Improved information and perceptions shown to be critical for more effective clinical trials in Parkinson’s

In a survey of 291 people connected with Parkinson’s it was shown that although funding was cited as the biggest barrier to those involved in conducting research, for people with Parkinson’s the principal barriers preventing participations were the clarity and availability of information and their perceptions of the clinical trials system as a whole.

Survey Results
The results from the “Rallying to the Challenge” survey found the top five barriers to effective clinical trials as identified by those conducting clinical trials to be funding (66%), administrative support (46%), recruitment of people with Parkinson’s (PwPs) (44%), practical support from other organisations involved in the trial (36%) and time taken for institutional contracting (32%). Over a quarter of those involved in conducting clinical trials also reported the importance of the subject matter of the trial, and problems associated with accurate measurement of results.

The barrier of recruitment was further reflected when PwPs when asked why they might not engage/participate in clinical trials. The results show the top 5 reasons to be the potential of adverse consequences/side effects (58%), the disruption of medication regime (53%), the possibility of being on placebo (39%), the upheaval to life (38%) and not being informed of the progress and results of the trial (34%).

Over 25% of respondents also reported the possibility of not being able to reclaim all the costs incurred through participation, being excluded from future trials and lack of access to understandable information about what the trials involves as other important reasons why they might not participate in clinical trials.

How can we change this situation?
The survey demonstrates the ability for people with Parkinson’s to influence the effectiveness of clinical trials. There is an opportunity for people with Parkinson’s to take a more proactive role, becoming an influential and constructive force in Parkinson’s trials.

At a satellite meeting called “Rallying to the Challenge”, part of the Grand Challenges in Parkinson’s meeting in Grand Rapids Michigan, over 110 people with Parkinson’s will debate the results of the survey focusing on three key areas, Communication, Practicalities and Teamwork with the vision that people with Parkinson’s can add so much value to clinical trials rather than just being participants.

Background Information: Why do clinical trials fail?
The process of medicine development from test-tube to patient can take a decade or more, and is extremely costly to the investing company. These costs can only be recovered and converted to profit in drugs that demonstrate efficacy in phase 3 clinical trials.

Novel therapies are comparatively infrequent and the development of each new medicine is a significant event for the Parkinson's community.

Historically, clinical trials in Parkinson's have a poor success rate, with many drugs failing to show efficacy at phase 3, where the evidence for licensing a drug is assessed by the FDA and other regulators.

The failure of a clinical trial is therefore a major setback to a drug company engaged in drug development for Parkinson's. Failure also has implications for the patient community, depriving them of potentially useful new therapies.

Clinical trials fail for many reasons. Poor study conception, design and execution can be compounded by poor patient compliance, engagement and apathy.

To read more information about the survey follow this link