Nava Dayan, Dr. Nava Dayan LLC05.01.18
Part II
Marketing experts refer to a “purchase experience” as a key in imprinting a correlation between sensorial memory and a specific product. Our choice to invest in an experience is strongly tied to the level of our development and the understanding of what is “good for us.” A self-aware individual will invest in what makes him feel at peace and not necessarily in what society indicates as a positive. This requires great self-awareness and bravery. We are surrounded by people whom we may not have chosen to be in proximity and influences that we may not have elected to be exposed to, sometimes forgetting that we have the choice to either dwell on or block our emotional connection to anyone or anything around us. When a thought that crosses our mind is not connected to how we feel, it is merely a response to the flood of information in our surroundings that, if we act upon them, makes us robots.
A thought that is translated from our feeling to our awareness is our own creation and choice. The Kabbalist Baal Hasoolam once noted: “what cannot be attained cannot be named.”
When we let our heart experience, we may not be able to define the experience verbally in our brain. We need a direct sensation, our own feeling, in order to have true sense of inner individual perception. In addition, we are programmed in a way that all perception comes from comparing and contrasting. We can never measure in a vacuum. If there was no day, we could never understand night. What may be a total disaster to one person, can be the greatest achievement to another. It’s our position that matters. Being able to see a larger scale arc connecting various experiences provides us with the ability to choose and experience the good in everything around us; a choice that is always available to us.
Understand the Study
Panelists in clinical studies undergo complex experiences that go well beyond the mere use of the product and periodical measurements at the clinical facility. It’s a commitment they undertake to be involved in an experience and should be considered as such. For best participation practice, panelists are to understand the study, and, feel part of it. Poor panelist compliance is a major issue in clinical studies. Compliance can be defined as the extent to which the study participants behavior coincides with the experimental protocol. Poor compliance is a deviation in panelist behavior from the protocol regimen. Failure can stem from various reasons such as deprived communication between the panelist and the study instructor, panelist fatigue or neglect, product adverse reactions and other unknown panelist behavior of choice. Poor compliance also directly correlates with reduced panelist retention. The retention is defined as the strategy and tactics designed to keep panelists enrolled in clinical trials, and from discontinuing participation and “dropping out.” A non-adherent panelist who is involved in a clinical study may be at an increased risk to discontinue their study participation. There are certain responsibilities a study participant may have in addition to adhering to requested pattern of product use. These responsibilities can include changes in plans or lifestyle (such as for example, refraining from sun exposure), diary completion, dietary restrictions, follow-up phone calls or other study-specific accountabilities.
Here are a few suggestions to elevate the odds of study adherence and panelist retention and compliance. It should be stressed that since every study is customized for its objectives, the following information may not apply to all situations.
Know Your Panelist
One of the key elements in study design is the inclusion criteria. These criteria describe the common denominators in the study population that are required for the study and the study objective. The panelists enrolled to the study must fit into specific standards of condition and/or behavior; i.e., population with dry skin, population with sensitive skin, specific ethnicity, and so on. The way by which this population is selected and the understanding of the aspects associated with it are key. A “dry skin panel” can be selected by simply screening questionnaires filled by the population considered for the study. This is a personal perception that can further be filtered by instrumental testing (transepidermal water loss and/or conductance). It creates a study baseline from which a change is expected. Other important information that should be collected and considered with the study design in mind include: understanding the panelist’s residence location and commute to the testing facility, occupation, lifestyle, familial situation, disease history and mental state. For example, if a panelist resides far from the testing facility and is required to come often to the clinic, he may not be able to adhere to the schedule. Such a panelist may be a fit for a study that involves one or two visits, but lengthy studies with frequent visits will reduce the odds of compliance.
Respect the Panelist
Study panelists are volunteers. They are the most precious asset in the study and should be treated as such. The study director should convey helpful information to the panelist, within the restrictions of information exposure. While it is obvious that the panelist in a double-blind study must not know the exact nature of the product they are using (tested product, placebo or benchmark), the approach should be as if all panelists are using the tested product and should be conveyed as such. Study directors should ask themselves: what would I want to know about the study if I am the panelist? How would I want it to be approached? Since for ethical reasons panelists cannot be compensated for their participation as if it is their occupation, the proper attitude toward them is of high importance.
Clear Communication
Without divulging confidential information, significant information can still be communicated to the panelist for clarity, all while maintaining blindness and randomization. We tend to adhere to lifestyle changes if we understand their meaning and importance. Explaining to the panelist the reasons for the need to adhere to the protocol can significantly improve compliance. Participants who understand that the regimen they are asked to follow will be similar to that advised to the general population when the product is launched understand that they may be responsible for potential future efficacy and adverse reactions issues when the product hits the market. Adherence to protocol is a moral issue. Panelists should be asked to repeat and explain the treatment regimen to make sure they internalized it. Furthermore, they should be asked explicitly if following such program is a routine they can commit to follow. Any potential breaches from adherence should be weighted before enrollment to the study.
Adverse Reaction vs. Efficacy
If we could predict adverse reactions, we would not need to test for them. Every product tested is a unique combination of components that can trigger various reactions such as primary irritation, allergies and/or photo-reactions. A product must be tested for potential adverse reactions before it is tested for efficacy. This practice is not only ethically appropriate, it also makes business sense. If the product exhibits adverse reactions, compliance may be reduced. In some cases, the non-adherence or dropout rate may be such that it will not allow achieving the number of panelists for statistical significance. While it’s imperative to collect adverse reaction information during efficacy study, full toxicological information should be obtained prior to conducting it.
Sensorial Attributes
The skin is a sensory organ tightly connected to the nervous system and the brain. If a product is pleasant to use, it is more likely to be used and its application more thorough, too. In some cases, skin care formulations may allow better penetration if rubbed and massaged into the skin. If the product is not pleasant to apply, panelists will not make the effort to massage it onto their skin and apply it evenly. If the formulation is limited in its elegance, due to constraints such as active solubility, one should consider running a sensory study to capture the magnitude of its appeal or rejection by the population of interest. Such a product can range from “tolerable if delivers on its premise” to “absolutely unacceptable.” Understanding where it is on the scale can be the difference between a successful study and a failed one. It may drive changes to the formulations prior to investing in an efficacy clinical study.
In summary, when conducting a clinical study on human beings, it is imperative to carefully define the population of interest, ensure that such a panel can be recruited by the clinical facility and understand the means of recruitment. Ideally, the panel will closely resemble the population to which the product is designed. For example, if an anti-aging product is designed for women in their 60s, such a population should be recruited. Other characteristics that marketing professionals can convey can be of help too, including ethnicity, occupation and hormonal state.
The filtering and selection of the study panel, the communication of study regimen and objectives, and, most importantly, the respect to the panelists are the foundation of the study.
Nava Dayan
Owner
Dr. Nava Dayan LLC
Nava Dayan Ph.D. is the owner of Dr. Nava Dayan L.L.C, a skin science and research consultancy and serving the pharmaceutical, cosmetic, and personal care industries. She has 25 years of experience in the skin care segment, and more than 150 publication credits.
Tel: 201-206-7341
E-mail: nava.dayan@verizon.net
Marketing experts refer to a “purchase experience” as a key in imprinting a correlation between sensorial memory and a specific product. Our choice to invest in an experience is strongly tied to the level of our development and the understanding of what is “good for us.” A self-aware individual will invest in what makes him feel at peace and not necessarily in what society indicates as a positive. This requires great self-awareness and bravery. We are surrounded by people whom we may not have chosen to be in proximity and influences that we may not have elected to be exposed to, sometimes forgetting that we have the choice to either dwell on or block our emotional connection to anyone or anything around us. When a thought that crosses our mind is not connected to how we feel, it is merely a response to the flood of information in our surroundings that, if we act upon them, makes us robots.
A thought that is translated from our feeling to our awareness is our own creation and choice. The Kabbalist Baal Hasoolam once noted: “what cannot be attained cannot be named.”
When we let our heart experience, we may not be able to define the experience verbally in our brain. We need a direct sensation, our own feeling, in order to have true sense of inner individual perception. In addition, we are programmed in a way that all perception comes from comparing and contrasting. We can never measure in a vacuum. If there was no day, we could never understand night. What may be a total disaster to one person, can be the greatest achievement to another. It’s our position that matters. Being able to see a larger scale arc connecting various experiences provides us with the ability to choose and experience the good in everything around us; a choice that is always available to us.
Understand the Study
Panelists in clinical studies undergo complex experiences that go well beyond the mere use of the product and periodical measurements at the clinical facility. It’s a commitment they undertake to be involved in an experience and should be considered as such. For best participation practice, panelists are to understand the study, and, feel part of it. Poor panelist compliance is a major issue in clinical studies. Compliance can be defined as the extent to which the study participants behavior coincides with the experimental protocol. Poor compliance is a deviation in panelist behavior from the protocol regimen. Failure can stem from various reasons such as deprived communication between the panelist and the study instructor, panelist fatigue or neglect, product adverse reactions and other unknown panelist behavior of choice. Poor compliance also directly correlates with reduced panelist retention. The retention is defined as the strategy and tactics designed to keep panelists enrolled in clinical trials, and from discontinuing participation and “dropping out.” A non-adherent panelist who is involved in a clinical study may be at an increased risk to discontinue their study participation. There are certain responsibilities a study participant may have in addition to adhering to requested pattern of product use. These responsibilities can include changes in plans or lifestyle (such as for example, refraining from sun exposure), diary completion, dietary restrictions, follow-up phone calls or other study-specific accountabilities.
Here are a few suggestions to elevate the odds of study adherence and panelist retention and compliance. It should be stressed that since every study is customized for its objectives, the following information may not apply to all situations.
Know Your Panelist
One of the key elements in study design is the inclusion criteria. These criteria describe the common denominators in the study population that are required for the study and the study objective. The panelists enrolled to the study must fit into specific standards of condition and/or behavior; i.e., population with dry skin, population with sensitive skin, specific ethnicity, and so on. The way by which this population is selected and the understanding of the aspects associated with it are key. A “dry skin panel” can be selected by simply screening questionnaires filled by the population considered for the study. This is a personal perception that can further be filtered by instrumental testing (transepidermal water loss and/or conductance). It creates a study baseline from which a change is expected. Other important information that should be collected and considered with the study design in mind include: understanding the panelist’s residence location and commute to the testing facility, occupation, lifestyle, familial situation, disease history and mental state. For example, if a panelist resides far from the testing facility and is required to come often to the clinic, he may not be able to adhere to the schedule. Such a panelist may be a fit for a study that involves one or two visits, but lengthy studies with frequent visits will reduce the odds of compliance.
Respect the Panelist
Study panelists are volunteers. They are the most precious asset in the study and should be treated as such. The study director should convey helpful information to the panelist, within the restrictions of information exposure. While it is obvious that the panelist in a double-blind study must not know the exact nature of the product they are using (tested product, placebo or benchmark), the approach should be as if all panelists are using the tested product and should be conveyed as such. Study directors should ask themselves: what would I want to know about the study if I am the panelist? How would I want it to be approached? Since for ethical reasons panelists cannot be compensated for their participation as if it is their occupation, the proper attitude toward them is of high importance.
Clear Communication
Without divulging confidential information, significant information can still be communicated to the panelist for clarity, all while maintaining blindness and randomization. We tend to adhere to lifestyle changes if we understand their meaning and importance. Explaining to the panelist the reasons for the need to adhere to the protocol can significantly improve compliance. Participants who understand that the regimen they are asked to follow will be similar to that advised to the general population when the product is launched understand that they may be responsible for potential future efficacy and adverse reactions issues when the product hits the market. Adherence to protocol is a moral issue. Panelists should be asked to repeat and explain the treatment regimen to make sure they internalized it. Furthermore, they should be asked explicitly if following such program is a routine they can commit to follow. Any potential breaches from adherence should be weighted before enrollment to the study.
Adverse Reaction vs. Efficacy
If we could predict adverse reactions, we would not need to test for them. Every product tested is a unique combination of components that can trigger various reactions such as primary irritation, allergies and/or photo-reactions. A product must be tested for potential adverse reactions before it is tested for efficacy. This practice is not only ethically appropriate, it also makes business sense. If the product exhibits adverse reactions, compliance may be reduced. In some cases, the non-adherence or dropout rate may be such that it will not allow achieving the number of panelists for statistical significance. While it’s imperative to collect adverse reaction information during efficacy study, full toxicological information should be obtained prior to conducting it.
Sensorial Attributes
The skin is a sensory organ tightly connected to the nervous system and the brain. If a product is pleasant to use, it is more likely to be used and its application more thorough, too. In some cases, skin care formulations may allow better penetration if rubbed and massaged into the skin. If the product is not pleasant to apply, panelists will not make the effort to massage it onto their skin and apply it evenly. If the formulation is limited in its elegance, due to constraints such as active solubility, one should consider running a sensory study to capture the magnitude of its appeal or rejection by the population of interest. Such a product can range from “tolerable if delivers on its premise” to “absolutely unacceptable.” Understanding where it is on the scale can be the difference between a successful study and a failed one. It may drive changes to the formulations prior to investing in an efficacy clinical study.
In summary, when conducting a clinical study on human beings, it is imperative to carefully define the population of interest, ensure that such a panel can be recruited by the clinical facility and understand the means of recruitment. Ideally, the panel will closely resemble the population to which the product is designed. For example, if an anti-aging product is designed for women in their 60s, such a population should be recruited. Other characteristics that marketing professionals can convey can be of help too, including ethnicity, occupation and hormonal state.
The filtering and selection of the study panel, the communication of study regimen and objectives, and, most importantly, the respect to the panelists are the foundation of the study.
Nava Dayan
Owner
Dr. Nava Dayan LLC
Nava Dayan Ph.D. is the owner of Dr. Nava Dayan L.L.C, a skin science and research consultancy and serving the pharmaceutical, cosmetic, and personal care industries. She has 25 years of experience in the skin care segment, and more than 150 publication credits.
Tel: 201-206-7341
E-mail: nava.dayan@verizon.net
