When considering a decentralized approach to your clinical trial, it can be confusing or overwhelming to identify a provider that will truly understand and support specific study needs. ProPharma Group has put together a list of questions to guide you in selecting a Decentralized Clinical Trial (DCT) provider to enhance your trial and provide the convenience that decentralized services do offer.
Companies or organizations that facilitate, manage, and support offsite clinical trial visits, are considered decentralized clinical trial providers. These providers can be independent organizations or a division within a CRO.
DCT providers are experts in guiding the design of, implementing, and managing decentralized clinical trial visits. They work closely with sponsors and sites to highlight decentralized visit potential and benefits, train, support and oversee the nurses performing the visits, and coordinate the collection and transfer of data from the visit to the site.
If you do not have expertise on hand and are looking to adopt a decentralized approach for your clinical trial, you can bring in an outside DCT provider to implement this approach. DCT providers understand what it takes to perform study visits in the field and can make recommendations as to which visits in your study will work best, and those that will not.
When seeking a decentralized clinical trial provider, here are some questions to ask.
One of the benefits of utilizing a decentralized approach is that it can give sponsors access to more patients and help build a more diverse patient population. DCT is especially helpful for trials where patients have the opportunity to participate from various parts of the world.
If you need to reach patients in a specific location, ask your DCT provider what kind of presence they have in that region. Do they have nurses located in that area? Do they have offices nearby?
There are two models that DCT providers use for employing their clinicians who will perform the decentralized visits.
Subcontracted clinicians are often employed by other agencies such as home health organizations and add decentralized visit services on a contract basis with DCT providers. This type of employment can have challenges because often their employer might not provide the opportunity for research learning. Additionally, there can be a high turnover rate within the home health agency that can lead to nurses seeking employment elsewhere, leading to the loss of continuity of care with a single nurse. These situations lead to failed or low-quality visits, which can cause site and sponsor frustration and a poor patient experience.
For DCT providers with directly employed nurses, the direct 1:1 protocol training is completed with the study team, which enhances a streamlined training processes to support the nurses and provide them with clear communication pathways and a supportive work environment. It allows the nurse to provide continuity of care across multiple visits, establish trust and a good relationship with the patient and their families, and enhances clinical skills and techniques for success with future visits.
The time it takes for information from a decentralized visit to flow back to the site is often time sensitive. Be sure to understand whether your DCT provider uses paper-based or electronic reporting so that you can get a clear expectation of the timing for data transfer.
Ideally, electronic submission of source data collected during the visit will be faster than paper reporting which can also be prone to more errors. When the nurses in the field collect source data in real time, by utilizing software there is a reduction in turnaround time for data and allows for faster data entry into the site’s EDC. This process improves PI oversight and overall patient safety.
At ProPharma Group, we use our proprietary, 21 CFR Part 11 compliant web-based eSource application called GoClinical for our decentralized visits. It’s accessible via a mobile device or desktop browser and is customizable per protocol and visit procedures so that our clinicians capture the exact data needed for each visit.
When evaluating DCT providers, it is important to ascertain the quality of their team and resources. How do they assign team members to your study – based on who is available or based on experience with your type of trial? You can also find out more about the background of the clinicians that will be provided and the training requirements of the nurses or clinicians. Does this include company-based SOPs training and relevant ICH-GCP and Dangerous Goods (IATA) training?
Adding a DCT provider shouldn’t make things more complicated. By working directly with a DCT provider, Sponsors are consulted and guided to understand all necessary components in the design of various types of decentralized visits. The DCT provider should also be available and invested in promoting DCT services this to the sites.
Because sites can feel unsure about decentralized visits and fearful of losing control of some aspects of the patient schedule, it’s important to understand how the DCT provider plans to work efficiently to partner with and communicate effectively to execute visits off-site.
Further investigate the DCT provider’s processes for interacting with sites and whether they can be modified to accommodate study-specific requirements should you have a need.
Often patients may not understand decentralized visits or be worried about letting a person into their home. Additionally, sites might not be familiar with decentralized visits or have had a poor experience in the past. DCT providers should have collateral pieces that can be shared with both sites and patients to help them understand the process and how it works, ultimately making everyone more comfortable with the idea.
Not all DCT providers are created equal, so it is important to understand how each provider is positioned so that the proper selection can be made that fits best for the clinical trial processes and overall goals.
For example, at ProPharma Group our services are considered an extension of the site. The team works hard to create and maintain a good relationship with sites so that together we can safely and successfully complete the appropriate study visits and provide a positive experience for patients. Additionally, we understand that every trial is unique, so we bring a consultative approach to our DCT services to provide a solution that works for each study, rather than try to fit a study into a standard approach.
Other DCT providers may aim to provide the lowest cost, have the best technology, target studies within specific therapeutic areas, geographies, etc., so it’s best to ensure specific study goals align with the DCT provider capabilities and processes.
Utilizing decentralized visits adds a competitive edge to a study that does not adopt the DCT services. It is important to remember that not all DCT providers are the same, so a thorough vetting of the provider will lead to a more successful partnership.
Many sponsors start the selection process by asking their CRO to find a DCT provider. That idea is good, in theory, but CROs are often focused on selecting a provider that has the least impact to the overall cost rather than selecting the provider that is the best fit for the study. Patient safety and satisfaction as well as study goals are vulnerable if the most appropriate DCT provider is not selected. It could be the difference in the ability to provide a positive experience for patients and successfully complete the study.
At ProPharma Group, we are willing and able to partner with your CRO to provide decentralized clinical trial services. If you do not have a CRO, we look forward to providing full-service clinical trial support in union with our DCT services. Our experts work together to determine the right fit-for-purpose solution that meet study processes goals.
Contact us to get connected with a member of our team.
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