Informed consent is not only an ethical requirement but also a legal one, with specific guidelines outlined in the Common Rule and FDA regulations. Other informed consent regulations include: The Office of Human Research Protections (OHRP) regulation 45 CFR 46.116, General Data Protection Regulation (GDPR) in Europe, and the National Statement on Ethical Conduct in Human Research in Australia. These regulations ensure that participants are fully informed about the risks and benefits of the study, as well as any alternative treatments or procedures. The regulations also require researchers to minimize the risk of harm to participants and to protect their confidentiality and privacy.

However, creating an informed consent document can be a complex and challenging task. The guidelines for Informed Consent Forms (ICFs) can use technical jargon that may be difficult for participants to understand, and researchers may struggle to balance the requirements of the regulations with the need for clear and concise information. Preparing an informed consent document is a crucial step in conducting ethical and responsible research, and understanding the basics can help researchers navigate the process with greater ease. In this blog, we shall delve into the intricate art of crafting informed consent documents that comply with the exacting standards of the FDA and Common Rule guidelines.

FDA and Common Rule: Basic Elements for Informed Consent Writing

The FDA and Common Rule require nine fundamental elements to be included in informed consent documents:

1. Introduction: The introduction should identify the research project, explain its purpose, and describe the procedures that will be performed.
2. Purpose of the research: The purpose of the research should be clearly explained, including the scientific goals, the procedures involved, and the expected duration of the study.
3. Foreseeable risks and discomforts: The potential risks and discomforts associated with the research should be described in detail, including any physical, psychological, social, or economic harm that may result.
4. Possible benefits: Any potential benefits of participating in the study should be explained, including direct benefits to the participant, benefits to others, and benefits to society.
5. Possible alternatives: The participant should be informed of any available alternative treatments or procedures and the benefits and risks associated with each.
6. The Extent of confidentiality: The extent to which confidentiality will be maintained should be described, including any exceptions to confidentiality.
7. Terms for compensation for injury: The terms for compensation for any injury that may result from participation in the study should be explained.
8. Statement of voluntary participation: The participant should be informed that participation is voluntary and that they can withdraw from the study at any time without penalty.
9. Clinical trial disclosure statement for Phase II studies: If the study is a Phase II clinical trial, a statement disclosing whether the drug or device being tested has been approved by the FDA for any use should be included. A Phase II study must also include the following statement as mentioned on the FDA website:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.”

FDA and Common Rule: Additional Elements for Informed Consent

In addition to the 9 basic elements of informed consent required by the FDA and Common Rule, there are 10 additional elements that are essential to ensure that research participants are fully informed before deciding to participate in a study. These additional elements address specific concerns and considerations that may arise in certain types of research studies and provide important information for participants to make an informed decision about their participation.  In this section, we will discuss each of these 10 additional elements in detail.

1. Potential risks to pregnant subjects or developing fetuses: If the study involves pregnant women or women of childbearing age, this element informs them of the potential risks to their own health or that of their developing fetus.
2. Possibility of termination of participation: This element outlines the process for terminating participation in the study, including the participant’s right to withdraw at any time without penalty.
3. Costs to the participant: This element explains any costs that the participant may incur as a result of participating in the study, such as travel expenses or medical procedures that are not covered by insurance.
4. Procedure for terminating participation: This element explains the steps that the participant must take to terminate their participation in the study.
5. Commitment to update the subject on study findings: This element outlines the researcher’s commitment to keeping the participant informed about any significant findings that emerge during the course of the study.
6. Estimate of the total number of participants: This element provides an estimate of the total number of participants in the study, which can help the participant understand the scope of the research.
7. Description of the “Certificate of Confidentiality” for NIH-funded studies: This element explains the purpose and significance of the Certificate of Confidentiality, which is intended to protect the participant’s privacy and confidentiality.
8. Information on the Genetic Information Nondiscrimination Act (GINA) for genetic testing studies: This element explains the implications of GINA for genetic testing studies, including the participants’ right to privacy and protection against discrimination based on their genetic information. For infectious diseases or epidemics, this element requires including a statement that results are required by law to be reported to local health authorities.
9. Statement on reporting results for infectious diseases or pandemics: This element explains the researcher’s obligation to report any positive test results for infectious diseases or pandemics, such as HIV or COVID-19.
10. Additional statements for Common Rule studies: This element may include any additional statements or disclosures that are required under the Common Rule, which is a set of federal regulations governing research with human subjects.

In order to safeguard the rights of subjects in research that is governed by the Common Rule, it is crucial to incorporate certain essential statements. Firstly, a statement should be included regarding the possibility of removing identifiers from collected data for future research purposes without the need for further informed consent to maintain subject privacy and prevent unauthorized use of their personal information. Alternatively, a statement should be added that obtained biological samples cannot be utilized for future research without the explicit consent of the subject, particularly for sensitive or personal data such as genetic information, to protect their privacy. Thirdly, it is necessary to incorporate a statement that specifies whether the subject’s biological samples may be commercially reused. This is important to allow the subject to make an informed decision regarding the potential commercial usage of their samples. Fourthly, a statement must be included to explain the circumstances under which clinically relevant research findings will be disclosed to the subject. This is important to ensure that the subject understands the possible benefits and risks associated with participation and can make an informed decision. Finally, a statement should be added indicating if the investigator intends to perform whole genome sequencing to inform the subject about any associated risks and allow them to make an informed decision.

By including these statements in research governed by the Common Rule, researchers can ensure that they adhere to ethical and industry standards, protect the privacy of subjects, and respect their rights during the research process.

 3 Ways Laboratory Software for Clinical Research Supports Informed Consent Management

 Utilizing laboratory software for clinical research, also known as Laboratory Information Management System (LIMS), can aid clinical researchers in automating and simplifying the handling of informed consent procedures. This not only decreases the chances of human error but also eliminates the possibility of tampering with the Informed Consent Forms (ICFs).

Let’s look at 3 ways a LIMS helps support clinical researchers in consent management.

1. Manage Documents  A LIMS manages all internal and external documents including consent forms, standard operating procedures (SOPs), and quality management manuals. The system keeps track of each document’s revision history to ensure that employees only access the most recent version. Additionally, a LIMS assigns role-based access rights to staff, allowing controlled access to confidential documents. With the document management feature, users can manage the latest version of the consent form. A LIMS can also associate filled-out consent forms with individual participant records for proper tracking and consent management.
2. Protect the Privacy of Participants  A LIMS ensures the anonymity of sensitive participant data and grants role-based access rights to protected health information (PHI) of participants. Only authorized personnel can view the masked data, and any changes or views of PHI are logged in the audit trail. This feature is beneficial for audits as external auditors can request a PHI audit report at any time
3. Associate Participants with a Study  A LIMS allows users to create a clinical research study and associate participants with it. In this way, all participants are associated with the study. Thus, all the consent forms, participant data, and all SOPs that apply to a study can be organized in one place.

A clinical LIMS helps automate and streamline the management of informed consent. It minimizes human error associated with manual paper-based processes and also eliminates ICF tampering risks. What’s more, a clinical LIMS can be integrated with digital tools used for the collection of informed consent.

Conclusion

Creating an informed consent document is a complex and challenging task that requires balancing regulatory requirements with the need for clear and concise information. Laboratory software for clinical research streamlines the process of managing informed consent documents to help researchers comply with the standards of the FDA and Common Rule guidelines. Using a LIMS can be a differentiator for clinical research labs, as it can make the consent management process a breeze, leading to better participant satisfaction and improved research outcomes.

About CloudLIMS

CloudLIMS.com is an ISO 9001:2015 and SOC 2-certified informatics company. Their SaaS, in-the-cloud Laboratory Information Management System (LIMS), CloudLIMS, offers strong data security, complimentary technical support, instrument integration, hosting and data backups to help biorepositories, analytical, diagnostic testing and research laboratories, manage data, automate workflows, and follow regulatory compliance such as ISO/IEC 17025:2017, GLP, 21 CFR Part 11, HIPAA, ISO 20387:2018, CLIA, ISO 15189:2012, and ISBER Best Practices at zero upfront cost. Their mission is to digitally transform and empower laboratories across the globe to improve the quality of living.

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across
their organizations.

The post Navigating the Complexities of Informed Consent Writing: Tips and Strategies for Clinical Researchers appeared first on Astrix.

Decentralized clinical trials (DCTs) are a modern approach to conducting clinical trials that allow some or all trial-related processes to be carried out at non-conventional locations. This can be more convenient for trial participants, as they may be able to complete trial-related activities in places like their homes or local healthcare facilities. A hybrid DCT combines traditional clinical trial settings with alternative locations for different activities. These new approaches offer exciting possibilities for clinical trial research and can improve patient participation.

FDA Nonbinding Recommendations for Decentralized Clinical Trials:  May 2023, Not for Implementation¹

Design of Decentralized Clinical Trials

Decentralized clinical trials (DCTs) are becoming increasingly common, allowing trial-related activities in non-traditional locations like local healthcare facilities or the patient’s home. Although the investigator oversees all activities like imaging and lab services, a physical location for clinical trial-related records and personnel interviews are required. This location must be disclosed on Form FDA 1572 or included in the investigational device exemption (IDE) application.²

Remote Clinical Trial-Related Activities

When planning strategies for remote clinical trials, it is essential to keep in mind the convenience and accessibility these trials offer to participants. Consider the following points when creating your non-traditional clinical trial plans:

• Consider telehealth visits when in-person interaction is not required.³ Case report forms and required documentation should be completed for all telehealth visits.
• In-person visits and trial-related activities can be conducted by trial personnel at participants’ homes or other suitable locations.
• Activities related to the trial may also be done by health care professionals (HCPs) close to the trial participants’ homes but not a part of the trial staff. These services should not require deep protocol knowledge or the investigational product (IP).
• Investigators must verify the identity of the trial participant during each remote trial visit.
• The protocol for the trial should outline how any adverse events identified remotely will be assessed and handled.

Digital Health Technologies (DHTs) for Remote Data Acquisition

Decentralized clinical trials are being powered by Digital Health Technologies (DHTs), which enable remote healthcare services. DHTs are versatile and can be used for various health purposes, including general wellness and medical device applications. Popular examples of DHTs include wearables, sensors, mobile health apps, and telemedicine platforms.

Through the use of DHTs, sponsors, clinical investigators, and participants can remotely measure critical clinical events and characteristics of interest. These technologies allow data transmission from anywhere, making trials more affordable, efficient, and safe. With DHTs, study participants can transmit data from anywhere, eliminating the need for constant in-person monitoring.

Roles & Responsibilities of Sponsors and Investigators

The responsibilities of sponsors are the same for both DCTs and traditional trials conducted at a site.⁴ It is important for sponsors to ensure that the trial population is diverse and inclusive.⁵ To account for multiple data collection sources in a DCT, the sponsor should create a data management plan (DMP). This plan should include information about the origin and flow of data from all sources to the sponsor, such as a diagram showing how the data is created and stored. Additionally, the plan should detail the methods used for remote data acquisition from trial participants, trial personnel, and contracted service providers (e.g., local clinical labs and healthcare practitioners performing trial-related activities).^6,7 Lastly, the plan should contain a list of vendors involved in data collection, handling, and management.

Investigators are responsible for the conduct of the DCT and the oversight of individuals delegated to perform trial-related activities, including ensuring that these delegated activities and tasks are conducted according to the investigational plan, applicable regulations, and relevant laws.^8,9 When allowed by the trial protocol, a trial investigator may delegate trial-related activities to local HCPs to perform medical procedures requiring in-person interactions with trial participants (e.g., physical examinations).¹⁰ These procedures may occur at the participant’s location or another local healthcare facility as outlined by the trial protocol.

Informed Consent and IRB Oversight

Investigators can get electronic consent from trial participants at their remote locations as long as all necessary regulations regarding informed consent are met. Institutional review board (IRB) oversight is required to ensure the process is carried out correctly.¹¹ Obtaining electronic consent remotely may include a remote visit if necessary. The informed consent should detail who will have access to the personal health information gathered during the trial.¹²

Investigational Products in a Decentralized Clinical Trial

Drugs and Biological Products

The investigator responsible for the trial must administer investigational products (IPs) only to participants under their direct supervision or the supervision of a sub-investigator.¹³ The IP’s complexity should be considered when deciding whether administration in a DCT is appropriate. IPs with a high-risk safety profile, especially in the immediate post-administration period or those still in the early stages of development such that their safety profile is not yet known, may require the investigator to be present at the trial site. However, if the safety profile of the IP is well-established and does not require specialized monitoring immediately following administration, it may be feasible for HCPs or trial personnel to administer the IP at local healthcare facilities or participants’ homes. Hybrid DCTs may be suitable for drugs that require supervised but infrequent (e.g., monthly) administration, as the administration can be done at trial sites with follow-up done remotely.

Medical Devices

When deciding the proper use or application of an investigative device in a clinical trial, sponsors should consider the type of medical device, its purpose, how it should be used, and whether it poses a significant risk.¹⁴ Medical devices that are safe to use at home (such as over-the-counter devices) and do not present substantial risks to the trial participants may be used in a DCT without the investigator’s direct supervision. On the other hand, medical devices not meant for self-use (such as those used in hospitals or ambulatory care settings) or that pose a significant risk should be operated or administered by qualified trial personnel, and the investigator should be present to oversee it.

Packaging and Shipping Requirements for Investigational Products

DCTs may allow investigational products to be directly distributed to trial participants at their locations.¹⁵ The protocol should detail how the physical integrity and stability of the IP will be maintained during shipment, including the packaging materials and methods that should be used (e.g., temperature control). A central distribution service may be employed to ship the IP to trial participants. It is the responsibility of the investigator or delegated trial personnel to control the release of the IP from the distributor, monitor receipt and use by trial participants (or their legal representatives) according to the protocol, and monitor the return or disposal of any unused product as directed by the sponsor.¹⁶ It is important to adhere to applicable Federal, State, and international laws and regulations that address the shipping of IPs in the respective jurisdictions.

Safety Monitoring Plan

The sponsor must ensure the investigation is monitored correctly and carried out according to the general investigational plan and protocols in the IND or IDE applications.¹⁷ A safety monitoring plan should also be implemented to guarantee the safety of participants in a DCT, including information on how to report and respond to any adverse reactions, as well as where to find local medical help and follow-up care.¹⁸ If any significant safety concerns arise from the remote administration or use of an IP, the sponsor must immediately stop the remote administration or use, inform the FDA, IRB, and all the investigators involved, and decide if the trial should go on.¹⁹

Software Used for Managing DCTs

Software can be used to help manage clinical trials (DCTs) on various platforms, such as tablets, cell phones, and personal computers. This software can be used to perform many tasks, including managing electronic informed consent forms, capturing and storing reports from remote trial personnel and HCPs, managing electronic case report forms (eCRFs), scheduling trial visits and activities, tracking the shipment of IPs to trial participants, syncing data recorded by DHTs, and serving as a communication tool between trial personnel and participants. Local HCPs can submit trial-related data to be included in records in several ways, such as entering it directly into the eCRF or uploading forms and documents through secure data transfer methods.²⁰ Investigators or other trial personnel are then responsible for entering this data into the eCRF, and any remote trial personnel or local HCPs submitting data directly should be on the sponsor’s list of authorized data originators.^21,22

Software programs used to generate and manage trial data required by the FD&C Act and FDA regulations are subject to 21 CFR Part 11. These programs must ensure the data’s accuracy, security, privacy, and confidentiality.^23,24 Real-time video interactions, such as telehealth, as a live exchange of information between trial personnel and participants, are not considered electronic records and are not subject to 21 CFR Part 11. However, local laws related to telehealth may still be applicable. It is important to ensure the privacy and security of these real-time visits and to document them.²⁵ If this documentation is stored electronically, it is subject to 21 CFR Part 11.

Summary

Digital technology is opening up a wide range of possibilities for clinical trials. Remote activities involving participants no longer need to occur exclusively at traditional clinical trial sites using software solutions and services capable of running fully remote, virtually managed decentralized clinical trials (DCTs). However, implementing DCTs comes with its challenges and complexities. For example, remote assessments may differ from on-site assessments, especially when trial participants are responsible for performing their own physiological tests (e.g., home spirometry).

Assessments done by local healthcare professionals (HCPs) as part of their regular clinical practice, such as evaluating patient symptoms, may also be more variable and less precise than assessments done by dedicated trial personnel. Combining in-house and HCP expertise with the latest technologies can help minimize patient testing variance, while enterprise risk assessments and secure data management systems can help ensure data collection and privacy remain protected.

The potential benefits of DCTs are vast. They expand access to more diverse patient populations, increase trial efficiency, and provide greater convenience for participants and caregivers. Telehealth, digital health technologies (DHTs), and remote data collection enable trial participation from different locations. This can help improve participant engagement, recruitment, enrollment, and retention of a more meaningfully diverse clinical population.

About Astrix

Astrix is the unrivaled market leader in creating & delivering innovative strategies, technology solutions, and people to the life science community. Through world-class people, process, and technology, Astrix works with clients to fundamentally improve business, scientific, and medical outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of fully integrated services designed to deliver value to clients across their organizations. To learn the latest about how Astrix is transforming the way science-based businesses succeed today, visit www.astrixinc.com.

References: 

¹ This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Oncology Center of Excellence (OCE) at the Food and Drug Administration.

²  See 21 CFR 812.20(b).

^3,4 See 21 CFR parts 312 and 812.

⁵ FDA, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials – Draft Guidance, April 2022, https://www.fda.gov/media/157635/download, accessed May 23, 2023.

^6,23 FDA, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers – Draft Guidance, March 2023, https://www.fda.gov/media/166215/download, accessed May 23, 2023.

⁷ FDA, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations —Draft Guidance, December 2021, https://www.fda.gov/media/155022/download, accessed May 23, 2023.

⁸ See 21 CFR 312.60, 312.61, and 812.100.

⁹ FDA, Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects, October 2009, https://www.fda.gov/media/77765/download,  accessed May 24, 2023.

¹⁰ See 21 CFR 312.3 and 812.3.

¹¹ See 21 CFR 56.103, 56.104, and 56.105.

¹² See 21 CFR part 50, 21 CFR 50.25, 21 CFR 50.27, and FDA, Use of Electronic Informed Consent: Questions and Answers – Guidance for Institutional Review Boards, Investigators, and Sponsors, December 2016,  https://www.fda.gov/media/116850/download, accessed May 24, 2023.

¹³ See 21 CFR 312.61.

¹⁴ FDA, Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors — Significant Risk and Nonsignificant Risk Medical Device Studies, January 2006, https://www.fda.gov/media/75459/download, accessed May 24, 2023.

¹⁵ See 21 CFR 312.61. 39 and FDA, Guidance for Industry CGMP for Phase 1 Investigational Drugs, July 2008, https://www.fda.gov/media/70975/download, accessed May 24, 2023.

¹⁶ See 21 CFR 312.61, 312.62(a), and 812.110.

¹⁷ 21 CFR 312.50, 21 CFR 812.40 and FDA, Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring — Guidance for Industry, August 2013, https://www.fda.gov/media/116754/download, accessed May 24, 2023.

¹⁸ FDA, E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) — Guidance for Industry,  March 2018, https://www.fda.gov/media/93884/download, accessed May 24, 2023.

¹⁹ See 21 CFR 312.56(d) and 812.46.

^20,22,24 FDA, Guidance for Industry Electronic Source Data in Clinical Investigations, September 2013,  https://www.fda.gov/media/85183/download, accessed May 24, 2023.

²¹ See 21 CFR 312.62 and 812.140.

²⁵ See 21 CFR 312.62(b) and 812.140(a)(3).

All CFR regulations cited above can be accessed through this portal: National Archives, Code of Federal Regulations Title 21, March 28, 2023, https://www.ecfr.gov/.

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The drive to establish capabilities cannot come at the expense of measuring meaningful impact. Establishing criteria for success will help guide sponsors in selecting the appropriate decentralized clinical trials (DCT) elements for a given trial to best meet goals for patient recruitment, diversity, and retention, along with the site and sponsor benefits. As sponsors carefully consider different DCT elements and as the industry progresses through to the point of increasing adoption, it’s important to measure both short and long-term value and to determine how to best interpret that value for future decision-making. DCT represents a way to provide value to both patients and sites as well.

Ultimately, sponsors should look to how best to create both value and differentiation in terms of understanding the impacts of DCT enablement. This, then, helps organizations to assess where and how to invest, and how to measure outcomes, and impacts of DCT for their trials. Sponsor organizations that succeed in understanding DCT impact will be better positioned to make strategic decisions to establish their DCT portfolio to succeed as leaders in digital patient engagement.

Decentralized Clinical Trial Adoption

Leveraging these approaches requires a thorough digital transformation. It involves a change in the way the organization works to transform the business and the operating models. It requires a rethinking of how the value to the patient and site experiences are ultimately delivered.

DCT exists on a spectrum and the journey to enablement relies on continuous improvement. In the last few years, there have been significant changes in the area of clinical trial modernization. We see a rapid pace of change in many of the capabilities being offered. Whether it’s related to patient recruitment, site enablement, or novel ways of capturing patient data, capabilities are continually progressing. As we work with our clients and look at the longer-term view and the road ahead to map out the vendors and suppliers, we’re seeing many new innovations that are disrupting the market. We, therefore, need to work towards an agile transformation. Concepts like hackathons and innovation labs, along with establishing different ways of working, can hasten the enablement of effective digital transformation.

Delivering on the promise of digital transformation will, however, require thinking beyond the frameworks of technology and data. It requires a look at the structure of the business processes and roles, both internally and with partners, so they are oriented to fully capitalize on improvements in data access and decision-making, (i.e., modernization of the operating model). Taking a holistic view can provide the organization with the ability to pilot models for clinical trial modernization at a smaller scale to not only validate the technology but also enable, through evaluation and planning, adoption to scale.

It starts by looking at the concept of human centricity and how we can foster and empower the workforce to embrace a continuous Improvement mindset mindful of the customer experience.

Several Key Considerations Relative to an Organization’s Adoption of DCT

Think People First 

• Organizations change when people change
• Understand the organization change readiness & opportunities for adoption… quick wins

Align Across the Business-Customer

• Understand the impact of a new solution/services on people, process & governance and how value is defined and measured

Agile Transformation

• Many organizations are looking to change their ways of working to adopt “Human centricity” approaches
• This places humans at the centre of a business’s purpose, strategy and everyday business, to enhance the human experience
• It aims to create organizations which are agile and optimized for continuous improvement of the customer experience, while empowering the workforce

Digital Transformation

• Digital transformation marks a rethinking of how an organization uses digital technologies with data, people, and processes to fundamentally change business performance and the customer experience

Change as way of working

• Change is as much as journey as it is a destination, grounded in qualifiable measures to manage the transformation

Summary

We’re seeing the first iteration of DCT 1.0. This area continues to evolve with new technology and methods to improve both digital trial enablement and digital patient centricity.

It is critically important, when looking to incorporate clinical trial modernization via DCT into your business, that you ensure you have the right external organizations involved who can assist you. Formulating the appropriate strategy along with the proper processes, and technology is imperative. Astrix’s team of professionals has worked with many of the top life science organizations to assist them with respect to their business needs in these areas. As a technology-agnostic partner, without a preconceived preference for a specific supplier or product, we work closely with your team to ensure solutions are reviewed and incorporated into your business so that you succeed in realizing your vision and achieving your organizational goals.

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world-class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

The post Decentralized Clinical Trials: Measuring the Impact and Gaining Adoption appeared first on Astrix.

We are seeing the following trends in clinical trial modernization being facilitated by increasing decentralized clinical trials use:

Limited growth in solutions with cross Patient-Site-Sponsor views and exchanges of information, with enabling workflows (e.g., Still Point Solutions)

Increase in offerings and tools around:

• Digital CRO and decentralized clinical trials vendor/partner solutions
• ‘Digital Diagnostics’​ for decentralized clinical trials  outcome measures
• AI/ML enablement

Continued challenges with:

Interoperability to share decentralized clinical trials as a ‘Service’ (vs adjunct technologies and service providers)

• Sites want to use their own technology beyond e-content, eCOA, and the Telehealth definition of DCT. Innovation is happening in Digital CRO, DCT Solutions & Partners, and in Wearables and the medical home, along with ‘value-based care’ outcomes.
• Need for sponsors to have measurable outcomes for site and patient adoption of DCT, i.e. what are the benefits to the customer vs sponsor value.

DECENTRALIZED CLINICAL TRIALS ENABLEMENT

Much of our work is being done for our clients looking to improve their process, technology, capability, and organizational culture. The improvement can be either:

• Foundational (base capabilities)
• Enabling (more advanced capabilities)
• Innovation (expanding beyond the enabling capabilities)

Most of our clients are split between the Foundational space and Enabling areas with some moving up into the Innovation region relative to clinical trial modernization enablement through decentralized clinical trials.

Our clients are focusing on some key decentralized clinical trials areas. While some are focused on capabilities associated with Telemedicine, Home Health, and the coordination of care, others are enabling technologies centered around digital protocol, and SOA to automate workflows and communications.

 Some of our clients are considering the incorporation of: 

• e-content document exchange,
• risk-based, and remote monitoring.

Any of these can influence the designs of the actual protocol, as well as changes to current process and ways of working. One theme among our engagements is assisting our clients to assess ways in which they can improve the overall clinical operating model through: simplifying the number of points and use of platforms and integrations, and reducing [the volume of] data capture, entry, and updates as they work to improve their overall clinical operating model.

In working with our clients, one main area they look to focus on is clearly understanding the availability of decentralized clinical trials capabilities, technologies, and the vendors providing them. This is typically one of the first areas we focus on with the client to understand capabilities and how they could be leveraged. Using this information, we can help shape the organization’s requirements and construct a client-centric strategy for clinical trial modernization for both the current and future business needs.

Summary

We’re seeing the first iteration of decentralized clinical trials 1.0. This area continues to evolve with new technology and methods to improve both digital trial enablement and digital patient centricity.

It is critically important, when looking to incorporate clinical trial modernization via decentralized clinical trials into your business, that you ensure you have the right external organizations involved who can assist you. Formulating the appropriate strategy along with the proper processes, and technology is imperative. Astrix’s team of professionals has worked with many of the top life science organizations to assist them with respect to their business needs in these areas. As a technology-agnostic partner, without a preconceived preference for a specific supplier or product, we work closely with your team to ensure solutions are reviewed and incorporated into your business so that you succeed in realizing your vision and achieving your organizational goals.

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

The post Astrix Blog – Decentralized Clinical Trial Trends appeared first on Astrix.