Patient engagement is crucial for the success of a clinical trial. The compliance exhibited by the patient is vital as it can  impact the final outcome of a clinical study. The patients are often recruited haphazardly in order to meet the recruitment timelines. This is not always the scenario but many investigators opt for bulk recruitment with no other go. This should not be the case. Each patient (or subject participant as we call them in clinical research) is important. The data obtained from them (both safety and efficacy related) are the ones that ultimately make or break an investigational product. Though most research-oriented investigators are aware of this, yet there are a few investigators who take up clinical trials purely for the financial benefits that it offers. This should not be the case. Every patient is actually doing a favour by voluntarily agreeing to participate  in a clinical study knowing very well that the medication is a ‘trial’ medication under study and the potential risks can be both serious and life-changing. Yes, the patient does receive free medical treatment as long as he/she is part of the study however often the risks can be greater than the benefits. The stakes are higher in Phase 1 studies wherein the participants are not even patients but only healthy volunteers who are willing to offer their bodies for experimenting on new drugs solely for the purpose of betterment of medical science.

So, what are the typical, or rather idealistic, engagement activities that a patient or a subject participant should be aware of? Let us dwell on this aspect as we go further on.

These activities can be broadly be classified under the following 5 headers:

1. To understand the study purpose.
2. To understand his/her rights.
3. To pledge study compliance.
4. To be responsible in sharing safety and efficacy parameters.
5. Feedback on the overall study product and process.

Firstly, a subject (for the sake of inclusiveness, we can coin a single term ‘Subject’ that includes both healthy volunteers and patients participating in a clinical research study) is KING. He/she is the core of clinical research. A sponsor may have the best product, hire the best CRO who would have selected the best doctor to be the investigator – however if there is no human subject to test upon – then that investigational product is practically useless. This has to be informed to every subject who participates in a clinical study. The subject should be made aware of the purpose of conducting the study. Often many subjects participate in a clinical study just because their doctor told them to do so and at other times since they get free check-ups and medication. They are not really interested in knowing the study objectives on why this product or process is better than the current conventional treatments and how this will help them in managing their health condition in a better way and how this can help future patients suffering from a similar disease. It is important for the patient to understand the study purpose as best as he/she can. The investigator is always around to provide clarifications at all times too.

Secondly, every subject should be aware of his/her rights of participating in a clinical trial. The very reason that they are addressed as a ‘Subject’ and not by their name is to conceal their identity. They should understand the confidentiality clause of participating in a clinical study appropriately. By signing the informed consent form, every subject is confirming that he/she is aware of her rights and also knows who will be able to see their medical data generated and who are not authorized to access their records. This should be made very clear to the subject in order to avoid issues arising from misunderstanding or misinterpretation.

Thirdly, every subject should pledge to himself/herself a certain level of compliance. Most of the clinical trials are visit-based (meaning the subject is not always hospitalized for round-the-clock monitoring). So often the study medication is dispensed to the subject to be taken to their homes and to be used as directed by the investigator. Every subject should understand that it is very important to be compliant with this process of self-administering. There is a specific scientific reason for the dose, frequency and time of self-administering the investigational product and unless the subject is made aware of these things, compliance will become non-existant.

Fourthly, the subject should be honest about his/her medical conditions – both study related and pre-existing or co-morbid conditions. There have been cases when naive subjects have gotten themselves into serious medical trouble because they knowingly or unknowingly hid their existing medical conditions from the investigators. This can prove to be fatal at times. Hence the subject should make sure to be totally honest with his/her investigating doctor about how the study medication is acting upon their bodies and if they feel any other-than-normal bodily reactions since the time they began using the study medication. This data is very crucial for the advancement of the product. Hence every investigator must also make it a point to meet the subject during each of their hospital visits to ensure that they are not experiencing any adverse events.

Last of all, every subject should know that his/her overall feedback is very important to determine the success of the study medication. This feedback is usually taken after they have completed the study as per the schedule mentioned in the study Protocol. The investigator should meet the subject during his/her last scheduled visit to the hospital to ensure their feedback is well-documented. Often this is ignored and crucial data goes uncaptured. Many times there are a lot of positive side-effects of the study medication which can lead to an expansion of the efficacy claims, but due to lack of interest towards the end – this data goes unnoticed. This should not happen, the subject should make it a point to spend some time towards the last visit to give his/her honest opinion not only about the study medication but the general feedback in overall study conduct.