Clinical trial is a situation in which specific group of people take a compound which can become a new medicine. There may also be a situation when a medical device is examined and it can be used to administer a drug or to monitor patients’ vital functions.
Clinical trials are a wide subjects on which many pages can be used, however the common part of all the studies are patients. New medicines and medical devices are developed for them to help them with various diseases so they can have a chance to be cured or to have quicker preventive diagnosis (eg. in case of some medical devices).
Without the voluntary participation of patients in clinical trials, it would not be possible
to develop science and new therapies.
However, some studies, although having a potential compound/particle that can help in a given disease, last for years. There are many reasons for this, but I would like to focus on one of them here.
Once the patient have decided, after the Investigator has informed him/her properly, after the opportunity to ask questions and receive a comprehensive answer, to take part in a clinical trial, there will usually be a number of different tests to complete, followed by appointments that need to be made within a specific timeframe. This is where the problem often arises – arranging appointments.
From the patient’s point of view, arranging a visit is not just about entering a doctor’s office. This is a range of logistics activities, from:
to find the relevant day (which must, of course, be in the time window provided for by the protocol),
determining the time of the visit,
time spent on the visit and travelling to and from the site.
That is not all. To this must be added the form of transport:
how to get there,
what time you should leave,
which bus/train will travel closest to the site.
If travel is by a car:
if there will be traffic jam – hom much time should be added,
where to park a car,
whether there is a charge for the parking lot,
if I get a receipt to get a refund for the car park.
The ‘problems’ described above may seem very trivial, but they affect the willingness to travel, especially if the participation is not paid, it is voluntary.
People, when have a wider range of possibilities, are inclined to postpone decisions and take action, and the more small details that need to be considered in such situations, the probability (in this case) of reaching the site decreases.
Reimbursing the costs to the patient of getting to the site:
The FDA issued a statement that reimbursement alone and the provision of material money to patients are not prohibited, but that the amount, timing and amount of reimbursement must be accepted by the Commission (IRB). This statement allows the word ‘compensation’ to be distinguished from ‘reimbursement’, with the first indicating payment to patients for their time sacrifice and the second indicating reimbursement of travel factual expenses.
Paying for participation in clinical trials (compensation) can raise difficult ethical questions: “is the payment appropriate or does it not encourage participation in the study’, as we already know, participation in the study itself is and will remain entirely voluntary.
However, the reimbursement of travel expenses to and from the clinical site is not considered to be an ethical problem with regard to inappropriate influence on persons wishing to participate in the study.
“In the past, people involved in clinical trials were very close to the site” said Lindsay McNair, the WIRB-Copernicus Group’s chief physician. However, if the study is about an orphan disease, patients can travel from the whole country to the site.
The definition of ‘compensation’ from ‘reimbursement’ remains the same in Europe:
Reimbursement – reimbursement of costs:
Loss of revenue
Compensation also takes into account the time spent by the patient on clinical trial and the recognition of the contribution made to the development of science.
However, the mere payment for participation in a trial is usually made in the I phase of a clinical trial, where the subjects are healthy patients.
The practice of paying patients varies across Europe. Some countries have banned this completely (without taking into account reimbursement) to reduce ethical problems in encouraging patients’ participation in a study. The most common practice is that the payment and its amount is evaluated by the Bioethics Committee.
According to Directive 2001/20/EC and Regulation 536/2014, which will soon replace the Directive, incentives to participate in the study in special populations (such as minors, disabled people who are represented by a legal representative or pregnant women) cannot be applied (except for loss of income resulting from participation in the study).
Although the reimbursement of travel expenses is allowed, it does cause a number of problems, as I mentioned above. On the part of the Sponsor it will mainly be impossible to predict where the potential patient will arrive from, what amount will have to be added to the budget of the study, on the part of the Investigator the necessity of collecting bills and paying travel refunds. It is also important to remember about the patient and the need to keep an eye on the date of the visit, the time of travel and all other details that are related to the visit.
How to overcome such a problem?
We have developed a system of management of patients transport to the study sites.
We prepare invoice that depends on the number of study participants not on their distance to the site.
We manage transport for the patients, issues regarding such transport and changes regarding visits’ schedule.
No issues concerning personal data of study subjects
Higher patient retention
Fixed flat rate for patient/visit
Fixed budget for a study
Assistance for patients
Ability to travel with assisting person
Flexibility – travel schedule is updated in case of change in visit date
No more problems for patiens like:
inconvenient location, physical limitations to travel, financial constraints or forgeting visits
Clear and transparent conditions of the service