Millions of patients are diagnosed each year with acute pain conditions, whether as a result of surgery, trauma or acute illness.

ICON’s experienced neuroscience and drug development teams work with clients at all stages of clinical design and execution of trials in acute and chronic pain disorders, including autoimmune rheumatic diseases and specialised CNS teams for rare diseases and pediatric pain. This includes a collaborative, joint review of your key documents, such as Target Product Profile, Clinical Development Plan, Investigator Brochure and Regulatory Strategy materials to identify the methodologies that will best add value to your research, meet your objectives and ensure success of your pain study.

Managing placebo response

ICON has developed a unique set of materials to address the key drivers for placebo responses; patient expectations, baseline bias/inflation, and rating inconsistencies. This includes site training materials for site staff, a patient e-workbook, data analytics to manage baseline inflation, and integration of more objective endpoints which are indirectly linked to pain, for inter-scale plausibility assessment. See brochure below for more details.

ICON experience in pain studies in the last five years

  • 60+

    Acute and chronic pain studies
  • 25,500+

    Patients involved
  • 4,000+

    Experienced pain sites worldwide

Accellacare experience in pain studies

  • 284

    Pain studies conducted
  • 4,400

    Patients involved
  • 77

    Sites worldwide

Accellacare, ICON's dedicated global site network, has strong back pain, fibromyalgia, migraine, neuropathic pain and post herpetic neuralgia experience in particular, and provides a range of services for both ICON and sponsor-direct studies:

  • Board Certified Neurologists, Internal Medicine, and family physicians
  • Assessment and reporting of pain related AE’s and SAE’s
  • Electronic diary management/training
  • End point collection
  • Current knowledge regarding use of pain rating scales
  • VAS questionnaires
  • Numerical pain score
  • Pain detect
  • Training with analgesic solution
  • E-diary
  • Nerve conduction tests
  • Access to MRI/Xrays
  • Access to physiotherapists for back pain
  • Access to chiropodist for neuropathic pain
  • Access to pain clinics/neurologists

 

Endpoint quality strategies

ICON has all relevant services for wet, imaging and digital biomarker endpoints in house.

Since soft endpoints are still crucial in pain studies, ICON recommends implementing these in a way that maximises the reliability of the generated data. ICON is the leading sponsor of Mapi Research Trust, a non-profit organization and license holder of over 4,360 COAs including 274 pain related instruments and the official distributor of 26 COAs in pain indications, including some of the most commonly used as efficacy endpoints. ICON Clinical Outcomes Assessment (COA) experts have the world's largest database of PRO and other clinical outcomes assessments (COA), work in over 300 langauges, and will support you at all stages of development, from endpoint selection and Patient Reported Outcomes (PRO) development, to use in clinical trials, through post-approval work and publications.

To address the potential weaknesses of subjective pain endpoints, ICON provides an end-to-end approach to effective integration of wearable devices into trial design, execution and reporting. ICON's end-to-end framework for digital endpoints including digital biomarkers, has been used in over 40 studies.

Medical Imaging for pain studies

Disease which causes pain and severe discomfort for patients that worsens as the disease progresses includes arthropathies, such as osteoarthritis, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Imaging, in particular x-rays and magnetic resonance imaging, plays a large role in the objective evaluation of joint structure for disease modifying anti-rheumatic drugs and pain relieving drugs. ICON Medical Imaging routinely provides expert imaging services for acute and chronic pain trials, using subspecialty, primarily academic radiologists as readers.

Adaptive design for pain trials

Often short treatment periods in pain studies easily allow for adaptive designs to accelerate the development.

  • ICON has experience in over 250 adaptive design trials for over 30 sponsors
  • ICON is the only CRO to offer a validated design, simulation and analysis software platform for adaptive clinical trials. This platform, ADDPLAN®, is used by regulatory agencies around the world: FDA (US), EMA (Europe) and PMDA (Japan).
  • FLEX ADVANTAGE, ICON’s interactive response technology (IRT) system, is built to manage complex adaptive study designs.