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International Clinical Trials

Feasibility Focus

There is some debate about the real cost of drug development, but the figure is certainly very large and is increasing year on year. Back in 2003 the US Journal of Health Economics published a figure of $802 million (£521 million) as the estimated cost of a pharmaceutical company bringing a new drug to market (1). This figure was based on the research and development of 68 drugs launched by 11 pharmaceutical companies.

More up to date estimates suggest that these costs have risen to as much as $1.7 billion (£1.07 billion) (2). According to CenterWatch, less that 10 per cent of clinical trials are completed on time. The largest cause of delays is contract and budget negotiation, patient recruitment and enrolment, and protocol design and refinement (3). With a typical drug trial costing between $5 million (£3.25 million) and $15 million (£9.74 million) each, these delays lead to significant overspending. We argue here that the root cause of these delays and overspending is insufficient commitment to the feasibility studies needed to optimise the study protocol and commercial relationships between the sponsor (pharmaceutical company), clinical research organisation (CRO) and investigator sites. We propose that a more collaborative approach to these feasibility studies, based on the principles of value management, could significantly reduce overspending and identify significant reduction in costs.

DELAYS & OVERSPENDING

CRO project managers and clinical research associates (CRAs) with experience of implementing studies are often not closely involved in the development of the initial protocol and procurement process, which is a major limitation to clinical research procurement. This can lead to a number of issues, such as project objectives and protocol being defined by the sponsor without input from either the in-house or outsourced research teams. Hence these objectives can be arbitrary and unrealistic. The feasibility study is sometimes performed in isolation from the CRO that is going to complete the study, or the CRO is asked to carry out a feasibility study as part of the selection process. As a result, many assumptions about the best way to implement the protocol are made with insufficient or no input from the CRO. The assumptions made at this point in the process may not reflect the most practical approach to key areas such as recruitment of patients, selection of centres and so on, which can have a profound impact on the timeline and cost at a later stage.

During the procurement process CROs rarely have longer than two weeks to tender for the work, and the contracts are usually set at a fixed price. The aim of the CRO at this point is to win the contract and limit the liability. Little time exists to do any proper feasibility study into the proposed protocol, and as the CRO is in sales mode, it may be biased towards a particular approach. The more likely strategy is to ensure that the scope is tightly defined and the CRO is protected from the weakness in the protocol by clearly defined assumptions, which pass the risk back to the sponsor. During the implementation phase, virtually all project plans need to be amended, often in response to a more realistic assessment of site set-up times, patient recruitment and practicalities of the protocol. The CRO will expect the sponsor to cover the costs of these amendments. Many of these changes could have been readily foreseen in the feasibility phase if the people involved in completing the study were also involved in the design of the protocol.

Furthermore, the design may not allow for new innovations in techniques, which could have saved significant time as well as increased patient recruitment and retention – for example, when the protocol does not reflect the typical medical practice in the selected country. The site set-up can be delayed by contract negotiations with investigational sites, and competitive studies that change the site selection or overoptimistic recruitment due to insufficient risk analysis.

Consequently, many studies fail because they set unrealistic timelines, do not perform adequate feasibility checks, or start projects well into the process. As a result, many trials run late and the cost overruns become significant. For a £10 million study, an overspend of 10 per cent is not unusual. We seem to have forgotten the advice of Abraham Lincoln: “Give me six hours to chop down a tree and I will spend the first four sharpening the axe.”

We believe that a more collaborative but challenging approach to the design and procurement of clinical trials, with more focus on the feasibility phase, could result in significant savings and a reduction in delays by addressing the root causes early in the process. Value management is a widely recognised framework to improve the collaboration and cooperation between the parties in projects.

VALUE MANAGEMENT: A STEP-BY-STEP APPROACH TO COLLABORATION

Many sectors are facing the same challenge of how to get the best value out of the supply chain, and as a result many have moved towards a value management approach. The UK Office of Government Commerce has summarised a wide range of case studies in which value management has saved significant project cost (4). For this approach an integrated feasibility team (from both the sponsor and preferred supplier(s)) focuses on value, not cost, by implementing a number of simple steps: 
  • Firstly it is important to understand and challenge the relative importance of the sponsor’s objectives. This helps define realistic criteria for the success of the project from the outset and prevents the adoption of arbitrary timescales. Value management ensures that everyone understands the relative importance of the project objectives, together with the project constraints and risk from an early stage 
  • Secondly, identifying alternative courses of action including different techniques, approaches and methods may be more cost effective. The early input from CRO project managers and CRAs into the design of the protocol can significantly improve the selection of the most appropriate investigative sites, diagnostic techniques and data collection processes 
  • Finally, analysis and evaluation of different approaches against defined criteria allows project managers to select the best option. This practical and collaborative input to feasibility reduces the chance of delays and additional costs introduced by the amendment of the protocol once the study has started
The change, however, is not just procedural; it is also cultural, with sponsors and suppliers adopting a more open approach to collaborative working. There are a number of areas for change, such as joint leadership and commitment from the top, with a collaborative approach to project management can eliminate the need to duplicate project managers in the sponsor and the CRO with the formation of an integrated study team. Rewards for a CRO against a balanced scorecard can measure the overall success of the study financially in terms of quality, for the staff and the customers, and not just the cost. Ideally, both CRO and pharma staff incentives would be linked to the successful completion of the project within the agreed objectives.

It is also important to utilise an integrated knowledge management database using shared electronic data management systems. Much has been done in this area to use technology to improve the flow of information within study teams; however, an integrated approach and system has the potential to further improve the flow of information between the sponsor and the CRO. Flexible workforces with strong team working (involving secondments and so on) between the partners in the project can help the members of the pharma team get an appreciation of the challenges faced by the CRO and vice versa.

A multi-disciplinary team working across all phases of a study can bring the key people involved in the design, feasibility and implementation of the study together at critical times, and most controversially the use of open book accounting can allow the true costs of a study to be open, so rewards can be based on a more holistic assessment of performance.


BRIDGING THE GAP BETWEEN FEASIBILITY & IMPLEMENTATION

The process for value management is well-defined and includes clear steps to be completed at each stage of the project, where a number of workshops should be conducted. The aim is to bring together the different teams in a collaborative view of the project’s objectives and strategy.

Stakeholder Needs,Objectives and Priorities (VM1)
The primary objective of value management at concept stage is clarifying why the need exists in order to ensure that the project objectives have been thoroughly analysed and understood. The workshop should be conducted early in the development of the protocol, with input from the CRO who will be bidding for the contract to complete the study. It gives the CRO the opportunity to understand the sponsor’s objectives and influence the approach for the protocol to avoid unnecessary complications and unrealistic constraints.

Project Definitions and Options (VM2)
The next step is to ensure that the project options are evaluated and the one which offers best value for money is selected. To select the best value option project managers must review the validity of the objectives, agree modifications and evaluate the feasibility of options, develop the preferred option (best value) and determine if this preferred option can be improved or enhanced. They must also agree on recommendations about the preferred option and produce a programme for development and action plan. This workshop would ideally be conducted during the feasibility phase just prior to the issue of the RFP so that the CRO organisations who are bidding can bring their experience to the design of the protocol.

Value Engineering (VM3/4)
Value management during the feasibility stage, or VM3/4, provides a structured approach to ensure that the most cost effective means of implementing the project are identified. It ascertains elements of the study design and specification that add no value to the project in terms of satisfying the brief and objectives or those which could be provided through another method, thus increasing value. It could be completed between the submission of proposals for the study and the award of contract. Typically, one preferred bidder would be asked to participate in the value engineering workshop.

Value Reviews (VM5/6)
Value reviews, or VM 5/6, should repeat the exercise undertaken in VM 3/4 during the implementation of the study. Value reviews need to be undertaken as part of the project’s change control mechanism to allow the opportunity to value manage the project to determine if the functionality could be altered and be more cost effective, so that the project may be delivered within the original budget. Ideally, a value review must be undertaken at least once during the start-up and implementation phases to identify more effective ways of working. More frequent reviews may be necessary due to the complexity of the project.

CONCLUSION

Value management is a tried and trusted way to reduce the overall cost of projects and has a successful track record in many sectors. It brings together the complete project team to understand the challenges and identify smarter, quicker and more cost effective ways of completing the project, often by simple changes to the approach and requirements. The clinical research and development sector could learn much from these more collaborative and value focused approaches.

References
  1. DiMasi HG, The price of innovation: new estimates of drug development costs, Journal of Health Economics 22: pp151-185, 2003
  2. Collier R, Drug development cost estimates hard to swallow, Canadian Medical Association Journal, 180(3): pp279-280, 2009
  3. US Sites Rate Medpace, Kendle and ICON at top CROs in 2009, The CenterWatch Monthly, June 2009
  4. Office of Government Commerce, Achieving Excellence in Construction, 2007, retrieved from Office of Government Commerce, http://www.ogc.gov.uk/documents/ CP0064AEGuide4.pdf


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Paul Naybour is a co-founder and Director at Parallel Project Training. Paul is an experienced project management practitioner and has particular expertise in change programme management, risk management, earned value management and project management training development and delivery. He has managed the delivery of multi-million pound development programmes and consultancy assignments for clients such as Network Rail, Transport for London and the remote handling specialists Strachan and Henshaw. He has also delivered training for clients in many sectors including telecommunications, where he facilitated risk reviews for e-commerce projects at Orange, financial services (American Express, TD Waterhouse and Abbey National), engineering (British Nuclear Fuels, Network, Infraco SSL and Strachan and Henshaw) and construction (Carillion, Lend Lease Consulting and Wilson Bowden).

Roger Joby is a chartered scientist and a member of the Association for Project Management (APM), and has been involved in the pharmaceutical industry for over 30 years. He has experience in clinical operations, project management, proposal generation and third-party contracts at all levels. He has worked as an employee or more recently as a consultant for several pharmaceutical companies and clinical CROs. Roger also takes an active part in project management research, and has published several papers on the role of earned value analysis in clinical research with Dr David Bryde of Liverpool JM University. In addition to earned value, Roger is also interested in risk analysis, project pricing, forecasting and stakeholder analysis.
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