Protocol Design



Protocol is vitally important to ensuring a standard of care and scientific accuracy in a clinical trial. Without a standard operating procedure, trials are at risk of failing due to incompatible results. Worse, patients are at risk of wasting time, opportunity cost, money, or eligibility for other treatment options.

Even when everything does go according to plan, sometimes the plan itself can be polarizing to patients and cost considerable time and dollars for a sponsor.



Discovering optimal balance between the needs of the patient and the need to collect strong evidence of the efficacy of a new therapy is crucial.

Does your trial require frequent lung biopsy samples? This may make sense from a scientific perspective, but let’s look at it from the patient side. Frequent sampling of lung tissue means recurrent punctures externally or internally, considerable downtime to heal after each sample, or even recurrent exposure to radiation and anesthesia.


Even reducing sampling by a few visits can drastically increase compliance by the participants, and reduce dropout rates.

Conducting a focus group with patients, caregivers, and family members of the target population in the process of designing the trial protocol can help uncover crucial areas to consider. Reviewing the protocol for competing trial options with patients can provide incredible insights on the feasibility of your own design. Improving the overall will not only enhance the reputation of clinical trials, but also support patient enrollment, retention, and ultimately increase cost efficiency.



We would like to believe that all marketing materials, study questions, and email communications are vetted by patients and caregivers. Sadly, that often isn’t the case.

Missteps in language and imagery can range from inconsiderate (images of mono-race patients for a disease that does not discriminate) to downright offensive (language that blames, shames, or miscategorizes its target audience).


At Clara, we are incredibly proud to work with our Breakthrough Crew (a group of diverse, dedicated, and knowledgeable patient advocates) to consult on our website copy, marketing materials, and proposal language.

Patients can be instantly turned off to an opportunity by thoughtless or insulting language and imagery. We exist to empower patients to seek their own therapies and treatments. In doing so, we have pulled in our Breakthrough Crew advocates to consult on our work, ensuring that what we release to the external population is comprehensively vetted.

To read about how a paitient's expereince affects recruitment, Read Ahead