Welcome to M.V Hospital for Diabetes, established by late Prof. M.Viswanathan, Doyen of Diabetology in India in 1954 as a general hospital. In 1971 it became a hospital exclusively for Diabetes care. It has, at present,100 beds for the treatment of diabetes and its complications.

Tuesday, November 11, 2014

A New Approach to Clinical Trials

Patients play the role of researchers in drug trials 

Scientists regularly sign up new patients in clinical trials to test new forms of treatment. In a recent trend, they are getting help from patients to help them design some of the treatments!

Patients and researchers can contribute to treating disease as each group perceives a problem from different points of view. For example, in a trial of a potential prostrate cancer drug at Mount Sinai in New York, doctors had planned to ask patients periodically about side effects such as nausea but patient input convinced them to ask additional questions such as how many days they felt good enough to go to work.

Patients have also helped design a trial at the University of Wisconsin where researchers are testing a new strategy to help children with diabetes monitor their disease. A mother of a 10- year old child with diabetes serves on the advisory board for the diabetes trial that is testing a survey tool to identify patient needs and see if adapting interventions to these needs enable patients to control their blood sugar better.

An epilepsy patient has joined a trial as a member of the executive committee and her vote counts the same as that of the researchers when it comes to making a decision. 

Parents of pediatric patients show great concern about the possibility for side effects such as paying attention in school and remembering things when using some drugs and researchers hope to identify the drug with the least cognitive  and behavioural side effects.
In a prostrate cancer trial, researchers say that data suggested that metformin , an anti- diabetes drug, might also slow down the progression of prostrate cancer. In a bid to test whether patient input was useful, they designed a trial, set it up on a web- based platform and invited feedback from patients for 6 weeks. They decided they would consider the process useful if the input led to at least 1 major change in their design or 3 minor changes.  In the end, the trial design incorporated 4 major and 5 minor changes!

Other ways to involve patients is by enlisting them to serve on hospital committee. Some researchers create a dictionary of scientific and technical terms to help patients who are advisors in their studies. 

The new approach represents a dramatic shift in sharing control at the critical stage of designing trials to test new treatments. However some researchers are concerned that patient involvement will not work in every clinical trial as it might slow down the process. 

Pharma companies and researchers who earlier used methods like  public awareness campaigns or monetary  incentives hope that the outreach program helps to  increase the number of patients who participate in clinical trials.  Patients also seem to be the best resource to highlight the relevance of the research and show if it is really meaningful to the end users. 

(Source: The Wall Street Journal)

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