When discussing ways to reduce cost and complexity in clinical trials, the over-riding mantra is to keep expectations realistic. Any clinical trial that begins with an unrealistic budget or schedule is bound to become mired in unexpected costs and the complexities associated with getting back on budget, raising more money and revising the schedule. Those complexities might, in fact, lead to abandonment of the trial.
However, if expectations are realistic, the cost and complexity of clinical trials may be reduced by preventing turnover, ensuring consistency and maintaining a smooth flow of materials, equipment and communication.
Preventing Turnover: Retention Strategies
While warnings abound concerning the difficulties of patient and staff recruitment, surprisingly little attention is given to retention. Even with optimum recruitment processes, some patients and staff will drop out of a clinical trial. Patient and staff turnover affects not only the budget and scheduling but also the reliability and consistency of data. Staff turnover means additional expenses for recruitment and training; in the meantime, morale may be affected and patient confidence may be eroded. Patient and staff retention should be a priority for every clinical study, with frequent checks for situations that may lead to turnover. Sites that are performing well below expectations should be dropped before the cost and time required to fix their problems upends the entire trial.
Ensuring Consistency: Training
Investigator training is another important influence on costs and especially complexity in clinical trials. Most trials are held at several sites, and consistency across sites is essential in operating procedures, patient care, data collection and so on. Online training, computerized training and the leadership of a clinical research organization (CRO) with years of experience working as a team all help to maintain consistency across sites and thereby reduce costs and complexities. Training is also an excellent way to promote retention, especially in emerging countries where medical staff are eager to further their skills and qualifications in western medicine.
Maintaining Smooth Transportation/Communication: Supply Chain Management
With clinical trials increasingly held overseas in emerging countries, supply chain management becomes an issue. The supply chain covers every phase of the trial, including sending required equipment and drugs to the site; storing materials and information at the site; distributing trial materials to patients, either through the site or directly; sending samples and information from the patient to the site and from individual sites to a centralized location; and disposing of equipment and materials after the clinical trial ends. Reducing both costs and complexity requires a clear export/import process to avoid customs delays; familiarity with regulations and required documentation; and a supply chain plan developed well in advance of need. Here again technology is helpful but it cannot provide the benefits of a personal relationship when a shipment is held up in customs or a package goes astray.
Ultimately, the single most important factor in decreasing both the costs and complexity of clinical trials is experience, which not only helps in developing realistic expectations but also in preventing turnover, recognizing what procedures are most likely to need reinforcement and keeping equipment and materials moving along the supply chain.
Where Confidence Pharmaceutical Research Fits In
With its decades of experience and a highly integrated team of clinical research associates and vendors, Confidence Pharmaceutical Research saves costs and reduces complexity in clinical trials without jeopardizing results. From a realistic evaluation of budget and schedule to the development of an exit plan when the trial is complete, Confidence is your partner in global clinical research. Contact us today.