Effectively Managing Your CRO – Establish A Solid Blueprint

Before you build that new home or put an addition on your house, you sit down and sketch out a variety of looks and features that you would like to have included in the project. You take your notes and prints to some area contractors and ask them to propose upon your project. In some cases, you learn that the project is within your budget, or some sacrifices have to be made to meet those budgets. Then, the work begins.

During the project, you find out that an allowance was included for your bathroom fixtures which is something above the least expensive item at Home Depot; you learn that the budget proposed a certain number of light fixtures which falls far short of your expectations, so this is added. You learn that your measurements are off just enough that you now require an extra piece of granite to be purchased for your kitchen island. What went wrong?

There are often many references made to the construction industry when speaking about clinical trial execution, but arguments from both industries are very similar when it comes to identifying your plan, whether it is a blueprint and specifications book or a protocol and defined vendor agreements. If the protocol is cut and pasted, or it is something that was constructed 10 years prior using out-dated procedures, you will find challenges and difficulty in executing your program, regardless of your vendor choice.

The basic tenets of writing a protocol – the regulatory input, the identification of primary/secondary/tertiary endpoints, etc. – are understood. A few additional considerations can help to ensure that you have the appropriate detail and information to lean on a well-constructed protocol to guide your service providers:

  1. Be sure that the protocol considers Standard Of Care practices. Our team has been involved with two studies that exceeded the Standard Of Care practices in the field. In both situations, the trial proceeded forward despite many physicians not allowing patients to use higher doses of toxic drugs or allow patients to reach measurable levels of disease that exceed protocols of many healthcare organizations. In many cases, across international lines, the standards of treatment can vary from country to country. Consider the field conditions when developing your program.
  2. Be certain that physicians can actually identify subjects who match your needs (feasibility). Site selection is continually a challenge; physicians want the business and their teams feel that they can recruit the required number of subjects, yet 70% of sites fail to meet the minimum accrual requirement. Canvassing treating physicians to review your protocol is one way to ensure that the procedures referenced are current, patients do fit the profile required and the sites can be successful when engaged. In addition, there are services that will mine databases to locate patient pools and validated physicians to further validate the protocol and identify areas that have patients to support your needs.
  3. Ensure that patients who exist will want to participate (viability). Many protocols include a variety of tests, blood draws and data collection that impede on a patient’s quality of life. In addition to ensuring that sites see the appropriate patients, a consideration is strongly suggested to inquire with patients who have the condition to determine if they will comply with the requirements of the program. In addition to site selection, patient compliance is also a great challenge for sponsor companies.
  4. Walk through the logistics of the program to identify any outliers in terms of service support. Your program requires interesting logistics around sample collection, and it is assumed that your CRO partner has addressed it. But, they have only budgeted for the basics of sample handling while your requirement is much greater and more involved. Working out the logistics of the entire study with each participating functional area can help identify some areas of challenge that should be discussed proactively and addressed in the timeline and budgeting process.
  5. Be sure that your selected CRO partners have an opportunity to contribute enhancements. CROs, whether full service, or functional/specialty blends, have a wealth of experience and history. Many of these people have had experiences across multiple programs in similar areas. If they have the experience, use it – get it during your protocol development or during the logistics discussion. It is one of the reasons that you chose your partner, so get them involved – it will also help them provide a better service if they are making suggestions to enhance the study.

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