Involving patients in clinical trials

Without clinical trials, patients all over the world wouldn’t be able to benefit from new drugs and treatments. Yet, without patients, there can be no human clinical trials.

Patient recruitment is an ongoing challenge for clinical trial sponsors and CRO’s, yet for decades, a lack of volunteer patients has caused delays and budget increases. The COVID 19 pandemic also caused a drop in the number of trials launched – in the US, for example, only 57% of the expected pre-pandemic number got under way in the first half of 2020. However, out of the pandemic came opportunity for change in the form of increased remote participation. Putting the patient at the heart of trials, too, is a growing trend within the industry so early steps to easier participation have been taken.

It’s still clear, however, that the clinical research industry needs to look at new strategies to get and keep patients on board.

1. Trial design and location.

Taking patient requirements into consideration in terms of where and how the trial is being conducted can very much increase willingness to participate. Will the IP be shipped directly to them? How much in-person interaction will be required throughout? What are the patient requirements specifically based on geography, culture, local healthcare, and therapeutic indications? By building the plan around the patient, participation – and trial success – can become more likely.

2. Global feasibility

Patient insight has traditionally been provided by Principal Investigators. However, these may differ from what patients actually feel. Conducting feasibility activity at trial design and protocol-creation stages will clearly outline all considerations to a patient and enable them to make an informed decision on their participation. A comprehensive feasibility study will help to create an accurate strategy and identify key risks for consideration.

3. Reducing Risk

Patient enrolment and retention should be factored into the risk management plan for each study. Even with the best plans in place, something can always go awry. Mapping out key risk indicators at specific timepoints to measure success throughout a trial is important – as is factoring in a Plan B from the outset.

4. Alignment and Expectation Management

As the song says, no alarms and no surprises. It’s not the easiest task but getting everyone singing off the same hymn sheet – sponsor, CRO, all providers and sites – is crucial to success. Keeping expectations clear is vital, but so is keeping them fluid and flexible as is constant communication of same.

5. Recruit, Engage, Retain

A discrete strategy for getting and keeping patients on board should be created and integrated into the overall trial plan. In this way, the chance of retention is optimised, risks to timelines mitigated.

Each study faces its own challenges, however increased availability of patient data through new platforms and EMR technology is giving CRO’s more opportunity to listen to the voice of patients themselves. If they 

• listen closely 

• design accordingly 

• plan practically

• consider risk carefully

then it should follow that patients will be more willing to participate in research, and successful trials should happen.