Vijayanand Rajendran

A critical part of clinical trial conduct is providing medical guidance by the responsible medical monitor (MM) to investigative sites and various operations team members, including, but not limited to, clinical research associates (CRAs) and clinical study managers (CSMs). It is imperative that a harmonized two-way communication is established between the MM and the clinical operation team, so that all study-related medical support is delivered in a timely fashion to ensure the safety of study participants and integrity of study data. Timely intervention and documentation of the key medical decisions are crucial elements in this communication.

	Establishing a project-specific knowledge base is a common practice in clinical projects via which relevant clinical and medical information is shared with various operations team members. Nowadays, a Q&A log is commonly used as a tool to establish the needed project-specific knowledge base. However, completeness of the developed Q&A log and the comprehensiveness/correctness of its contents are critical factors to ensure the usefulness of this project-specific knowledge base in providing the needed medical/clinical information to the operations team. 

	In our efforts to study the existent practice of medical management in clinical studies and to explore potential channels of improvement, we designed this survey to reflect the industry trend on this topic.

	The main objectives of the survey are to record the existing mode of communication between MM and monitoring team (CRAs and CSMs) with regard to medical guidance provided in clinical trials, and to elucidate the usefulness of the project-specific knowledge base in the form of Q&A logs. The essential qualities of the MM that ensue harmonized communication and flow of information, as assessed by the operation team, were also explored.

	Target participants: The survey was meant to obtain the perspective of study-team members involved in day-to-day monitoring of the study on medical guidance provided in clinical trials. The target participants were CRAs, project managers, and CSMs, all of whom were carefully selected from our network. All the targeted participants were currently working at medium-to-large biopharmaceuticals or at global contract research organizations (CROs), and have experience in working on multi-centric large global trials.

	Survey questions: To ensure the simplicity and punctuality of the survey, it was designed to include only three straightforward questions that capture the most relevant information concerning the interaction and shared information between the operations team and MMs in clinical trials. Figure 1 shows the three questions posed to the participants in this survey.

	Communication:  To ensure the ease and protected access to the survey by the participants, it was posted online on a designated/protected page of our organization server. A link to the survey page was provided to the targeted participants both via email and social media portals (LinkedIn, Twitter).

	The survey was conducted over a period of one month during which 92 CRAs and CSMs responded and provided their input. The identity of the participants was kept confidential and any identifying information of the participants was blinded. Additionally, results of the survey were analysed in aggregates.

	Email was reported as the most reliable (78%) mode of communication with study-responsible MMs when medical guidance is required. Seeking medical guidance via a phone call was considered the most reliable mode of communication by almost 22% of the participants. None of the participants chose short messaging system (SMS) to communicate with the responsible MM when medical guidance is required.

	Figure 2: Reliable mode of communication with MM

	The results of the grading scale of Q&A usefulness from the survey (0 to 10, where 0 is equal to useless and 10 is equal to extremely useful) are shown in Figure 2. The average score indicated by the participants with regard to the usefulness of Q&A logs was 6.75 (median score = 7). About 6.52% of the respondents considered the Q&A logs as extremely useful (grade of 10 on the provided scale) and 2.17% considered the Q&A logs as useless (grade 0 on the provided scale). A score of 8 was selected by the biggest proportion of respondents (35%), followed by the score of 7 (17%). About 29% of the participants selected a score of < 5.

The importance of various medical monitor qualities

	As shown in Figure 4, the majority of the respondents (with various percentages per individual quality) indicated that being knowledgeable, responsive, and easily accessible are extremely important qualities for the MM, providing them medical guidance in clinical projects.

	The rating of importance within the listed qualities in a MM are reflected in the charts.

	Figure 4: Importance levels of MM qualities, as selected by the participants

	To quantitate the importance level as chosen by the responders and draw a comparison between the various listed qualities, a score was assigned to the various levels of importance included in the survey, as shown in Table 1. This scoring approach was applied to every individual response from the participants and for each of the different qualities included in the survey. Applying this scoring approach while analyzing the results would ensure that each chosen response by every participant is optimally represented in the resultant score. The individual scores were then summed up to determine the importance hierarchy within these MM qualities.

	As shown in Figure 5, the importance scores for being knowledgeable, responsive, and easily accessible were comparable, thereby affirming their significance in fruitful medical communications governing study conduct.

	The majority of the respondents (78.26%) preferred email as the communication tool for medical queries. This is not surprising, as emails are widely used within the industry for most of the correspondence. This could be due to easy accessibility, default archival, time-stamped proof of interaction, and to keep other required designators informed. International Conference on Harmonization good clinical practice (ICH-GCP) guidance defines electronic communication as a documentation method to describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

 Thus, traditionally emails are preferred over other modes of communication in clinical trials.

	However, the practical effectiveness of these email features to suffice the project medical communications needs are to be explored further. It is understood that the urgency of the situation decides whether an email or phone call is preferred. Surprisingly, none of the participants utilized SMS to reach out to the MM, despite its ease of use and reachability provisions. This might be due to the lack of appropriate documentation of critical guidance when provided via SMS, in addition to the systemic constraint regarding the maximum allowed size of messages.

 However, in addition to being a very popular mode of communication in social life, the use of SMS has been rising, with a strong pace in critical sectors such as healthcare

 In the healthcare sector, the use of SMS was found to have a positive impact and significant cost-saving potential in various areas of healthcare activities.

 With a reduction of missed appointments that varies between 26% and 39%, the use of SMS reminders was estimated to amount to annual savings of £471,158 in the Islington Primary Care Trust in London.

In the banking sector, SMS is considered a powerful, cost-efficient tool for the majority of financial institutes. The use of SMS in banking transactions is estimated to reach 1.6 trillion transactions executed via SMS in 2015, up from 500 million transactions in 2000.

	In the clinical research arena, and based on our experience, SMS can be conventionally deployed in various aspects of the clinical trial conduct in a way that induces operational efficiencies while keeping in mind the GCP-triggered environment. For example, deploying SMS for triggering action alerts and follow-up reminders will not necessitate sharing critical study data via the SMS. At the same time, it can certainly increase the probability of timely response from the responsible MM, especially in situations where the MM does not have access to email (e.g., travelling or away from PC, and in other situations where it is not convenient for the MM to respond to a phone call, such as being engaged in a work meeting). Taking into consideration that senior members of study teams are frequently engaged in work-related on-site and off-site meetings, we have been successfully utilizing SMS to communicate trigger alerts signifying the need for urgent input. Accordingly, we believe that the use of SMS can be a swift and useful mode of communication, especially when the communication is meant to be for trigger alerts or urgent reminders.

	The importance of a project-specific knowledge base (in the form of a Q&A log) was obviously indicated by the participants in this survey. Generally, the usefulness of the project-specific knowledge based in the form of Q&A log was reported to be in an acceptable level (average score was 7 on a scale of 10). However, almost one-third of the responders (29%) indicated a below-average level of usefulness (a score of 5 or less on the scale of 10). Moreover, 2.2% of the responders considered the Q&A logs as useless (score of 0).

	It is understandable that the usefulness of the Q&A Log as a project-specific knowledge base would be significantly influenced by the quality of each individual Q&A log with regard to its thoroughness in providing relevant information and the correctness of its contents. However, the results of the survey clearly indicate the existence of a significant margin of improvement with regard to project-specific knowledge base, which forms a critical tool in the hands of clinical monitors to support their daily tasks in clinical studies. Knowing the time consumption and resources utilization of various operational and scientific team members associated with managing the medical issues, an easily-searchable and accessible, and thorough project-specific knowledge base in the form of a Q&A log or any other guiding tool would not only have a positive impact in the cost-efficient conduct of the project but would also be of an added value to the integrity and robustness of the study data.  

	The cumulative importance score was comparable for the MM qualities of being knowledgeable, easily accessible, and responsive, with no remarkable differences drawn out between these qualities in the survey data. This indicates the importance of being knowledgeable, easily accessible, and responsive as essential requirements for each MM to ensure successful medical management of the clinical project. 

	The survey was designed to outline communication methods in medical management of clinical research projects and their significance in troubleshooting medical issues during study conduct. Electronic communication, primarily via email, is the most used tool. However, its utility and effectiveness in establishing an informative and complete project-specific knowledge base should be studied further.

	The Q&A log is a useful tool in establishing an ongoing knowledge base within a study. Based on our practical experience, we believe that thoroughness, comprehensiveness, and convenience of use are the key requirements to improve the effectiveness of the Q&A log or any other tool utilized as a project-specific knowledge base.  

	Being knowledgeable is not sufficient when it comes to providing medical guidance in clinical studies; a MM is expected to be equally responsive and easily accessible to ensure harmonized study monitoring and management.

Medical Consultancy; and Vijay Rajendran, MD, is 

		“Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance.” 

http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf

		Richardson J. and Lenarcic J. “The blended discourse of SMS communication in a mobile student administrative system.” Proceedings ascilite Auckland, 2009

http://www.ascilite.org.au/conferences/auckland09/procs/richardson.pdf

	     Atun R., Sittampalam S., Mohan A. “Uses and Benefits of SMS in Healthcare Delivery.” Imperial London College and Tanaka Business School. Volume 21, Issue 1 of Tanaka Business School Discussion Papers, 2005.

		Sinclair A. and Nespola R. “Mobile Technology’s Promise for Healthcare.” GSMA and TNMG Global, 2010

http://www.gsma.com/newsroom/mobile-technologies-promise-for-healthcare-1-05-mb/

		Riley B., Schmidt A., Tubin G. “SMS in Financial Services: Accessing Your Customers on Their Terms.” Tower Group Research, 2011. 

Articles

A critical part of clinical trial conduct is providing medical guidance by the responsible medical monitor to investigative sites and various operations team members, including, but not limited to, clinical research associates and clinical study managers.

Vijayanand Rajendran

Articles

Acquiring Medical Guidance in Clinical Trials