Clinical trials newsletters: just fluff or a critical trial management tool? (Issues in Clinical Trials Management).

As clinical trials become more complex, the need for innovative clinical trial management strategies increases. Clinical trial managers play a pivotal role in determining what strategies will be implemented to ensure the integrity of trial operations. Logistical issues, the need for ongoing protocol and trial operations communications and training, the importance of supporting ancillary trial activities, and management objectives including creating partnership relationships with trial sites and vendors test the trial manager's resolve in selecting effective strategies to meet these challenges. A clinical trial newsletter may be an innovative and effective trial management communication and training strategy to orchestrate a well-managed trial. Utilizing the teamwork and leadership abilities of the sponsor's clinical research associates responsible for monitoring the trial, vendors who provide trial services, and the site clinical trial staff is necessary for clinical trial management. The clinical trial newsletter serves as a catalyst far pooling the knowledge and talent of all trial support staff while achieving the overall goal of effective trial management.

Key Words: clinical trial management, communications, knowledge management, staff development, clinical trial newsletter

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Challenges in clinical trial conduct abound. Clinical trial sponsors, clinical research associates (CRAs) who monitor sites, and the site clinical trial staff (investigators and support staff) conducting trials race to meet the challenges of shrinking development timelines and increasing trial complexity, while striving for regulatory compliance and good clinical practice (GCP). Scientific advances, such as the application of genomics to biopharmaceutical research; technologic advances, such as imaging; and molecular diagnostic techniques applied to clinical development increasingly are offering more ways to reliably evaluate the safety and efficacy of investigational drugs. The layers of complexity in today's clinical trial has increased the responsibility of clinical, trial management. Historically, the burden of excellence in clinical trial management largely fell on the clinical trial manager's shoulders; however, that burden no longer can be contained on the shoulders of any one manager. It is imperative that the CRAs monitoring the trial and the site clinical trial manager and staff function as a team and display strong leadership skills.

Further, multidisciplinary expertise increasingly is integrated into clinical trials to ensure that the drug's clinical effects, including adverse effects, are profiled body system by body system. Although one medical discipline may take the lead in the clinical trial evaluation (i.e., dermatologists serving as investigators of an investigational compound for a dermatologic condition), more often than not, numerous medical subspecialties and the expertise of other health care providers are included in the clinical trial evaluation processes. The result is that much more training, management, and orchestration are required in any one clinical trial.

These clinical trial challenges provide the opportunity for innovative solutions. Mounting clinical trial complexity, i.e., trials having more medical specialty evaluation components than ever before, means that therapeutic area knowledge and expertise are not enough. Clinical trial managers find themselves having to learn and incorporate the specialty knowledge of other therapeutic areas into the trials for which they are responsible. While weaving the subspecialty evaluations into the protocol operations, the clinical trial manager must consider how these evaluations will be carried out in a manner that is consistent with the protocol, regulations, and GCP. The manager must consider how clinical trial data from offsite evaluators will be passed to the trial sites or trial vendors, such as a central laboratory or radiology center, in a GCP compliant manner. At the very least, the medical specialty knowledge and expertise specific to the protocol evaluations must be communicated to the trial site staff who will conduct the trial, to the clinical trial staff who will monitor the trial sites, and to certain trial vendors, allowing each to grasp how their role interfaces with and contributes to the integrated overall trial conduct.

Training clinical research staff active in today's complex trial may now be considered a Herculean task. Training site staff on protocol roles and responsibilities typically is initiated either at an investigator meeting or a site trial initiation training visit performed by an individual CRA. These one-stop training sessions--once the training is over, it's over--however, no longer will be satisfactory for clinical trials that have become increasingly complex. The girth of the training--what it will take to assure ongoing symphony rather than cacophony regarding protocol conduct--may necessitate instituting innovative strategies in clinical trial management, specifically relating to trial communications and training from start to finish.

The newsletter as a clinical trial management tool

A newsletter can serve as one communication and training strategy for assuring chorus among the sponsor staff, the clinical trial site staff, and trial vendors throughout the course of the trial. Certainly, the idea of creating a newsletter to advise site staff of trial progress and activities is not new. However, the time now may be right to rethink the purpose and objectives of a clinical trial newsletter and decide whether it would be a useful management tool.

Clinical trial managers have multiple levels of responsibility and accountability in the conduct of a clinical trial. Starting the trial, i.e., first patient in and last patient out, is a key, well-recognized industry milestone. Yet, how well the trial is conducted site by site is more important, although not necessarily center stage to corporate milestones. Trial managers stay abreast of overall trial conduct by being pulsetakers. Responsibilities include:

* reviewing the site monitoring reports,

* taking phone calls from sites to discuss trial-related activities,

* being copied on e-mail and teleconference communications between CRAs and trial sites regarding site queries,

* receiving vendor updates,

* co-monitoring visits to select sites, and

* meeting regularly, i.e., weekly, with the CRAs to discuss trial status site by site.

The data received from these sources allow the manager to spot actual or potential problem areas in trial conduct. As a result, the manager may conclude that additional communication and training strategies may be beneficial to overall trial performance. The manager then must consider the best strategy for communicating to the trial sites, reinforce proper trial conduct, and provide anticipatory guidance and ongoing training so that potential protocol deviations are prevented. Moreover, if the clinical trial manager believes that drug development is a partnership between the sponsor, trial sites, and supporting entities, then a …