WHAT WE DO

Clinical Survey Outcomes (CSO) combines health economics and applied anthropology to assess the perceptions of individuals towards your study medication during the development phase. A mixed method approach, integrating knowledge from both quantitative and qualitative data, is used to formulate nuanced and expanded insights of how patients, healthcare professionals, and where relevant, family members or other key parties experience your treatment.

Quantitative deductive approaches are useful when testing the prevalence of expected effects. For example, a clinical trial will usually apply this approach and define pre-specified endpoints as a measure of the efficacy and safety of a new medical treatment. Patient-reported outcomes (PROs) questionnaires are also included in clinical trials to evaluate how patients and other user’s experience a treatment. A shortcoming of PRO questionnaires’ is that endpoints are pre-specified and that there may be benefits associated with the treatment which are consequently not reported. In this scenario, an advantage of applying a qualitative inductive approach is that patients can be permitted to elaborate on aspects of the effect they value most, and a more comprehensive picture of their experience of a study medication can be established.

Additional information can help challenge and broaden the target drug candidate profile. Therefore, our approach at CSO is to support the pre-specified outcomes from the quantitative designs of clinical trials by setting and executing qualitative research strategies. This is accomplished by collecting, analysing and reporting of both qualitative and quantitative survey data. The research-based insights extracted from the in-depth interviews and tailor-made questionnaires with patients and healthcare professionals at exit interviews support our clients to understand the patient’s-experience better and improve their drug candidate before launch.

The value of employing a mixed-method approach is that it provides a greater understanding of complex situations. The use of a combination of different methodological approaches benefits our clients because CSO can assist them to generate a more holistic understanding of the full effect of treatments – providing invaluable information about a new medical intervention. The insights gained from using mixed methods research in clinical trials or a real-world setting may be relevant, both as part of a study protocol or in the context of market research.

Our Services Include

OUTCOMES STRATEGIES

Health economics and outcomes strategies

Developing a robust health economics and outcomes research (HEOR) strategy is critical for ensuring that a company proactively plans the right clinical trials, endpoints and outcomes, and collects and presents the data in a way that will be accepted by payers at the time of launch.

The team of staff working at CSO have many years of experience in devising HEOR strategies for pharmaceutical and medical companies, which are planned from the very early stage of drug development (Phase I and Phase II) right up to launch. The expertise CSO’s staff has in defining HEOR strategies is merged with the research skills of scientific anthropologists, so that we may assist our clients in creating innovative game plans for a new treatment’s entry into the market.

As we do with our existing clients, CSO can help you interview and/or survey patients and healthcare professionals who have come into contact your medical treatment. Thereby, enlightening you as to what they observed, thought or felt about the encounter. These insights can guide you towards which outcomes to focus on in future trials. Also, based on the outcomes from the surveys, CSO can work with you to map out a HEOR strategy.

Contact CSO to discuss the best process for collecting the appropriate endpoints in your trials, and how you can ensure that they are relevant to payers.

Advisory boards to challenge outcomes strategies

CSO has more than 10 of years of experience in organising and facilitating health economics and outcomes advisory boards. Given our experience, CSO is able offer our clients strategic foresight into which endpoints collected in a clinical trial are likely to be challenged and, or, validated by a health technology assessment (HTA).

A further critical advantage, for our client, is CSO’s network of leading HEOR experts and Payers. CSO has well-established relationships with HEOR experts who can be called upon for assistance, either during the HTA process or when organising an advisory board meeting. CSO also have ensured to have access to a large Payer panel covering US and top-5 EU countries – by which CSO can help our clients getting fast access and answers from payers in these key countries.

In addition, CSO is also experienced in seeking formal scientific advice from authorities at organisations such as the National Institute for Health and Care Excellence (NICE), UK, and Pharmaceuticals Market Reorganisation Act (Arzneimittelmarkt-Neuordnungsgesetz – AMNOG), Germany.  And, if required, we have a leading partner-organisation capable of facilitating a formal HTA process.

Contact CSO to help you secure the right HEOR experts capable of challenging the planned endpoints in your trials and in the format of your preference.

FDA dialogues in collaboration with leading PRO experts

The structured gathering of patients’, and healthcare professionals’, experiences early on in clinical trials may open up opportunities for patient-reported outcome (PRO) label claims or to expand the use of established PRO instruments for an existing medical treatment. CSO not only assists you with early and structured interviewing and surveying of users, but also collaborates with relevant PRO experts to facilitate dialogue with the FDA in pursuing PRO label claims.

Contact CSO to assist you with both interviewing and surveying users of your investigational medical treatment. CSO can also facilitate dialogue with the FDA together with our PRO experts.

Co-creations

The pharmaceutical industry increasingly values active user-involvement in the research and design of medical treatments. At each critical development stage, patient-feedback is being incorporated to generate a better understanding of, among others, the unmet needs linked to their behaviours and preferences.

CSO strongly advocates for strengthening and broadening this trend of co-creation that involves a dialogue between the company and patient about a medical treatment, as it is being developed – where parties both may benefit in the long-term. Our role as a service provider is to design and facilitate the co-creation processes to meet our client’s specific needs. We definitively recommend using co-creation as a collaborative method when there is openness to adjusting goals and outcomes based on user responses.

At CSO, co-creation can involve:

  • Fostering and facilitating a dialogue between stakeholders (pharmaceutical companies and, e.g. patients, physicians, doctors or nurses)
  • Defining a common challenge across stakeholder groups
  • Bringing all the necessary skills, resources and user insights into play
  • Addressing the interests of everyone involved, strengthening the experience of ownership and anchoring development in practice

Two approaches are commonly used to source users for a co-creation process:

  1. Users are sourced from a client’s previously conducted clinical trials. When this approach is adopted, co-creation is a collaboration between our client, as a company, and users of the medical treatment with CSO as an intermediary.
  2. When co-creation needs to be set up in the context of a real-world setting users are sourced from existing patient and physician panels. Among the global solutions that CSO offers our clients is the ability to target any number of countries of interest worldwide. We collaborate with strong global panel partners, providing access to more than five million patients and 20.000 primary/secondary physicians and other healthcare professionals across all disease areas, and in more than 55 countries. Read more about our RWE Services here.

Contact CSO to hear more about how we can organise co-creations for your company.

OUTCOMES COLLECTION

 

Input to clinical trial outlines and protocols

CSO provides input to clinical trial outlines and protocols. The aim thereof is to optimise the collection of experiences and insights sourced from patients, physicians and nurses, and to ensure that participants are surveyed optimally as planned. This can be conducted as a part of the protocol or outside of the protocol. Furthermore, CSO has at our disposal a broad range of qualitative research tools for clients to choose from when they want a 360-degree perspective of how a medical treatment works. Our toolbox of specialised skills includes an assortment of qualitative methods, such as in-depth interviews, exit interviews, focus group interviews, building surveys, PROs, diaries and log books.

Contact CSO as a first step to developing a 360-degree perspective of how your medical treatment works in clinical trials. We can assist you with input to clinical trial outlines and protocols.

Interviewing and surveying of users in relation to clinical trials

Gathering research on the experiences of patients, physicians and study nurses can help uncover useful information about new medical interventions, which may otherwise be overlooked until a treatment makes it to market. Using a qualitative approach can be a valuable tool for identifying the full effect of a treatment and how it is experienced by trial participants.

Qualitative research and surveys of patients participating in clinical trials are usually done on completion of a clinical trial and are commonly called exit interviews. This type of research is categorised as market research and can be commissioned at any other stage of a pharmaceutical treatment’s life-cycle, or as part of the protocol.

Contact CSO if you want to integrate a market research project as part of a clinical trial or conduct it outside of the trial protocol.

Collecting real-world evidence by interviewing and surveying users

Most often, the purpose of real-world evidence (RWE) studies is to highlight the cost or challenges or the burden of an existing treatment. But, in the case where a new treatment has been introduced to the market this type of study may help elaborate on how a treatment benefits the patient’s daily life.

Focus groups and surveys, especially when used together, can unveil insights of how a treatment is experienced in real-life, and render visible, often unexpected and positive benefits for patients. Different viewpoints from patients, relatives, healthcare professionals and other stakeholders that are brought to the fore in a focus group can be supported with surveys to provide useful data in the development and design of a medical treatment.

A key competence at CSO is our ability to gather people into focus groups where deep insights are generated into the individuals’ lived experience of a particular illness, as well as the medication prescribed to alleviate their condition. To strengthen and quantify the outcomes from focus groups and qualitative interviews, CSO also collects large samples of real-world evidence through tailor-made questionnaires. Is so doing, we expose the effects of a medication or treatment as it is experienced and managed outside a clinical trial.

CSO has built strong, collaborative partnerships with large patient and physician panels covering more than 55 countries enabling us to correctly identify eligible patients in the countries of interest to our clients.

Contact CSO to help you generate rigorous real-world evidence. We have access to large RWE panels and can often solicit responses to questions within 24 hours. Questions about orphan drugs are generally responded to within 48 hours.

Field visits to collect data from patient's everyday lives

CSO is skilled in conducting field visits to the homes and workplaces of patients and their relatives. Depending on the focus of the work, we can engage patients and relatives through qualitative methods such as a photographical diary, user journeys and other design anthropological exercises. These methods produce qualitative input through visual observation. This qualitative input may be used both strategically and for communication purposes, and to improve a treatment’s profile.

Contact CSO to find out how we can help you collect research data from the everyday lives of your patients, and present the findings to the relevant stakeholder groups.

OUTCOMES RESULTS

 

Reporting of outcomes results

CSO has a depth of experience that we are able to draw from when communicating both statistical and qualitative results and insights. These findings, and learnings therefrom, are then translated into different formats and materials for clients to use internally within their organisation and, when appropriate, for external use.

Internal use

CSO is skilled at creating written reports and slide decks that present the interpreted research results, and can be used to communicate with internal stakeholders.

External use

  • Preparing for dialogue with regulatory bodies and HTA agencies

Patient experiences and physician feedback from exit interviews can be used to support early dialogue with regulatory bodies or health technology assessment (HTA) agencies. CSO can help formulate the results from the research to suit the written material format requested by a particular organisation, and to prepare for dialogue with relevant institutions.

  • Publication

Research findings that are deemed suitable for publication (e.g. RWE from qualitative research and surveys) can be, on your behalf, and with assistance from CSO’s team of medical writers, written up, submitted and the results published in an appropriate format. There are several format options CSO is able to assist our clients with developing such as abstracts, poster presentations, peer-reviewed papers and other media. Note that CSO does not advocate for nor participates in publishing materials that could be perceived as pre-launch marketing.

  • Video materials

Video materials are becoming an increasingly important media for communicating important findings from research projects in a short and simple way to both internal and external stakeholders.
Working together with our supplier-network, CSO can help create animations and video sequences to communicate key messages from our qualitative and quantitative research.

Contact CSO for assistance to communicate and publish qualitative research findings for both internal and external audiences in a way that supports your medical treatment.

Contact:

Jens Harald Kongsø
Founder and Strategic Lead
Clinical Survey Outcomes
jhk@csoutcomes.com
+45 60 78 58 86

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