Introduction
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.