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The Disruption Series: Challenges in Moving Clinical Trials Off-Site

Assessing clinical and patient-reported outcomes without site visits

This is the seventh piece in the Lionbridge Disruption Series, a collection of commentary from life sciences experts on how the industry is changing as a result of the COVID-19 crisis.

Patients of the world

“It’s a small world.” How often have we heard others say this phrase (or said it ourselves)? The COVID-19 pandemic has certainly added a new angle to its meaning. The speed with which the virus has reached the most remote corners of the planet and the changes and challenges that it has created for individuals and whole countries have been astounding. Indeed, all that brought home the realisation that people are part of one big global family.

Around the world, this realisation is visible in the vigorous response and tremendous collaboration between the scientific, industry and regulatory communities. All these groups are uniting around a common goal: curing and preventing for COVID-19. The clinical research into this novel virus has expanded exponentially within a short period of time. It shows no sign of slowing, as is evidenced by the continuously growing number of clinical trials conducted in different countries.

Governments and regulators such as the FDA, EMA, MHRA, and PMDA, are taking action to expedite this research. Open communication, guidance documents and accelerated approval pathways are all aiding the progress towards possible therapies for COVID-19.

Patient participation remains central to the success of a clinical trial, no matter what disease or condition is the focus. Reports on patient health status outcomes, such as symptoms, functioning, tolerability and satisfaction with treatment, and health-related quality of life provide the researchers with valuable data. The resulting information concerning potential benefits and risks of the new treatment is then considered in regulatory decision-making.

Under normal circumstances, the strategies for the collection and processing of patient-reported outcome (PRO) and other clinical outcome assessment (COA) data in a clinical trial require thorough preparation, planning and implementation. The continuously evolving “new normal” is making it necessary for the drug development and clinical research industries to re-think and adapt those strategies.

Keeping the voice of the patient heard in the time of disruption

The impact of the pandemic on the clinical trials has been wide ranging: from suspending the enrollment of new patients to early withdrawal of individual study participants to complete study halts. In many cases, the quarantine and social distancing measures have made on-site patient visits infeasible. Many clinical outcome assessments are typically administered during in-person visits to the trial site. As a result, the current disruption presents a number of challenges in maintaining continuity of data collection in a remote fashion:

  • Emailing paper questionnaires to patients for completion off-site increases the likelihood of incomplete or incorrect data on return. Quite simply, the poor quality of the scanned copy may make it hard for the patient to complete the questionnaire and for the site staff to transcribe the data back into the electronic record system. Likewise, mailing paper questionnaires to and from the patient may raise additional concerns of potential exposure.

  • Replacing a questionnaire that would have been completed by the patient at the trial site with telephone administration of that same questionnaire by the site staff introduces concerns about the scientific validity and reliability of the collected data. This is due to potential variability of the manner in which the interviews are conducted, which may influence the patient’s responses and introduce bias into the data.

  • Switching between electronic modalities, such as from tablet to patient’s own device (BYOD), may not be practical or feasible due to the timelines for set-up required by various involved vendors as well as considerations for data validity, integrity and privacy.

  • Even where remote administration is feasible, the foremost consideration should be whether the patient’s setting/home environment and their other circumstances are adequate to protect their safety and privacy.

Adapting with the patient in mind

These are only few of the many challenges. In addressing those, sponsors and trial sites have to consider legal, regulatory, ethical and scientific implications as well as practical and logistical aspects. In that respect, the recent update to the FDA’s March 2020 guidance offers helpful new content on conduct of remote COA assessments, with focus on the clinician-reported outcome or performance outcome assessments. Another valuable reference source is a presentation  prepared by the Critical Path Institute’s PRO and ePRO consortia. This document presents a set of risk assessment and mitigation strategies for the collection of patient-reported outcome data in clinical trials through COVID-19.

Unquestionably, along with the acknowledgement that a certain level of flexibility and adjustments to clinical trials are necessary in light of the pandemic, the key message of all guidance documents is loud and clear: protecting the safety, welfare and rights of the trial participants remains paramount and non-negotiable.

Going back to the new normal

The COVID-19 pandemic has offered us a glimpse into a different reality. A reality in which human contact and face-to-face interaction have to be carefully managed to safeguard lives. A reality in which the availability and application of innovative technologies matter as never before, not just to facilitate that management but also to ensure the progress of the scientific research.

The uptake of the eCOA/ePRO technologies in clinical trials had been continuously and steadily growing over the recent years. There is no doubt that this trend will remain in place post-pandemic due to the multiple benefits offered by these technologies, particularly their patient-centric capabilities and suitability for a remote model of clinical trial conduct. With that, one might also expect that further advancements in the regulatory environment prompted by the pandemic will soon make decentralised clinical trials a more common fixture on the clinical research landscape.

The pandemic has also acutely underscored the importance of truthful, transparent, and timely communication. With respect to COA assessments and clinicial trials that involve participants who speak multiple languages, that means translating and adapting such assessments and documentation with cultural competence and linguistic accuracy. Properly managing the nuances of communication serves to enhance data quality, improve regulatory compliance and acceptance, and bring products to markets faster. To achieve these goals, it is critical to work with a partner that has the linguistic quality, industry experience, and global operating model needed to support your COA activities: a partner like Lionbridge Life Sciences.

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Nataliya Volohov
Nataliya Volohov