On 2017 Dec 17, Iain Chalmers commented:

We agree with Hilda Bastian that poor recruitment leads to waste in research, and work to reduce barriers and improve recruitment is needed. We point this out in the book we co-authored for the public - Testing Treatments, http://en.testingtreatments.org/book/what-can-we-do-to-improve-tests-of-treatments/regulating-tests-of-treatments-help-or-hindrance/do-regulatory-systems-for-testing-treatments-get-it-right/. We wrote "And for researchers planning clinical trials, it can take several years to get from a trial idea to recruiting the first patient, and even then recruitment to trials can be slowed by regulatory requirements. But while researchers try to get studies through the system, people suffer unnecessarily and lives are being lost."

These same barriers also act to inhibit even considering attempts to undertake trials to address uncertainties. With the result that "clinicians are discouraged from assessing treatments fairly, and instead can continue to prescribe treatments without committing to addressing any uncertainty about them."

As Hilda rightly concludes, "the clinical trial project still has a lot of basic education to do". But informed recruitment to and retention in clinical trials will depend on far greater general knowledge about why it is important to address uncertainties about the effects of treatments, the adverse effects of failing to address uncertainties, and how uncertainties should be addressed. This implies responsibility for the educational challenge being taken up by educators way beyond "the clinical trials project" (see www.informedhealthchoices.org).

On 2017 Dec 02, Hilda Bastian commented:

Another major area of research waste is the high rate of trials abandoned for poor recruitment. Briel M, 2017 suggests that about a quarter of all trials in Switzerland are stopped, generally because of poor recruitment. A study of phase II and III trials closed in 2011 in ClinicalTrials.gov found that 19% "either terminated for failed accrual or completed with less than 85% expected enrolment, seriously compromising their statistical power" (Carlisle B, 2015).

Bower P, 2014 point to the need to develop more effective methods to increase recruitment and retention of participants. That is critical. We still don't know how to prevent all the waste associated with poor recruitment to clinical trials. However, the Swiss study of stakeholders makes it clear that there are serious inadequacies in coordination and preparedness for many trials (Briel M, 2017). The authors point to clear areas of responsibility for funders of trials and others. The NIHR's 70-day rule, a benchmark for time to recruiting the first patient is one example of a funder trying to reduce this area of waste (NIHR).

Briel M, 2017 also point to the contribution public negativity about clinical trials makes to poor recruitment. That is a problem for clinicians as well, and, too often, members of IRBs/research ethics committees. In every direction, the clinical trial project still has a lot of basic education to do.

On 2017 Dec 02, Hilda Bastian commented:

Another major area of research waste is the high rate of trials abandoned for poor recruitment. Briel M, 2017 suggests that about a quarter of all trials in Switzerland are stopped, generally because of poor recruitment. A study of phase II and III trials closed in 2011 in ClinicalTrials.gov found that 19% "either terminated for failed accrual or completed with less than 85% expected enrolment, seriously compromising their statistical power" (Carlisle B, 2015).

Bower P, 2014 point to the need to develop more effective methods to increase recruitment and retention of participants. That is critical. We still don't know how to prevent all the waste associated with poor recruitment to clinical trials. However, the Swiss study of stakeholders makes it clear that there are serious inadequacies in coordination and preparedness for many trials (Briel M, 2017). The authors point to clear areas of responsibility for funders of trials and others. The NIHR's 70-day rule, a benchmark for time to recruiting the first patient is one example of a funder trying to reduce this area of waste (NIHR).

Briel M, 2017 also point to the contribution public negativity about clinical trials makes to poor recruitment. That is a problem for clinicians as well, and, too often, members of IRBs/research ethics committees. In every direction, the clinical trial project still has a lot of basic education to do.

On 2017 Dec 17, Iain Chalmers commented:

We agree with Hilda Bastian that poor recruitment leads to waste in research, and work to reduce barriers and improve recruitment is needed. We point this out in the book we co-authored for the public - Testing Treatments, http://en.testingtreatments.org/book/what-can-we-do-to-improve-tests-of-treatments/regulating-tests-of-treatments-help-or-hindrance/do-regulatory-systems-for-testing-treatments-get-it-right/. We wrote "And for researchers planning clinical trials, it can take several years to get from a trial idea to recruiting the first patient, and even then recruitment to trials can be slowed by regulatory requirements. But while researchers try to get studies through the system, people suffer unnecessarily and lives are being lost."

These same barriers also act to inhibit even considering attempts to undertake trials to address uncertainties. With the result that "clinicians are discouraged from assessing treatments fairly, and instead can continue to prescribe treatments without committing to addressing any uncertainty about them."

As Hilda rightly concludes, "the clinical trial project still has a lot of basic education to do". But informed recruitment to and retention in clinical trials will depend on far greater general knowledge about why it is important to address uncertainties about the effects of treatments, the adverse effects of failing to address uncertainties, and how uncertainties should be addressed. This implies responsibility for the educational challenge being taken up by educators way beyond "the clinical trials project" (see www.informedhealthchoices.org).