How coronavirus is impacting clinical protocol today
Whether it's Alzheimer’s clinical trials or research on depression, every area of clinical research has been hit by COVID-19. Thankfully, many studies are now accessing the crucial financial resources that disappeared over the lockdown period; in the UK, a £400 million government investment will contribute to the essential grant funding relied on by many research sites today. Yet, despite the industry’s financial recovery, there is still a lot of work to be done in rebuilding confidence across the board. A recent survey by the British Medical Association found that, of the 10,000 doctors who took part, over two-thirds stated that they had either ‘little’ or ‘no confidence’ in the NHS’ ability to provide safe patient care.
The problem lies in how some clinical protocol used up until now just aren’t viable in the current climate. In the US, while details published by the FDA makes clear that anything written in their March 2020 document is recommended and not required, how the industry has responded to this advice appears to have influenced a positive change in public opinion that clinical research everywhere may want to emulate. According to Healthgrades COVID-19 Patient Confidence Study, around 86% of patients surveyed are now comfortable visiting health care providers.
Today, we take a look at some of the key changes to our industry that are guaranteed to help any researcher restart or start-up their clinical trials. Whether you are finalizing the plans on your own study or interested in joining a clinical trial yourself, here are some of the clinical protocol changes that clinical studies are now successfully implementing to ensure safety and security in a time of high external dangers.
Some key changes
Besides social distancing that is now mandatory to all clinical trials and every area of the everyday for that matter, clinical studies are being given a lot of freedom when it comes to regulation. As part of the recommended assessment that will determine if any changes need to be made, research sites should consider themselves whether it is appropriate to delay some assessments for ongoing trials, or, if the study cannot be properly conducted under the existing protocol whether to stop ongoing clinical recruitment, or even withdraw trial participants. A further recommendation by the FDA considers the employment of third-party health care providers in carrying out daily COVID screenings. Lexology provides an excellent resource for research sites concerned about the intricate mechanisms of a procedure of this nature; check out their guide here.
Robust efforts by sponsors, investigators, and IRBs/IECs to maintain the safety of trial participants and study data integrity are expected, and all efforts should be documented. As stated in their report, the FDA recognizes that protocol modifications may be required, including unavoidable clinical protocol deviations. Ultimately, efforts to minimize impacts on trial integrity, and to document the reasons for protocol deviations, is paramount to running clinical research today.
With all this change, it is important that how data is recorded is appropriately modified also. Changes in study visit schedules, missed visits, or patient discontinuations may lead to missing information. It’s important that companies capture specific information in the case report form that explains the basis of the missing data, including the relationship to COVID-19 for missing protocol-specified information (e.g. from missed study visits or study discontinuations due to COVID-19). This information, summarized in the clinical study report, will be helpful to clinical trial sponsors and the FDA in determining the efficiency of the trial as a whole.
In addition, COVID-19 screening procedures that may be mandated by the health care system in which clinical trials are being conducted do not need to be reported as an amendment to the clinical protocol even if done during clinical study visits, unless the sponsor is incorporating the data collected as part of a new research objective. These guidelines are put in place to ensure maximum clarity on the presentation of trial data that, ultimately, determines the tested product's efficacy and safety in further studies and in potential public use.
Something to consider
What is clear is that traditional clinical protocol, in many areas of clinical recruitment and patient-welfare, just isn’t cutting it for COVID-19 research. With our digital world now demanding digital solutions, clinical research recruiters must now seriously consider the impact of automation on clinical trials to start rebuilding patient confidence. Partnering with analytics and marketing experts is now an essential step in trial planning that will soon become standard practice - even for smaller companies or independent researchers.
Employing a patient recruitment dashboard makes screening, scheduling, and communicating with patients a breeze. It is the time and money saving tool that research sites sorely need right now. Whether you’re a site coordinator, administrative professional, or clinical trial sponsor, you’ll be able to log in and check on the status of your study’s enrollment, send communication to potential participants, and measure your enrollment goals. With a blinded-access trial recruitment dashboard (like Citrus), clinical trial sponsors and CROs can even view their clinical studies’ progress without risking study validity. An easy-to-use clinical recruitment dashboard tool is the ultimate automated assistant for patient recruitment and retention.
With around 40% of large companies expected to use robotic process automations (RPAs) this decade, going digital is the future of clinical research; and here at Citruslabs we know a thing or two about digital patient recruitment. Today, our patient recruitment dashboard, Citrus, is helping researchers everywhere improve their current enrollment metrics with less effort, drive deeper communication, and boost effective retention that works. Further, we ensure research sites are connected to a thoroughly educated and engaged pool of participants with over 3 million patients on record; so, it is no wonder why we have such high patient confidence! Now, we would say that other models are available - but this would be a lie. In fact, unlike that offered by other patient recruitment companies, our easy-to-use platform is the first-of-its-kind for the market; giving researchers a unique insight into their patients’ wants and needs via industry-leading technology. The future of clinical recruitment and retention starts here.
Interested in finding out more? Get in touch with us here, and check out our archives for all our top tips and tricks on running successful clinical trials in today's constantly changing industry.
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