feasibility_questionnaire_credevo

Clinical trial feasibility is a process to evaluate the possibility of conducting a clinical trial in a particular region, specific medical centers/site with an objective of optimum project completion in terms of timelines, targets and cost.

This forms an integral and unavoidable step in beginning any clinical trial. A clinical trial feasibility is always facilitated by a well-structured feasibility questionnaire.

feasibility_questionnaire_credevo

Feasibility questionnaire (FQ) are the set of questions prepared by study sponsor or contract research organizations (CROs) to identify the potential and interest of a site/investigator to run clinical trial feasibility successfully.

Why feasibility questionnaire?

A detailed clinical trial feasibility assessment is an important step towards conducting a successful clinical study. Thus, feasibility questionnaire becomes an important tool in ensuring successful project planning.

As per one analysis,

  • 35% of delay in clinical trials occur due to patient recruitment,
  • Early one-fifth investigators do not enroll any patients and
  • About one – third enroll only 5% of evaluable patients.

This puts a lot of burden on project costs, timelines and other investigators who may be performing satisfactorily.

This is where a well administered feasibility questionnaire can help avoid such issues.

  • Clinical trial feasibility questionnaire identifies these challenges and help in taking a decision to work efficiently with different countries and sites with their respective challenges.
  • Clinical trial feasibility questionnaire’s help in identifying region-specific or even institution-specific practices which can have an impact on overall study completion.
  • Asking questions can inform the design and implementation, avoiding major downstream and operational problems.
  • Its an efficient way to collect certain types of information for screening purposes and as the basis for a discussion.
  • The benefits of a proper assessment are realized during the execution of the trial.
  • With proper planning, unnecessary protocol amendments, delays due to recruitment challenges and operational problems can be avoided.
  • If the site thinks or realizes it is not a good fit, everyone saves time.
  • Data collected from sites from prior projects in database helps to find capability of sites and eliminates the need for sites to complete redundant information again. [1][3]

Get a FREE

  • consultation for your clinical trial,
  • set of recommended questions for your FQ, or
  • trial of Credevo Web-Based feasibility system.

See details below (including link to download a sample FQ format)

How does an FQ help an investigator / site?

An FQ is not only a pragmatic approach for a sponsor, it also helps investigator and his/her staff to understand and accept the

  • Investigational nature of the study and the investigational product.
  • Expectations to access an appropriate subject population.
  • Roles and obligations as defined in the study contract and protocol.
  • Applicable regulatory requirements and responsibilities to the IRB/EC.
  • Content, maintenance and retention of source documents, records and Investigational Product. [2]

In order to determine the best design for your FQ, it is important to consider the type of feasibility study that you intend to perform.

Types of Feasibility studies

Program level feasibilities

These feasibilities are broad and are aimed towards finding prevalence of particular diseases or conditions in a particular region and hence include clinical and epidemiological information.
e.g. a program on antibacterial in a variety of infections.

Study level feasibilities

Study level feasibilities are more customized towards assessing whether a particular clinical study can be conducted in a country or region.

e.g: an antibacterial in skin and soft tissue infections.

Site or Investigator level

This is a micro- feasibility conducted to decide whether to work with an investigator, identifying challenges and probable solutions as selecting the right investigator/site is of paramount importance. [3]

e.g: Accessing the safety and efficacy of a drug at a site or multiple sites.

Web based questionnaire

Web based questionnaires are generally applied when the sponsor has multiple centers to conduct clinical trial feasibility. It’s also helpful in epidemiological studies and survey studies.

  • Web-based questionnaires with branching questions can efficiently collect required information.
  • It helps the CRO/sponsor when there are multiple regions, centers, sites and investigators.
  • The industry has access to many applications that can quickly set up a web-based system.

Advantages of web based feasibility questionnaire

  • Online system with audit trail, reporting tools, electronic tracking and quick setup and response.
  • Immediate response to potential collaborators allows tremendous savings on time and resources in decision-making and trial setup. [2]

Credevo offers a well-structured, yet customizable, web based system that can cater to your specific study needs

Try web-based feasibility for your clinical trial

Include brief details about patient population, therapeutic segment and intended countries for clinical trial sites
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Now, depending upon type of your feasibility, you can set objectives for your FQ to achieve.

What are FQ objectives?

In most of the feasibility conducted at sites / investigator level, the objective of the FQ prepared by any sponsor/CRO may be to

  • Determine site/Investigator’s level of interest in the study.
  • Determine readiness of the site / investigator to fulfill project expectations
  • Obtain statements and commitments.
  • Collect information useful in changing or managing the study.
  • Help the site think through operational aspects, such as subject recruiting.
  • Finding whether the disease under study is relevant to the patient population.
  • Assess anticipated regulatory, ethical challenges and general timelines for study approval and site start-up.
  • Evaluate overall commitment of potential partners- country offices, CROs, sites towards completion of the program. [1][3]

It is also possible to add / modify / delete more points in this list and make the objectives more relevant to the project. The responsibility to set the objectives of FQ rests with the sponsor and trial manager.

Having set the objectives, next step is to consider import points, formats, DOs and DONTs of FQ.

Designing FQ

Format of Feasibility Questionnaire (FQ)

Format of a questionnaire generally includes sections pertaining to

  • Introduction,
  • Summary of study,
  • Purpose,
  • Contact address,
  • Body and
  • Conclusions.

Important Points

Before designing an FQ, here are some points to be considered

  • The language of questionnaire should be considered based upon the region and site/investigator.
  • Purpose of a questionnaire should be clearly described.
  • FQ should be necessary sufficient, clear and unambiguous to the purpose.
  • Straightforward, adequate options and space for the answer.
  • Allow a broad range of answers and not reveal the “right” answer.
  • Accommodate the characteristics of different types of sites.
  • Generate answers that the sponsor can interpret, score and validate for predictive ability.

Additionally, there are few suggestible Do’s and Dont’s. These are as follows

Do’s

  • A compact and easy questionnaire.
  • Elicit comments and allow space to elaborate.
  • Detail summary of the study and sponsor.
  • Allow to skip on questions particularly in electronic questionnaire.
  • If web based FQ, allow sites to elaborate on information, as it may not be easily answered by using a single number in the data entry field.
  • Giving sites the time they need to get the best possible answers.
  • Providing sponsors contact information.

Dont’s

  • True/false, multiple-choice and numeric answers format as they do not reveal the site’s thought processes.
  • Sloppy questionnaires with typos, ambiguous questions and inadequate space for answers.
  • Asking the same question in two different ways and have all fields marked as required.
  • Assuming that there’s only one PI at a site.
  • Sending out a survey that can’t be printed.

Having considered all these factors, now one is ready to design and administer a well-structured FQ.

Download Feasibility Questionnaire Format

From our experience in conducting many clinical trial feasibility and suggestions from industry experts, we have identified list of many questions that can be helpful in designing your feasibility questionnaire. We’d love them to be used in your clinical trial feasibility.

Click here to download feasibility questionnaire format for conducting clinical trial feasibility

Click here for more useful links

References:

  1. https://firstclinical.com/journal/2009/0911_Site_Questionnaires.pdf
  2. http://store.centerwatch.com/pdfs/samples/sopsp14_ss401.pdf
  3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146075/