Feasibility of global clinical trials, the clinical trial scene today is full of trials that failed to meet the planned timelines and patient accumulation for any broad phase III program, and the global footprint is essential, in order to stay on schedule and recruit enough patients, so understand Where it goes and what benefits each area can achieve is critical to successful planning and implementation so in this article we will talk about the feasibility of global clinical trials.
Feasibility of global clinical trials
By planning in advance and developing a draft protocol outline along with a formal pre-feasibility assessment of finalizing the protocol, timelines and patient merit, it is possible to establish a more realistic schedule and budget for your clinical research program.
A carefully constructed and executed feasibility questionnaire helps determine where to conduct trials, patient-based and investigator availability and interest in local areas, among other factors. With these tools, you will also get early feedback on study design so that the study can be revised before launching the program.
We will realize the benefits of having comprehensive feasibility throughout the clinical research program.
You will quickly learn that feasibility is not a luxury good or just “nice to have”.
It is the necessity for successful global clinical trials.
Tips for a successful feasibility
Research in emerging countries:
Take a good look at the countries in which you plan to make your feasibility.
A feasibility assessment can be a rigorous process, so research is key to using time and resources wisely.
First, you have to know the local sick population. So, you can benefit from the supporting data that has already been gathered through resources like IMS and pharmacist databases, which cover sectors of the US and EU markets.
Define your comfort zone:
How necessary is it to keep studying the details confidential? Do you feel comfortable that the investigator you are questioning will respect your need for confidentiality? How much will maintaining a secrecy shield delay your schedule or create a checkpoint to complete your feasibility process? Do you need to issue a blind questionnaire to protect confidential information?
Feasibility of global clinical trials Consider what you need to rate:
Based on a questionnaire that will give you answers to these questions.
Do medical standards of care match the protocol?
Is the design of the experience consistent with local standards of practice?
What ethical or cultural issues should you think about?
Are there any reimbursement issues?
What medications will you be required to pay for?
What are the standards of supportive care and who pays?
Are diagnostic and follow-up services available, such as positron emission tomography, computed tomography or magnetic resonance imaging?
Are medications needed to be injected or administered?
Will the care be handled on an inpatient or outpatient basis?
What issues of follow-up care need to be addressed?
Feasibility of global clinical trials
The most important step is to design your own feasibility questionnaire well, because a poorly designed tool will result in useless data.
Questions should support study design as well as anticipate potential problems.
You need to balance your questions so that you ask enough for a clear fee, answers with information without soliciting extraneous data that will be collected at a later date anyway during the pre-study site visit.
Potential study sites will want to know everything they can about the study program in advance.
By submitting a summary study as an addition to your feasibility questionnaire, you will receive clearer, better-informed answers to your questions.
Plan your curriculum:
Will you run your survey from a central location or regionally? Consider the effects that language, culture, and local relationships can have on engagement.
Do you have a centralized fax service you can use? Another avenue is to create a customized website with different levels of access.
Take care of goodwill:
Show that you value the time and knowledge of the sites you are scanning.
Keep the program viability-driven relationship to improve your response rate, to increase your returns, and to provide some form of payment or reward.
The good intentions that you extend it now will pay off later while carrying out studies.
Expect realistic results:
To obtain a rate of return of 20-40 percent per survey, you have to plan to send three to four times the number of questionnaires as many responses as you need.
Check your results:
It is better not to take all the data you receive on face value.
Use registration data as a referral and analyze your viability further results by checking literature, past history accounts, past experience and other resources.
As you move forward with developing your protocol, keep in mind that timelines and assumptions cannot be based solely on feasibility results.