Get Earlier Insights On Product Profile
Getting the earliest possible insight into a study medication’s profile is crucial to determine whether a treatment is likely to be successful.
GET EARLIER INSIGHTS ON PRODUCT PROFILE
The timing, as well as, the quality of the information at hand are critical to determining a treatment’s likelihood of success. It is key to get the strongest possible insights into a study medication’s profile at the earliest stage to make an assessment and respond effectively.
CLINICAL TRIALS DO NOT GUARANTEE A FULL PICTURE OF A MEDICAL TREATMENT
The results from randomised controlled trials (RCTs) have to be reported to regulatory authorities. Consequently, pharmaceutical companies often have an incentive to design their clinical trials, choosing comparators and pre-specifying the endpoints in a manner that provides successful answers. But that may not give the full picture of the product, as the users may have experienced other benefits not measured in the trial. And the users may have their views on what they liked about the product, which is difficult to capture in a RCT.
This may result in that the full picture of a treatment, or how the users perceive a study medication is not revealed before it is on the market. At this time point it can be difficult to adjust as most important trials are over, the marketing materials had been printed and the price has been set with the payers.
ASK THOSE WHO HAVE EXPERIENCE WITH THE MEDICAL TREATMENT
We recommend interviewing and surveying patients as well as physicians and study nurses exposed to a drug candidate as early as possible in the trial programme to capture their experiences of the treatment. This type of feedback can be used as input to the discussion and design of future trials.
Contact CSO to learn more about raising the quality of insight you have into your study medication.
Speed Up And Structure Trial Investigators Feedback
A clinical trial is generally designed to measure and test pre-specified endpoints; nonetheless, to know what was seen and experienced by the physicians and study nurses during the trial programme is also of critical importance.
FEEDBACK-SESSIONS OFTEN HAPPEN VERY LATE
It is customary to organise a result meeting with the investigators and study nurses who were involved in a clinical trial when it has completed. However, these meetings often take place five to six months after the trial has ended. At this point, it can be difficult for investigators and nurses to remember what they experienced and saw, and they might already be preoccupied with new trials or other projects. In addition, language and discomfort with sharing critical thoughts directly with a trial sponsor can be barriers in feedback session for global trials. If an investigator shares his/her experiences, it can be difficult for the company to use: Was it only him/her who experienced this? Or did everyone experience this? What are the characteristics of those patients he/she is referring to?
ASK WHILE OBSERVATIONS ARE TOP-OF-MIND
To obtain relevant input, we recommend doing exit interviews and surveys with investigators and study nurses immediately after a trial ends and while their observations are still top-of-mind. By surveying investigators and study nurses individually, we can help structure feedback and ensure you to get their inputs earlier.
Contact CSO to learn more about how we can help you get faster and more structured feedback from investigators.
Sharpen Your Marketing Efforts
When developing new pharmaceutical drugs, it takes time to understand how a medication works, and how to communicate and position the treatment in an optimal way.
SHARPEN YOUR MARKETING EFFORTS
When developing new pharmaceutical drugs, it takes time to understand how the medication works, and how to communicate and position the treatment in the optimal way.
DO YOU OVER RELY ON EARLY CLINICAL TRIALS?
To a large extent marketers have to rely for a long time during the development of a new product on the early clinical- and PRO results from phase 1-2 studies which often are of small scale and have another perspective. Larger trials – so called phase 3B trails are made to help marketing. But these trials are often not designed to hear the users express their views and experiences. This means that important marketing questions such as: in what way the product impacts their daily life, what users like about the product, how they view the positioning- or value messages of the product are not asked to people who have actually used the product. Added to this when the 3B trials are completed many important marketing decisions have often already been made in order to launch the product as quickly as possible.
QUALIFY YOUR MESSAGING
If you use exit interviews and survey patients who participated in a clinical study immediately after the trial, you can obtain valuable input to pertinent marketing questions such as: How do users compare this treatment with treatments? What difference did it make for the patients? How do patients and physicians value the benefits? What do they prefer about the treatment? ?
Contact CSO and we can help you get better insights on how users view and value your medical treatment.
Improve Your Outcomes Strategy
Use interviews and surveys to improve the outcome strategy of your medical treatment
EARLY PHASE I AND PHASE II TRIALS ARE RARELY MADE FOR PATIENT-REPORTED OUTCOMES (PROS)
A pharmaceutical company designing the early Phase I and Phase II trial of a study medication knows often relatively little about the treatment’s profile. As a result, it might be a “guessing game” of which standardised and generic PROs to include. Generic PROs are also often difficult to read and interpret for patients and companies alike, and they do not leave room for patients to elaborate.When a company get the results from PROs used in early trials, the results are also often difficult to interpret due to the small sample of patients used in the early trials which makes it a challenge to choose the right PROs for the following trials.
HEAR THE USERS TO IMPROVE YOUR OUTCOMES STRATEGY
We recommend to interview and survey a group of patients or caregivers soon after their participation in a clinical trial. Administer exit interviews to help you form an earlier and clearer picture of how they experienced using the study medication. Their user-feedback can aid you in deciding how to set your outcome strategy and optimise the presentation of the treatment in subsequent follow-up clinical trials.
Contact CSO to hear how we can help you get a better understanding of which outcomes assessment instruments to use in upcoming clinical trials.
Strengthen Health Economic Arguments
It is important to demonstrate the health economic value of bringing a new treatment to the market: How does the new medication improve a patient’s life? Does it have an impact on their caregiver or relatives? Do the benefits outweigh the costs?
USERS ARE RARELY ASKED DIRECTLY
Many companies fail to directly ask patients specific questions about the value a treatment brings to them. Instead, patients are often asked to fill out standard/generic questionnaires that do not necessarily provide the answers which the company is really looking for.
ASK THE RIGHT QUESTIONS
If you want answers that can better support health economic arguments, you need to develop a questionnaire that specifically addresses how a new treatment helps those who use it – patients and/or their relatives. Or, consider asking investigators and study nurses how it impacts on their normal daily life and practice: Do they recognise any cost-offsets? What value do users see in the treatment bringing to them?
Despite the artificial nature of RCTs, insights can be gained through interviewing subjects after their participation in a clinical trial. These insights can help focus and strengthen the health economic arguments for the medical treatment.
Contact CSO to learn how we can help you strengthen your health economic argumentation.
Capture Real World Evidence
When introducing a new medication, or supporting an existing treatment on the market, it is important to contextualise it with other current treatment regime(s) in a real-world setting
ASK THE RIGHT REAL-WORLD QUESTIONS
Health economic arguments that support bringing a new treatment to market need to document cost and burden of current diseases/regimes in real life settings. Question to ask is: What is the current situation today for patients? What are their unmet needs? What issues and costs do the patients have associated with their disease? How do the disease and current treatment impact on the patient’s caregivers or relatives? This type of information can be
STRONG PANELS TO GENERATE STRONG REAL-WORLD EVIDENCE
CSO collaborates with some of the strongest panel partners who can provide us with access to patients and physicians to interview and/or survey in all disease areas for more than 55 countries. Our chosen panels focus on key countries:
Our broad access to patients and healthcare personal help ensure that recruitment to RWE interviews and surveys will not only be timely but also more precise in terms of meeting selection criteria.
Contact CSO if you are interested in improving the quality of the type of RWE answers from your research questions.
Patient dropouts from clinical trials can have far-reaching consequences, prolonging the duration of the study or, in the worst of case scenario, resulting in the discontinuation of a trial. Dropouts are costly in terms of money wasted and lost ability to document the clinical effect of a drug candidate on one person.
Patient dropouts from clinical trials can have far-reaching consequences, prolonging the duration of the study or, in the worst of case scenario, resulting in the discontinuation of a trial. Dropouts are costly in terms of money wasted and lost the ability to document the clinical efficacy of a drug candidate on one person.
KNOW THE UNDERLYING REASON FOR A DROPOUT
The underlying reasons for why a patient discontinues in a trial can vary, and may not necessarily be obvious to the investigator – especially if it is not due to an adverse event. In such instances, the underlying reasons for the dropout are often not communicated in a structured fashion to the sponsoring company. By surveying patients, investigators and study nurses who have experienced dropouts, you can generate a better understanding of why patients choose to discontinue a trial.
Findings from surveys that investigate underlying reasons for trial dropouts may inform designs for future trials and help improve patient retention.
Contact CSO to gain a better understanding of why patients have dropped out of your clinical trial.