Establish Clinical Sites

Overview

Developing clinical centers that have expertise in diagnosing and caring for patients with your disease increases the ability to conduct clinical trials and optimizes clinical care. When clinicians and staff have specialized experience and established relationships with patients, they are better prepared for conducting clinical trials. Additionally, when clinical centers have been uniformly trained in evaluation procedures, variability among the sites in the trial Network is minimized.

Clinical Care Networks

Establishing certain hospitals as Clinical Care Centers of Excellence for your disease can increase the quality of care every patient receives. In many cases, the diagnostic criteria, clinical care guidelines, and measures to monitor disease progression have not yet been established. Clinicians and staff at the Centers can develop these important elements, forge relationships with patients and their families, and increase the readiness for performing clinical trials when a new therapy is developed.

Advantages to having clinical centers include:

  • Diagnostic criteria can be developed and published to clearly define the patient population and decrease time to diagnosis.
  • Clinical care guidelines (standards of care) can make certain that patients with your disease are receiving the best medical care no matter where they live.
  • New clinicians and staff can be trained at established Centers, as well as at future Centers.
  • Clinical measures can be developed to track changing outcomes overtime.
  • Strong relationships between patients and their families and the clinicians and staff at Centers can increase the medical and quality of life knowledge about your disease.
  • Clinical Centers of Excellence can work together as a network to collect medical data, perform natural history studies,  establish and validate clinical outcome measures, and help design clinical trials.

Clinical Trial Sites

An established Network of Clinical Centers of Excellence can provide the clinical sites needed for a clinical trial. When a new therapy is being tested to determine safety and efficacy, it is important that the Sponsor is confident that the data collected during the trial is consistent across clinical research sites. Using established Centers for clinical trials sites website can:

  • Increase participation in a clinical trial, since the trial will be available at Centers many patients and their families are already going to for their clinical care.
  • Ensure participant eligibility is correctly determined using the established diagnostic criteria for the disease as well as other clinical trial specific eligibility requirements.
  • Decrease time needed to train clinicians and staff in the clinical trial procedures and data collection for the clinical trial.
  • Make sure patients enrolled in the clinical trial are also receiving established clinical care.

Tips for Success

Even though it is clear that establishing a Center of Excellence Network is important for clinical care and research efforts, it may seem like an overwhelming task. If your disease is newly discovered or very rare, there may not be many identified patients and they may be scattered across the globe. Learning how other rare disease patient groups have established their own Network can provide you with the inspiration you need to move forward. 

  • Ask members of your Medical/Scientific Advisory Board whether they are willing to establish a Center of Excellence at their associated university medical center. 
  • Find  a university or tertiary care medical center or centers that have been caring for at least a few patients with your disease.
    • Contact 1 or more of the clinicians who have seen the patients to determine whether they would be willing to be involved in a Center of Excellence for your disease.
    •  If specialists for your disease tend to be in one main department, approach the department chair.
    • Reach out to the university medical center administration to determine whether their center has a framework for establishing a Center of Excellence. 
  • Find a university or tertiary care medical center that already has established multidisciplinary clinics for other diseases. 
    • Determine whether there are any open time slots in the space used for the multidisciplinary clinic that can be used to establish a multidisciplinary clinic for your disease.
    • Contact relevant specialists at the center to determine whether they would be willing to participate in a multidisciplinary clinic for your disease.
    • Start small, maybe offering 1 morning or afternoon a month, and grow as needed.
    • Grow the Network in other areas of the country using the same strategy.
  • Provide families with resources that can help with travel costs or consider partnering with other organizations or a donor to more directly provide assistance.
  • Consider establishing a Data Coordination Center to which all data are sent, maintained, and analyzed as the number of clinical centers in your Network grows.
  • Offer research grants to help support the Principal Investigator and Clinical Trial coordinator when a clinical trial begins. Partnering with other, larger organizations or philanthropic organizations may make this more feasible.
  • Read Centers of excellence in healthcare institutions: what they are and how to assemble them (2017), a published medical article detailing 1 university medical center’s framework for establishing multidisciplinary clinics.

Developing clinical centers that have expertise in diagnosing and caring for patients with your disease increases the ability to conduct clinical trials and optimizes clinical care. When clinicians and staff have specialized experience and established relationships with patients, they are better prepared for conducting clinical trials. Additionally, when clinical centers have been uniformly trained in evaluation procedures, variability among the sites in the trial Network is minimized.

Establishing certain hospitals as Clinical Care Centers of Excellence for your disease can increase the quality of care every patient receives. In many cases, the diagnostic criteria, clinical care guidelines, and measures to monitor disease progression have not yet been established. Clinicians and staff at the Centers can develop these important elements, forge relationships with patients and their families, and increase the readiness for performing clinical trials when a new therapy is developed.

Advantages to having clinical centers include:

  • Diagnostic criteria can be developed and published to clearly define the patient population and decrease time to diagnosis.
  • Clinical care guidelines (standards of care) can make certain that patients with your disease are receiving the best medical care no matter where they live.
  • New clinicians and staff can be trained at established Centers, as well as at future Centers.
  • Clinical measures can be developed to track changing outcomes overtime.
  • Strong relationships between patients and their families and the clinicians and staff at Centers can increase the medical and quality of life knowledge about your disease.
  • Clinical Centers of Excellence can work together as a network to collect medical data, perform natural history studies,  establish and validate clinical outcome measures, and help design clinical trials.

An established Network of Clinical Centers of Excellence can provide the clinical sites needed for a clinical trial. When a new therapy is being tested to determine safety and efficacy, it is important that the Sponsor is confident that the data collected during the trial is consistent across clinical research sites. Using established Centers for clinical trials sites website can:

  • Increase participation in a clinical trial, since the trial will be available at Centers many patients and their families are already going to for their clinical care.
  • Ensure participant eligibility is correctly determined using the established diagnostic criteria for the disease as well as other clinical trial specific eligibility requirements.
  • Decrease time needed to train clinicians and staff in the clinical trial procedures and data collection for the clinical trial.
  • Make sure patients enrolled in the clinical trial are also receiving established clinical care.

Even though it is clear that establishing a Center of Excellence Network is important for clinical care and research efforts, it may seem like an overwhelming task. If your disease is newly discovered or very rare, there may not be many identified patients and they may be scattered across the globe. Learning how other rare disease patient groups have established their own Network can provide you with the inspiration you need to move forward. 

  • Ask members of your Medical/Scientific Advisory Board whether they are willing to establish a Center of Excellence at their associated university medical center. 
  • Find  a university or tertiary care medical center or centers that have been caring for at least a few patients with your disease.
    • Contact 1 or more of the clinicians who have seen the patients to determine whether they would be willing to be involved in a Center of Excellence for your disease.
    •  If specialists for your disease tend to be in one main department, approach the department chair.
    • Reach out to the university medical center administration to determine whether their center has a framework for establishing a Center of Excellence. 
  • Find a university or tertiary care medical center that already has established multidisciplinary clinics for other diseases. 
    • Determine whether there are any open time slots in the space used for the multidisciplinary clinic that can be used to establish a multidisciplinary clinic for your disease.
    • Contact relevant specialists at the center to determine whether they would be willing to participate in a multidisciplinary clinic for your disease.
    • Start small, maybe offering 1 morning or afternoon a month, and grow as needed.
    • Grow the Network in other areas of the country using the same strategy.
  • Provide families with resources that can help with travel costs or consider partnering with other organizations or a donor to more directly provide assistance.
  • Consider establishing a Data Coordination Center to which all data are sent, maintained, and analyzed as the number of clinical centers in your Network grows.
  • Offer research grants to help support the Principal Investigator and Clinical Trial coordinator when a clinical trial begins. Partnering with other, larger organizations or philanthropic organizations may make this more feasible.
  • Read Centers of excellence in healthcare institutions: what they are and how to assemble them (2017), a published medical article detailing 1 university medical center’s framework for establishing multidisciplinary clinics.