Tranquil Clinical Research provides Rapid Study Start-up Service
Optimize the results with Rapid study startup
Launching a new drug in the market is a complicated and expensive process. According to the study by Tufts Center for the Study of Drug Development, a common drug requires a massive amount of $2.6 billion investment on an average for the launch. Only a few drugs get the opportunity to launch every year. The majority of the expenses on the medicines are generally induced at the time of the clinical development and research phase. One unplanned study can easily hinder the regulatory approvals, delay the introduction of new drug and even waste millions of dollars. However, the process of rapid study startup assures the legibility of the studies in terms of scientific validity and the accuracy of the clinical trial process. Rapid Study Startup is a cooperative trial method which emphasizes on proactive planning, rigid procedural and high-quality communication. The process assures the high productivity with the collaborative work of all the people involved to accomplish the time sensitive and interdependent milestones. The process works on the principle of the implementation of milestones at the planned time. Mostly all the clinicians are known by the importance of working under the strict guidelines, the Rapid Study Startup works on the approach of pressure tests the clinical investigation plan, initially with the data collection plan and clinical protocol. It relies on the importance of clear and high-quality communication of the clinical trial blueprint as the primary basis for the efficient, accurate and scientifically valid study outcomes. To achieve the high coordination of all the points, each component must be in the final form when needed in the precise moment. The Rapid Study Startup approach deflects the conflicts create between the study investigators involved in the clinical trial by resolving the issues prior to the investigator meeting. It makes sure that the clinical startup processes don’t need any additional supplies or resources in the middle of the study and minimizes regional differences between the data sets.
The primary items which are required for the execution of rapid study startup are:
- The ultimate clinical study synopsis
- The investigating site information and list (by considering the times of approvals)
- The ultimate clinical research protocol ( including the updated investigator brochure and the informed consent form template)
- Electronic case report form
- The strategy for the collection of clinical site data
- The data management plan
Four principles of Rapid Study Startup:
1. Consider the data analysis and collection
It is essential to have a clear, single and definite approach towards the study data measurements because of the different interpretations of the protocol endpoints. The data may not be evident until the various testing centers submit their data for comparison. It is generally avoided to make amendments in the middle of the study or clinical trial or to have database surprises. Irrespective of the perfection in the writing of study protocol, there may be minute variation in the actual execution of the trial or study across the different sites. It is advised to avoid the introduction of the additional variability and stay in contact with a single laboratory for each trial subject if possible. The same team of the highly trained reader to collect and analyze data will perform the respective job with high precision.
2. Finalize the clinical study protocol
Finalizing the clinical study protocol to reduce the variations and deviation is a primary step towards a well-articulated and well-defined study protocol. There should be no lack of specificity in the protocol. Everything must be equally detailed and clear for the conduction of the clinical trial. If the study protocol contains any gaps at any stage, then the sites will eventually perform the study in an undesired manner, or many unwanted variations may occur. To minimize the deviations, it is advised to run the protocol past both the groups of experienced physicians who have recently performed a similar trial and the internal study team. The protocol must not be tinkered at any moments of the trial. It should be fixed at the initial stage whereas more minute details of the study documents, case report form guidelines, and procedure manuals can be added.
3. Define site training requirements
After creating a fixed and stable protocol, the site training requirements must be defined to improve the implementation of the corresponding protocol. The procedure guides and site training requirements such as the aforementioned study protocols should be accurate. A clear checklist should also be maintained in order to do every task in an organized way. A live and clear communication with live training at the different investigator meetings must also be maintained. There may be slight decimal points and length variations visible in the collected data. Make sure that slight variations may cause a massive effect on the efficacy of the study results of the respective clinical trial.
4. Finalize the investigation site
After implementing a regiment and clear approach to the study requirements, define the investigation site to order the equipment for the trial. Ordering the equipment can be hampered due to the laws of import and export in the different nations. The investigators and the team should understand the rules and regulations of the nation and plan accordingly. The import issues can undoubtedly delay the initiation of the study and even balloon the costs of the overall trial. The investigators should be aware of the availability of supplies and resources.
The financial and unwanted time-related setbacks of various foreseen challenges or badly written protocols are enough to hinder any study. However, an eye must be kept on the respective issues to overcome the adverse events of the study and subject safety. Rapid study startup approach is necessary as it ensures the studies are precisely structured for the rapid implementation and success. Nearly every study experiences a few setbacks, but it is the approach of the investigators and members to make it flawlessly successful. The rapid study minimizes the rates of failures and deviations with high precision and rates.