Clinical trials have humble beginnings that may or may not see the light of day. The research starts way before any trial ever gets to the point where humans are involved. The transition from thought to human research depends on a set of predetermined suppositions that make up the potential efficacy of a new drug. Bay Area Research Logistics (BARL) look at the key skills required for a successful clinical trial.
The speed at which drug development travels presents myriad issues, not limited to the determination of patient populations and sites for testing research. There exists a space where the intersection of science and real life meet - and at the space are the people who are involved in the transition of clinical trial drug from sponsor to patient.
In planning for implementation, the trial sponsor must select a partner to provide the services that are essential to determining specific parameters, from advice on bottles, label design, scheduling, packaging and shipping to expediting drugs to foreign countries.
In doing so, consideration should not only be of the team's expertise, but their ability to think critically and make clear and reasonable judgements that guide the sponsor through the phases of their research.
All too often, the elements of applying, analysing, synthesising and evaluating information are overlooked as key components.
There are numerous steps that go into this transition that sponsors are generally not well versed in. The engagement of a clinical trial logistics organisation with a specific set of skills can alleviate significant issues.
A company that specialises in clinical trials supplies and logistics is paramount to success; however, clinical trial coordinators (CTCs) are also critical to ensure smooth transition.
With their knowledge and expertise, CTCs are effectively able to solve investigator queries at every stage of the process.
In addition, their behavioral skills, knowledge and abilities contribute to the overall success of the organisation of the trial through communicating, planning, monitoring and supporting project sponsors while establishing and maintaining a positive client relationship.
The clinical trial pharmacist, acting as the initial point of investigator contact, is able to provide information about everything from sourcing the drugs to investigators' interactions and suggestions for alternate or equivalent drugs that are required for the trial.
Currently, pharmacists are in the perfect position to bridge the gap between the information acquired through genomics and their relevance to clinical trials.
Their application of complex thinking skills and deliberate problem solving enhance the probability that the proposed outcomes of the clinical trial will be successful.
Trial management is on the list of essential key competencies that are required to deliver high-quality results. The ability to ensure accurate data management within clinical trials and analyse information to interpret its potential outcomes must be partnered with high-quality people.
Therefore, ensuring that the team involved in executing the phases of the clinical trial possesses the appropriate knowledge and skills will significantly mitigate issues in complex trials.