Author: Harsha K Rajasimha, MS, Ph.D.

Editor: Sharlene Brown, Ph.D.

When clinical investigators and study coordinators start planning a new study design, speed and efficiency are paramount.

Running a clinical study takes careful planning. Whether this is your 1st clinical study or your 21st, the last thing you probably want to do is waste time and resources on data collection delays that are easy to prevent.

Traditionally, major bottlenecks occur during study startup, eligibility screening, the informed consent period (including assent in pediatric studies), and patient travel to the clinical site(s). Researchers eager to get the ball rolling on their study can save time and ease logistical burdens by stopping data gridlock before it begins.

Here are five rules to overcome the major pitfalls that can derail your clinical study.

1.      Don’t toggle between multiple software to manage the study.

Clinical teams spend long hours coordinating study logistics using multiple a la carte tools including email, text messaging, phone, video communication, calendar scheduling, form building, and electronic signatures. Juggling all of these tools to manage your sensitive human studies may eventually get the job done, but at the cost of data quality, information security, procedural compliance, and trial efficiency.

If this seems familiar to you, don’t worry. You are not alone. In the past, there were no quality, validated, secure, and affordable integrated solutions specifically designed to empower investigators to coordinate all the logistical aspects of a study in one place. The good news is, researchers have better options today—decentralized clinical studies most of all.

2.      Don’t expect your clinical team to manually configure & execute the study.

The attrition of study subjects during the screening and recruitment process is the biggest cause of study delays and failures. Not planning to automate the process means that you have set implicit expectations for your study team to do this manually—a move that can lead to disaster, especially in studies with enrollment goals greater than 100.

Be sure to select a software that allows you to automate repetitive, manual tasks that also has search and filter functions for sorting participants based on factors relevant to your study. Automation will not replace clinical teams, but it will save them valuable time that can be devoted towards ensuring data quality, saving costs, and maximizing the chances of study success.

3.      Don’t confuse informed consent with collecting signatures (electronic or otherwise).

Informed consent is an ethical and legal obligation for all researchers who study volunteers. Institutional review boards (IRBs) view the process of obtaining informed consent as divine. But this does not mean it has to be done manually during face-to-face consultations between subjects and clinicians at the study site.

A clinical study undergoes an average of 2-3 protocol amendments requiring re-consenting of study subjects. A software solution that enables the clinical team to remotely and electronically disclose new information, assess the competency of the patient (or surrogate), and obtain consent to participate with or without in-person site visits has now become a critical tool for ensuring study success.

Savvy investigators will be sure to automate and integrate the informed consent process wherever possible. Cloud software that supports bi-directional communication between the study team and their subjects—written, oral, and video—flexibly accommodates informed consent as well as other routine dialogs carried out in the study.

4.      Don’t skip planning for travel restrictions that could halt in-person office visits.

Coordinating diverse patient groups across territories has been a major accomplishment for modern medicine. However, many studies each year shut down when recruitment goals are missed and patient retention falls off.

Before the COVID-19 pandemic, the travel burden for participants and their loved ones often delayed data collection processes in clinical studies. In 2020, the international health crisis exacerbated this issue. Unfortunately, clinical studies that did not adapt to the travel restrictions imposed by governments and clinics (or self-imposed by would-be participants) were halted or scrapped altogether. However, regulatory amendments around telemedicine and others did enable COVID-19 vaccine trials and other critical studies to continue even during the pandemic. Updating clinical research tools can help investigators overcome travel limitations that are common to studies that collect real world data and/or implement long-term follow ups (e.g. patient registries, cohort studies, observational studies, etc.).

If the pandemic has taught clinical research stakeholders anything, it is that we must be nimble and flexible to complete study milestones on time. The ability to begin and complete a study that is years in the making may depend on how quickly researchers can adapt to fully remote and touch-less subject recruitment, study visits, and communication.

5.      Don’t limit your study participants to a specific mobile device manufacturer.

Some of the tools developed to organize clinical studies work only on specific hardware platforms and operating systems such as IOS (Apple) or Android (Google, various).

MedTechs seeking the financial benefits of appearing in exclusive app stores may not be aware that taking this action can harm the clinical studies for which their products were designed. Choosing an exclusive provider is less effective for accelerating subject recruitment. Patient diversity is also more difficult to achieve when a single mobile device manufacturer or operating system is selected. For researchers seeking equity and broad reach in their studies, a cloud solution that can work on a variety of mobile devices—a bring your own device (BYOD) model—may be a more appropriate option.

Following the 5 steps above will help any clinical study avoid common time-draining pitfalls and can optimize the concerted efforts of the study team and participants. To keep up with the time-sensitive demands of clinical studies, stakeholders such as academic hospitals, patient advocacy groups, clinical research organizations (CROs), and clinical trial sponsors should make a strong effort to select an integrated, automated, compliant cloud software that can scale with their growing patient populations and can be accessed in a BYOD model at all times.

Because each clinical study is different, researchers and coordinators must be careful in selecting the right solution for their specific study objectives and patient populations. Though it may seem complicated with the growing number of options and specialties available, it is easier than you may think to choose a suitable cloud solution for your study. By adopting a checklist of key features and/or metrics relevant to your particular study, you can select a software solution that best fits your study needs. Then, you’re all set to track study progress, create data summaries, and prepare for regulatory compliance audits—all in one place.

 About the Author and Editor

Harsha Rajasimha is a rare disease social entrepreneur globally recognized for his work in genomics data science, persistent advocacy, and technology innovations addressing grand challenges facing the estimated 350 Million people suffering from rare diseases world-wide. Harsha earned his bachelor’s degree in computer science and engineering from Bangalore University, a master’s degree in computer science and a doctorate in the interdisciplinary program genetics, bioinformatics, and computational biology from Virginia Tech. He can be reached on LinkedIn. Harsha is Founder and CEO and Jeeva Informatics. To learn more about Jeeva, click here.

Sharlene Brown, PhD, is a Scientific Consultant and the founder of Dr. Bird Consulting, LLC, a boutique firm specializing in the life sciences and ikigai. She is also the Vice Chair of the Women In Bio – Capital Region. She can be reached on LinkedIn.