Factors Affecting Physicians Referring Patients to Clinical Trials
by Ayesha Bhargava Basic KnowledgeIntroduction
It has long been recognized that a very low number of patients
are referred into clinical trials. According to estimates, only 2–3% of
patients are referred for trials, a low number. Poor accrual is a threat to the
timely completion of increasingly large studies, which are very important
considering the criticalness of properly evaluating the latest treatments,
while also avoiding the potential for random error associated with small
studies.
Referral for a clinical trial is not simple
as it can be quite difficult with numerous steps to be taken in order to become
a part of the process, such as:
•
Patients need to be identified
•
The study concept must be introduced
•
The positive and negatives of experimental
therapy must all be outlined
•
The risks and benefits of standard treatment
also need to ascertained
There are other things such as issues related to the trial, the
placebo control and randomization, also need to be discussed. This discussion
will allow the patient to make the final decision of whether or not to enter
into a specific clinical trial.
Even though this discussion has taken place between the physician
and the patient, more often, the patient is usually in close contact with
personnel who specialize in clinical trials. A Clinical Research Associate,
also known as CRA, is the most common term used for clinical trial specialists.
This term is also used for both clinical data managers and clinical trials
nurses.
However, patients most of the time prefer to take advice from
their physicians regarding any entry into clinical trials. Physicians who are
associated with any clinical trial need to note that it is their job to:
•
Review any and all the information related to
the clinical trial
•
Solicit a decision from the patient
•
Formally obtain a signature from the patient
•
Ensuring the patient has provided informed
consent to enter the clinical trial
It is critical to establish a delicate balance between the
potential benefits of being involved in a clinical research, and traditional
nursing of the patient.
The physician is important in the sense that they are responsible
for influencing patients’ decisions in regards to their entry into a clinical
trial. Before gaining entry into a clinical trial, patients are usually given a
phone call from a clinical trials nurse. The objective of the phone call is to
discuss specific issues relating to the clinical trial with the patient and
asking whether they are considering entering or not.
The phone call will benefit by providing improved information
transfer and reduced patient anxiety of entering the trial. Most of the time,
patients have already made up their minds whether they will entering the clinical trial
or not, way before they receive the phone call regarding the study.
A physician's views about a clinical trial can make a world of a
difference for the patient. However, the physician will have to identify
themselves as either a researcher or a clinician to the patient in order to
gain their trust. They have to be careful when discussing the uncertainty of
the results of the trial as it can have a negative impact on the patient.
There are some factors from the patient’s perspective that can
also affect their decision to enter the clinical trial. This can be due to
their higher levels of socioeconomic status, something that can hinder their
decision making. Something like this usually happens when the patient's
employment is at a higher status.
Although studies have shown that there must be a personal motive
which can get even patients such as these to enter the trial, anything that
benefits them on a personal level will enable them to enter the trial.
Patients who usually refuse to enter the clinical trials are
usually those who do not wish to share their own personal decision or those
patients who consider their standard therapy to be enough for their current
situation. Another factor that greatly affects decision making in this regard
are the physician’s recommendations and the opinions of physicians. This also
greatly influences a patient's decision to become research participants.
A study was initiated to provide a better understanding of what
actually matters when it comes to influencing a patients’ decision regarding accepting
to get into a clinical trial.
Focus group interviews have shown to be among the better methods
of research for this. This is because of the reason that these methods have
been designed to accumulate in-depth and descriptive information about the
issues involved in a specific research topic.
These focus groups are directed by a skilled facilitator, this
ensures that the aspect is brought forward regarding the details of complex
experiences. There are also a fast and cost effective way of gathering
information from the participants of the clinical trials such as their ideas,
needs and views. A focus group can yield far better results than individual
interviews as a wider range of issues can come to light due to the interactions
of the group.
Factors Affecting
Physician Referrals for Patients
Physician’ Factors
It is crucial for the physician to have the ability to
communicate in a fashion that is caring towards the needs of the patient. Also,
more importantly, they should be able to answer their questions and to provide
a sound reasoning for the specific clinical trial. This can, and most of the
time does, lead to enhanced prospects of referrals.
For the physician to show their level of care and enthusiasm is
more likely to lead to successful referrals of patients. This is due to the
fact that patients will feel like they are going into a clinical trial that has
been designed for their best interest.
There are many examples where physicians who supported their
patients for clinical trial studies had more success with their patients than
those who were not enthusiastic to support. It can be because at times there is
no personal interest in the said research for the physician to go that extra
mile. This is important as at times the patients have to be consistently asked
and approached about entering a study. Patients tend to make up their minds
quickly when something is recommended by a physician.
Patient Factors
Patient's own research or knowhow can also lead to them willingly
joining a clinical trial. This is called patient factor where they learn about
the study from an outside source, other than anyone related to the clinical
trial. This can be a column in the local news paper, or an article on a
reliable online source. By reading about the clinical trial here, they have
more trust in the information.
A lot of patients refuse to enter a study when they learn from
their physician about the trials with a placebo arm. This is mainly because of
the preconceived belief that placebo-controlled clinical trials are not good
studies to enter.
However, it is important to note that patients who are facing
extreme diseases, are more likely to give the clinical trial a chance as they
are hopeful for living longer. Such patients are also willing to enter clinical
trials that are new or experimental. These patients have limited treatment
options, which is why they are, most of the time, more inclined to enter any
available study. The case is reversed when patients who thought their chances
of potential treatment were minimal were more likely to decline entry to the
clinical trial.
Ethnic & Cultural Factors
When it comes to the cultural and ethnic background of the
patient, it too can be a big factor for them entering or refusing the clinical
trial. For example, patients who are from third world countries are more likely
to accept any treatment option in the clinical trial that is suggested by a
physician. This is because they think it must be a good clinical trial if the
physician is recommending it.
Whereas, someone from the first world country is more likely to
decline, unless they have little to no other treatment options.
Additional Physicians’ Factors
Another big factor influencing referrals was the physicians’
sense of their own impact on the process. Their actions can have big
consequences, and can be the difference between a 'yes' or a 'no'. Many
physicians remain neutral, this way the patient can make their own choice.
However, there are times when checking a patient, it turns out
they may be that may be considered good
candidates, this is where the physician will have to try just a bit harder to
convince the patient to undergo a clinical trial. In this context, a patient
typically is in better overall health and appears more willing to be compliant
with the requirements of the clinical trial. Such a patient is more likely to
receive a telephone call regarding their interest in the trial as well as to
answer any of their questions and to seek a decision regarding study referral.
The major role of the physician is to ensure information sharing
from the patient to the clinical trial team, as it allows for a better
prediction of the referrals success. A physician’s own impressions of the
overall importance of the clinical trial can have a big impact on the component
of the performance of the patient.
It should be noted that referrals are more successful when they
are honestly and completely presented. The patient must be given the pros and
cons of the clinical study before they enter the trial. A physician should walk
the patient through the different steps of the trial so that they know exactly
what they are stepping into.
The patient should be told about:
•
Potential chance of toxicities during the trial
•
The extra the patient might have to be in the
trial
•
Tests and questionnaires during and after the
trial
•
The follow-up requirements of the clinical trial
This approach to educate the patients is important as it can
instill confidence into the patient, encouraging them to take part in the
trial. Using equipment to showcase presentations like multimedia, laminated
display boards and anatomic teaching models, can also enhance the patient's
chances becoming a successful referral. Questions from patients are encouraged
to ensure decision-making on their part.
When approaching a patient for a clinical trial, it is important
to make a good first impression. This can be done by:
•
Showing that you care by sitting down with them
and listening
•
Engaging with eye contact and a smile
•
Not rushing the conversation and showing that
you have plenty of time for them
It also helps if the physician has sound information about the
clinical trial study. This helps to create a bond of trust between the two as
it also gives the patient the chance to be relaxed and confident with the
clinical study information. Helping alleviate patient fears is one of the most
important aspect of a successful referral.
Physicians should create an environment where questions can be
asked freely and answered patiently. Any and all the issues need to be
clarified as giving enough time to support this process can be crucial to the
success of getting patients for clinical trials.
Conclusion
The importance of being empathetic towards patients cannot be
underestimated for a physician. There are times when patients are given their
diagnosis and at the same time, are given the option to enter a clinical trial.
This is not a good idea as the patient is already overwhelmed with the
diagnosis information. However, giving them hope is important at the same time
as they should be asked to go home and consider this option.
It is crucial that physicians make a good impression as it
encourages the patients to join the clinical trial. The role of a physician in
positively affecting referring patients to clinical trials cannot be understated
as it can mean the difference between the patient accepting or refusing entry
into the clinical trial.
Sponsor Ads
Created on Apr 4th 2020 03:00. Viewed 246 times.