Global Clinical Trials – Feasibility:
Today’s clinical trial landscape is littered with trials that fail to meet planned timelines and patient accrual. For any large Phase III program, a global footprint is necessary, in order to stay on schedule and recruit enough patients, so understanding where to go and what benefit each region can bring is critical to successful planning and implementation.
By planning ahead and developing a draft protocol synopsis along with a formal feasibility assessment prior to finalizing the protocol, timelines and patient accrual, it is possible to devise a more realistic timeline and budget for your clinical research program. A carefully constructed and implemented feasibility questionnaire helps in you determining where to hold your trials, based on patient and investigator availability and interest in local regions, among other factors. With these tools, you will also gain early feedback on the study design so that the study program can be refined before launching.
You will realize the benefits from having performed a thorough feasibility throughout the course of the clinical research program. You will quickly learn that feasibility is not a luxury item or merely “nice to have.” It is a necessity to conducting successful global clinical trials.
Tips for Feasibility Success
Research Emerging Countries:
Take a good look at the countries where you plan to conduct your feasibility. Assessing feasibility can be a meticulous process, so research is the key to using your time and resources wisely. First, you should know the local patient populations. For this, you can take advantage of the supporting data that have already been compiled through such resources as IMS and pharmacist databases, covering segments of the US and EU markets. Also, check the literature and prior FDA or SBA approvals. Find out who else has run similar studies in those areas; what countries did they choose; and how well did their sites accrue. Also, look if the existing data supports the need for a global study.
Determine your Comfort Zone:
How 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?
Consider what you Need to Assess: Build a questionnaire that will give you answers to these questions.
- 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 any 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?
Design it Well:
The 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.
Test and Refine:
Use 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.
Potential study sites will want to know all they can about your study program up front. By providing the study synopsis as an addendum to your feasibility questionnaire, you will receive more meaningful, better informed answers to your questions.
Plan your Approach:
Will 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.
Show 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.
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 self-reported accrual rates are not necessarily accurate and may be inflated by at least 50 percent in the US, although somewhat less in other world regions. However, standard-of-care data, medical data and regulatory and ethical data are generally reliable.
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.