Wednesday, February 1, 2017

How to Coordinate a Successful Clinical Trial Collaboration

A lot of work goes into planning and running a clinical study. Sponsors have found that collaboration with a Clinical Research Organization (CRO) is needed to achieve the ultimate goal. A CRO is an organization that help sponsors conduct clinical studies. CROs use web-based collaboration to set up project managers and electronic document control systems to ensure the sponsor has up to date information on study progress. Based on 2005 statistics, biotechnology and pharmaceutical companies paid an estimated $14 billion to CROs for out sourced services. It is estimated that by 2010, approximately $20 billion will have been paid out to CROs for their services. This is a good sign that CROs are here to stay and sponsors, investigators, and CROs must learn to function cohesively to run successful clinical studies. Here are some tips to keep in mind.

The Hierarchy

First, a successful collaboration is very dependent on having a clearly defined relationship. Each person must know to whom to report certain aspects of the clinical trial. Once the relationship is defined, managers should ensure everyone adheres to the reporting structure. In an ideal situation, the sponsor hires the CRO and delegates all or select responsibilities to the CRO. Once hired, the CRO typically hires the clinical investigator staff (In the resource section, see the article on choosing good investigators for specifics). Therefore, the reporting structure should be that the CRO reports to the sponsor and the investigator reports to the CRO. If the sponsor interacts with the investigator site, it should only be due to communication breakdown between the CRO and the investigator site personnel.

During audits, I noticed the biggest complaint from the investigator site is that the CRO and the sponsor both contacts them at different times for the same information. This disrupts the site, causing them to stop their routine work to copy and fax the same record more than once. The sponsor should have contacted the CRO for the information and let the CRO get the information they needed. If the CRO is not performing up to expected standards, replace them, but don’t do their jobs for them.

Communication is the Key

Communication is always the core of the issue when people aren’t getting along. All three entities must learn to respect each others needs. The sponsors main concern is getting specific data from the protocol within a certain time frame. The CRO’s concern is meeting the sponsor’s predetermined time line. The investigator’s concern is conducting the clinical trial with as little as possible interruption to his or her routine. The three need to discuss how they prioritize certain elements related to their general routine, how clinical research can be integrated effectively in that routine and how good, honest and accurate data can be obtained in a timely manner. Respect for each other will go a long way in accomplishing a mutual goal.

Listen, truly LISTEN and understand how each person operate

In the Center Watch 2007 Survey on clinical trials, the CRO Kendle was rated number one by 522 US clinical investigator sites. According to the investigators, Kendle stood out over their competitor because they listened to what the investigator and staff had to say. Additionally, they were quick to respond to the investigator’s questions and provide feedback to ensure the clinical study progressed. The other fact that was impressive was their realistic time-lines. Sponsors and CROs tend to forget that they are not the investigator’s only client. Investigator site personnel do not always know or understand the significance of certain protocol requests and therefore do not follow through. For example, transcription errors occur a lot. I suggest that a few minutes of proofreading could reduce errors by more than 75%. Since investigator personnel do not have to analyze the data, they do not understand the significant setback caused by transcription errors.

The sponsor, CRO and clinical investigator’s site can be extremely productive when working together to achieve the common goal. To work well together, each one only need to implement these three ethical principles: 1) respect for persons, 2) beneficence and justice.

Labels: How to Coordinate a Successful Clinical Trial Collaboration

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