Clinical trial feasibility: the importance of cooperation and steps

In clinical trial feasibility involved several groups of specialists. All groups have a common responsibility for conducting clinical trials, which is why it is so important and necessary to be able to cooperate with other teams for the successful management of the request.

There are usually three main teams:

Clinical Operations

Members of this team make valuable inputs into study specific operational aspects based on prior experience including overall startup time, requirement of translated questionnaires, quality and infrastructure. In addition, they can add inputs on overall regulatory requirements including time for approvals, specific requirements such as approvals from other participating countries, contents of the regulatory dossier etc.

Medical Affairs

The Medical Affairs team can take responsibility for answering questions on the prevalence of the disease, presenting symptoms and signs of patients, patient management such as diagnosis, standard care, and overall prognosis. While inputs from investigators are a must, Medical Affairs colleagues can also assess relevance and quality of provided information.

Commercial teams

In various companies, teams specializing in marketing and sales often provide a source information on market size of a particular therapeutic area and class of products, availability of comparator or background therapy. In any case, such information may be verified by Medical /Clinical teams appropriately. Finally, specialists of the business development department can provide information about new sites with which clinical teams may not have any experience.

To conduct a qualitative clinical trial feasibility, a well-designed algorithm should be followed:

Step 1: constitute a team with clear roles and responsibilities and timelines. The task ownership matrix (TOM) can be a general one related to all feasibilities or it may be study specific.

Step 2: select good clinicians or potential investigators for inputs. It would be preferable to seek opinions from physicians you have either worked or interacted with and who have a sound understanding of the disease under study. For protocol feasibilities, it may be advisable to consider 3-4 potential investigators while for site feasibilities, the number of sites would depend on the country, geographical features, disease under study etc. An average of 8-12 specialists. The numbers can vary depending on the therapeutic area, phase of the study, study procedures etc.

Step 3: collect as much of data that is possible but collate it yourself. It may not be advisable to blindly copy all information that you get. It is essential to review and refine the quality of information, without affecting the integrity.

Step 4: adhere to deadlines at any cost. The request for a further increase in time indicates the poor management of the team, as well as the poor performance of the CRO.

Step 5: review, review and review before sending a response to the request. You need to be as accurate, clear and specific as possible in your answers.

X7 Research understands the complexity of clinical trial feasibility, so it is constantly guided by the above algorithm and provides all necessary information on time.

Source: ncbi.