Steps to Ensure a Successful Clinical Trial

Successful clinical trials will be ensured if you are concise in the steps you utilize. The area that you will be using to conduct your research is one consideration. Check for any supporting data that you can find from other sources. Find out who else, if anyone has conducted studies of this nature in the area you choose. Research will be the best tool you have to allow you to use your available resources shrewdly.

8 Steps to a Productive Clinical Trial

1) Do you need to keep any findings in a safe place because they are strictly confidential? Private information is sometimes hard to extract from people. If the need arises you may use an anonymous questionnaire. The need for the name of the person completing it will not be used, just the information provided. If time is of the essence, you will need to obtain permission as quickly as possible.



2) The best way to ensure that the information you obtain is what you need is to make a list before getting your questionnaire together. Write down what you want to ask and double check to make sure you did not miss anything. The clinical trials you are going to conduct may require special circumstances. Consider the following:

• What are the standards you will be utilizing and where does the money come from for this aspect of the clinical trials?
• Are drugs going to be used and if so, who foots the bill for them?
• Will the subjects be reimbursed for their time?
• Will there be follow up services?
• Will the trials be on an inpatient or outpatient basis?

3) The questionnaire must be created for the utmost ease of use. If not, you could end up with a lot of data that will be totally useless. The concise use of questions to get the information you need has to be the first order of business. They must be pertinent to the study and you will need to expect other issues to come into the scope of the information you are seeking. At this point, non-essential information should be kept to a minimum as it will be considered later when you conduct your pre-study visit.

4) In order to have the best clinical trials study you will need to test it first for practicality. The questionnaire that you are planning to use will be a test run to make sure you have all the necessary questions to support your research and data. Using a control group to get feedback for your study is one way of making sure your questionnaire is easy to understand. Not only should it be understandable but the questions should get you the answers that you require.

5) Provide an explanation for the resulting study in addition to the questionnaire and any other supporting information. Explain what you are trying to accomplish and how you plan to do so. The best plan will lay all of this out for the potential clinical trials site to know what to expect. When you do this, the answers you will receive for your questionnaire will be more in tune with what you are seeking.

6) Where will you be conducting the clinical trials? Will you be at a location centrally located to the subject area or will this be a regional survey? Different cultures have various meanings and wording that may not be the same in other locations. This could have an effect on the answers you will receive to your queries. A website could be helpful at this point.

7) The relationship you foster with the sites you are going to survey may mean the difference between getting co-operation or not getting it. The subject of your study may not be clear at the beginning so the best approach would be to use a general study idea to start with. As an incentive a payment could be offered. The start of a good relationship will be to your benefit later when the clinical trials are started.

8) The number of answers you will receive to your survey will not be one for every one sent. You need to expect about 20% to 40% response. For the number of responses you require you should send three or four times above the normal. If for example, you send 500 questionnaires, you more than likely will receive 100 to 200 responses, although these will only be the equivalent of 30 to 60 sites. There are several factors that will determine the response rate, so this has to be taken into consideration. If your plan for clinical trials is to do a global study, a minimum of 6 to 8 weeks will be the timeline for achieving your goals. The most reliable sources of data are medical, ethical, and regulatory.

When you receive your data you cannot just accept it as the absolute truth. Analysis and using data as a reference point to check the resources will be necessary. The previous experience and various literature will help you to do this. The one thing to keep in mind is the degree to which something is carried out can not always be the basis for timelines.

Conclusion

The best clinical trials will be the ones that you have prepared for in advance. Planning should begin far enough to ensure that if there are any last minute hitches to your studies you will have a chance to fix them and proceed. When you conduct clinical trials on a global basis, your sponsors may be in touch with any relevant parties that are associated with the trials. In accordance with good protocol, procedures are to be followed that respect the privacy of all participants. As well, depending on the study itself, the host government or health professional may need to address issues related with the study and any follow-up treatments that are proposed.