The direction of flow along the translational pathway is often two-way. That is, findings from basic research or clinical observations can inform a clinical intervention or development of a product (T1) and then testing of that intervention or product (T2) can feed back to the T1 stage and help improve upon the intervention or product.
As products and novel approaches to disease are developed from basic and clinical research, health technology assessment and service delivery research are used to ascertain how and when best to apply them in practice (Cooksey, 2009).
Lab to Bedside Example
Observations made in the laboratory may lead to better understanding of disease and novel interventions to be used in clinical settings. Equally, clinical research, sometimes involving these novel interventions, will provide insight and information which can feed back into the laboratory and inform future laboratory studies.
For example at MCRI;
- The Surgical Research Group developed a medical device to treat constipation (T1).
- They originally tested a physiotherapy method to provide electrical stimulation across the abdomen to make the bowel push more and to empty stool out (T2).
- They found that existing stimulation devices were hard for patients to set up and use at home. The Surgical Research team patented the method and then applied for funding to support commercial development of a device specifically for constipation (findings in T2 inform T1 improvement of the device).
- An unmet needs analysis showed a large patient group worldwide and a business plan was developed. Key opinion leaders were contacted in the UK and USA to determine if they would use the device. A start-up company was formed and design and regulatory requirements are underway.
- A prototype will be ready for trials in early 2013 (T2 to T3), with sales expected in 2015 (T4).
Bedside to Population example
Often interventions developed and tested in tightly controlled environments can then be translated into a wider population.
For example at MCRI;
- The Community Child Health Group observed that mothers who reported infant sleep problems had double to triple the odds of developing postnatal depression compared with mothers who reported no infant sleep problems.
- They developed a sleep intervention program and trialled it in a small randomised controlled trial with one person delivering the intervention (efficacy trial).
- The intervention was successful so the group then conducted a large, effectiveness trial (T3), with 92 nurses delivering the intervention. The trial also included a health economics evaluation.
- The intervention was effective and cost-effective so the Victorian government chose this intervention for the 8-month maternal & child health well child visit and has funded state-wide training in it for all 1,200 nurses (T4).