In recent years, patient engagement in clinical trials has emerged as an increasingly important aspect for the success of clinical trials. The European Medicines Agency (EMA) has long been committed to greater patient’s involvement and has expressed the benefits of working with patients throughout the drug development process. Recently, at the DIA Europe 2019 conference, Guido Rasi, EMA General Director, said that the Agency will play its role “to make patient engagement the rule by 2025”.

The need and challenge to recruit and then retain patients in clinical trials is not new to the industry. Moreover, while the rate of premature termination of clinical trials has historically been around 30%, the effects of non-compliance are, by nature, impossible to quantify and add a potentially significant confounding factor. Clinical study adherence rates have been reported on average from 43% to 78% among studies dealing with chronic diseases.

How to increase patient engagement in clinical trials?

In this article we will not deal with the involvement of the patient in the study protocol discussion, but we will focus on patient engagement from the moment in which the patient is offered the possibility to participate in a clinical study.

In particular, we will analyse the following activities:

  • The electronic informed consent (eIC)
  • The remote monitoring
  • The electronic reported outcome (eCOA/ePRO)

The electronic informed consent promotes understanding of study procedure

The first step in improving patient engagement is to modify the informed consent process. The administration and discussion of consent through an electronic and multimedia modality, the eConsent, allows the patient to better understand the procedures of the study as well as the benefits and possible risks and, as widely demonstrated by specific studies, this awareness contributes to his retention in the study. In fact, the lack of understanding of procedures, benefits and possible risks, as well as obligations, leads in that group of subjects a rate of abandonment 3-4 times higher than the others.

Center Watch, a global leader in providing clinical trial information to professionals working in the pharmaceutical field, has highlighted how, with this type of consent, it is possible to enroll up to 25% fewer patients to achieve the same goals of completion of studies with a traditional consent.

The eConsent uses patient-specific features, such as familiar and practical mobile devices (smartphones and/or tablets), video content, audio narrations, explanatory glossaries and pop-ups, for simpler, and more understandable content.

In addition, the eConsent eliminates all the deviations associated with the consent procedure that make up approximately 9% of all issues that arise during clinical trial inspections, such as the use of an incorrect version of the consent form or the lack of the date or other deviations.

 

The importance of electronic signatures

Another important aspect for both the quality and completeness of the procedure is the electronic signature that reduces the errors mentioned above, facilitates the signature of those patients who have mobility problems in the hands and allows the collection of the “remote” informed consent. The regulatory aspects and the legal validity of the electronic signature of the informed consent will be the topic of a future article.

Remote patient monitoring increases compliance and retention

Clinical trials are highly regulated to ensure compliance with good clinical practice and patient safety. As such, protocols often require frequent visits to the clinic for the patient to be evaluated by the trial team.

Unfortunately, almost 70% of the participants live more than two hours away from a clinical centre, which makes it quite expensive to go to the centre frequently for the planned follow-up visits,mainly for elderly patients, children and/or patients with severe walking problems. These visits could be carried out virtually through telemedicine applications, allowing the patient to make the visit from home as well as to measure several parameters independently through specific devices.

Using remote visits, at least for those controls that do not require direct meetings, can reduce the discomfort for patients and the commitment of doctors, while maintaining high operational standards.

Less frequent visits to the clinical center give more patients the opportunity to participate in clinical trials and remain in the trial up to the end. Some data indicate that the drop-out rate in virtual trials is only 5% compared to standard trials, where the rate is 30%.

Virtual studies, what are the advantages ?

Virtual studies provide the flexibility to streamline and speed up complex studies such as oncology and central nervous system studies, those that require a wide geographical distribution, such as in rare diseases, and those with long follow-up periods, such as in chronic diseases.

Parkinson’s disease is an area where virtual clinical trials have reduced barriers to participation, particularly for patients with cognitive and physical disabilities. For the first time, few months ago, in the United States, the National Institute on Aging (NIA) has launched a project that will recruit 3,500 patients with Parkinson’s disease for a clinical trial that will be conducted entirely with patients who will remain in the comfort of their homes.

Obviously, traditional clinical trials will not disappear, as many studies require the performance of instrumental examinations, such as MRIs, biopsies, X-rays and others examinations that must necessarily be performed in a hospital setting. However, we need to think more carefully about how to exploit the technology available for hybrid studies, where the clinical center and the patient’s home are both included to make  best of both worlds. Therefore, both the investigator’s and the patient’s centricity are important.

Electronic questionnaires are an essential component for a drug clinical evaluation

When evaluating the effectiveness and tolerability of a drug, the data reported through questionnaires or electronic diaries (eCOA/ePRO) can be  powerful and deeply personal tools. Whether in terms of symptoms, physical and/or mental well-being, or side effects, electronic evaluations of the clinical outcomes reported by the patient, give a more complete picture of how an experimental treatment works.

With eCOA and ePRO technologies, patient has better experience within the study, which supports the ultimate goal of acquiring more reliable data and achieving higher retention rates and better compliance with the study procedures. While a paper option may seem easier  to record information when needed, electronic questionnaires oblige patients to respond correctly, with guided responses, and only within the time specified by the protocol, thus preventing unreliable and misleading data from being collected that may also compromise the overall study results.

Electronic recording stimulates and increases patient-doctor interactions and allows subjects to reflect on their symptoms before meeting with the study staff. As confirmed by many studies with ePRO, patients are more likely to raise clinical events in discussions with the physician, as the completion of the ePro requires the memory of further details of the recorded symptoms. The data also confirm that physicians are more likely to discuss problems reported through the ePRO and that the duration of the visit was not affected.

In addition to providing greater responsibility for reporting of  symptoms and events, electronic media, in general, are considered

by patients to be more engaging than paper media. For example, patients’ preference for ePRO over paper has been demonstrated in all therapeutic and demographic areas regardless of the patient’s age and degree of technological expertise.

Conclusions

The regulatory environment and technological opportunities indicate that the time has come to revolutionize clinical trial processes to improve efficiency and exploit the value of patient centricity.

Benefits for sponsors are certainly faster recruitment and reduction of drop-outs, as well as lower associated costs. However, the greatest benefit is for patients who, by improving their understanding of the study procedures, removing obstacles to their participation, minimizing the unnecessary burden of frequent visits to the centre, allowing repeated measurement of parameters from home, facilitating the recording of events and symptoms through electronic tools, are more motivated to participate and remain in the study until its completion.

Exom Group, which since its foundation has set the mission to modernize the clinical research processes through greater involvement of both patients and investigators, is able to concretely solve the problem of patient engagement in clinical research, through widely used and validated digital solutions, such as the electronic informed consent (Genius Engage), the remote monitoring platform (Genius Rosa) and the ePro applications.

 

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