The successful recruitment of healthy volunteers and patients has been achieved in former studies through the support of a qualified recruitment team, which utilizes an extensive database of participants and patients, as well as employing a number of recruitment strategies using various forms of media.
Our recruitment department located in center of Warsaw has access to a population of > 5 Million inhabitants. The database of >10.000 healthy volunteers and >1000 patients is continuously updated. Large database of healthy volunteers is essential to assure a fast recruitment of large groups. This is of particular importance for bioequivalence and biosimilar studies with large cohorts.
The main recruitment sources for healthy volunteers are:
- Volunteers database
- Advertisements in newspapers, handouts, flyer
Regarding patients, we gain direct access to numerous patient populations of interest for clinical trials through close cooperation with network of referring physicians and clinics (for details see below). At Biokinetica we understand successful subjects’ recruitment rests largely on the interest of participating clinicians and places critical importance on the selection & internal feasibility process.
Healthy young volunteers: large database of healthy volunteers is essential to assure a fast recruitment of large groups
Healthy elderly: population of special interest and importance for drug development. Thus, our recruitment staff is continuously updating the database with new healthy elderly subjects. Currently we have identified > 2.000 elderly volunteers fulfilling “general” inclusion/exclusion criteria for a standard early phase study.
For healthy young population, we do not expect any recruitment challenges and consider a standard screening ratio of 1:1.5 for protocols with common inclusion/exclusion criteria.
For healthy elderly population, the recruitment rate is more dependent on the selection criteria for a given study, e.g. the acceptance of concomitant medication, age-related deviations in lab safety parameters, in vital signs, in ECG etc. Comparing to young population, the screening ratio of elderlies is higher and could exceed 1:2 in case of strict selection criteria.
Finally, to guarantee the anticipated cohort size, sufficient subjects are screened to make provision for at least two reserve subjects per cohort.
Recruitment capability of specific patient population is assessed during the feasibility process and mainly based on
- Patient search in our database
- Previous experience with the specific population
- Expertise and input from our network of referring physicians and clinics
In general, Biokinetica has access to special patient populations by
- Cooperation with large hospital centres and networks of referring physicians in Warsaw and surrounding area
- Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH)
- Collaboration with clinics and large diagnostic centres across Poland (with access to app. 300 referring physicians, mainly oncology, cardiology, rheumatology, cardiology, oncology, urology, hepatology, nephrology) is frequently used by our recruitment group
- Close contact with 13 patients' associations (mainly immune disorders, oncology)
- Web: cooperation with portals and services dedicated for physicians
- Physicians within the outpatient clinics (16 specialists)
With these numerous cooperation’s we are able to successfully recruit following patient:
- Hepatic impairment (Child-Pugh A, B and C) and renal impairment (mild, moderate and severe)
- Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)
- Respiratory (Asthma, COPD)
- Metabolism (Type II Diabetes, Hypercholesterinaemia etc.)
- Oncology (cancer of large intestine, breast, stomach, pancreas, liver etc.)
- Infectious diseases (e.g. chronic viral hepatitis type B and C)
- Rheumatoid arthritis, osteoarthritis
- Dermatology (psoriasis, atopic dermatitis, rosacea etc.)
- Gynaecology (endometriosis, uterine fibroid)
- Neurological disorders (chronic pain, and others)
From study award notification through ethics committee approval, potential study participants will be identified and contacted. This enables the unit to line up participants and have them ready for informed consent and screening once all approvals are in place.
We make every effort to ensure subject´s compliance in all our studies, and more importantly, in longer-term studies in elderly population.
- Provision of clear verbal and written information to potential subjects, so they understand the full scope of the study commitment.
- Telephone contact by the site staff to remind subjects of appointments.
- At each site visit, ensuring the subject is still in compliance.
- Ensuring the subject has easy access to study staff in case of any concerns which may cause them to drop out if they are not able to speak to someone easily.
- Stratified remuneration payment to ensure compliance (significant amount payed after successful completion of all procedures)
- The drop-out rate for healthy volunteers at our unit is below 5%.