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Feasibility assessment is the cornerstone of a successful clinical trial. It enables contract research organisations (CROs) to carry out an in-depth analysis of a trial’s specific challenges and address risks head-on before it commences – helping to prevent delays in start-up and patient enrolment.

In many CROs, a feasibility assessment is assigned to experienced project managers. However, the gradually increasing spectrum and volume of feasibility assessment tasks – related to the growth in the number of new studies, the expansion of their geomix and the increase in their complexity – can make it necessary to develop the assessment methodology further and set up a dedicated division to focus on this work.

A regular, thorough feasibility assessment should include the following steps:
  • Analysis of the study concept and the client’s needs
  • Development of a specific feasibility assessment plan and the availability of the leader
  • Collection of information
  • Analysis of obtained information
  • Potential study scenarios design and feasibility report compilation
  • Investigator’s grant calculation and the assessment of the need to purchase additional study materials (concomitant medications, laboratory supplies, and so on)
  • Help in the preparation of bid defence presentations and participation in bid defence meetings
Study Analysis

Only the client determines the extent of study documents provided to the CRO when a proposal is requested. In most cases, this involves supplying draft versions of the synopses, although in limited cases it might entail provision of the study protocols at different degrees of completion. The available documents are then analysed to determine further actions and tactics. This includes:

Comparing treatment and diagnostics algorithms of the study protocol with accepted international standards and recommendations
Currently, the majority of drug developers are American and European companies that mostly aspire to sell their products on the US market, which takes up at least half of the global pharmaceutical market. Relating to this, one of the important elements of the medical feasibility assessment of the project is to compare the study design with the recommendations of the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and professional/medical associations and institutes whose guidelines are publicly available (1-9).

Identifying key inclusion criteria that determine the target patient population
The analysis of the availability of the target patient population for the study starts with the analysis of data on the frequency of registering patients with the target indication. The frequency of patients is determined by two parameters:
  • Incidence – the number of new cases registered in a country annually
  • Prevalence – the current number of all registered cases in the country population
Subjecting the study protocol to medical analysis (study criteria, study design) and comparing it to international and the FDA recommendations, as well factoring in the CRO’s experience, will help to identify the main characteristics of a potential study subject.

Projecting the identified key limiting factors onto the overall patient population with the target indication, using a deduction principle (general-to-specific pattern), will provide an understanding of which fraction of the overall patient population is taken by the target population.

Competitive Landscape

The set of criteria of target population is not the only factor determining enrolment capacities of the investigator sites. The competitive studies ongoing and planned at the sites have significant influence – and must also be assessed.

The National Institutes of Health database of investigational new drug (IND) trials, clinicaltrials.gov, is a great help in the assessment of the competitive trial climate. Since it lists only the IND-controlled studies, the database gives only a relative idea of the clinical trial load of the sites, but it does reveal how competitive a certain indication currently is, and also provides an estimation of the maximum number of sites used in a certain country in a certain indication. An analogous resource in Europe is: www.sukl.eu/modules/evaluation/index.php?lang=2

Investigator and Patient Motivation

Studies compete with each other not only for patients and administrative resources, but also for the interest of investigators and potential participants. The most influential factors that determine this interest and motivation are outlined in Table 1.

Potential Sites Needed to Enrol

Another important aspect of a feasibility assessment is planning the number of sites that may effectively enrol patients into the study. Their number is limited by the following factors:
  • Certification for the conduct of clinical trials in general in a number of countries and/or specific type of trials in particular
  • Logistic characteristics of each particular trial, limiting the geomix of potential sites – for example, the use of central laboratories requiring shipment of biosamples within a limited time, such as 24 hours or less
  • Ranking of potential sites
Client Priorities

Competitive landscape, investigator and patient motivation, and logistics criteria are very important in projecting the geomix of the study, but there is another no less important factor to consider when assessing feasibility: the client’s priorities.

A specific study is only a small part of the entire drug development pathway that the client must take before the drug appears on the pharmaceutical market. This is why only the client can formulate the conditions of the study on which the success of developing the drug depends. Such client priorities or conditions typically include:
  • The fastest possible patient enrolment: sites that have above-average enrolment capacities and good motivation to enrol patients
  • Guaranteed compliance with enrolment timelines: risk mitigation principles, such as distributing the sites among a larger number of countries
  • Maximal cost efficacy: more potential sites from each particular fast-enrolling country, since the start-up of a new country implies additional expenses
  • Recruiting internationally recognised key opinion leaders: having particular investigators who are well-known to the international medical community participating in the study, as well as to quote patients enrolled in the studies per country
Feasibility Projections

Having assessed the feasibility of the study, projections can be developed to build a potential scenario(s) for a future study. These feasibility projections include:
  • Screening rate: the number of patients signing informed consent and starting screening procedures in a median centre per month
  • Screen-out rate: percentage of patients who have signed informed consent, but have not been included in the main part of the study because they did not meet the inclusion criteria
  • Enrolment rate (randomisation rate in randomised studies): the difference between screening rate and screen-out rate
  • Drop-out rate: often, patients are checked for eligibility after enrolment in the study (after randomisation in randomised trials). If a patient begins to meet exclusion criteria, he/she is withdrawn from the study prematurely
  • Availability of potential investigative centres: recommendations on the number of potential sites for the study are formulated based on the client’s priorities and the ranking of potential sites 
Building Scenarios

The starting points for building a scenario are the key conditions of the study:
  • Sample size of the study or its quote for the future CRO
  • Planned or projected first patient-in
  • Planned or projected last patient-in
  • Client’s wishes regarding the study geomix
A scenario is built on these four factors, the tactics of selecting a geomix and the sites based on their ranking and the client’s priorities, as well as on the feasibility projections – that is, the screening rate and the screen-out rate.

Feasibility scenarios, even though being theoretical models, should reflect the significant factors of actual conditions, namely:
  • Seasonal factors: enrolment capacities of sites during the year vary due to seasonal holidays, typical time for vacation and other seasonal factors
  • Time required to initiate the sites
  • Non-simultaneous start-up of the investigative sites in different countries. Each country has its own minimal period required to obtain regulatory approval for the study. Only after an approval is obtained can a CRO start initiating sites
Heightened Reliability

A feasibility assessment of a clinical study is a complex multi-stage process, and the result is the joint product of an international team of highly professional experts with different backgrounds (medical, regulatory, laboratory, specialists in the organisation of clinical trials, and so on). Conducting a feasibility assessment significantly heightens the reliability of making projections for a clinical study.

References
1. Practice Guidelines and Tools, American Academy of Neurology. Visit: www.aan.com/ go/practice/guidelines
2. Clinical Practice Guidelines in Oncology, National Comprehensive Cancer Network. Visit: www.nccn.org/professionals/ physician_gls/f_guidelines.asp
3. Practice guidelines of the American College of Rheumatology. Visit: www.rheumatology.org/practice/clinical/guidelines/index. asp#available
4. The CDC Prevention Guidelines Database, US Center for Disease Control and Prevention. Visit: http://wonder.cdc.gov/wonder/prevguid/prevguid.html
5. The rules governing medicinal products in the European Union, Volume 1: Pharmaceutical legislation medicinal products for human use, EMA. Visit: http://ec.europa.eu/health/documents/eudralex/ index_en.htm
6. The rules governing medicinal products in the European Union, Volume 2: Pharmaceutical legislation notice to applicants and regulatory guidelines for medicinal products for human use, EMA. Visit: http://ec.europa.eu/health/ documents/eudralex/index_en.htm
7. The rules governing medicinal products in the European Union, Volume 3: Scientific guidelines for medicinal products for human use, EMA. Visit: http://ec.europa.eu/health/documents/eudralex/index_ en.htm
8. The rules governing medicinal products in the European Union, Volume 10: Clinical trials guidelines, EMA. Visit: http://ec.europa.eu/health/documents/eudralex/ index_en.htm
9. FDA guidance, compliance and regulatory information. Visit: www.fda.gov


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Andrey Savateyev is Associate Director of the Feasibility Department at PSI (www.psi-cro.com). He graduated from Pavlov State Medical University in St Petersburg, Russia, in 2000 and completed a PhD in Immunology and Pharmacology at the Experimental Medicinal Institute, before joining the company in 2004.

Maxim Belotserkovsky is PSI’s Head of Medical Affairs. He is a board certified Physician in Internal Medicine, Rheumatology, Haemodialysis, Anesthesiology and Intensive Care, and a certified Associate Professor of Pathological Physiology. Maxim has more than 20 years of experience as a clinical research investigator and professional.

Domenico Palumbo is Managing Director for PSI Pharma Support America, Inc and former Director of Feasibility Research and Patient Recruitment Services. He has been with PSI since 2008. Domenico has eight years of laboratory experience, and has worked for over 13 years in clinical research, particularly in the area of patient recruitment.

Katarzyna Moscicka is a Director of Feasibility Research and Patient Recruitment Services at PSI Pharma Support in Poland. Katarzyna, who has an MSc in Pharmacy, worked for two years at the Angiogenesis and Anti-angiogenesis Research Group at Maria Sklodowska-Curie Oncology Center-Institute, where her main research focus was angiogenic gene therapy.
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Andrey Savateyev
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Maxim Belotserkovsky
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Domenico Palumbo
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Katarzyna Moscicka
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