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Ten Tips for Feasibility Success1. Research emerging countriesTake a good look at the countries where you plan to conduct your feasibility. Assessing feasibility can be a meticulous process, so research is key to using your time and resources wisely. First you should know the local patient populations. Take advantage of supporting data that has already been compiled through such resources as IntrinsiQ, IMS and pharmacist databases, covering segments of the US and EU markets. Also check the literature and prior FDA or SBA approvals. Who else has run similar studies in those areas? What countries did they choose and how well did their sites accrue? Does existing data support the need for a global study? 2. Determine your comfort zoneHow necessary is it to keep the study details confidential? Are you comfortable that the investigator you are questioning will honor your need for confidentiality? How much will maintaining a confidentiality shield delay your timeline or create a barrier to completion of your feasibility process? Do you need to issue a blinded questionnaire to protect proprietary information? 3. Consider what you need to assessBuild a questionnaire that will give you answers to:������ Do the medical standards of care match the protocol?������ Does the trial design fit into the local standard of practice?������ What ethical or cultural issues should you consider?������ Are there reimbursement issues?������ For which drugs will you be required to pay?������ What are the supportive care standards and who pays?������ Are diagnostic and follow-up services available, such as PET, CT or MRI scans?������ Are infusions or administrations of drugs needed?������ Will care be handled on an inpatient or outpatient basis?������ What follow-up care issues need to be addressed? 4. Design it wellThe most important step is to design your feasibility questionnaire well, because a poorly designed tool will lead to useless data. The questions should support the study design and also anticipate potential issues. You need to balance your questions so that you ask enough to draw clear, informative answers without soliciting extraneous data that will be collected later anyway during a pre-study site visit. 5. Test and refineUse a control group to test your feasibility instrument. As with any questionnaire, a usability test before implementation will give you feedback to inform your revision process. The result will be questions that are precise and easy to answer and that provide useful information. 6. Be informativePotential study sites will want to know all they can about your study program up front. Byproviding the study synopsis as an addendum to your feasibility questionnaire, you will receive more meaningful, better informed answers to your questions. 7. Plan your approachWill you be administering your survey from a central location or regionally? Keep in mind the effects that local language, culture and relationships can have on participation. Do you have a centralized fax service you can use? Another route is to set up a designated website with varying levels of access. 8. Nurture goodwillShow that you value the time and knowledge of the sites you survey. If your study intent is uncertain use a ballpark feasibility approach as a precursor to a full feasibility assessment. Keep your feasibility program relationship-driven to optimize your response rate, and to further increase your returns, offer some form of payment or reward. The goodwill you extend now will pay off later during the execution of the studies. 9. Expect results…realistic results To obtain a 20-40 percent return rate on your survey, you have to plan to send three to four times the number of questionnaires as the number of responses you need. For instance, for 300 questionnaires sent out, you might receive 100 responses, which would represent 30-40 actual sites. Therapeutic indication, drug class, patient/physician needs and name recognition are other factors that will influence the response rate. You can realistically plan on a 6-8 week process for your global feasibility program. Keep in mind that selfreported accrual rates are not necessarily accurate and may be inflated by at least 50 percent in the US, although somewhat less so in other world regions. However, standard-ofcare data, medical data and regulatory and ethical data are generally reliable. 10. Check your resultsIt is best not to take all the data you receive on face value. Use registry data as a cross reference and analyze your feasibility results further by checking the literature, prior history accounts, previous experience and other resources. As you move forward with your protocol development, keep in mind that trial timelines and assumptions cannot be based solely on feasibility results.1. Research emerging countriesTake a good look at the countries where you plan to conduct your feasibility. Assessing feasibility can be a meticulous process, so research is key to using your time and resources wisely. First you should know the local patient populations. Take advantage of supporting data that has already been compiled through such resources as IntrinsiQ, IMS and pharmacist databases, covering segments of the US and EU markets. Also check the literature and prior FDA or SBA approvals. Who else has run similar studies in those areas? What countries did they choose and how well did their sites accrue? Does existing data support the need for a global study? 2. Determine your comfort zoneHow necessary is it to keep the study details confidential? Are you comfortable that the investigator you are questioning will honor your need for confidentiality? How much will maintaining a confidentiality shield delay your timeline or create a barrier to completion of your feasibility process? Do you need to issue a blinded questionnaire to protect proprietary information? 3. Consider what you need to assessBuild a questionnaire that will give you answers to:������ Do the medical standards of care match the protocol?������ Does the trial design fit into the local standard of practice?������ What ethical or cultural issues should you consider?������ Are there reimbursement issues?������ For which drugs will you be required to pay?������ What are the supportive care standards and who pays?������ Are diagnostic and follow-up services available, such as PET, CT or MRI scans?������ Are infusions or administrations of drugs needed?������ Will care be handled on an inpatient or outpatient basis?������ What follow-up care issues need to be addressed? 4. Design it wellThe most important step is to design your feasibility questionnaire well, because a poorly designed tool will lead to useless data. The questions should support the study design and also anticipate potential issues. You need to balance your questions so that you ask enough to draw clear, informative answers without soliciting extraneous data that will be collected later anyway during a pre-study site visit. 5. Test and refineUse a control group to test your feasibility instrument. As with any questionnaire, a usability test before implementation will give you feedback to inform your revision process. The result will be questions that are precise and easy to answer and that provide useful information. 6. Be informativePotential study sites will want to know all they can about your study program up front. Byproviding the study synopsis as an addendum to your feasibility questionnaire, you will receive more meaningful, better informed answers to your questions. 7. Plan your approachWill you be administering your survey from a central location or regionally? Keep in mind the effects that local language, culture and relationships can have on participation. Do you have a centralized fax service you can use? Another route is to set up a designated website with varying levels of access. 8. Nurture goodwillShow that you value the time and knowledge of the sites you survey. If your study intent is uncertain use a ballpark feasibility approach as a precursor to a full feasibility assessment. Keep your feasibility program relationship-driven to optimize your response rate, and to further increase your returns, offer some form of payment or reward. The goodwill you extend now will pay off later during the execution of the studies. 9. Expect results…realistic results To obtain a 20-40 percent return rate on your survey, you have to plan to send three to four times the number of questionnaires as the number of responses you need. For instance, for 300 questionnaires sent out, you might receive 100 responses, which would represent 30-40 actual sites. Therapeutic indication, drug class, patient/physician needs and name recognition are other factors that will influence the response rate. You can realistically plan on a 6-8 week process for your global feasibility program. Keep in mind that selfreported accrual rates are not necessarily accurate and may be inflated by at least 50 percent in the US, although somewhat less so in other world regions. However, standard-ofcare data, medical data and regulatory and ethical data are generally reliable. 10. Check your results It is best not to take all the data you receive on face value. Use registry data as a cross reference and analyze your feasibility results further by checking the literature, prior history accounts, previous experience and other resources. As you move forward with your protocol development, keep in mind that trial timelines and assumptions cannot be based solely on feasibility results. regards Sreedhar |
