.
FDA plans greater diversity in clinical trials
The FDA is to focus on increasing patient diversity in clinical trials in 2016, to …
