Partnership Between admedicum and IEXP To Involve Patients In All Phases Of Clinical Trials For Drug Development
The Institute of Patient Experience - IEXP - and admedicum Business for Patients, join forces to expand in Spain and Latin America to help conduct patient-centered trials to decrease dropout rates from clinical studies.
Forty percent of the costs of clinical trials come from patient recruitment, a critical phase where many problems can arise like patient dissatisfaction and misunderstanding. Many of these problems are avoidable when we involve patients from the outset in the design of clinical trials and later in the recruitment procedures. Numerous studies provide evidence that including patients in the design of trials reduces attrition because the research questions patients ask are more relevant, the options are better and the risks of trials are significantly reduced.
In addition, there is a significant economic impact in that protocols do not need to be redesigned, recruitment is improved and drop-out rates are reduced. For both pharmaceutical companies and CROs, patient knowledge is an added value that translates into lower costs and greater safety in their trials. 80% of trials do not meet the target for patient recruitment due to the high degree of patient drop-out and slow recruitment. Pharmaceutical companies lose a lot of money when they have to cancel new drug development studies.
How do you involve patients in trials? How do you make their knowledge lead to safer protocols, better communication and recruitment rates, and lower drop-out rates? To achieve this objective, the Institute for Patient Experience (IEXP) and admedicum have joined forces to announce a new partnership, as first mentioned during IEXP's webinar dedicated to patient-centered clinical trial design at the end of November 2020.
The aim of this partnership is to contribute to safer and more efficient clinical trials in Spain and Latin America. "The partnership with admedicum brings knowledge and experience that will allow us to offer patients, laboratories and CROs a complete cycle from clinical trial to prescription and adherence of therapies that significantly reduces the costs of clinical trials and clearly improves the quality of trial data", according to Carlos Bezos, CEO of IEXP.
Phillip von Gallwitz, a founding partner of admedicum, adds; "We can demonstrate the efficacy and social value of medicine, i.e. the real-life impact it has beyond its functional value". The partnership between IEXP and admedicum means giving patients a voice. In order to give voice to patients, they must cease to be the object of research and become co-researchers with professional and proven participatory action research methodologies in healthcare, allowing them to contribute their knowledge to faster, more optimised and meaningful developments in pharmaceutical treatments and healthcare technologies. One of the competitiveness factors is to involve patients.
The US Food and Drug Administration (FDA) states that "patients should be treated as experts in what it means to live with the disease and can bring valuable knowledge to understanding the therapeutic context for drug development and evaluation. Involving patients in the various phases of a clinical trial has many other benefits:
1. improved protocol design
2. information about clinical trials that patients can understand
3. in/exclusion criteria adjusted to unmet medical needs
4. highlight key data to investigate
5. improve clinical trial safety
6. increase signatures on informed consent documents
7. ensure permanence and final accompaniment in the dissemination of results
8. cost reduction by reducing the time of the trial through support from patient associations during the recruitment and throughout the study
Andreas Reimann, founding partner of admedicum, states "Participating in a clinical trial is an uncomfortable, tiring and emotionally draining process for the patient. People do not participate because they are excited, but because they see hope. Involving the patient in a professional manner and with proven methodologies is fundamental to reducing the stress of a trial for patients.
In addition, the knowledge that patients have is essential for designing more effective protocols. There are many research questions that patients bring to the table from their own experience that researchers don't see because they lack that perspective.
Nicole Hass, manager of the COPD patient association, APEPOC, shares her experience as an expert in patient advocacy: "Patients have long been hearing the industry talk about patient centricity, but the reality is that behind that concept there is often nothing but kind words for patients. So seeing two companies with real cases with proven impact coming together tells us that things are changing.
About IEXP. www.iexp.es
The IEXP has extensive experience in involving patients in patient-centred prescription and adherence improvements. As a result, it can demonstrate with evidence the impact of a therapy on the real-life of patients, beyond the merely functional or clinical impact; that is, if their adherence improves, if changes in habits occur, if there is a better quality of life, if family relations improve, if there is integration at work, etc. IEXP works in Spain, Brazil, and Colombia. Last October, it announced its alliance with HumanITcare to improve patient wellbeing, combining the data power of the technological platform with the high-quality insights and big data of IEXP.
About admedicum www.admedicum.com
A network of patient engagement experts with experience in Europe in designing patient-centred clinical trials. admedicum has provided conclusive results both in improved recruitment and in co-creation and co-design from recruitment landing pages to information materials, reducing the burden on patients in terms of logistics, travel and clearly improving the communication of the entire process.