Clinical Research

Establishing a good relationship between a sponsor and a contract research organisation (vendor) is the responsibility of both the sides in the partnership. Sponsor accessibility and responsiveness is a critical piece of the solution. The vendors, in turn, must meet their obligations in a professional manner.

Susan Bassion, CDISC Lab Team Leader, CDISC, USA

The outsourcing industry, from its small early beginnings in the US in the 1970s, has emerged as a h4 global partner in the worldwide clinical development market. The worldwide clinical or contract research organisation (CRO) market revenues are estimated to exceed 17.5 billion US dollars in 2007 (Goldman Sachs, 2005) and the percentage of expenditure on worldwide research and development outsourced is expected to increase to 21.7% in 2007 and reach 28.3% by 2009 (Reuter’s Business Insight, 2003).

Reasons for increase in outsourcing There are many reasons for the increase in outsourcing, including:

•  Several cycles of industry downsizing
•  Decreasing revenue streams due to blockbuster drugs coming off-patent, and decreasing number of new molecular entities approved
•  The pressures of healthcare reform in many countries and the resulting pricing pressures on pharmaceuticals
•  Increasing costs of drug development
•  Pressure to limit internal development costs and therefore headcount (the single largest expenditure line for any company)
•  Globalisation of drug development with companies seeking approvals in countries worldwide and needing assistance in generating local data to support regulatory applications

Also there has been a great deal of interest in approaching the Asia Pacific markets due to a number of factors:

•  Access to good patient population
•  Ability to run clinical trials cost effectively
•  Availability of highly qualified clinical research professionals
•  Maturation of CRO resources in the Asia Pacific market

The Sponsor-CRO partnership: It’s a two way street The development of a good relationship between a sponsor and CRO is the responsibility of both sides in the partnership. Sponsor accessibility and responsiveness is a critical piece of the solution. The vendor, in turn, must meet its obligations in a professional manner.

A 2000 Centerwatch survey of CROs identified five essential elements for sponsors in the sponsor-CRO relationship, including:

•  High level of accessibility
•  Responsiveness to inquiries
•  Realistic project timelines
•  Collaborative team environment
•  High level of team preparation and organisation

Sponsors often look to the CRO side of the relationship for causes of and solutions for difficulties. However, almost all examinations of the issues between sponsors and CROs identify that effective solutions must look at both sides.

Ways for sponsors to fail

A variety of sponsor practices promote adversarial relationships and unproductive work environments, some of them include:

• Selecting a wrong partner

The most important piece of this process is selecting the right partner. The right partner is one who is selected on the basis of its capabilities and cost competency. However, compatibility is a third element that should not be overlooked. In the final analysis, the relationship between a sponsor and CRO involves people on both sides. And the key contacts on both sides must feel comfortable with the relationship. They should be able to trust their counterparts and feel that they have compatible styles and approaches to their work.

• Providing unclear expectations and vague or conflicting requirements

One of the most important early steps in the relationship is the provision of a clear and complete list of study requirements or specifications. The death of the relationship between sponsor and CRO begins with assumptions. Relationships often flounder because of the assumptions or expectations of one partner and the assumptions of the second. There is almost always more than one way to get something done. And the way that any company carries out much of its work is likely to be based on their own internal policies or traditions and not based on regulatory requirements. It is vital therefore for any sponsor to tell the CRO as clearly as possible what THEIR expectations are.

• Micromanaging every step OR taking a totally hands-off approach

One of the keys to success is, after finding the right partner, find the middle ground in which the sponsor can provide oversight and support but within a framework of project planning, tracking, reporting and problem solving where the sponsor can step back and allow the CRO to be the implementer.

• Setting unrealistic expectations

It is of course true that the CRO is paid for its efforts. However, that does not mean that it is productive for the sponsor to ask for the impossible or unlikely to accomplish things even if they are paying for them.

• Never asking for vendor input

It is always helpful to ask the vendor for their perspective. The sponsor may not be able to accommodate it, but a CRO likes to be asked. And in providing input, they may be identifying risks and potential problems, an important part of planning and problem solving.

• Expecting vendor to replicate sponsor’s processes exactly

It is more productive to manage outcomes, rather than process. And by allowing the CRO to take advantage of its process, it works more efficiently.

Ways for Vendors to Fail

A variety of vendor practices also encourage sponsor mistrust and uneasiness, resulting in a failed relationship. Some of the practices include:

• Promising more than you can deliver

Vendors need to sell what they do or are capable of doing, not sell whatever sponsor needs and figure out later how to get it done. They should commit to only those things which they can deliver to the sponsor. And then do everything they can to live up to that agreement.

• Providing less resources for the project or change contacts frequently

Vendors need to work closely with sponsors to understand their needs and assign resources to the project so that deliverables can be met.

• Not coordinate management or communication

Developing a thoughtful project plan by the CRO upfront before the start of a project is an important step in making sure that the CRO understands and implements the sponsor’s wishes. This is an important step for a global study (a study in which sponsor and CRO are located in different parts of the world). Cultural differences especially the ones which affect communication should be considered.

• Sending change orders for every small thing

Sponsors understandably dislike being sent frequent change orders, especially when the change orders reflect a poorly thought out proposal and poor planning—so often the vendor that seems to be the most cost effective choice, after numerous out of scopes, ends up being a more expensive and often less efficient option.

• Never analyzing or proposing solutions

Many sponsors are looking for true partners in the drug development process. Rather than just pairs of hands, many sponsors are looking for vendors who can truly “take a seat at the table”, working proactively to predict problems, analysing trends and develop options for solutions and make recommendations.

• Providing little information and no timely notification of problems

Sponsors dislike not having access to information about what is going on with their study. Vendors should determine what information is needed or desired and find a way to provide that information on a regular basis. They should notify the sponsors as soon as possible about any problems or issues uncovered together with proposals for solutions to the problem.

Keys to success

Different approaches to problem solving and communication hold the key to success, including:

•  Practicing open and honest communication - the basis of any good relationship
•  Planning for succession management - We know that turnover is a significant problem in our industry – so it is a risk that should be planned for and accommodated
•  Establishing consistent practices - Consistency supports a team’s ability to understand how to approach its work – and is therefore a foundation for accountability
•  Realistic assessment of timelines and needs - Perhaps the hardest one the management often pushes, pressuring both sides of the partnership. Working with management on a more realistic assessment of timelines and requirements would permit us to plan better and to better ensure outcomes
•  Maintaining flexibility - Stuff happens. And we need to maintain our flexibility and sense of humor.
•  Maintaining a respectful environment - We all respond better in an environment in which we are treated with respect and our abilities are acknowledged

With well considered planning and good communication between parties, a positive and productive relationship between a sponsor and their vendor partners is well within reach.