There is an ongoing public consultation by the World Health Organization which aims to update its guidelines on clinical trials.

There are some really good recommendations in the draft guideline and below is my analysis.

Bureaucracy

It is interesting that bureaucracy is pointed as a main issue in conducting research. This is a known issue for all of us working in the industry which is barricaded by standard operating procedures (SOPs) telling people what they need to do at each step. No matter how up to date the SOPs are they cannot cover all situations and all countries globally. Other big challenge is the constantly evolving regulatory guidelines, legislations and processes which need a lot of flexibility. This inevitably creates additional paper work and even non-compliance when companies are not able to follow their own procedures.

Patients Diversity

Patient diversity is a top priority internationally and all countries are looking for recommendations how to include more people in research and give them access to new therapies and medical devices. Interestingly, WHO guideline is encouraging involving more children and pregnant women in research together with older patients, people with disabilities and ethnic minorities. They recommend that children are included in clinical trials for adults to avoid running additional paediatric studies which add more cost to research. This is also an opportunity to extend treatment options to children. However, including children in clinical trials is seen by many companies as additional risk, not to mention that this could complicate the approval process of the clinical trial in terms of dose to be used in paediatric patients, etc. Yet I think this is a positive recommendation that could make a difference to patients.

Informed consent

Participant information sheets (PIS) are known for their length and complexity. I admit to have seen PIS as long as 44 pages. One of the excellent recommendations in the WHO new guideline that the participant information sheet should contain information relevant for the participant and not to the company. This is a big spot on! Current PISs are written in a way that the companies try to disclose as much as possible to cover themselves against any potential issues. Some PISs are even written from a clear legal perspective telling participants what they are rights are and what the sponsor can do without their agreement.

Study Design

There are a few recommendations in terms of study design which were very relevant to everyone working in clinical trials.

1. Inclusive studies – The guideline recommends to make clinical trials more inclusive and consider diverse population to allow the overall data to be relevant and close to real life.

2. Sample size – The guideline recommends larger sample sizes for the clinical trials but also acknowledges that this may not be feasible in rare diseases. This is something that could affect the overall cost of the clinical trials so maybe there should be some balanced approach.

3. Placebo – The guideline recommends the use of placebo in clinical trials. What is interesting is that it also recommends placebo for medical device studies too. This is inspired by research data showing that some procedures are not proven to be better placebo and yet they are widely used in the clinical practice exposing patients to potentially unnecessary interventions.

4. Follow up period – The guideline recommends longer follow up period (sometimes years) to minimise missing data. This is interesting point as it may add costs to the overall already costly clinical trials.

5. Collecting relevant data – The guide stresses on the importance to collect relevant data for the study to avoid unnecessary assessments for the patients and additional burden to the healthcare system.

Monitoring

Another interesting recommendation is to avoid excessive monitoring, auditing and inspection activities to reduce the burden of conducting clinical trials. This is indeed true for many companies in the industry where hospitals are dreading monitoring visits and the inefficacy in managing the studies. I would add that companies should also avoid unnecessary complex set ups and training requirements for the hospitals. Some studies have a huge number of vendors all of them having their own training requirements and expecting hospitals to adapt to their way of working. This makes research a big burden to resource-stretched hospitals.

You can provide feedback to their consultation here

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Published on 25 July 2023