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The Value of Communication in Clinical Collaborations

Source: Dr Faiz Kermani
Published: 08/01/07

External partnering

Pharmaceutical and biotech companies often pay third-party vendors millions of dollars for their expertise, and routinely outsource the services and processes involved in the formulation, manufacture and delivery stages of pharmaceutical R&D. Leveraging the resources of third parties can be both efficient and cost-effective. By sharing information, pharmaceutical companies can get more out of their relationships with vendors. By overseeing the testing methods that external partners use, these companies can share, receive and use that knowledge in a way that is productive and beneficial for both parties. However, not all pharmas and biotechs successfully communicate and collaborate with their partners to capitalize on those benefits.

In a highly competitive market such as the pharmaceutical one, a high communication level helps ensure a timely supply of data and material, speed the product’s time to market, and improve return on investment. Although many study sponsors often hesitate to share information with external partners out of concern about disclosing valuable data, knowledge transfer with suppliers can help them receive better service and manage risk more effectively. “Pharma companies that focus only on the risks of sharing information with third parties lose sight of the benefits” (1). In fact, by not communicating closely with suppliers, companies often neglect to give them clear incentives to improve yield and outsourced processes. A close collaboration between partners helps identify opportunities for efficiency improvements and cost reductions as they arise throughout the project.

Being proactive

Despite technological advances in pharmaceutical R&D, nearly 80 percent of all clinical studies for new products fail to finish on time, and 20 percent of those are delayed six months or longer (2). Therefore, it is important that all the factors that might affect a trial are considered at the outset and are discussed with the potential trial partner.

In situations that might delay the trial, the client will be looking for a partner that can show adaptability and flexibility. This is particularly important for smaller clients, such as start-ups, who have limited experience of clinical development and have limited funds. For example, if patient recruitment is sub-optimal at a particular site, how proactive is your partner in reacting to the situation? Most companies will already have experience of such a situation and should be able to suggest alternatives that will help keep the project on track. This could involve the use of reserve sites in the same region or using centres in a different geographical region. Some of the contingency plans that can be used are shown below.

Contingency Site Recruitment Plans

Select more sites with ethics approval than required

Consider reserve countries

Set targets within recruitment phase

Assess inclusion/exclusion criteria

Learn from successful centres


Understanding the nature of collaborations

Managing a collaboration is not an “exact science” and it takes time to set up an efficient system of communication. In fact the very “obviousness” of the benefits of communication lead people into the trap of taking things for granted when setting up collaborations. Unfortunately, once a project is ongoing it can be difficult to develop an effective communication strategy as the day-to-day project work and the pressure of timelines take over.

Furthermore, there has to be a degree of realism involved in collaborations because some problems that will be encountered may be inherent to the risk-intensive process of drug development. What is important is that any decisions made along the way are reappraised and the lessons learned are applied to future projects.

References

  1. E. Tomlinson (2002). The 3Cs of Successful Outsourcing: Communicate, Collaborate, Capitalize. Pharmaceutical Executive. October 1, 2002.
  2. Frank Kirkpatrick, “Rev Up Patient Recruitment”(Pharmaceutical Executive, April 1st 2002)


Dr Faiz Kermani has several years experience in both academia and the pharmaceutical industry. He has worked in pharmaceutical R&D, pricing and reimbursement, marketing and medical communications. He holds a PhD in Immunopharmacology from St. Thomas’ Hospital, London and a First Class Honours degree in Pharmacology with Toxicology from King’s College, London. He has written extensively on international healthcare issues, and is on the editorial board of a number of publications. In March 2006, he was a delegate on the UK Government’s Trade and Investment Biotech Scoping Mission to China and was a speaker at the subsequent presentation.

You can contact Dr Kermani via jobs@leaddiscovery.co.uk

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