REMOTE MONITORING IN CLINICAL TRIALS
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REMOTE MONITORING IN CLINICAL TRIALS
INTRODUCTION:
The scenario of clinical research studies becoming more complex in view of the ever increasing regulatory compliance demands, increased intricacies and the increasing cost of conducting research. If these constraints have to be tackled then technological optimization is a must remote monitoring allow monitoring activity which were previously conducted on – site to be conducted remotely, phase increasing efficiancy and speeding up time to market. The CRA is still very much involved, but he / she does not spend time on site. Instead the CRA performs all the study monitoring processes remotely, using a secure online platform. Today’s crisis climate is creating a diphocomy in clinicla reearch. On the one hand, researcher are experiencing major clinical research disruptions across the globe due to direct proxamity to patients, priorities of helath care workers, and a fragile over all health care ecosystem. As a result, sites are closing, medical facilities are enforcing acess restrictions, and there are constant delays are sttopage of non essential studies. On the other hand, this health crisis is highilighting the critical need for clinical research due to ongoing COVID-19 trials the sponsor face circumstances that have the potential to flow clinical research. With many monitories now restricted from travel, sites and sponsors are reassessing waste to share information and collabarate virtually. As a result, sites and sponsors are exploring the potential of remote monitoring solutions. Moreover, industry groups like associate of clinical research organizations (ACRO) association of clinical research professionals (ACPR), and the society for clinical research sites (SCRS) are advocating for processes and programs to help their members be successful when conducting remote trials. Organizations are more intrested in meeting up with the raising costs and deadline on one hand an ensuring patient safety and regulatory compliances and the other. This has led to the increased importance of remote monitoring for clinical trials.
WHAT IS REMOTE – BASED MONITORING IN CLINICAL TRIALS AND HOW IT WORKS ?
Remote – based monitoring is an approach where clinical professional are not needed to visit the research clinic physically for purpose of monitoring they review the data remotely through secure online work spaces. The data reviewing through one such platform like intralinks VIA is highly used to in this contact. Protocal is executed by the research clinic in a normal manner and additionally data is entered in the electronic case report form (eCRFs) . All sorce documents, medical, labshistories and document including informed consent forms an the like are uploaded to the secured online workstation. The data can be immediately accessd by the clinical research associate (CRA) and the notification of the same is received by the research clinic. Once the data is uploaded the CRA compares the source document data with that included on the eCRF and this becomes his monitoring visit. As the verification of the source data is conducted remotely, this is termed as remote- based monitoring .
COMMON METHODS FOR REMOTE MONITORING:
Today the most sites are sharing source document through fax, email, cloud- based file sharing systems, are by granting monotirs direct access to the electronic medical record. Faxing and emailing source document increase the email load on already fully allocated staff. So monitors must allocate effort away from areas where site need support to organise and track documents received. Methods involving fax, email and file share also increase oppurtunity for error as site staff may forgot to redact identifying information, misdirect a document, or lose track of who has access to sensitive data. So we can direct access to the electronic medical record providing monitors direct access to an EMR can work, provided the proper consents and agreements in place. Research institutions should impement well thought out politics when providing direct EMR access to monitors, as many EMR systems don’t have controls in place to restrict views for study monitors.
BENEFITS OF CLINICAL TRIAL IN REMOTE MONITORING:
The common and major benefits of remote monitoring is that the CRA indeed stends less time, if any, at the clinical sites. When you consider that an average of 30% of the total clinical study budget is spent on CRA site visits it is easy to understand why remote monitoring are quickly becoming key elements of the global study process
- Remote trials reduce cost, boosts recruitment and retention
- Remote monitoring reduces the patient burden as there are fewer site visit required and those patients with mobility issue, travel concerns and chronic and debiltating illnesses have an increased chance to participate in the research
- Remote mnitoring adds value to patient
- Remote monitoring provides greater over site
- Remote monitoring enables continuity
- Remote monitoring includes centralized monitoring and risk assessment
- Remote monitoring maintain control and accountablity
- Verifying the a source of the data and reconciling data from the patient files and electronic case report forms
- Checking that the investigational medicinal products is handled properly and checks for unreported adverse effects
IMPORTANCE OF REMOTE MONITORING FOR CINICAL TRIALS
Utilising a partner that provides clinical research serves is amust for conducting smooth, hassle-free and successful clinical trials. Among the many services offered, remote-based monitoring is gaining increasing importance because of the several advantages obtained through it.
EFFECTIVE COLLABORATION: remote monitoring facilitates effective collaboration between the sponsors and the clinical research associates with respect to finalizing documents during the site initiation process
TIME SAVING: significantly reduces time taken by research clinics to start screening the study participants
COST EFFECTIVE: site visits may not always be feasible or they can can be very costly. In this approach, time if any, needed to be spent by the clinical research associate at the clinical sites drasticlly reduced, consequently reducing the budget allocation for the same.
PATIENT CENTRIC: highly useful in monitoring patients affilicted with chronic diseases like diabetes as they are not required to be confined to the clinical environment all the time. With patient centricity being the current trend this approach is very favourable.
FOCUS ON CORE STUDY: clicical research staff and associates find more time to concentrate on the core study rathee than restricting themselves on operational checks.
PATIENT AVAILABILITY: one of the tiresome processes of clinical research is patient recruitment. Patient dropout which is normally linked to travel inconveniences is another aspect that effect the succesful completion of a clinicla trial. Remote based monitoring maximises availability of patients and enrolments in clinical research studies and reduces incidences of patient dropouts too.
DATA QUALITY: access to data is immediate and transfer of data is most secure. This promotes data quality and brings the element of quality assurance in clinical trials.
CONCLUSION:
Of course, traditional trial processes will remain valuable for many years still. And, in some cases, completely remote or virtual trials won’t be suitable for all patient population. Neverthless, remote monitoring can provide significant value to reseacher and patients alike through more efficiant processes and greater freedom to participate in research. Notwithstanding the challenges, remote-based monitoring has made a lot of positive contribution to clinical trials.
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